葛蘭素史克 (GSK) 2026 Q2 法說會逐字稿

內容摘要

  1. 摘要
    • Q2 營收成長 5%,達到超過 84 億英鎊,核心營業利益成長 7%,核心 EPS 成長 9%,現金流穩健,Q2 股息為 17 便士。
    • 2026 全年指引上修:銷售與營業利益預期提升至區間上緣,EPS 因 Nuvalent 併購產生額外利息費用,預期落在區間下緣。HIV 與疫苗事業指引上修,GenMed 下修。
    • 市場反應:未特別提及盤後股價或同業對比。
  2. 成長動能 & 風險
    • 成長動能:
      • 專科藥品(Specialty Medicines)與疫苗為主要成長動能,分別成長 14% 與 8%。
      • HIV 長效注射劑(Cabenuva、Apretude)推動 HIV 事業雙位數成長,並持續搶市。
      • 新產品上市(如 Nucala COPD、Exdensur、Blenrep)帶動新一波成長。
      • Nuvalent 併購強化精準腫瘤學布局,Jideytro 已獲批。
      • R&D 加速計畫推動 20+ 項 Phase III 臨床啟動,聚焦高價值腫瘤、呼吸、肝病等領域。
    • 風險:
      • GenMed(一般藥品)銷售下滑 9%,受成熟產品價格壓力與美國 Trelegy 市場需求疲弱影響。
      • Dolutegravir 專利到期(2028-2030)帶來獲利壓力,需靠新產品與成本控管因應。
      • 併購 Nuvalent 增加利息費用,短期 EPS 承壓。
      • 部分新藥進入競爭激烈市場(如 B7-H3/4 ADCs),需證明差異化與商業化能力。
  3. 核心 KPI / 事業群
    • 總營收:Q2 成長 5%,達 84 億英鎊。
    • 核心營業利益:Q2 成長 7%。
    • 核心 EPS:Q2 成長 9%。
    • 現金流:Q2 現金流 43 億英鎊,較去年同期增加 5 億英鎊。
    • Specialty Medicines:Q2 成長 14%。
    • Vaccines:Q2 成長 8%。
    • General Medicines:Q2 下滑 9%。
    • Nucala(COPD):美國新處方成長 69%,國際銷售成長 18%。
    • Cabenuva(HIV):銷售成長 33%,美國新處方 77% 來自競品轉換。
    • Apretude(HIV):銷售成長 39%。
    • Blenrep(多發性骨髓瘤):已在 49 國獲批,德國、西班牙取得給付,英國新病人起始領先。
  4. 財務預測
    • 2026 年營收與營業利益預期提升至區間上緣,EPS 預期落在區間下緣(因併購 Nuvalent 增加約 1.6 億英鎊利息費用)。
    • 2026 年營業利益率預期超過 31%,2028-2030 年間(Dolutegravir LOE 期)維持穩定或改善(28-30%)。
    • 加速成長計畫(Accelerate Growth Program)預計至 2029 年每年節省 19 億英鎊成本,需一次性支出 24 億英鎊(其中 21 億為現金),大部分節省將再投資於 R&D。
  5. 法人 Q&A
    • Q: 加速成長計畫的成本節省是否會推升 2031 年後的營業利益率?
      A: 2026 年營業利益率目標超過 31%,Dolutegravir LOE 期間(28-30%)將維持穩定或改善,部分節省將反映在利潤率提升。
    • Q: 加速資產決策的標準為何?Nuvalent 資產是否屬於加速範圍?
      A: 加速資產以數據為基礎,聚焦已驗證標的、潛在 blockbuster 機會與資源配置效率。Nuvalent 資產因交易時程與進度未納入首波加速,但未來若可加速會考慮。
    • Q: Cabotegravir(HIV 長效注射劑)專利保護策略與營收假設?
      A: 現有專利保護至 2031 年,6 次/年劑型已延長至 2040 年,3 次/年劑型專利申請中(至 2047 年)。財測以最早到期日為基礎,未來若獲延長將調整。
    • Q: GenMed 指引下修主因?CMS 協議有無負面影響?
      A: GenMed 受成熟產品價格壓力與美國 Trelegy 放棄率上升影響,CMS 協議未有重大負面驚喜,預期下半年情況改善。
    • Q: Shingrix MACE(心血管事件)研究目標為何?若獲標籤擴充對價格有何影響?
      A: 目標取得標籤擴充,已與監管機構討論,若成功將提升醫師推薦意願與接種率,並有助於價格提升。

完整原文

使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good afternoon, and welcome to this GSK Q2 Results and Accelerate Growth Event. Today, we look forward to having a good event. And if we could have the agenda slide on the screen, please. Just a few words on logistics before I hand over to Luke.

    各位下午好,歡迎參加本次 GSK 2026 年第二季業績與加速成長活動。今天,我們期待與各位共同度過一場精彩的活動。也請將議程投影片顯示在螢幕上,謝謝。在我把時間交給 Luke 之前,先簡單說明幾點會議安排。

  • The first thing is that we have a Q&A session for you planned at 2:45 and another one then at 4:20. After the first Q&A, you will have a short break, and the event is planned to end around 5:00 PM.

    首先,我們為各位安排了兩場問答環節:一場在 2:45,另一場在 4:20。第一場問答之後會有短暫休息,活動預計在下午 5:00 左右結束。

  • Next slide, please. Also note the legal disclaimer on our cautionary statement regarding forward-looking statements. And I would like to add that any definitions in terms of our reporting as well as assumptions on accelerated growth can be found at the end of this deck.

    請看下一張投影片。也請注意我們關於前瞻性陳述的警示聲明中的法律免責聲明。另外補充說明:任何與我們報告口徑相關的定義,以及對加速成長的假設,都可在本簡報最後找到。

  • Lastly, if we comment on performance, any of these comments will be made at constant currency or CER, unless otherwise stated.

    最後,若我們評論業績表現,除非另有說明,所有評論將以固定匯率或 CER(固定匯率)為基礎。

  • And with this, I'm delighted to hand over to Luke.

    那麼,我很高興把時間交給 Luke。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Thank you. Welcome, everyone, and thanks for investing your time here to join us in person at the London Stock Exchange and on the webcast. If anyone wants photos of the South Cambridge Railway Station, which is a lovely orange color, Mick Readey has them, so we can send them to you after.

    謝謝。歡迎各位,也感謝大家撥冗親臨倫敦證券交易所現場並透過網路直播參與。如果有人想看南劍橋火車站的照片——那是一個很漂亮的橘色——Mick Readey 那裡有,我們之後可以寄給各位。

  • Seriously, today is in two parts. The first, we'll give you an overview of our Q2 results. Then we'll move to what is the primary focus of today, which is GSK products and our plan to grow the business and how we'll create value for both patients and shareholders.

    認真說,今天的內容分為兩個部分。第一部分,我們會先概述第二季業績。接著進入今天的主要重點:GSK 的產品與我們推動業務成長的計畫,以及我們將如何為病患與股東創造價值。

  • So first, I'll cover the results we announced today quickly. So Q2 performance was strong. We've got continued operational momentum with sales up 5% to more than GBP8.4 billion. Core operating profit grew 7% and core earnings per share were up 9%. Our cash generation remains very positive at GBP4.3 billion, and our Q2 dividend is 17p. And we're on track in terms of our responsible business rating.

    首先,我會快速回顧我們今天公布的業績。第二季表現強勁。我們的營運動能持續,銷售額成長 5%,超過 84 億英鎊。核心營業利益成長 7%,核心每股盈餘成長 9%。現金創造仍非常正面,達 43 億英鎊;第二季股利為 17 便士。此外,我們在負責任企業評等方面也按計畫推進。

  • In July, we also closed the acquisition of Nuvalent. Nuvalent is a precision oncology company closely aligned to our approach to Vd. And I'm delighted to say that this acquisition has already contributed to our portfolio with the approval of Jideytro, an pretreated ROS1 positive non-small lung cancer just last week.

    7 月,我們也完成了對 Nuvalent 的收購。Nuvalent 是一家精準腫瘤公司,與我們在 Vd 方面的方法高度一致。我也很高興地表示,這項收購已為我們的產品組合帶來貢獻:就在上週,Jideytro 獲得核准,用於既往治療後的 ROS1 陽性非小細胞肺癌。

  • Looking forward, we are updating our full year 2026 guidance with sales and operating profit now towards the upper half of the range with EPS now expected in the lower half of the range following the acquisition of Nuvalent.

    展望未來,我們更新 2026 全年指引:目前預期銷售與營業利益將落在區間的上半部;在完成 Nuvalent 收購後,每股盈餘(EPS)則預期落在區間的下半部。

  • I'll now hand over to Nina, who is going to summarize how we're delivering this growth and she'll also take you through some color on Nucala and COPD, Exdensur and Blenrep.

    接下來我把時間交給 Nina。她將總結我們如何實現這些成長,並進一步說明 Nucala 與 COPD、Exdensur 以及 Blenrep 的最新進展。

  • Nina Mojas - President - Global Product Strategy

    Nina Mojas - President - Global Product Strategy

  • Thank you, Luke. Hi, everyone. So commercial momentum continued in the second quarter, driven by key products across our specialty and vaccines portfolio. Growth was driven by Specialty Medicines, which grew 14% and vaccines, which grew 8%. Vaccines growth benefited from the global expansion of Arexvy, our RSV vaccine, strong performance from our meningitis vaccines and Shingrix in Europe. Specifically, Arexvy benefited from a tender win for a two-year supply in Australia.

    謝謝你,Luke。各位好。第二季商業動能持續,由我們專科與疫苗產品組合中的關鍵產品所帶動。成長主要來自專科藥品(成長 14%)以及疫苗(成長 8%)。疫苗成長受惠於 Arexvy(我們的 RSV 疫苗)的全球擴張、腦膜炎疫苗的強勁表現,以及 Shingrix 在歐洲的表現。其中,Arexvy 受惠於在澳洲贏得一項為期兩年的供應標案。

  • Specialty growth was driven by Nucala's continued COPD launch and our long-acting HIV treatment, Cabenuva as well as Dovato. General Medicines was down 9% in the quarter with declining sales of the older established portfolio. Also, there was a challenging pricing comparator for Trelegy in the US due to a positive true-up that took place in the second quarter last year, also softer inhaled respiratory market demand, both of which we expect to improve in the second half of this year.

    專科藥品的成長來自 Nucala 持續推進的 COPD 上市,以及我們的長效 HIV 治療 Cabenuva,還有 Dovato。一般藥品第二季下滑 9%,主要因較舊、既有產品組合的銷售下降。此外,美國 Trelegy 的價格比較基期也較具挑戰性,原因是去年第二季有一次正向的追溯調整(true-up);同時吸入式呼吸道市場需求較疲弱。我們預期這兩項因素在今年下半年都會改善。

  • As Luke mentioned, we are focused on the products that drive the most value, including new launches and growth contributors.

    如 Luke 所提到的,我們聚焦於能創造最大價值的產品,包括新上市產品與成長貢獻者。

  • Next slide, please. Here, we have pulled out the three major launches of 2026. Starting with Nucala. We once again had strong global growth driven by the COPD launch and its halo effect on the other indications. In the US, new-to-brand prescriptions were up 69%, with COPD driving more than 70% of the growth. Internationally, sales were up 18%, primarily driven by our success in China, where Nucala gained majority share of bio-naive patients in COPD and already has NRDL listing in severe asthma and nasal polyps.

    請看下一張投影片。這裡我們整理出 2026 年三項主要上市產品。先從 Nucala 開始。我們再次實現強勁的全球成長,主要由 COPD 上市帶動,並對其他適應症產生光環效應。在美國,新轉換至本品牌(new-to-brand)的處方量成長 69%,其中 COPD 貢獻超過 70% 的成長。在國際市場,銷售成長 18%,主要由我們在中國的成功所帶動;Nucala 在 COPD 的生物製劑初治(bio-naive)病患中取得過半市占,且已在重度氣喘與鼻息肉適應症納入國家醫保目錄(NRDL)。

  • We are also continuing with the launch of Exdensur, our twice yearly IL-5 for severe asthma. The J-code went live on July 1, reducing the logistical burden on prescribers and providing certainty on reimbursement. We are continuing to build access and coverage with more than 50% of insured patients now being covered. The majority of new patients are coming from the bio-naive population, which we expect will continue as around 70% of patients who could be on a biologic for severe asthma still are not.

    我們也持續推進 Exdensur 的上市,這是我們用於重度氣喘、每年給藥兩次的 IL-5 產品。J-code 已於 7 月 1 日生效,降低開立處方醫師的物流負擔,並提升給付報銷的確定性。我們持續擴大可近性與給付覆蓋,目前已有超過 50% 的投保病患獲得覆蓋。多數新病患來自生物製劑初治族群;我們預期此趨勢將持續,因為在可能適用重度氣喘生物製劑治療的病患中,仍約有 70% 尚未使用。

  • And finally, Blenrep, our community-ready antibody drug conjugate for multiple myeloma is building in line with our expectations. We now have approval in 49 countries. And recently, we have gained reimbursement for Germany and Spain. In the UK, that's the country where Blenrep launched first, we are seeing a shift in second-line treatment, as shown in this very nice chart provided directly by NICE, with Blenrep now leading in new patient starts. In the US, we are receiving positive feedback from physicians with strong intent to continue use.

    最後是 Blenrep。我們這款可在社區端使用的多發性骨髓瘤抗體藥物複合體(ADC),其進展符合我們的預期。目前已在 49 個國家獲得核准。近期也在德國與西班牙取得給付報銷。在英國——Blenrep 最早上市的國家——我們看到二線治療出現轉移;如 NICE 直接提供的這張非常好的圖表所示,Blenrep 目前在新病患起始治療中已居領先。在美國,我們收到醫師的正面回饋,且持續使用的意願強勁。

  • As we've said before, our approach is to go slow to ensure positive experience, helped by the J-code, which is now in effect for Blenrep as well. As we enter the second half of the year, we will continue to focus on unlocking the community opportunity where the majority of the patients are.

    如同我們先前所說,我們的策略是放慢步調,以確保正向的使用體驗;這也受惠於 J-code,而該 J-code 現在也已適用於 Blenrep。進入下半年後,我們將持續聚焦於釋放社區端的機會,因為多數病患都在社區端接受治療。

  • And with that, I will hand over to Deborah.

    接下來,我把時間交給 Deborah。

  • Deborah Waterhouse - Chief Executive Officer - ViiV Healthcare and President - GSK Global Health

    Deborah Waterhouse - Chief Executive Officer - ViiV Healthcare and President - GSK Global Health

  • Thanks, Nina. I'm delighted to report another quarter of double-digit sales growth at 10%, reflecting continued execution of our strategy and sustained market growth for our long-acting injectable portfolio, which in Q2 represented 80% of our total HIV growth.

    謝謝你,Nina。我很高興報告本季再度實現兩位數的銷售成長,達 10%。這反映我們策略的持續落實,以及長效注射劑產品組合所在市場的持續成長;第二季長效注射劑占我們 HIV 總成長的 80%。

  • In the US, we accelerated our market share growth, continuing to outpace the competition with sales growing 14%. Long-acting injectables contributed 35% of sales, underscoring strong execution in a competitive market and increased demand for our HIV medicines.

    在美國,我們加速市占成長,銷售成長 14%,持續領先競爭對手。長效注射劑貢獻了 35% 的銷售額,凸顯我們在競爭激烈市場中的強勁執行力,以及市場對我們 HIV 藥物需求的提升。

  • Cabenuva continued to convert patient preference into sustained growth with sales plus 33%. This performance was fueled by patient demand. And in the US, 77% of new prescriptions came from competitor products, reflecting increasing confidence among both health care providers and people living with HIV and the benefits of long-acting treatment.

    Cabenuva 持續將病患偏好轉化為可持續的成長,銷售成長 33%。此一表現主要由病患需求所驅動。在美國,77% 的新處方來自競品的轉換,反映醫療照護提供者與 HIV 感染者對長效治療益處的信心日益提升。

  • Apretude sales increased 39%, supported by more than four years of real-world evidence and tolerability data. At AIDS 2026, six-month follow-up clarity data further reinforced a more favorable injection experience versus lenacapavir after a single dose of each drug with 70% of participants rating CAB as very or totally acceptable compared with 37% for LEN.

    Apretude 銷售成長 39%,受惠於超過四年的真實世界證據與耐受性資料支持。在 AIDS 2026,大會公布的六個月追蹤明確性資料,進一步強化相較於 lenacapavir,在各藥物各施打一劑後,注射體驗更為有利;其中 70% 的受試者將 CAB 評為「非常可接受」或「完全可接受」,相較之下 LEN 為 37%。

  • In addition, fewer HCPs reported challenges with administration and patient management. Given our continued growth momentum, we are raising our 2026 sales growth guidance to high single-digit growth from mid- to high single-digit growth.

    此外,回報在施打與病患管理方面遇到挑戰的醫療照護專業人員(HCP)更少。鑑於我們持續的成長動能,我們將 2026 年銷售成長指引由「中至高個位數成長」上調至「高個位數成長」。

  • I'll now hand over to Julie.

    接下來我把時間交給 Julie。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Thank you, Deborah. And I will now cover financial performance. So turning to the next slide. Starting with the core income statement for the quarter with all commentary at CER. Sales grew 5% and gross margin improved 250 basis points due to product mix benefits driven by the growth of specialty and vaccines, together with supply chain optimization charges that we took in Q2 last year.

    謝謝你,Deborah。接下來我將說明財務表現。請看下一張投影片。先從本季核心損益表開始,所有評論皆以固定匯率(CER)呈現。銷售成長 5%,毛利率提升 250 個基點,主要受惠於產品組合改善(由專科與疫苗成長所帶動),以及我們在去年第二季認列的供應鏈最佳化費用。

  • SG&A grew 5%, driven by launch investments and phasing compared with the prior period, partially offset by continued productivity gains. R&D growth in double digits continues to be driven by accelerated investment in the pipeline with three Phase IIIs initiated across specialty in half one. And the royalties decline simply reflects the RSV IP settlement that we received last year.

    SG&A 成長 5%,主要由上市投資與相較前期的費用時點分配所驅動,部分被持續的生產力提升所抵銷。研發(R&D)以雙位數成長,持續反映我們加速投資研發管線;上半年在專科領域啟動了三項第三期(Phase III)試驗。權利金下滑則單純反映去年我們收到的 RSV 智財(IP)和解款項。

  • Operating profit grew 7% and EPS 9%, benefiting from a lower tax rate of 17.9% and the benefits of the share buyback. And then turning to the total P&L. Results were impacted by the impairment of Camlipixant following the recent CALM-2 readout.

    營業利益成長 7%,每股盈餘(EPS)成長 9%,受惠於 17.9% 的較低稅率以及庫藏股回購的效益。接著看整體損益表(P&L)。近期 CALM-2 試驗結果公布後,Camlipixant 的減損影響了本期結果。

  • Now turning to the first half cash flow. CGFO was GBP4.3 billion, up GBP0.5 billion versus last year, driven by operating profit, receivables and the CureVac settlement income. Free cash flow improved by GBP1 billion with around half driven by the business and around half driven by one-off cash receipts relating to linerixibat and ViiV.

    接著看上半年現金流。營運活動現金流(CGFO)為 43 億英鎊,較去年增加 5 億英鎊,主要由營業利益、應收款項以及 CureVac 和解收入所帶動。自由現金流增加 10 億英鎊,其中約一半來自本業,約一半來自與 linerixibat 與 ViiV 相關的一次性現金收款。

  • On July 15, we completed the acquisition of Nuvalent at a net cost of GBP7.1 billion, increasing net debt to GBP22 billion, just under 2 times net debt to 2025 core EBITDA. And the share buyback is now complete with an average price of GBP16.13 over the 18 months.

    7 月 15 日,我們完成對 Nuvalent 的收購,淨成本為 71 億英鎊,使淨負債增加至 220 億英鎊;淨負債對 2025 年核心 EBITDA 的倍數略低於 2 倍。此外,庫藏股回購已完成,18 個月期間的平均回購價格為 16.13 英鎊。

  • Now turning to guidance. I will now cover 2026. And at the end of the event, I will cover the longer-term outlooks. So following the strong start to the year, we are pleased to be updating our sales and operating profit guidance towards the upper half of the range.

    接著談指引。我先說明 2026 年。在活動結束時,我會再說明較長期的展望。在今年強勁開局之後,我們很高興將銷售與營業利益指引更新至區間的上半部。

  • Sales by product area has been modified with HIV and vaccines expectations improving to reflect the strong performance of Cabenuva and also Shingrix, respectively. GenMed is downgraded to reflect the tough environment together with generic competition.

    按產品領域的銷售預期已做調整:HIV 與疫苗的預期上修,分別反映 Cabenuva 與 Shingrix 的強勁表現。GenMed 則下修,以反映艱困的環境以及學名藥競爭。

  • Operating profit reflects the underlying strong business performance and is now expected to be in the upper half of the range with reduced SG&A and improved royalties, partially offset by increased R&D investments. EPS is now expected to be in the lower half of the range, and this is predominantly due to the additional interest of around GBP160 million following the acquisition of Nuvalent.

    營業利益反映本業強勁表現,現預期將落在區間上半部;SG&A 降低與權利金改善部分抵銷了研發投資增加的影響。EPS 現預期落在區間下半部,主要原因是收購 Nuvalent 後新增約 1.6 億英鎊的利息費用。

  • Now to support your modeling with respect to phasing, we expect operating profit growth to be significantly Q4 weighted. And a number of factors lead to this, including productivity charges taken in Q4 last year, whilst Q3 is impacted by the consolidation and phasing of Nuvalent costs and the acquisition-related interest together with a tough tax comparator.

    為協助各位在時點分配(phasing)上的模型假設,我們預期營業利益成長將明顯偏重第四季(Q4)。造成此情況的因素包括:去年第四季認列的生產力相關費用;而第三季(Q3)則受到 Nuvalent 成本併表與費用時點分配、收購相關利息,以及較具挑戰的稅率比較基期所影響。

  • Thanks. And with that, I will hand back to Luke.

    謝謝。接下來我把時間交回 Luke。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Thanks, Julie. All right. So coming back to the agenda, we'll now move to the accelerate portion of our event. As a reminder, we have allocated time for your questions halfway through and then again at the end of the presentations.

    謝謝,Julie。好的。回到議程,我們現在進入本次活動的「加速(accelerate)」部分。提醒各位,我們在中場以及簡報結束時都安排了提問時間。

  • Now at the start, I mentioned before that the focus of today is about products and growth. And we'd now like to take -- like to take you through our plan to do this. So first, we'll give you more details on our products and why we're confident in our ability to grow the business. And then second, we're going to update you on how our late-stage pipeline is evolving. We're also going to talk about what we're doing to accelerate and expand our key late-stage assets as well as working hard to improve our ability to find and develop new competitive products.

    一開始我提到,今天的重點在於產品與成長。接下來我們想帶各位了解我們的計畫。首先,我們會提供更多產品細節,以及為何我們對業務成長能力充滿信心。第二,我們將更新後期研發管線的演進情況。我們也會談到如何加速並擴大關鍵後期資產,同時努力提升我們尋找並開發具競爭力新產品的能力。

  • And then finally, we'll update you on how we are funding all of this. And essentially, we will be reallocating capital and resources in a disciplined way to focus on what creates value. And hopefully, at the end, you'll have the same confidence that the team and I have in our plan and our ability to execute it.

    最後,我們會更新我們如何為這一切提供資金。本質上,我們將以嚴謹自律的方式重新配置資本與資源,聚焦於能創造價值的事項。希望在最後,各位能與我和團隊一樣,對我們的計畫以及執行能力抱持同樣的信心。

  • Next slide, please. So what do we think our business is going to look like over time. Over the last few years, we have delivered considerable strong growth with commercial execution, and we will work very hard to maintain that growth in the near term, while we invest in the late-stage pipeline. In the midterm, we've identified key growth drivers. We think those growth drivers will compensate for the loss of dolutegravir exclusivity and allow us to push through this transition period that I'm talking about.

    請看下一張投影片。那麼,我們認為隨著時間推移,我們的業務會呈現什麼樣貌?過去幾年,我們透過商業執行交出相當強勁的成長;在投資後期研發管線的同時,我們也會非常努力在短期內維持這樣的成長。在中期,我們已辨識出關鍵成長驅動因素。我們認為這些成長動能將彌補 dolutegravir 專利獨占到期的影響,並協助我們度過我所提到的轉換期。

  • In the longer term, the changes we're making now to how we operate will accelerate the next wave of products to continue delivering top line growth. And finally, we remain very, very active in terms of BD. And here, we're looking for increment growth opportunities that make strategic sense for GSK.

    長期而言,我們現在對營運方式所做的改變,將加速下一波產品推出,持續帶動營收成長。最後,我們在商務開發(BD)方面仍然非常、非常積極。在這裡,我們尋找能為 GSK 帶來增量成長、且在策略上合理的機會。

  • Next slide, please. So the biopharma business, our biopharma business has changed over the last 10 years. Here you can see that operational execution has driven a move from being a company that was highly reliant on a genericizing business of largely primary care products and commoditized vaccines to a growth-orientated company with a broad mix of innovative products.

    請看下一張投影片。生物製藥事業——我們的生物製藥事業——在過去 10 年已經改變。在這裡你可以看到,營運執行推動我們從一家高度依賴逐漸學名化的業務(以基層醫療產品與商品化疫苗為主)的公司,轉型為一家以成長為導向、擁有多元創新產品組合的公司。

  • And if we look at where we aim to be in 2021 and beyond, on the right-hand side of this slide, GSK will continue to evolve to be more specialty focused. And that means a much larger proportion of our sales coming from oncology, respiratory and hepatology, supported by a differentiated long-acting HIV portfolio.

    如果我們看向 2021 年及之後我們希望達到的樣貌,在這張投影片右側,GSK 將持續演進為更聚焦專科的公司。這意味著我們銷售中將有更大比例來自腫瘤、呼吸與肝病領域,並由具差異化的長效型 HIV 產品組合所支撐。

  • Now, right now, our portfolio is built around five core therapy areas. So today, our team will engage with you about the promising potential we see in each of these areas. And these are the five areas we're investing in. This is where we are focused. And whether they're walking into a lab, a manufacturing site, one of our offices or meeting our customers, every single one of our people needs to know how their role helps us deliver on these five priority areas.

    目前,我們的產品組合建立在五大核心治療領域之上。因此今天,我們的團隊將與各位交流我們在這些領域所看到的可觀潛力。這就是我們投資的五大領域。這也是我們聚焦的方向。無論是走進實驗室、製造基地、我們的辦公室,或是拜訪客戶,我們每一位同仁都必須清楚自己的角色如何協助我們在這五大優先領域交付成果。

  • Because in our business and certainly with this audience, you'll understand this, a company's valuation is based on products and the core ability of management to recognize and deliver competitive innovation. And to do that, senior managers have got to be close to the products and the people leading the project teams. So we've taken material steps with the late-stage portfolio, BD and advancing our early stage to ensure that we are evolving to do just that.

    因為在我們的業務中,尤其面對在座各位這樣的受眾,你們會理解,一家公司的估值取決於產品,以及管理層辨識並交付具競爭力創新的核心能力。而要做到這一點,高階管理者必須貼近產品,以及帶領專案團隊的人員。因此,我們已針對後期產品組合、商務拓展(BD),以及推進早期階段等方面採取了實質性措施,以確保我們持續演進,做到上述目標。

  • Now, I'll cover the mid and early parts of this slide shortly, but starting with the late stage on the top left-hand side. Every two weeks, a subset of the Executive Committee. So Tony and Nina as well as Regis. Regis you're there. I don't think many people know you, Regis, so that's Regis there. And Mondher, who everyone knows, Mondher Mahjoubi, who everyone knows, who's on holidays right now.

    我稍後會簡要說明這張投影片的中期與早期部分,但先從左上角的後期階段開始。每兩週,執行委員會的一個小組會聚在一起。也就是 Tony、Nina,以及 Regis。Regis,你在那裡。我想很多人不認識你,Regis,所以那位就是 Regis。還有大家都認識的 Mondher——Mondher Mahjoubi,大家都認識——他現在正在休假。

  • So we meet to look at the progress of our late-stage portfolio and selected assets every two weeks. These meetings are led by the product teams, the people running the projects. And this allows us to delayer the organization and it promotes accountability. And the aim is to keep us all on top of the internal, but also critically the external factors that influence our success.

    因此,我們每兩週會開會檢視後期產品組合與部分選定資產的進展。這些會議由產品團隊、也就是負責專案運作的人來主導。這讓我們能夠精簡組織層級,並促進問責。目標是讓我們所有人不僅掌握內部情況,更重要的是掌握影響我們成功的外部因素。

  • Now, since these reviews were started in January, we have identified acceleration opportunities across 7 assets, 18 indications and 25 studies. And you'll learn more about all of this today. Now as a result of these efforts by our team, we have over 20 Phase III starts this year. And that is more than double the expectations that we set out at the start of the year when we committed to 10.

    自從今年 1 月啟動這些檢視以來,我們已在 7 項資產、18 個適應症與 25 項研究中識別出加速機會。你們今天會進一步了解這些內容。而在團隊這些努力之下,我們今年啟動了超過 20 項第三期(Phase III)試驗。這比我們年初承諾的 10 項、也就是當時設定的預期,增加了兩倍以上。

  • You can see on the right-hand side of this slide that there is a good spread across our therapy areas. And you can also see the increasing importance of oncology. These Phase III trials are based on validated data with strong medicine profiles. And each opportunity has been thoroughly interrogated as part of the strategic portfolio reviewing process and in order to give us the confidence to invest right now.

    你們可以在投影片右側看到,我們在各治療領域的分布相當均衡。也能看到腫瘤領域的重要性日益提升。這些第三期試驗是建立在已驗證的數據與強勁的藥物特性之上。每一個機會都已在策略性產品組合審查流程中被徹底檢視,以便讓我們有信心在此刻投入資源。

  • This is a busy slide, but I love it. I think this slide does a good job of showing you how these elements come together in terms of the late-stage portfolio, the momentum that we have and the bolus that we've built up in Phase III starts. There will be attrition after we are talking about drug development, but that's why we have a broad portfolio. And our portfolio really is a set of assets that we are confident that is competitive and that can drive growth.

    這張投影片資訊很多,但我很喜歡。我認為它很好地呈現了這些要素如何在後期產品組合、我們所具備的動能,以及我們在第三期啟動數量上累積的「量能」方面相互結合。藥物研發一定會有淘汰率,但這正是我們需要廣泛產品組合的原因。而我們的產品組合確實是一組我們有信心具備競爭力、並能推動成長的資產。

  • For the mid-stage portfolio, we will continue to supplement our pipeline with business development, and we'll focus on products that address a validated target and where there is an efficacy or tolerability gap. So far this year, we have executed three deals. Looking at this list, we missed with Bellus and Camlipixant in cough, but we've just got approval with Jideytro in lung. And overall, the majority of assets we've acquired with these deals have progressed to Phase III.

    在中期產品組合方面,我們將持續透過商務拓展來補強研發管線,並聚焦於能對應已驗證標的、且在療效或耐受性上存在缺口的產品。截至今年目前為止,我們已完成三筆交易。從這份清單來看,我們在咳嗽領域的 Bellus 與 Camlipixant 沒有成功,但我們剛在肺部領域的 Jideytro 取得核准。整體而言,我們透過這些交易取得的大多數資產都已推進至第三期。

  • Next slide, please. In the early stage, we need to improve our output. And we've got to keep evolving how we work and who we work with. And I mean, this slide shows we're putting our money where our mouth is. This is why we're closing Stevenage and moving our people up to Cambridge.

    下一張投影片,謝謝。在早期階段,我們需要提升產出。我們也必須持續演進我們的工作方式,以及合作對象。我的意思是,這張投影片顯示我們言行一致、把資源投入到我們所說的方向。這就是為什麼我們要關閉 Stevenage,並把人員遷移到 Cambridge。

  • I mean, having lived in Cambridge and worked at one of the places listed up there, I know the power of relocating to this environment, and it is designed to help Tony and his team drive change and to make us fundamentally better at discovering and developing new drugs. And Tony is going to take you through this in depth shortly.

    我曾在 Cambridge 生活,也曾在上面列出的其中一個機構工作過,我了解搬到這樣的環境所帶來的力量;這項安排旨在協助 Tony 和他的團隊推動變革,讓我們在新藥發現與開發方面從根本上變得更強。Tony 很快會帶各位深入說明。

  • So how are we making all of this happen and how are we paying for it? To realize the opportunities in the late-stage portfolio and R&D, we have announced today an accelerate growth program. This program is about reallocation within our existing P&L to fund these studies and labs. This is a three-year program that will enable us to increase investment in R&D by targeting annual cost savings of GBP1.9 billion by 2029. To do that, we will incur an expected onetime cost of GBP2.4 billion, which will be GBP2.1 billion in cash.

    那麼,我們要如何讓這一切發生,又要如何為此買單?為了實現後期產品組合與研發(R&D)的機會,我們今天宣布一項加速成長計畫。這項計畫的核心,是在既有損益表(P&L)內部重新配置資源,以資助這些研究與實驗室。這是一項為期三年的計畫,透過在 2029 年前達成每年 19 億英鎊的成本節省,讓我們得以增加對研發的投資。為此,我們預計將產生一次性成本 24 億英鎊,其中 21 億英鎊為現金支出。

  • The majority of these savings we were making will be reallocated to the late-stage pipeline and some of that money will also go towards strengthening the margin through the dolutegravir loss of exclusivity period between 2028 and '30. Now this is fundamental to our strategy. We plan to evolve the company's cost base in line with its shifting product portfolio and to accelerate -- to deliver accelerated long-term growth and value to both patients and our shareholders.

    我們所節省的大部分成本將重新配置到後期研發管線;其中一部分資金也將用於在 2028 至 2030 年 dolutegravir 失去專利獨占期(LOE)的期間,強化利潤率。這是我們策略的根本。我們計畫讓公司的成本基礎隨著產品組合的轉移而演進,並加速——為病患與股東帶來加速的長期成長與價值。

  • Next slide, thanks. Finally, this is how we see the late-stage portfolio. As you can see, the portfolio will evolve over time, accelerating growth to drive long-term value for patients and shareholders.

    下一張投影片,謝謝。最後,這就是我們對後期產品組合的看法。如各位所見,產品組合將隨時間演進,加速成長,以為病患與股東創造長期價值。

  • Now with that, let's get into the nuts and bolts of how we're going to make this happen as a team. And to get that started, it gives me enormous pleasure to hand over to Tony. Tony?

    接下來,讓我們進入團隊要如何把這件事做成的具體細節。為了開始這一段,我非常高興把時間交給 Tony。Tony?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Hi, everyone. Delighted to be here with you, and thanks, Luke. As Luke highlighted earlier, accelerating R&D is a key priority for us, and this means focusing on three important areas: maximizing the value of the late-stage portfolio, supplementing that portfolio through business development and of course, accelerating the progress we've been making in changing the way we work in R&D.

    各位好。很高興與各位在此相聚,也謝謝你,Luke。正如 Luke 先前強調的,加速研發是我們的關鍵優先事項,這意味著聚焦三個重要領域:最大化後期產品組合的價值、透過商務拓展補強該產品組合,當然還包括加速我們在改變研發工作方式方面已取得的進展。

  • I'm pleased with the progress we've already made. Starting on the left-hand side of this slide, you can see the value of our pipeline is increasing. In fact, we've more than doubled the number of Phase II and Phase III assets with blockbuster potential since 2022. Our pipeline is also moving 25% faster, meaning we're now in the upper quartile of our peers based on recent CMR benchmarks. We expect this trend to continue to improve.

    我對我們已經取得的進展感到滿意。從這張投影片左側開始,你們可以看到我們的研發管線價值正在提升。事實上,自 2022 年以來,我們具備重磅潛力(blockbuster potential)的第二期與第三期資產數量已增加一倍以上。我們的研發管線推進速度也快了 25%,這表示依據近期 CMR 基準衡量,我們目前位於同業的前四分位。我們預期這個趨勢將持續改善。

  • Together, this means we can do more. And as you can see, we significantly increased the number of Phase III starts this year compared to the past. 2026 will be a bolus year for Phase III starts based on our acceleration decisions, which I'll cover in more detail in a moment. Much of this has been achieved through our use of data and technology. It enables faster decision-making with greater confidence, something we continue to embed in all aspects of R&D.

    綜合而言,這代表我們能做得更多。如各位所見,相較於過去,我們今年大幅提高了第三期啟動數量。基於我們的加速決策,2026 年將是第三期啟動的「量能」年度;我稍後會更詳細說明。其中很大一部分成果來自我們對數據與科技的運用。這讓我們能以更高的信心更快做出決策,而這也是我們持續在研發各個面向中深化落實的能力。

  • As Luke mentioned, we're taking a new approach to reviewing the portfolio. And this means experts from project teams present directly to myself, Luke and Nina, so we can make quick decisions, resolve issues promptly and provide support to advance exciting programs. The approach ensures we have the right alignment across R&D, commercial and medical to make the most informed decisions possible. It's fully cross-functional, data-driven and has already allowed us to confidently make a number of acceleration decisions, which you can see on the right-hand side of this slide.

    如 Luke 所提到的,我們正在採用一種新的方式來審視產品組合。這意味著由專案團隊的專家直接向我、Luke 與 Nina 報告,讓我們能快速做決策、及時解決問題,並提供支持以推進令人振奮的計畫。這種做法確保研發、商業與醫學部門之間具備正確的一致性,以做出盡可能最充分知情的決策。它是完全跨職能、以數據驅動的,並且已讓我們能有信心地做出多項加速決策,你們可以在這張投影片右側看到。

  • These are the assets and programs you'll be hearing more about today, so you can understand why we're excited about them based on their differentiation and potential benefit to patients. In oncology, our ADC portfolio has been significantly accelerated. This is supported by data from our partner, Hansoh as well as our own global clinical program.

    這些是您今天將會聽到更多內容的資產與計畫,讓您能理解我們為何因其差異化與對病患的潛在效益而感到振奮。在腫瘤領域,我們的 ADC 產品組合已大幅加速推進。這得益於我們合作夥伴漢森(Hansoh)的數據,以及我們自身的全球臨床計畫所支持。

  • Our decision to accelerate five Phase III studies for Mo-rez in gynecological tumors and four for Ris-rez in lung and prostate cancer demonstrates our confidence in these assets. In respiratory, we'll start six Phase III -- sorry, Phase III trials across indications for our ultra-long-acting TSLP GSK'283. This is a significant acceleration of its development path.

    我們決定加速 Mo-rez 在婦科腫瘤的五項第三期研究,以及 Ris-rez 在肺癌與前列腺癌的四項第三期研究,展現了我們對這些資產的信心。在呼吸領域,我們將啟動六項第三期——抱歉,是第三期試驗——涵蓋多個適應症,用於我們的超長效 TSLP GSK'283。這代表其研發路徑的重大加速。

  • Kaivan will describe emerging data, which support the use of the 6-monthly regimen for treatment of diseases like COPD. For efimosfermin data suggests a best-in-class profile for the treatment of MASH. The program has recently been accelerated against our original time lines and now includes F4 in addition to F2 and F3 patients. And I'm pleased to announce that the F4 program recruited its first patient only last week.

    Kaivan 將說明新出爐的數據,支持每 6 個月一次的給藥方案可用於治療如 COPD 等疾病。對於 efimosfermin,數據顯示其在治療 MASH 方面具備同類最佳(best-in-class)的特徵。該計畫近期相較於我們原先的時程已加速推進,且目前除 F2 與 F3 病患外,也納入 F4 病患。我也很高興宣布,F4 計畫就在上週才招募到第一位病患。

  • As you can see on this slide, the changes we've been making in R&D, particularly in development have led to a transformation in our late-stage portfolio, which is now much more focused in areas with greater patient benefit and value. Overall, we're significantly increasing the number of Phase III starts significantly this year. We expect this trend to continue to be above that as a past, although not at the level we're seeing at this year.

    如您在此投影片所見,我們在研發(R&D)方面所做的變革,特別是在開發端,已促成我們後期產品組合的轉型;如今更聚焦於能帶來更大病患效益與價值的領域。整體而言,我們今年第三期啟動數量將顯著增加。我們預期此趨勢將持續高於過往水準,儘管不會達到今年所見的程度。

  • Importantly, these are in high-value areas with a major driver of this being a significant increase in the number of oncology Phase III studies. 2026 will see the start of pivotal trials for Mo-rez in gynecological cancers, Ris-rez in genitourinary cancers, Velzatinib in first-line GIST, efimosfermin in F4 MASH and our 3 times yearly treatment for HIV.

    重要的是,這些都位於高價值領域,其中一個主要驅動因素是腫瘤第三期研究數量的大幅增加。2026 年將啟動多項關鍵性試驗,包括:Mo-rez 用於婦科癌症、Ris-rez 用於泌尿生殖系統癌症、Velzatinib 用於第一線 GIST、efimosfermin 用於 F4 MASH,以及我們每年 3 次的 HIV 治療方案。

  • External innovation and business development have been and will continue to be an important part of accelerating R&D. Luke's highlighted the deals we've added important assets to our late-stage pipeline, most recently, of course, Nuvalent. We'll continue our approach of bringing in assets with validated targets that address efficacy or tolerability gaps to complement our mid-stage pipeline.

    外部創新與商業發展一直是、且將持續是加速研發的重要一環。Luke 已強調我們透過交易為後期管線增添了重要資產,最近當然包括 Nuvalent。我們將持續採取引進已驗證標的、能補足療效或耐受性缺口的資產之策略,以補強我們的中期管線。

  • We use the same data-driven scientifically courageous approach I just described for our BD decisions as well. It's true for both clinical and earlier platform deals. And in the latter case, means R&D is increasingly externally focused. You'll hear more from me on the early-stage R&D later in the year. Now as we become more externally focused, we're also making sure we co-locate our key laboratories with major external innovation hubs containing leading academic institutes.

    我們在商業發展(BD)決策上,也採用我剛才描述的同一套以數據驅動、科學上勇於突破的方法。這同樣適用於臨床交易與更早期的平台型交易。而在後者情況下,意味著研發正日益轉向外部導向。今年稍晚您將會聽到我更多關於早期研發的內容。隨著我們更聚焦外部,我們也確保將關鍵實驗室與主要外部創新樞紐共同設置,這些樞紐匯聚頂尖學術機構。

  • We have four key locations, the East Coast of the US, UK, Europe and China, each with important academic partnerships, and I've highlighted the major ones on this slide. The partnerships span a portfolio of interests aligned to our core therapeutic areas and forge deep connections with leading researchers that expose us to groundbreaking innovation. The majority of these projects focus on human health data, giving us unique insights that derisk our target identification and translational efforts and allow us to advance faster with greater confidence.

    我們有四個關鍵據點:美國東岸、英國、歐洲與中國;各據點皆有重要的學術合作夥伴,我已在此投影片標示主要合作方。這些合作涵蓋與我們核心治療領域一致的一系列重點,並與領先研究人員建立深度連結,使我們得以接觸突破性的創新。多數專案聚焦於人類健康數據,為我們提供獨特洞見,降低標的辨識與轉譯研究的風險,並讓我們能以更高信心、更快速度推進。

  • We continue to actively look to expand our partnerships on the East Coast of America and in China, and I look forward to sharing updates with you in the future. In Europe, we already have a significant presence with very strong partnerships like the one we have with Oxford University. The announcement today that we're establishing a hub in Cambridge, UK shows our commitment to ensuring our people are in the right places with the right partners to accelerate innovation. Our new Cambridge site will accelerate the changes we're making within R&D, reflecting the new way of working we've built to discover and develop medicines.

    我們持續積極尋求在美國東岸與中國擴大合作夥伴關係,並期待未來與各位分享最新進展。在歐洲,我們已具備相當規模的布局,並擁有非常強健的合作關係,例如與牛津大學的合作。今天宣布我們將在英國劍橋設立樞紐,展現我們致力於讓團隊在正確地點、與正確夥伴合作,以加速創新的承諾。我們新的劍橋據點將加速我們在研發內部推動的變革,反映我們為藥物發現與開發所建立的新工作方式。

  • CBC is one of the leading integrated biomedical campuses in the world and as such is a perfect location for us. We'll be beside one of our key academic partners, Cambridge University as well as with internationally recognized research hospitals and clinical infrastructure. Our scientists will be able to work in state-of-the-art technology-enabled labs with an ecosystem of innovative AI and biotech companies. This move is part of a broader transformation of R&D, which I'll continue to update you on.

    CBC 是全球領先的整合式生物醫學園區之一,因此對我們而言是理想地點。我們將與關鍵學術夥伴之一——劍橋大學——比鄰而居,同時也靠近國際知名的研究醫院與臨床基礎設施。我們的科學家將能在最先進、科技賦能的實驗室中工作,並置身於由創新 AI 與生技公司構成的生態系。此舉是研發更廣泛轉型的一部分,我也將持續向各位更新進展。

  • Finally, I want to reiterate the strength of our late-stage portfolio, which has been delivered from the momentum we've been building over the past years through business development and most recently, our acceleration decisions. We have a number of exciting milestones ahead of us, and I look forward to updating you on these in the future.

    最後,我想再次強調我們後期產品組合的實力;這是我們過去數年透過商業發展所累積的動能,以及近期加速決策所帶來的成果。未來我們將迎來多個令人振奮的里程碑,我也期待在未來向各位更新。

  • With that in mind, I'm now going to hand over to the team to take you through these programs in more detail, and we're starting with Hesham and our oncology portfolio.

    基於此,我現在將交棒給團隊,帶各位更深入了解這些計畫;我們將從 Hesham 與我們的腫瘤產品組合開始。

  • Hesham Abdullah - Global Head of Oncology R&D

    Hesham Abdullah - Global Head of Oncology R&D

  • Thank you, Tony, and good afternoon, everyone. I'm Hesham Abdullah, Global Head of Oncology R&D at GSK. Today, I'll highlight the significant progress we've made in oncology, building on our strength in gynecological and hematological cancers and expanding into new tumor types. Given the additional R&D investment we're announcing today, I'll also discuss how we'll focus this investment to accelerate development and bring our pipeline of clinically meaningful medicines to patients faster.

    謝謝你,Tony,各位下午好。我是 Hesham Abdullah,GSK 腫瘤研發全球負責人。今天我將重點說明我們在腫瘤領域取得的重大進展:在婦科與血液腫瘤的既有優勢基礎上,並擴展至新的腫瘤類型。鑑於我們今天宣布的額外研發投資,我也將說明我們將如何聚焦運用這筆投資以加速開發,並更快將具臨床意義的藥物管線帶給病患。

  • Let's start with why oncology matters. Oncology is a large market opportunity, defined by significant and persistent unmet need. Cancer incidence continues to rise with many tumor types projected to see double-digit growth in incidents through 2030 and beyond. Despite meaningful advances over the past decade, driven by precision medicine and new modalities, many cancer diagnoses continue to have very low 5-year survival rates. There remains a substantial opportunity to improve patient outcomes. Our pipeline and team are well positioned to address this growing unmet need.

    先從為何腫瘤重要談起。腫瘤是一個龐大的市場機會,其特徵在於顯著且持續存在的未被滿足需求。癌症發生率持續上升,許多腫瘤類型預計在 2030 年及之後的發生數將出現兩位數成長。儘管過去十年在精準醫療與新型治療模式的推動下取得了重大進展,許多癌症診斷的 5 年存活率仍然非常低。改善病患預後仍有相當大的空間。我們的管線與團隊已做好充分準備,以因應這項日益增加的未被滿足需求。

  • We've built a portfolio of competitive, high-potential assets and critically, we have a talented team with a proven track record of execution in oncology. This combination of high unmet need, a high potential portfolio and a proven team will make oncology a key growth driver for GSK. We've been deliberate with how we've rebuilt the oncology pipeline at GSK, starting with strong franchises in hematology and gynecologic malignancies and now expanding into lung cancer, propelled by the recent Nuvalent acquisition as well as gastrointestinal, prostate cancer and other solid tumors.

    我們已建立一個具競爭力且高潛力的資產組合;更關鍵的是,我們擁有一支才華洋溢、且在腫瘤領域具備可驗證執行紀錄的團隊。這種高度未被滿足需求、高潛力產品組合與經驗證的團隊之結合,將使腫瘤成為 GSK 的關鍵成長驅動力。我們在重建 GSK 腫瘤管線的方式上一直相當審慎:從血液腫瘤與婦科惡性腫瘤的強勢基礎出發,如今在近期收購 Nuvalent 的推動下,擴展至肺癌,並延伸至胃腸道、前列腺癌及其他實體腫瘤。

  • Building on our marketed anchor assets, we're advancing a deep clinical stage pipeline across multiple modalities, including ADCs, next-generation targeted small molecules, immune cell engagers and novel precision oncology medicines.

    在已上市的核心支柱資產基礎上,我們正推進一個跨多種治療模式、臨床階段深厚的管線,包括 ADC、次世代標靶小分子、免疫細胞接合劑,以及新型精準腫瘤藥物。

  • We're focusing on developing a better understanding of cancer biology, generating unique insights from deep phenotyping, novel nonclinical model systems and foundational models for patient identification and stratification. These differentiated oncology technologies enable sustained growth and innovation with a quality portfolio of assets in our research pipeline. End-to-end, our GSK oncology portfolio is designed for scale and sustained leadership.

    我們正聚焦於加深對癌症生物學的理解,並透過深度表型分析、新穎的非臨床模型系統,以及用於病患辨識與分層的基礎模型,產生獨特洞見。這些具差異化的腫瘤技術,讓我們能以研究管線中高品質的資產組合,實現持續成長與創新。從端到端來看,我們的 GSK 腫瘤產品組合以可規模化與持續領導為設計目標。

  • Turning first to our two lead antibody drug conjugates, Mo-rez and Ris-rez. Both ADCs utilize a proprietary TOPO1 payload with a proven linker technology designed to deliver enhanced stability and tumor penetration with a potentially differentiated safety profile. For example, in our BEHOLD interim study results presented at SGO, we observed a 3% incidence of ILD pneumonitis, and we'll share further evidence of these potentially differentiated outcomes at ESMO with Ris-rez.

    首先談到我們兩項領先的抗體藥物複合體(ADC)候選藥物:Mo-rez 與 Ris-rez。兩款 ADC 均採用專有的 TOPO1 載荷,並搭配已獲驗證的連接子技術,旨在提升穩定性與腫瘤滲透性,並具備潛在差異化的安全性特徵。例如,在我們於 SGO 發表的 BEHOLD 期中研究結果中,我們觀察到 ILD 肺炎的發生率為 3%,並將在 ESMO 進一步分享 Ris-rez 可能具差異化結果的更多證據。

  • We've already advanced both ADCs into pivotal programs based on an extensive range of clinical data spanning across ovarian, endometrial, small cell and prostate cancer with data generation ongoing across other solid tumors. Early access to extensive Hansoh clinical data sets in large patient populations, combined with competitor insights and our own data in global populations allows us to rapidly incorporate learnings, design competitive Phase III trials and optimize our strategic positioning.

    我們已基於涵蓋卵巢癌、子宮內膜癌、小細胞癌與前列腺癌等多項適應症的廣泛臨床數據,將兩款 ADC 推進至樞紐性(pivotal)計畫;同時,其他實體腫瘤的數據產出亦在進行中。及早取得漢森(Hansoh)在大型病人族群中的豐富臨床資料集,結合競品洞察與我們在全球族群的自有數據,使我們能快速吸收學習、設計具競爭力的第三期試驗,並最佳化我們的策略定位。

  • At the same time, we're evaluating novel biomarkers to potentially further enhance activity with a multipronged translational strategy. Across both programs, we're delivering at pace, striving for flawless execution while making smart, disciplined choices along the way. Mse mocertatug rezetecan, or as we call it Mo-rez builds on the strong foundation of ZEJULA and Jemperli to drive GSK's next wave of innovation in gynecologic cancers.

    同時,我們也在評估新型生物標記,以多管齊下的轉譯策略,進一步提升療效的可能性。在兩個計畫中,我們以快速節奏推進,力求完美執行,同時在過程中做出明智且嚴謹自律的決策。Mse mocertatug rezetecan(我們稱之為 Mo-rez)建立在 ZEJULA 與 Jemperli 的堅實基礎之上,推動 GSK 在婦科癌症領域的下一波創新。

  • Strong clinical data in both ovarian and endometrial cancer position Mo-rez in the top tier of a competitive and emerging class of antibody drug conjugates in gynecologic malignancies. Mo-rez delivered numerically higher antitumor activity, combined with manageable safety with a 62% response rate in platinum-resistant ovarian cancer and a 67% response rate in second-line plus endometrial cancer.

    在卵巢癌與子宮內膜癌中展現的強勁臨床數據,使 Mo-rez 在婦科惡性腫瘤中競爭激烈且新興的 ADC 類別中位居第一梯隊。Mo-rez 在鉑類抗藥性卵巢癌中達到 62% 反應率、在二線及以上子宮內膜癌中達到 67% 反應率,呈現數值上更高的抗腫瘤活性,且安全性可管理。

  • Importantly, this activity is independent of B7-H4 expression level with no unique toxicities. For example, none of the TROP-2-specific stomatitis. Supported by an extensive data set, we've moved at pace to initiate a scaled Phase III development program, initiating five Phase III studies during 2026, including three ovarian and two endometrial cancer studies. Driven by a strong signal observed with Mo-rez in early clinical trials, the BEHOLD clinical program has recruited over 600 patients, and it has taken just 15 months to move from Phase Ib to initiating Phase III. Expect further safety and efficacy data updates from Mo-rez at ESMO.

    重要的是,該活性不受 B7-H4 表現量高低影響,且未見特有毒性。例如,未出現 TROP-2 特異性的口腔炎。在龐大數據集支持下,我們快速啟動擴大規模的第三期開發計畫,於 2026 年啟動五項第三期研究,包括三項卵巢癌與兩項子宮內膜癌研究。受 Mo-rez 早期臨床試驗中觀察到的強烈訊號驅動,BEHOLD 臨床計畫已招募超過 600 名病人,且僅用 15 個月便從 Ib 期推進至啟動第三期。預期在 ESMO 取得 Mo-rez 更多安全性與療效數據更新。

  • The second asset from this class-leading ADC platform is Ris-rez, our B7-H3 ADC, which is effectively an oncology pipeline in a single asset. B7-H3 is widely expressed across a large number of solid tumors. Across these potential indications, we're prioritizing early entry into small cell lung cancer and prostate cancer, where proof of concept has already been established.

    此一同級領先 ADC 平台的第二項資產為 Ris-rez,我們的 B7-H3 ADC,基本上可視為「單一資產即一條腫瘤產品線」。B7-H3 在多種實體腫瘤中廣泛表現。在這些潛在適應症中,我們優先布局小細胞肺癌與前列腺癌,因為概念驗證(PoC)已經建立。

  • In parallel, signal confirmation in a global population is underway in non-small cell lung cancer and sarcoma, now that PoC has been established in China. And we're also exploring additional opportunities across multiple other solid tumors. With already more than 930 patients dosed across in both trials globally, we have established a strong foundation to further accelerate Ris-rez development and maximize its potential.

    同時,鑑於 PoC 已在中國建立,我們正於非小細胞肺癌與肉瘤中,在全球族群展開訊號確認。我們也在多種其他實體腫瘤中探索更多機會。目前全球兩項試驗累計已為超過 930 名病人給藥,我們已建立堅實基礎,可進一步加速 Ris-rez 的開發並最大化其潛力。

  • Similar to Mo-rez, robust early clinical data provides conviction to move our Ris-rez program with pace and at scale. In the second-line small cell lung cancer setting, FDA granted Ris-rez breakthrough therapy designation based on the initial data presented by Hansoh at the World Conference on Lung Cancer in 2024. The updated data published in cancer cell this year showed an objective response rate of 60% with a 6.3-month median progression-free survival and a 14.9-month median overall survival in the TOPO-1 naive cohort.

    與 Mo-rez 類似,強勁的早期臨床數據使我們有信心以快速節奏並擴大規模推進 Ris-rez 計畫。在二線小細胞肺癌情境中,FDA 依據漢森於 2024 年世界肺癌大會(WCLC)發表的初始數據,授予 Ris-rez 突破性療法認定。今年發表於《Cancer Cell》的更新數據顯示,在 TOPO-1 未治療(naive)隊列中,客觀反應率為 60%,中位無惡化存活期(PFS)為 6.3 個月,中位總存活期(OS)為 14.9 個月。

  • Earlier in July, our partner, Hansoh, announced that Artemis-008, a Phase III China study, met its primary endpoint, demonstrating a clinically meaningful and statistically significant improvement in overall survival for patients with second-line small cell lung cancer. This marks a significant milestone as the first positive Phase III overall survival data for a B73-directed ADC in any tumor type. Our global GSK Phase III study in second-line plus EMBOLD Small Cell Lung Cancer 301 is actively recruiting, and we plan to initiate a first-line study later this year.

    7 月稍早,我們的合作夥伴漢森宣布,Artemis-008(中國第三期研究)達成主要終點,顯示二線小細胞肺癌病人的總存活期獲得具臨床意義且具統計顯著性的改善。這是一項重要里程碑,為任何腫瘤類型中首個針對 B7-H3 的 ADC 取得第三期總存活期陽性數據。我們在全球進行的 GSK 第三期研究(EMBOLD Small Cell Lung Cancer 301,二線及以上)正積極招募中,並計畫於今年稍晚啟動一線研究。

  • And at China non-squamous non-small cell lung cancer, second-line plus population, Ris-rez has demonstrated meaningful activity, both as a monotherapy and in combination with a PD-L1 inhibitor. Our ongoing Phase II combo study EMBOLD PanTumor-101 will aim to confirm the signal in PD-1 exposed patients in a global population.

    此外,在中國的非鱗狀非小細胞肺癌二線及以上族群中,Ris-rez 無論作為單藥或與 PD-L1 抑制劑合併使用,均展現具意義的活性。我們正在進行的第二期合併治療研究 EMBOLD PanTumor-101,將在全球族群中針對曾接受 PD-1 治療的病人,確認該訊號。

  • Prostate cancer is a key growth opportunity for Ris-rez, and we will initiate a number of Phase III studies in prostate cancer before the end of the year. The EMBOLD program includes two Phase III monotherapy studies in late-line and chemo-naive metastatic castrate-resistant prostate cancer as well as a Phase III combination study in metastatic hormone-sensitive prostate cancer. These accelerated investments are supported by the response data shown here on the left, a 37% confirmed objective response rate in metastatic castrate-resistant prostate cancer patients, supported by nine months landmark PFS rate of 56%.

    前列腺癌是 Ris-rez 的關鍵成長機會,我們將在年底前啟動多項前列腺癌第三期研究。EMBOLD 計畫包含兩項第三期單藥研究,分別針對晚線與未接受化療的轉移性去勢抗性前列腺癌(mCRPC),以及一項第三期合併治療研究,針對轉移性荷爾蒙敏感性前列腺癌(mHSPC)。這些加速投資由左側所示反應數據支持:在 mCRPC 病人中,確認的客觀反應率為 37%,並由 9 個月里程碑 PFS 率 56% 支持。

  • Ris-rez is complemented by a growing pipeline of early-stage prostate assets that position us for future expansion with different modalities. Highlights for the remainder of 2026 include the Artemis-008 data set, which look like Ris-rez in second-line treatment of small cell lung cancer. This trial met the overall survival primary endpoint and data will be published before the end of the year. These data are significant because this is the first pivotal trial to show a survival benefit for any B7-H3-directed ADC in any indication.

    Ris-rez 亦由一系列日益成長的前列腺癌早期資產所補強,使我們未來可透過不同治療模式擴張版圖。2026 年剩餘期間的重點包括 Artemis-008 數據集,該研究評估 Ris-rez 用於二線小細胞肺癌治療。此試驗達成總存活期主要終點,數據將於年底前發表。這些數據意義重大,因為這是首個在任何適應症中顯示存活獲益的 B7-H3 導向 ADC 樞紐性試驗。

  • In addition, our partner, Hansoh, has just announced positive results from a second China Phase III study, evaluating Ris-rez in osteosarcoma patients that have received at least two prior lines of therapy. The trial demonstrated a clinically meaningful and statistically significant improvement in its primary endpoint, IRC-assessed PFS with consistent benefit observed in key secondary endpoints. Osteosarcoma is an area of high unmet need, and Ris-rez has secured breakthrough therapy designation from FDA in this tumor type. Data from the Phase III study will be presented at a scientific congress later this year.

    此外,我們的合作夥伴漢森剛宣布第二項中國第三期研究取得正面結果,該研究評估 Ris-rez 用於至少接受過兩線既往治療的骨肉瘤病人。試驗在主要終點(由獨立審查委員會 IRC 評估的 PFS)上呈現具臨床意義且具統計顯著性的改善,且在關鍵次要終點亦觀察到一致的獲益。骨肉瘤屬高度未被滿足的醫療需求領域,Ris-rez 已在此腫瘤類型獲得 FDA 突破性療法認定。該第三期研究數據將於今年稍晚在科學會議上發表。

  • Additionally, at ESMO, we'll share the first Ris-rez data from a global population alongside ILD analyses that will further characterize the asset's potential differentiated monotherapy safety profile. This momentum is expected to continue into 2027 with Ris-rez data being presented at major medical congresses throughout the year. Together, this represents a rich multiyear data cadence across one of the broadest B7-H3 development programs.

    另外,在 ESMO,我們將分享首批來自全球族群的 Ris-rez 數據,並同時提供 ILD 分析,以進一步刻畫該資產作為單藥治療可能具差異化的安全性特徵。此動能預期將延續至 2027 年,Ris-rez 數據將於全年在主要醫學會議上陸續發表。整體而言,這代表在最廣泛的 B7-H3 開發計畫之一中,具備跨多年、密集且豐富的數據節奏。

  • Turning to our recent Nuvalent acquisition, which provides assets in precision oncology lung cancer. Neladalkib and Jideytro have the potential to transform treatment in ALK-positive and ROS1-positive non-small cell lung cancer. The potential to improve efficacy and tolerability in ALK-positive and ROS1 positive patient segments will support extended treatment duration and in turn, drive market growth.

    接著談到我們近期收購 Nuvalent,此收購為精準腫瘤學肺癌領域帶來相關資產。Neladalkib 與 Jideytro 具備在 ALK 陽性與 ROS1 陽性非小細胞肺癌中改變治療模式的潛力。在 ALK 陽性與 ROS1 陽性病人族群中提升療效與耐受性的潛力,將支持延長治療持續時間,進而帶動市場成長。

  • The ALK and ROS segments of the non-small cell lung cancer market represent around 2% to 4% of the overall population. But these segments are typically younger. They are more frequently women and fitter than the broader lung cancer population. Patients are usually diagnosed with metastatic disease and typically have a higher rate of CNS involvement at diagnosis. For patients with ALK ROS non-small cell lung cancer, next-generation agents like Jideytro and Neladalkib may extend median PFS beyond 46 months in ROS1-positive patients and over 84 months in ALK-positive non-small cell lung cancer patients.

    非小細胞肺癌市場中的 ALK 與 ROS 族群約占整體患者人數的 2% 至 4%。但這些族群通常較年輕。相較於更廣泛的肺癌族群,他們更常為女性且身體狀況更佳。患者通常在確診時即為轉移性疾病,且在診斷時中樞神經系統(CNS)受累的比例通常更高。對於 ALK/ROS 非小細胞肺癌患者,Jideytro 與 Neladalkib 等次世代藥物可使 ROS1 陽性患者的中位無惡化存活期(PFS)延長至 46 個月以上,並使 ALK 陽性非小細胞肺癌患者的中位 PFS 超過 84 個月。

  • While the majority of first-line lung cancer patients will be treated for around 9 to 10 months, the duration of therapy for a first-line -- the duration of therapy for a first-line ALK patient may be greater than seven years. Jideytro was recently approved by FDA for the second-line treatment of ROS1-positive non-small cell lung cancer patients. We're also working with FDA to support Neladalkib approval with an FDA decision for second-line ALK-positive non-small cell lung cancer expected by November 27.

    多數一線肺癌患者的治療時間約為 9 至 10 個月,而一線 ALK 患者的治療持續時間可能超過七年。Jideytro 近期已獲 FDA 核准用於 ROS1 陽性非小細胞肺癌患者的二線治療。我們也正與 FDA 合作以支持 Neladalkib 的核准,預期 FDA 將於 11 月 27 日前就 ALK 陽性非小細胞肺癌二線治療作出決定。

  • First-line studies for both Jideytro and Neladalkib are still ongoing and enrollment in Neladalkib's first-line ALKAZAR Phase III trial is already more than 30% complete. In the cross-trial comparison shown here for ALK-positive non-small cell lung cancer post second-generation TKI, neladalkib shows 14.5 months median PFS compared with 6.6 months achieved with lorlatinib, with 91% of patients maintaining a response for more than 12 months versus 70% with lorlatinib in a TKI-naive population.

    Jideytro 與 Neladalkib 的一線研究仍在進行中,而 Neladalkib 的一線 ALKAZAR 第三期試驗收案已完成超過 30%。在此針對第二代 TKI 治療後之 ALK 陽性非小細胞肺癌的跨試驗比較中,neladalkib 的中位 PFS 為 14.5 個月,相較之下 lorlatinib 為 6.6 個月;且在 TKI 未治療族群中,91% 的患者反應可維持超過 12 個月,而 lorlatinib 為 70%。

  • In ROS1-positive non-small cell lung cancer post TKI, Jideytro shows 23.8 months median PFS compared with 9.7 months for taletrectinib with 96% of patients maintaining a response for more than 12 months versus 74% for taletrectinib in a TKI-naive population. Acknowledging the caveats that exist with these cross-study comparisons, these data appear to suggest the potential to meaningfully prolong median PFS with Nela and Jideytro. These are best-in-class efficacy profiles, and I will review safety and tolerability data on the next slide.

    在 TKI 治療後之 ROS1 陽性非小細胞肺癌中,Jideytro 的中位 PFS 為 23.8 個月,相較之下 taletrectinib 為 9.7 個月;且在 TKI 未治療族群中,96% 的患者反應可維持超過 12 個月,而 taletrectinib 為 74%。在承認此類跨研究比較存在限制的前提下,這些數據似乎顯示 Nela 與 Jideytro 具有顯著延長中位 PFS 的潛力。這些是同類最佳(best-in-class)的療效表現,我將在下一張投影片回顧安全性與耐受性數據。

  • Data from the neladalkib clinical program indicate Nela is well tolerated with the lowest rates of dose reductions and discontinuation when compared with other assets in the class. Nela is a highly selective ALK inhibitor, which is reflected in the adverse event profile observed in clinical studies. Nela does not appear to be associated with the long-term metabolic and neurological adverse events seen with other TKIs in the class. While Neladalkib does show higher liver enzyme elevations, physicians' feedback indicates these are largely clinically asymptomatic and manageable with routine monitoring. In short, a tolerability profile designed for long-term first-line use.

    neladalkib 臨床計畫的數據顯示 Nela 耐受性良好,與同類其他藥物相比,其劑量下調與停藥率最低。Nela 是高度選擇性的 ALK 抑制劑,這也反映在臨床研究觀察到的不良事件特徵上。Nela 似乎不會出現同類其他 TKI 所見的長期代謝與神經系統不良事件。雖然 Neladalkib 的肝酵素升高較多,但醫師回饋指出多數在臨床上無症狀,且可透過例行監測加以管理。簡言之,這是一個為長期一線使用而設計的耐受性特徵。

  • Velzatinib is another asset in our precision targeted therapy portfolio. It's in Phase III development for the treatment of GIST or gastrointestinal stromal tumors, a rare type of cancer, which develops in the digestive tract, most commonly in the stomach or small intestine. The first-line standard of care for GIST patients has not changed since the introduction of imatinib over 20 years ago. While this first-line therapy has improved the outlook for patients over time, GIST tumors will ultimately become resistant to imatinib and patients typically progress to a second-line treatment strategy.

    Velzatinib 是我們精準標靶治療產品組合中的另一項資產。目前正進行第三期開發,用於治療 GIST(胃腸道基質瘤),這是一種罕見癌症,發生於消化道,最常見於胃或小腸。自 20 多年前 imatinib 問世以來,GIST 患者的一線標準治療一直未改變。雖然此一線治療隨時間改善了患者預後,但 GIST 腫瘤最終會對 imatinib 產生抗藥性,患者通常會進展至二線治療策略。

  • The standard of care in second-line treatment is not well tolerated with variable efficacy. Velzatinib is the only agent in the TKI landscape, which targets all primary and key secondary KIT mutations with a lower rate of adverse events when compared to other available treatment options or standard of care.

    二線治療的標準照護耐受性不佳,且療效差異很大。Velzatinib 是 TKI 領域中唯一可同時鎖定所有主要與關鍵次要 KIT 突變的藥物,且相較於其他可用治療選項或標準照護,不良事件發生率更低。

  • At ASCO this year, we presented velzatinib data, which showed a 61% confirmed response rate and a 65% unconfirmed response rate for velzatinib in the first-line setting with every patient on the trial demonstrating a reduction in tumor volume. These data were used to inform the StrateGIST frontline study, which recently started recruitment. We now have two Phase III studies underway, StrateGIST-3 in second-line GIST and StrateGIST frontline and first-line GIST, both exploring velzatinib as monotherapy.

    在今年 ASCO,我們發表了 velzatinib 的數據:在一線治療情境下,velzatinib 的確認反應率為 61%,未確認反應率為 65%,且試驗中每位患者的腫瘤體積皆出現縮小。這些數據用於支持 StrateGIST 一線研究設計,該研究近期已開始招募。目前我們已有兩項第三期研究進行中:二線 GIST 的 StrateGIST-3,以及一線 GIST 的 StrateGIST frontline,兩者皆在探索 velzatinib 單藥治療。

  • Recruitment for both studies is progressing strongly ahead of schedule. This momentum underscores the pace at which we're advancing this asset and velzatinib's potential to redefine the standard of care in GIST. Finally, I'd like to provide a short update on Blenrep, our ADC for the treatment of multiple myeloma. Blenrep's clinical development program is targeting all patient segments of newly diagnosed multiple myeloma.

    兩項研究的招募進度皆強勁,且明顯超前於原定時程。這股動能凸顯我們推進此項資產的速度,以及 velzatinib 重新定義 GIST 標準治療的潛力。最後,我想簡要更新 Blenrep——我們用於治療多發性骨髓瘤的 ADC。Blenrep 的臨床開發計畫鎖定所有新診斷多發性骨髓瘤的患者族群。

  • The DREAMM-10 study is designed to investigate a Blenrep combination, which is appropriate for the majority of first-line or newly diagnosed patients. These patients are described as either standard risk fit or high-risk frail patients. DREAMM-10 investigates a Blenrep triplet versus a daratumumab triplet, and we anticipate preliminary MRD negativity data in the first half of 2028.

    DREAMM-10 研究旨在評估一種適用於多數一線或新診斷患者的 Blenrep 聯合療法。這些患者被描述為標準風險且體能良好(fit),或高風險且虛弱(frail)的患者。DREAMM-10 比較 Blenrep 三藥組合與 daratumumab 三藥組合,我們預期在 2028 年上半年取得初步的 MRD 陰性數據。

  • For high-risk non-frail newly diagnosed patients, the Phase III PRECOX study will investigate a quad regimen of Blenrep plus VRd versus a CD38 combination of daratumumab plus VRd in a high-risk enriched population, addressing the need for deeper myeloma control through higher treatment intensity. Together, these two pivotal studies should support blenrep use in a large proportion of the first-line multiple myeloma patients. Blenrep's projected median progression-free survival of 101.8 months from the TERPOS data presented at EMN is competitive versus 100 months for a CD38 quadruplet regimen and 62 months from a CD38 triplet.

    針對高風險、但非虛弱的新診斷患者,第三期 PRECOX 研究將在高風險富集族群中,比較 Blenrep + VRd 的四藥方案與 daratumumab + VRd 的 CD38 聯合方案,以更高治療強度滿足對更深層骨髓瘤控制的需求。合計而言,這兩項關鍵性研究應可支持 Blenrep 用於相當大比例的一線多發性骨髓瘤患者。根據於 EMN 發表的 TERPOS 數據,Blenrep 預估的中位無惡化存活期為 101.8 個月,具競爭力:相較之下,CD38 四藥方案為 100 個月,CD38 三藥方案為 62 個月。

  • Next, real-life burden of care. BRd offers a meaningfully lower burden of care with dramatically fewer infusion days. This has real-world implications for patients. And then finally, the Grade 3/4 ocular event rate is significantly improved and matches first-line expectations. This is achieved with 1.9 mg per kg dosing on a once every 12-week dosing schedule in the maintenance setting. This is a regimen designed to optimize benefit risk in this newly diagnosed patient population.

    接著是實際照護負擔。BRd 以大幅減少輸注天數,提供顯著較低的照護負擔。這對患者在真實世界具有實質影響。最後,3/4 級眼部事件發生率顯著改善,並符合一線治療的預期。這是透過維持治療階段採用每公斤 1.9 mg 劑量、每 12 週給藥一次的給藥時程所達成。此一方案旨在為新診斷患者族群最佳化效益/風險。

  • Now let me close with the big picture. Our GSK pipeline and team are well positioned to address the growing unmet needs in oncology. We have a highly competitive oncology pipeline, and we're continuing to apply various acceleration levers. Starting in lung, we have a near-term acceleration opportunity into second line with Jideytro now approved and Nela on its heels with first-line expansion for Jideytro planned in first half 2027. Both address clear efficacy and tolerability gaps.

    現在讓我以整體觀點作結。我們的 GSK 研發管線與團隊已做好充分準備,以因應腫瘤領域日益增加的未被滿足需求。我們擁有高度具競爭力的腫瘤研發管線,並持續運用多種加速槓桿。從肺癌開始,我們在近期有機會加速切入二線:Jideytro 現已獲核准,而 Nela 緊隨其後;同時,Jideytro 的一線適應症擴展計畫預定於 2027 年上半年推進。兩者皆可補足明確的療效與耐受性缺口。

  • With our two ADCs, extensive clinical data sets provide conviction to progress multiple pivotal programs at pace with Mo-rez in Gyn-onc and Ris-rez pipeline in a single asset. Ris-rez brings the first positive Phase III OS data for any B7-H3 directed ADC with two positive Phase III trials to be presented in the second half of '26.

    在我們的兩款 ADC 方面,龐大的臨床數據集使我們更有信心,以加速節奏推進多項關鍵性計畫;其中 Mo-rez 用於婦科腫瘤(Gyn-onc),而 Ris-rez 的研發管線則集中於單一資產。Ris-rez 帶來首個針對任何 B7-H3 標的 ADC 的第三期整體存活期(OS)正向數據,且將於 2026 年下半年發表兩項第三期試驗的正向結果。

  • Continuing with our pipeline of differentiated precision oncology medicines in areas of unmet need, Velzatinib has the potential to redefine a two-decade-old standard of care for GIST patients as a well-tolerated monotherapy with potential superior activity and tolerability profile.

    延續我們在未被滿足醫療需求領域、具差異化的精準腫瘤藥物研發管線,Velzatinib 作為耐受性良好的單藥治療,具備可能更優的療效與耐受性特徵,有潛力為 GIST 患者改寫沿用逾二十年的標準治療。

  • Finally, we will continue to see upside with Blenrep. The ongoing clinical development and evidence generation program aims to ensure success in newly diagnosed patients while creating broad access for community-based BCMA therapy. Taken together, this is a high potential competitive oncology pipeline and one we're advancing with real pace and conviction.

    最後,我們也將持續看到 Blenrep 的上行潛力。目前進行中的臨床開發與證據產出計畫,旨在確保其在新診斷患者中的成功,同時為社區端的 BCMA 治療建立廣泛可近性。綜合而言,這是一條高潛力、具競爭力的腫瘤研發管線,我們正以真正的速度與堅定信念推進。

  • I'll now hand it back to Luke to commence the Q&A session. If I can also ask Julie, Nina, Deborah and Tony to join me on the stage as well, too.

    我現在把時間交回給 Luke,開始問答環節。另外也請 Julie、Nina、Deborah 和 Tony 一起上台。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Great. Thanks, Hesham. And as you said, we'll open the floor -- open the floor. (Operator Instructions) So Matthew, I think you were the first. I think you get a job as a Formula 1 driver with those reflexes. So Matthew.

    很好。謝謝你,Hesham。如你所說,我們將開放現場——開放現場提問。(接線員指示) Matthew,我想你是第一位。以你的反應速度,我想你可以去當一級方程式車手了。那麼 Matthew。

  • Matthew Weston - Equity Analyst

    Matthew Weston - Equity Analyst

  • It's Matthew Weston from UBS. One question really about -- and it's about the financials before we get into all the detail because there's more time to dig into the detail later. Slide 24, you gave the illustrative picture of the impact of the new GBP1.9 billion savings program. And it showed the cost base today and then it showed a smaller cost base in the future. And I think you're on track to deliver about 31% margin based on guidance in '26.

    我是 UBS 的 Matthew Weston。我有一個問題,主要是——在我們深入細節之前先談財務面,因為之後還有時間再挖細節。在第 24 張投影片,你們提供了新的 19 億英鎊節省計畫影響的示意圖。圖中顯示了目前的成本基礎,並顯示未來會有較小的成本基礎。而根據你們在 2026 年的指引,我認為你們有望達到約 31% 的利潤率。

  • So one of the most significant questions I've received today over and over is, does the new cost saving take that margin target higher? So am I right in interpreting slide 24 that, yes, you are now aiming for margins up at the end of the 2031 period relative to where we are today.

    因此,我今天反覆收到最重要的問題之一是:新的成本節省是否會把這個利潤率目標推得更高?所以我是否可以把第 24 張投影片解讀為:是的,你們現在的目標是在 2031 年期末的利潤率,相較於今天的水準會更高?

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • The reservation in the slide that we shared was basically saying it was the cost base as a percentage of sales, first of all, as a result of accelerate growth. We are guiding to more than 31% margin in '26. And what we've said previously before today was that the margin will be stable through dolutegravir LOE, which is 28% to 30%. And we feel confident of that because the portfolio is pivoting more and more towards specialty, number one. And as you've seen over a number of years now and with this program, we are driving productivity and improvement in the business. So that brings us to date.

    我們在投影片中所做的保留說明,基本上是指成本基礎占銷售額的比例,首先,這是加速成長所帶來的結果。我們對 2026 年的指引是利潤率高於 31%。而我們在今天之前曾說過,利潤率在 dolutegravir 專利到期(LOE)期間將維持穩定,也就是 28% 到 30%。我們對此有信心,原因之一是產品組合正愈來愈轉向專科領域。此外,正如你在過去幾年以及透過這項計畫所看到的,我們正在推動生產力提升與業務改善。因此,這就是我們目前的狀況。

  • Now what we've said is as a result of accelerate growth, we will also drop some of those savings through to the margin in the period of dolutegravir. So it builds in the dolutegravir LOE period, 28% to 30%. We've not given a specific percentage, but what we have done is changed the margin guidance through dolutegravir now to say it will be stable to improving. So we're giving a range and recognizing the drop-through from the Accelerate growth program.

    現在我們所說的是,因為加速成長,我們也會在 dolutegravir 的期間把部分節省反映到利潤率上。因此在 dolutegravir LOE 期間,利潤率仍是 28% 到 30% 的區間。我們沒有給出具體百分比,但我們已將 dolutegravir 期間的利潤率指引調整為「穩定至改善」。也就是我們提供一個區間,並認列加速成長計畫帶來的節省下沉(drop-through)效應。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • I think, Luisa, you are next, right?

    我想下一位是 Luisa,對嗎?

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • Luisa Hector from Berenberg. I wanted to check on the asset accelerations. So you've highlighted seven. What are the criteria for accelerating? Is there some new decision-making in that mix? And then I don't think Nelo is an accelerated asset. Is there a reason for that? Maybe it's in flight too recent?

    我是 Berenberg 的 Luisa Hector。我想確認一下資產加速的部分。你們強調了七項。加速的判準是什麼?在這當中是否有一些新的決策機制?另外我認為 Nelo 並不是被加速的資產。這有原因嗎?是否因為它正在進行中、時間還太近?

  • And if I can also ask on probabilities of success and linking that to the validated targets. So you have this awesome selection now of pipeline. Is there a reason for probability of success being higher with the '25 Phase III starts? You talked about the validated targets. I don't know how much of those -- what percentage of those are with validated targets and what that really means validated target.

    另外我也想問成功機率(probabilities of success)以及它與已驗證標的(validated targets)的連結。你們現在有一組非常出色的研發管線。為什麼在 2025 年啟動的第三期試驗,其成功機率會更高?你們提到已驗證標的。我不確定其中有多少——有多少比例屬於已驗證標的,以及「已驗證標的」實際上代表什麼。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Thanks, Luisa. I'll start, and then I think this is very much going to be a bit of a tag team answer. So maybe a little bit of heritage, a little bit of background. I mean, Nuvalent wasn't in there because it was running on a similar track with the deal and the programs are more advanced. But if we can go faster, we'll certainly look to do that.

    謝謝你,Luisa。我先回答,然後我想這會很像接力式的回答。先補充一點沿革與背景。Nuvalent 沒有列在其中,是因為它在交易與專案上走的是相似的軌道,而且那些專案更為成熟。但如果我們能更快,我們當然會考慮這麼做。

  • But essentially, we wanted to sit down and look at the portfolio, benchmark it versus external parameters, not just marking your own homework, but if you look at a classical program in lung, what are the appropriate timeframes, what's a typical white space that's a fair comparator? And then what can we do to compress that obviously applying common sense that we didn't want to go so fast that you increase risk.

    但本質上,我們希望坐下來檢視整個組合,並以外部參數作為基準來比較,而不只是自己給自己打分數。例如,如果你看一個典型的肺癌研發專案,合理的時間框架是什麼、典型的空白領域(white space)是什麼,哪些是公平的可比對象?

  • The other thing is, of course, as this portfolio is evolving, if you do have a validated target, you are removing elements of the risk, and therefore, you've got more confidence. I think just fundamentally, we want to look at ways that what were the things that were stopping us from making the decision to go faster. Was there any biological risk? Was it a resource risk? Was it our own process?

    另外一點是,隨著這個組合持續演進,如果你擁有已驗證標的,就能移除部分風險要素,因此信心也會更高。我想從根本上,我們希望找出有哪些因素阻礙我們做出加速決策。是生物學風險嗎?是資源風險嗎?還是我們自身的流程問題?

  • And really compressing all of those, and each program had different combinations. And then we ended up -- we ran up against Julie, who said, that's lovely. And she's doing her job, she said, this needs to be paid for. And that's what then triggered the second round of the process, which is to say, okay, well, then how do we effectively use our shareholders' money appropriately to try and unlock that.

    我們就是把這些因素都壓縮處理,而每個專案的組合都不盡相同。然後我們最後——遇到了 Julie,她說,這很棒。而她在做她的工作,她說,這需要有資金來支付。這就觸發了流程的第二輪,也就是說,好吧,那我們要如何有效且適切地運用股東的資金,來嘗試解鎖這些機會。

  • And clearly, moving it from historical areas of the business or areas where, frankly, we could partner or we could do things more simply and moving those monies to Phase III programs and to BD, we felt it's a better return and a better use of our shareholders' money. So that's the high-level answer.

    很明顯地,我們把資金從過去的業務領域,或坦白說我們可以透過合作、或用更簡化方式處理的領域移出,並把這些資金轉向第三期專案與商務開發(BD)。我們認為這能帶來更好的回報,也更能善用股東的資金。以上是高層次的回答。

  • I don't know, Tony, if you want to give a bit of color, Nina and then Julie, just sort of how that flows through. But clearly, at the end of the day, it's a benefit of -- a combination of benefit risk that we're looking at with these programs, classic portfolio management.

    Tony,我不知道你是否想補充一些細節,接著 Nina,再來 Julie,說明這如何一路傳導。但很清楚的是,歸根結底,我們在看的是這些專案的效益與風險的組合——這就是典型的投資組合管理。

  • Tony?

    Tony?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Why don't I just start a little bit with what data underpins confidence here. And you're going to hear a lot more about that from Kaivan, for example, and you already did from Hesham. And so I think you start with the fact that our portfolio now has a significant number of assets that have broad potential associated with them.

    我先從支撐我們信心的數據談起。例如你會從 Kaivan 那裡聽到更多,你也已經從 Hesham 那裡聽到一些。我認為首先要看到的是,我們目前的組合中有相當多的資產,具備廣泛的潛在價值。

  • And what we've been doing -- and by that, I mean, a number of potential indications that carry significant value as well. And we've been integrating data from one end human causal data from genetics all the way through clinical characterization of patients to individually detailed molecular data. And what that allows us to do is, if you like, draw lines of confidence in underlying biology across different indications. So that's one aspect of it.

    我們一直在做的——我的意思是,這些資產對應多個潛在適應症,而這些適應症也具有顯著價值。我們整合了從人體端因果數據(例如遺傳學)一路到患者的臨床特徵描述,再到個體層級的詳細分子數據。這讓我們能夠在不同適應症之間,對底層生物學建立起一條條「信心線」。這是其中一個面向。

  • You'll hear some nice examples from Kaivan after the break on that. Couple that then with the opportunity to be able to execute a clinical study in both an effective and shall we say, appropriately gated way when we're going with relatively strong data, as I've just described, but perhaps the absence of a Phase II. And what you have is a set of ingredients that allow us to then put confidence behind the seven assets that we described.

    休息之後,你們會從 Kaivan 那裡聽到一些很好的例子。再把這點與一個機會結合起來:在我們如我剛才所描述、擁有相對強勁數據、但可能缺少第二期(Phase II)的情況下,仍能以有效且可以說是適當分段把關的方式來執行臨床研究。如此一來,你就擁有一組要素,使我們能夠對我們所描述的七項資產建立信心。

  • And that's why we've described it as seven assets with 18 indications and I think 25 studies. All of that, coupled with having my friend here sat beside me telling me whether or not she thinks it's worth anything, really helps us to pull together a very different approach that we have now to accelerating the portfolio. I'll hand over to you.

    這也是為什麼我們把它描述為七項資產、18 個適應症以及我想是 25 項研究。所有這些,再加上我這位朋友就坐在我旁邊,告訴我她是否覺得這些真的有價值,確實幫助我們整合出一個非常不同的方法,來加速我們的產品組合。我把時間交給你。

  • Deborah Waterhouse - Chief Executive Officer - ViiV Healthcare and President - GSK Global Health

    Deborah Waterhouse - Chief Executive Officer - ViiV Healthcare and President - GSK Global Health

  • Yes. Thank you, Tony. Not much to add, but Luisa, to your point about the confidence, I'll use some examples. Velzatinib, we have seen -- we have ongoing second-line study, right? When you see a study recruiting at 200% rate, that gives you a bit of confidence that there is actually genuine interest and desire to use the program, to use the asset. And then we try to accelerate, obviously, starting first line and support to make it possible to hopefully repeat the same. I'm not promising it, but there is high confidence that, that is -- that study will recruit.

    是的。謝謝你,Tony。沒有太多要補充的,但 Luisa,針對你提到的信心,我用一些例子來說明。Velzatinib,我們已經看到——我們正在進行二線治療研究,對吧?當你看到一項研究以 200% 的速度在招募,這會讓你更有信心,因為這代表確實存在真實的興趣與使用該方案、使用該資產的意願。然後我們當然會嘗試加速,先從一線治療開始並提供支持,讓我們有機會希望能重複同樣的情況。我不保證,但我們對該研究能夠招募有高度信心。

  • Other examples are the two ADCs. We have this massive benefit of having a Chinese partner who generate a huge amount of data very quickly. We are all aware that sometimes data generated in specific Asian population might not be repeated. So the question here is which level of confidence we need to have in the global Western population to then embark very quickly into a Phase III study. And some of these, we -- for some of these, we feel very confident already.

    其他例子是兩個 ADC。我們有一個巨大的優勢:有一位中國合作夥伴能非常快速地產生大量數據。我們都知道,有時在特定亞洲族群產生的數據可能無法被重現。所以這裡的問題是:我們需要對全球西方族群具備到什麼程度的信心,才能非常快速地啟動第三期(Phase III)研究。而其中一些——對某些項目,我們已經感到非常有信心。

  • So I think it's based to what Tony said, it's underpinned by data, definitely. And also, you can imagine that we have -- we ask the teams to come bottom up with proposals. If you have a blue sky scenario, what would you bring as acceleration? We had more than 100 opportunities that were brought by various teams. And we obviously looked at how big are certain opportunities and what does it mean for our 2030, what does it mean for post-2030 growth.

    所以我認為,正如 Tony 所說,這絕對是以數據為基礎作支撐。另外,你可以想像我們要求團隊自下而上提出提案。如果有一個不受限制的理想情境,你會提出哪些加速方案?各個團隊帶來了超過 100 個機會。而我們當然會評估某些機會有多大,以及這對我們 2030 年意味著什麼、對 2030 年之後的成長意味著什麼。

  • And I think we are very confident that at this point, we are -- our kind of cutoff is blockbuster indication. So that plays a role as well, together with how much does it cost, operational execution? Is it feasible to do it and so on.

    而我認為我們在此刻非常有信心——我們的某種門檻是「重磅(blockbuster)適應症」。因此這也會扮演一個角色,同時還要看成本多少、營運執行如何?是否可行等等。

  • Hesham Abdullah - Global Head of Oncology R&D

    Hesham Abdullah - Global Head of Oncology R&D

  • And we -- just to stress something Luke said right at the beginning, we keep a very close eye on what's going on competitively. Particularly, for example, Kaivan, I'm sorry if I get ahead of you, but the TSLP's a nice example. We got a hint that our friends at Generate Bio are getting ahead of us, which we didn't like the idea of. So that was something that then went very quickly through this process, and you'll hear more about that program later.

    另外——只是要強調 Luke 一開始就提到的一點——我們會非常密切地關注競爭態勢。特別是例如 Kaivan,抱歉如果我搶先你一步,但 TSLP 是個很好的例子。我們得到一些訊息,說我們在 Generate Bio 的朋友正在領先我們,而我們不太喜歡這個想法。所以那件事就非常快速地走完這個流程,稍後你們會聽到更多關於那個專案的內容。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • And I think, again, we want to build a culture that's obsessed with products. Graham?

    而且我想,再次強調,我們希望建立一種對產品極度著迷的文化。Graham?

  • Graham Parry - Analyst

    Graham Parry - Analyst

  • It's Graham Parry from Citi. On the accelerating growth post 2031, can you just help us understand what you're assuming for cabotegravir IP protection there? So you've talked about protecting through dolutegravir, but the cabotegravir LOE is 2031. It would be pretty major if you actually lost it there. So you can detail how you're expecting to protect that.

    我是花旗的 Graham Parry。關於 2031 年之後的加速成長,你能否幫我們理解你們對 cabotegravir 智慧財產權保護的假設?你們談到透過 dolutegravir 來保護,但 cabotegravir 的專利到期(LOE)是 2031 年。如果你們真的在那時失去保護,影響會相當重大。所以請你詳細說明你們預期如何保護它。

  • And then secondly, on zidesamtinib, what's your confidence in the ability to get approval on the first-line data given I think it's only a 35-patient cohort and you've already got Taletrectinib approved from TRuST12, which actually had more patients. And have you had any discussions with regulators regarding the filing yet?

    第二個問題,關於 zidesamtinib:鑑於我認為一線數據只有 35 名病人的隊列,而你們已經有 Taletrectinib 依據 TRuST12 獲批,且那項研究其實有更多病人,你們對於憑藉這些一線數據取得核准的能力有多大信心?另外,你們是否已經就申報與監管機構進行過任何討論?

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Great. Thanks, Graham. Deborah, do you want to give some color on that? And then Regis, if you could just step through the process of making cabotegravir because I think that's -- it's quite interesting is what I would say. And then we'll come back to zidesamtinib first-line Hesham.

    很好。謝謝,Graham。Deborah,你要不要補充一些背景說明?然後 Regis,如果你能帶大家走一遍 cabotegravir 的製造流程,因為我想那——我會說那相當有趣。接著我們再回到 zidesamtinib 的一線,Hesham。

  • Deborah Waterhouse - Chief Executive Officer - ViiV Healthcare and President - GSK Global Health

    Deborah Waterhouse - Chief Executive Officer - ViiV Healthcare and President - GSK Global Health

  • Sure. So thanks for the question, Graham. So we've got a robust approach to intellectual property. You'll see on Charlotte's slides later, a little more detail on this, but I can talk about the additional intellectual property that we have in our hand today and potentially we will have in the future on cabotegravir. So let's look at 6 times yearly treatment for Cabenuva that's in the market today. We've got additional protection now granted through to 2040 for that asset. We've then got 3 times the yearly treatment.

    當然。謝謝你的問題,Graham。我們在智慧財產權方面有一套穩健的方法。你稍後會在 Charlotte 的投影片上看到更詳細的內容,但我可以先談談我們目前手上、以及未來可能在 cabotegravir 上取得的額外智慧財產權。我們先看目前市面上的 Cabenuva:一年 6 次的治療方案。我們已經取得額外保護,現已核准延伸到 2040 年。接著是一年 3 次的治療方案。

  • Again, we've got additional protection pending through to 2047. And then when we come into 60 early prevention, we actually have the patent granted to 2031. We don't have an additional coverage for that asset. And then 3 times the early prevention, we've now got secondary patents pending, which takes us out to 2045. So it is an incredibly difficult medicine to make and to bring rilpivirine and cabotegravir together in the treatment space.

    同樣地,我們有額外保護正在申請中,預計可延伸到 2047 年。然後當我們進入 60 早期預防時,我們實際上有專利核准到 2031 年。我們沒有針對該資產的額外覆蓋。而對於一年 3 次的早期預防,我們現在有次級專利正在申請中,可把保護延伸到 2045 年。因此,這是一種極其難以製造的藥物,要在治療領域把 rilpivirine 與 cabotegravir 結合在一起。

  • Enables us to have quite a moat of intellectual property either available today or patents that are pending, which are broad and cover both the combination of the two, how you make it and obviously, the original composition of matter patents.

    這使我們能建立相當深的智慧財產權護城河:不論是目前已可取得的,或是正在申請中的專利——這些專利範圍廣,涵蓋兩者的組合、製造方式,當然也包括最初的化合物組成(composition of matter)專利。

  • So we feel really confident in the future of our IP to protect the assets that we have in our hands and in our pipeline. Just so we don't leave because we're on the topic of IP, VH184 and 499 out, the base patents there run until hopefully, when they're granted 2040, but we have additional patents that will again take us out to 2047. Regis, do you want to just talk a little bit about how challenging it is to make these medicines?

    因此,我們對於未來的智慧財產權非常有信心,能保護我們手上的資產以及研發管線中的資產。另外,既然談到智慧財產權,我們也補充一下:VH184 和 499 的基礎專利期限希望在核准後可到 2040 年,但我們還有額外專利,將同樣把保護延伸到 2047 年。Regis,你要不要談談製造這些藥物有多具挑戰性?

  • Regis Simard - President - Global Supply Chain

    Regis Simard - President - Global Supply Chain

  • Yes. I had no idea. I would be describing the process this afternoon, but fasten your seat belt. We make the API in Singapore, quite a standard process, long chemistry, synthetic chemistry. Then after you bring it in UK.

    是的。我完全沒想到。我今天下午會在這裡描述這個流程,但請繫好安全帶。我們在新加坡製造 API(活性藥物成分),這是一個相當標準的流程,是很長的化學流程、合成化學。然後把它運到英國。

  • where you do nanomilling. When you have finished a nanomilling, you will do gamma irradiation. When you have finished the gamma irradiation, you bring it back, you're going to feed it as a sterile product. You're going to gamma irradiate again and you're going to inspect it and then you're going to inject it. So if we do it, we are not the only one to be -- someone else can do it, but not everyone.

    在那裡進行奈米研磨(nanomilling)。完成奈米研磨後,你會進行伽瑪射線照射(gamma irradiation)。完成伽瑪照射後,再把它運回來,作為無菌產品進行充填。接著你會再做一次伽瑪照射,然後進行檢驗,最後再注射。所以如果我們能做到,我們也不是唯一能做到的人——其他人也可以做,但不是每個人都能做。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Thanks, Hesham, first line. And maybe just build on some insights we've got as part of the due diligence process talking to physicians. And again, we had insight into the regulatory exchanges as well. So over to you, Hesham.

    謝謝你,Hesham,先從第一線開始。也許再補充一些我們在盡職調查過程中、與醫師交流所獲得的洞見。另外,我們也對監管機關之間的往來溝通有一些了解。那就交給你了,Hesham。

  • Hesham Abdullah - Global Head of Oncology R&D

    Hesham Abdullah - Global Head of Oncology R&D

  • Yes. Thank you, Luke. Yes, I'll start off first by saying, of course, that the Phase I study has actually been recruiting additional patients in that first-line cohort as well, too. I think the key really when we think about first line is the fact that we need the additional follow-up to be able to show that duration of response and that durability of response, which I think is really critical for regulators as well, too.

    是的。謝謝你,Luke。是的,我先說明一下,第一期研究其實也一直在第一線隊列中招募更多病人。我認為談到第一線時,關鍵在於我們需要更多追蹤資料,才能顯示反應持續時間(duration of response)以及反應的持久性(durability of response);我認為這對監管機關也非常重要。

  • With that in mind, I think probably what I would probably focus on and point to is really when we look at the comparisons of the efficacy, especially in this TKI-naive patient population, you look at the duration of response more than 12 months, it's really at about maybe 96% for zidesamtinib versus 74%, of course, for taletrectinib.

    基於這點,我想我會著重並指出的是:當我們比較療效時,特別是在這個未接受過TKI治療(TKI-naive)的病人族群中,若看超過12個月的反應持續時間,其實zidesamtinib大約是96%,而taletrectinib當然是74%。

  • And then, of course, to Luke's point, really had a lot of insight into physician experience with the drug, especially from a tolerability profile perspective as well, too. When we look at, for example, the GI side effects, including the diarrhea, the nausea, the vomiting.

    然後,當然如Luke所說,我們也從醫師對該藥物的使用經驗中獲得很多洞見,尤其是在耐受性特徵方面。例如我們看胃腸道(GI)副作用,包括腹瀉、噁心、嘔吐。

  • And then even, I would say, when we look at some of the CNS side effects as well, too, just given how selective and TrkB sparing the drug is, including on dizziness, where we see, of course, with taletrectinib about the 22% incidence versus 12% only with zidesamtinib as well, too. So I think we feel pretty confident about the first-line approach from a regulatory standpoint. We're expecting a filing probably before the end of the year and then hopefully, a regulatory decision in 2027.

    另外我會說,即使是一些中樞神經系統(CNS)副作用也是如此;考量到該藥物的選擇性很高且可避開TrkB(TrkB sparing),包括頭暈在內,我們看到taletrectinib的發生率約22%,而zidesamtinib只有12%。因此,我們對第一線策略在監管角度上相當有信心。我們預期可能在年底前提出申請,並希望在2027年獲得監管決定。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Great. Konstantin, I think we'll take one online and then we'll go back to the room.

    很好。Konstantin,我想我們先接一個線上問題,然後再回到現場。

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    TD Cowen的Steve Scala。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Relative to the General Medicines guidance decrease, it was in part attributed to the soft environment. I'm curious what emerged in the last three months that led to this softness. Specifically, the company signed the agreement with CMS on June 15. So were there any details of that agreement, which were negative surprises?

    關於一般藥品(General Medicines)指引下修,部分原因歸因於疲弱的外部環境。我想了解過去三個月出現了什麼情況導致這種疲弱。具體來說,公司在6月15日與CMS簽署了協議。那麼該協議是否有任何細節帶來負面意外?

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Nina, could you hear that?

    Nina,你聽得到嗎?

  • Nina Mojas - President - Global Product Strategy

    Nina Mojas - President - Global Product Strategy

  • I think --

    我想--

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • A little bit of an echo.

    有一點回音。

  • Nina Mojas - President - Global Product Strategy

    Nina Mojas - President - Global Product Strategy

  • Yes. Okay. So I think -- so look, this is a portfolio of mature, older assets that continue to be in many regions under pressure, under pricing pressure and generic medicines coming on board. That's one element. The other element is Trelegy.

    是的。好。所以我想——你看,這是一個由成熟、較老的資產所組成的產品組合,在許多地區持續承受壓力,包含價格壓力以及學名藥陸續上市。這是一個因素。另一個因素是Trelegy。

  • And I think you have seen -- we spoke about this in the first quarter already. We do see increased abandonment rates in the US for Trelegy and Trelegy is not the only one. It happens to actually all the assets in the [SIT] class. That is easing definitely. But overall, that level of abandonment, the trajectory is going down, but it's at a higher level than what we have seen in the previous years.

    我想你也看到了——我們在第一季就已經談過。我們確實看到Trelegy在美國的棄療率(abandonment rates)上升,而Trelegy並不是唯一的例子。這其實發生在所有[SIT]類別的資產上。這個情況確實正在緩解。但整體而言,雖然棄療率的走勢在下降,但仍高於我們過去幾年所看到的水準。

  • And to some extent, that is contributing, we mentioned that we expect this to now be removed in the second half. We expect the growth to come back, but it influences the whole year. And I would just ask Julie if she wants to add anything.

    在某種程度上,這也造成影響;我們提到預期這個因素在下半年會消除。我們預期成長會回來,但它會影響全年表現。我也想請Julie看看是否要補充。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • I think that's a perfect summary. We've obviously seen Gen Med under some pressure in Q1 and the pressure increased slightly in Q2. So the full year view reflects that. I think very importantly, we knew Trelegy would be under pressure in the first half and Trelegy has been the asset that's been growing double digits. So it's taken away some of the strength in Gen Med that we had before.

    我覺得這個總結非常到位。我們顯然在第一季看到一般藥品(Gen Med)承受一些壓力,而第二季壓力略有增加。因此全年展望反映了這點。我認為非常重要的是,我們早就知道Trelegy在上半年會承受壓力,而Trelegy一直是雙位數成長的資產。所以它削弱了我們先前在一般藥品上所擁有的一些強度。

  • So in the second half, we're anticipating there'll be less abandonment going on, and we haven't got a tough comp like we had in Q2 because of the rebate and return adjustment. So I think that's the summary.

    因此在下半年,我們預期棄療情況會減少,而且我們也不會像第二季那樣面臨因回扣與退貨調整所造成的高基期。我想這就是總結。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Yes. And there's a little bit of mix, of course, as the COPD component becomes more. Peter.

    是的。當然,隨著COPD組成占比提高,也會有一些產品組合(mix)的影響。Peter。

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Pete Verdult, BNP. Just a few for Tony. Just what time lines are you working to ballpark to get your people into Cambridge? When it comes to this new accelerated R&D strategy, have there been -- and I don't mind if it's not, the answer is no, but have been any notable leadership changes to your team in the last 12 months?

    BNP的Pete Verdult。我有幾個問題想問Tony。你們大概以什麼時間表為目標,把人員搬到劍橋(Cambridge)?關於這個新的加速研發策略,在過去12個月裡,你的團隊是否有任何值得一提的領導層變動?如果沒有也沒關係。

  • And then just specifically, when it comes to your B7 targeting ADCs, they are competitive, we agree with you. But there are a lot of others out there. And in many cases, they're ahead of you. So as part of this accelerated change in late-stage development and the nine studies you're doing, are there any indications you'd call out where you think you could be first to market as a B7-H3 or four targeting ADC?

    另外更具體地說,關於你們鎖定B7的ADC,你們很有競爭力,我們同意。但市場上也有很多其他競爭者。而且在許多情況下,他們走在你們前面。所以作為這次後期開發加速變革以及你們正在進行的九項研究的一部分,有沒有任何適應症是你們認為在B7-H3或B7-H4靶向ADC方面可能率先上市(first to market)的?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Okay. Let me start and Hesham, I'll give you a chance to have a think about where the B7-H3 and four question might go. First of all, in terms of Cambridge, remind me, there was three questions in there. The first question was --

    好的。我先回答,Hesham,我也給你一點時間想想B7-H3和H4那個問題要怎麼回應。首先,關於劍橋,提醒我一下,剛剛有三個問題。第一個問題是--

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Yes, timeframe became --

    是的,時間表是--

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Timeframe, early '29. We want to move the whole group and the first building is up. There are two more to go up, but early '29 is the plan for that. No immediate changes to my team. I've elevated one person.

    時間表是2029年初。我們希望把整個團隊搬過去,第一棟大樓已經蓋好了。還有兩棟要蓋,但計畫是在2029年初完成搬遷。我的團隊沒有立即的變動。我提拔了一位同仁。

  • Our Head of Clin Ops now reports directly to me, and that's all consistent with the way we're operating the business in R&D. She is an experienced leader and somebody we acquired actually from AstraZeneca. So she knows how to find the Cambridge Biomedical Campus.

    我們的臨床營運(Clin Ops)主管現在直接向我匯報,這也符合我們在研發(R&D)端的營運方式。她是一位經驗豐富的領導者,我們其實是從阿斯特捷利康(AstraZeneca)延攬來的。所以她知道怎麼找到劍橋生物醫學園區(Cambridge Biomedical Campus)。

  • And in terms of what you -- where you will see changes, and we will probably introduce you to some of these folks in the second half of the year when we do some of the earlier updates on research are the folks who report through to my colleagues who are here with us today. We continue to hire really exciting new leaders in MD PhDs who are still clinically practicing individuals. These are the folks who are helping us, for example, to integrate across different data layers. So I'm delighted with the progress we're making in really bringing the patient right to the center of our thinking in early research.

    至於你會看到哪些變化——我們可能會在今年下半年、當我們做一些較早期研究更新時,把其中一些同仁介紹給你——主要是向我今天在場的同事匯報的那些人。我們持續招募非常令人振奮的新領導者,他們是MD PhD,且仍在臨床執業。例如,這些人正在協助我們整合不同資料層(data layers)。因此,我對我們在早期研究中真正把病人置於思考核心所取得的進展感到非常高興。

  • In terms then of the ADCs and with regards to acceleration, look, before I give Hesham the opportunity to talk about which of the programs we see as coming first, I think it's worthwhile underscoring what we see as an emerging picture for both molecules, both in terms of their overall quality for response rate and now the first OS data, as you heard from Hesham for Mo-rez, together with an emerging, not yet fully qualified, but I think advantageous selectivity profile.

    那麼就 ADC 而言,並就加速推進這點來看,在我讓 Hesham 有機會談談我們認為哪些計畫會率先推進之前,我認為值得強調的是,我們看到兩個分子正在浮現的整體圖像:不論是在反應率的整體品質方面,以及現在的第一批 OS 數據——正如你從 Hesham 對 Mo-rez 的說明所聽到的——再加上一個正在形成、尚未完全確立,但我認為具有優勢的選擇性特徵。

  • And since Regis is in the room, I'll also mention the fact that our experience with Blenrep has set us up very well with regards to ensuring manufacture of these molecules, which is not the most straightforward proposition. But Hesham, you might talk about some more specifics on where we see acceleration.

    而且既然 Regis 也在場,我也要提到,我們在 Blenrep 上的經驗,讓我們在確保這些分子的製造方面打下了非常好的基礎,因為這並不是最容易的事情。不過 Hesham,你可以再談談我們認為在哪些方面會加速推進的一些更具體內容。

  • Hesham Abdullah - Global Head of Oncology R&D

    Hesham Abdullah - Global Head of Oncology R&D

  • Yes, I'm happy to, Tony. And I think probably starting off first to say -- it's not always about being first. I think there are a number of different variables when we think about these ADCs that we have to take into account. I think the first one really is the type of technology platform that you have. I think we're pretty confident about the fact that we have a well-validated linker payload technology. We're seeing that in the data sets that we're generating.

    好的,Tony,我很樂意。我想先說——並不總是要搶第一。我認為當我們思考這些 ADC 時,有許多不同的變數必須納入考量。第一個其實是你所擁有的技術平台類型。我們對於我們擁有一個經過充分驗證的 linker-payload 技術相當有信心。我們在所產出的數據集中也看到了這一點。

  • I think the second is, you heard me talk a little bit about the fact that we've got -- and Nina touched on this as well, too. We've got different sources of data that not everyone has access to. We've got large amounts of data that have been generated in China with both H3 and H4. And then we're complementing that with the data that we're generating across our own development programs, more than 600 patients for H4, more than 930 for H3. And that gives us unique insight in terms of not only which indications to pursue, which ones not to pursue.

    第二點是,你也聽到我稍微提到——Nina 也有提到——我們擁有一些並非人人都能取得的不同數據來源。我們在中國針對 H3 與 H4 產生了大量數據。接著我們再用我們自身開發計畫所產生的數據來補強:H4 超過 600 名病人,H3 超過 930 名。這讓我們在不僅是要追求哪些適應症、哪些不追求方面,獲得了獨特洞見。

  • And I think the third really is more around how we're thinking about translational strategy. To me, at least, probably, it feels like the most differentiated ADCs across different patient segments or tumors are going to be the ones that could better enhance the treatment effect relative to the ITT, and that comes through a really good understanding of the biology, but also how the drug actually works in the context of not only target expression, but also the linker and the payload and their importance in terms of how sensitive the tumor is to them.

    第三點則更多是關於我們如何思考轉譯策略。至少對我而言,最具差異化、能跨不同病人族群或腫瘤類型的 ADC,將會是那些能相對於 ITT 更好地提升治療效果的產品;而這需要對生物學有非常好的理解,同時也要理解藥物在實際情境中如何發揮作用——不僅是標的表現量,還包括 linker 與 payload,以及它們在腫瘤對其敏感性方面的重要性。

  • And so we've got a multipronged strategy where we're actually looking at a number of different technologies and platforms for biomarkers that we think will certainly be important in that regard. And then, of course, the execution is clear in terms of the pace and the scale, which is important. But I would say probably maybe for B7-H3, the one maybe tumor type that I'd highlight that could be of potential interest and could be differentiated is actually non-small cell lung cancer. We're seeing the data, of course, that was presented at AACR, 47% response rate in combination with PD-L1 in a PD-1 pretreated patient population.

    因此我們採取多管齊下的策略,實際上正在評估多種不同的技術與平台,用於我們認為在這方面必然重要的生物標記。當然,在速度與規模上的執行也很明確,這點很重要。不過我會說,對於 B7-H3 而言,我想特別點出一個可能有潛在興趣、也可能具差異化的腫瘤類型,其實是非小細胞肺癌。我們看到在 AACR 發表的數據:在 PD-1 已治療過的病人族群中,與 PD-L1 聯合治療的反應率為 47%。

  • Again, it's data from China. We have to validate it. We've got ongoing Phase II to do that and help confirm it, but it could certainly be an interesting opportunity that maybe is more unique at least in the short term.

    再次強調,這是來自中國的數據。我們必須加以驗證。我們有正在進行的第二期試驗來做這件事並協助確認,但這確實可能是一個有趣的機會,至少在短期內可能更為獨特。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • And that's probably worthwhile just quickly, particularly for Mo-rez where the data is more advanced. I think it serves to take a look across the various patient characteristics and dose use for our molecule relative to our competitors there to get a sense of what Hesham was talking about in terms of the emerging properties of Mo-rez relative to others.

    這點也值得快速補充一下,特別是對 Mo-rez 而言,因為其數據更為成熟。我認為有必要把我們分子在不同病人特徵與劑量使用情況,與競品做一個橫向比較,以理解 Hesham 所說的:Mo-rez 相較於其他產品正在浮現的特性。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Yes. And I'd also add, we've got a team, the layers below that has a fantastic track record across a number of companies in terms of navigating programs. All right. We've got time for one more question. Simon, then we'll go for a break.

    是的。我也要補充,我們有一個團隊——在其下的各層——在多家公司推動專案方面有非常出色的實績。好。我們還有時間再問一個問題。Simon,然後我們就休息一下。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Simon Baker from Rothschild & Co Redburn. I'll try and be quick. A big picture one on R&D. It's clear that R&D at GSK in five years' time will be in a very different place in every sense of the phrase. But I just wonder if you could give us an idea of the moving parts between the additional resources that's going in, productivity changes.

    我是 Rothschild & Co Redburn 的 Simon Baker。我會盡量簡短。這是一個關於研發(R&D)的宏觀問題。很明顯,五年後的 GSK 研發將在各方面都處於非常不同的位置。但我想知道,你們能否讓我們了解一下其中的變動因素:包括投入的額外資源、以及生產力的變化。

  • And really, the key question is, how are you going to measure that change in improvement? And how will we see that measure improvement beyond simply looking back in eight years and thinking GSK accomplished more than it did in the previous decade. Where sort of where are we now? Or where were we? Where are we now? And where could we be by the end of the decade?

    而真正的關鍵問題是:你們要如何衡量這種改善的變化?以及我們將如何看到這種衡量的改善,而不只是八年後回頭看,覺得 GSK 比前一個十年做得更多。也就是說,我們過去在哪裡?或我們曾經在哪裡?我們現在在哪裡?以及到本十年末我們可能會到哪裡?

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Tony?

    Tony?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Well, that's certainly another 1-minute answer, Simon. So look, I mean, where were we was a very distributed portfolio pointing to opportunities of little value. And you saw that we've transformed that substantially in the past four years. Also that we have a portfolio in which there are a number of meaningful life cycle innovation opportunities so that I'm getting more out of each asset.

    嗯,Simon,這當然又是一個只能用 1 分鐘回答的問題。所以你看,我們過去的狀態是一個非常分散的產品組合,指向一些價值不高的機會。而你也看到,我們在過去四年已大幅轉型。此外,我們現在的產品組合中,有許多具意義的生命週期創新機會,因此我能從每一個資產中取得更多價值。

  • They're moving quicker. We're 25% quicker than we were. We're in upper quartile as far as that's concerned. The decisions that we make about that portfolio and in terms of BD as well are made by exactly the same people who make the decisions on the early-stage portfolio. So you should expect to see the same discernment in terms of highlighting and accelerating assets to that as well. I will share with you at some point in time, if you want, the scorecard on how we evaluate individual areas of the business. I don't have time to go through that in detail right now.

    它們推進得更快。我們比以前快了 25%。就這點而言,我們位於同業的上四分位。我們對該產品組合的決策,以及在 BD(商務開發)方面的決策,都是由做早期產品組合決策的同一批人來做。因此你應該預期,在聚焦並加速資產方面也會有同樣的辨識力。如果你願意,我會在某個時間點與你分享我們如何評估各個業務領域的計分卡。我現在沒有時間詳細說明。

  • What you will see, hopefully, is continued momentum towards the areas of significant opportunity and competitiveness in terms of either pace and for first-in-class or careful decisions for best-in-class agents. And the best way I can illustrate that is through the portfolio that we'll be sharing today. In early stages, I could pick different examples across all of the parts of our business, looking, for example, at how we execute our clinical programs. A case in point might be as we apply more data there, for example, we're expecting to be able to half our study start-up time by the time we get to 2028.

    你將會看到的——希望如此——是我們持續朝向具重大機會與競爭力的領域推進的動能,無論是以速度爭取 first-in-class,或是審慎決策以打造 best-in-class 藥物。我能用來說明這點的最佳方式,就是我們今天將分享的產品組合。在早期階段,我可以從我們業務的各個部分挑不同例子,例如看看我們如何執行臨床計畫。其中一個例子是,隨著我們在那裡應用更多數據,我們預期到 2028 年時,能把研究啟動時間縮短一半。

  • So it would take me the next half an hour, Simon, to go through each one of the segments and give you the simple KPIs that we're using to judge progress there. But I can assure you they are in every single group. They're a relatively small number because I don't like to give people the opportunity to hide behind long lists, and it's extremely data enabled.

    所以,Simon,如果我要逐一走過每個區塊,並告訴你我們用來判斷進展的簡單 KPI,接下來會花我半小時。但我可以向你保證,每一個團隊都有。而且數量相對少,因為我不喜歡給人躲在冗長清單後面的機會;同時這是高度以數據驅動的。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • So the good news, Tony, is you've got 20 minutes at the coffee break to do exactly that. That concludes our first Q&A. If we didn't get your question, please obviously know the people to find, and we'll make sure that we get to your questions in the second round. And of course, we've got time at the end as well. I just want to get -- make sure we capture and get your questions.

    所以好消息是,Tony,你在咖啡休息時間有 20 分鐘可以正好做這件事。我們第一輪問答到此結束。如果我們沒有回答到你的問題,請你當然知道可以去找哪些人,我們會確保在第二輪回答你的問題。當然,我們最後也還有時間。我只是想——確保我們能收集並回答你的問題。

  • So with that, we'll have a break. Thanks, guys. We'll see you back in 20 minutes, at 3:35. It's a less than 20.

    那麼,我們先休息一下。謝謝各位。我們 20 分鐘後回來,3:35 見。不到 20 分鐘。

  • (Break)

    (休息)

  • So welcome back, and I now get to introduce Kaivan, over to you.

    歡迎回來,接下來我來介紹 Kaivan,交給你了。

  • Kaivan Khavandi - Head of R&D

    Kaivan Khavandi - Head of R&D

  • Thanks, Luke. Good afternoon, everyone. My name is Kaivan Khavandi. I'm the Head of R&D at GSK for Respiratory, immunology and Inflammation. GSK is well recognized as the leader in respiratory medicine, having pioneered multiple products across indications, notably asthma and most recently with the launch of Exdensur, the first ultra-long-acting biologic to be launched in airways disease.

    謝謝你,Luke。各位下午好。我叫 Kaivan Khavandi。我是 GSK 呼吸、免疫與發炎領域的研發主管。GSK 在呼吸醫學領域被公認為領導者,已在多個適應症上開創多項產品,尤其是氣喘;而最近推出的 Exdensur,是首個在氣道疾病中上市的超長效生物製劑。

  • However, when we think about the largest remaining unmet need and the sheer scale of opportunity, this is undoubtedly in COPD, which is an area of enduring growth and represents a core focus of our future portfolio.

    然而,當我們思考目前仍未被滿足的最大需求,以及龐大的機會規模時,毫無疑問是在 COPD(慢性阻塞性肺病)。這個領域持續成長,也是我們未來產品組合的核心重點。

  • Similarly, in hepatology, we have an important product launch planned with bepirovirsen for chronic hepatitis B, a rare opportunity to impact population health and where, of course, we're committed to realizing the full breadth and value of that product through its life cycle, including potential combinations, but it's steatotic liver disease, secondary to MASH and alcohol, where we see GSK continuing to innovate with efimesfermin and beyond.

    同樣地,在肝病學方面,我們規劃以 bepirovirsen 用於慢性 B 型肝炎的重要產品上市,這是影響族群健康的難得機會;當然,我們也致力於在其產品生命週期中實現完整的廣度與價值,包括潛在的合併療法。不過,在脂肪性肝病方面,特別是繼發於 MASH 與酒精所致者,我們看見 GSK 將以 efimesfermin 以及後續產品持續創新。

  • What's underappreciated, though, is that these two areas are much more connected than at first apparent, serious chronic diseases with shared underlying inflammatory and fibrotic as well as vascular risk, which frequently coexist. Patients with primary disease of the liver, heart and lung are also at risk of developing secondary pulmonary hypertension, a serious and much more expansive area than idiopathic PAH, for which there is largely no approved treatments.

    但較少被重視的是,這兩個領域的連結遠比表面看起來更緊密:它們都是嚴重的慢性疾病,具有共同的發炎與纖維化基礎,以及血管風險,且常常共存。罹患肝臟、心臟與肺部原發疾病的患者,也有風險發展為繼發性肺高壓;這是一個嚴重且範圍遠比特發性 PAH 更廣的領域,而目前大多沒有核准的治療。

  • Together, these three areas form an unaddressed comorbid access that carries a very high risk of mortality and for which GSK is strongly positioned to lead. So with that background, when we look at recent product developments at GSK, success has been demonstrated really as a consequence of mechanisms that stop the core inflammatory risk relevant to each disease.

    綜合而言,這三個領域形成一個尚未被處理的共病軸線,死亡風險非常高,而 GSK 具備強而有力的領先條件。因此,在這樣的背景下,當我們回顧 GSK 近期的產品發展,成功其實主要來自於:透過機轉阻斷與各疾病相關的核心發炎風險。

  • In areas like asthma and nasal polyps, these are primarily driven by T2 pathways identified by eosinophils and very well served with products like Nucala. Future innovation in these diseases will not come from marginal gains with new mechanisms, but from practical real-world innovation from modalities that can help patients comply and persist on their medicines, enter our ultra-long-acting portfolio with Exdensur and ultra-long-acting TSLP.

    在氣喘與鼻息肉等領域,主要由嗜酸性球所界定的 T2 路徑所驅動,而像 Nucala 這類產品已能很好地滿足需求。這些疾病未來的創新,不會來自於新機轉帶來的些微增益,而是來自於能協助患者在真實世界中遵從並持續用藥的實用創新;這也引出我們的超長效產品組合,包括 Exdensur 與超長效 TSLP。

  • There is one overlooked T2-driven disease, and that's food allergy, where IgE targeting has only recently been shown to be effective and where we rapidly build on that observation and early commercial success with an improved long-acting and potentially best-in-class approach with Ozareprevast. And that takes us to COPD and non-CF bronchiectasis. Whilst an important subset of COPD is T2-driven, most of it is not and a different set of risk factors with distinct inflammatory metabolic and vascular drivers are responsible for disease progression.

    有一個常被忽略、由 T2 驅動的疾病是食物過敏;IgE 標靶治療直到最近才被證實有效。我們將迅速在此觀察與早期商業成功的基礎上,透過 Ozareprevast 以更佳的長效、且可能為同類最佳的策略持續推進。接著就談到 COPD 與非囊性纖維化支氣管擴張症。雖然 COPD 中有一個重要子族群是由 T2 驅動,但大多數並非如此;疾病進展是由另一組風險因子所驅動,具有不同的發炎、代謝與血管驅動因素。

  • Here, we do need mechanistic innovation, and we apply our deep translational insights directly to late-stage product developments, notably with IL-33. This bridges us to pulmonary hypertension that can, of course, result directly as a consequence of COPD, but is a pulmonary vascular disease by definition with mechanisms of risk overlapping with COPD on the left and MASH on the right.

    在這裡,我們確實需要機轉上的創新,並將深厚的轉譯洞見直接應用於後期產品開發,尤其是 IL-33。這也把我們連結到肺高壓:它當然可能直接由 COPD 所導致,但依定義屬於肺血管疾病,其風險機轉與左側的 COPD、以及右側的 MASH 有重疊。

  • So with COPD really at the center in terms of the greatest burden of disease, GSK's competitive advantage and bridging these two worlds of inflammatory risk, let's take a moment to consider the scale of the problem. And it's substantial. You might have heard these stats before, but when you see them contrasted versus enormous established markets like rheumatology, it becomes evident that we're only scratching the surface with only two advanced therapies in one subtype of COPD reserved for late-stage disease.

    因此,COPD 在疾病負擔上居於核心,同時也是 GSK 的競爭優勢所在,並能橋接這兩個發炎風險世界;讓我們花點時間看看問題的規模。而這個規模非常龐大。你可能以前聽過這些統計數字,但當你把它們與像風濕免疫這類已非常成熟、規模龐大的市場對照時,就會發現:我們目前其實只觸及表面——在 COPD 的某一個亞型中,僅有兩種進階治療,而且還是保留給晚期疾病。

  • But with 400 million patients affected globally, over 20 times more patients than RA and 100x more deaths annually, it becomes very clear that multiple product solutions are needed. So what do things look like for a patient with asthma or COPD today? The orange line in the top figure shows exacerbations and with them, the step changes in lung dysfunction, which in asthma leads to disease progression and in COPD brings irreversible loss of lung.

    但全球有 4 億名患者受影響,患者數是類風濕性關節炎(RA)的 20 倍以上,每年死亡人數更是 100 倍;因此非常清楚,我們需要多種產品解決方案。那麼,今天氣喘或 COPD 患者的情況是什麼樣子?上方圖中的橘色線代表急性惡化,以及隨之而來的肺功能階梯式下降;在氣喘中這會導致疾病進展,而在 COPD 中則帶來不可逆的肺功能喪失。

  • And as seen in the red line below, these are associated with surges in mortality. Short-acting biologics today are started late with poor persistence leading to disease progression in asthma and unfortunately, hospitalizations and premature mortality in COPD.

    如下方紅色線所示,這些事件也與死亡率的飆升相關。現今的短效生物製劑往往在較晚期才開始使用,且持續用藥率不佳,導致氣喘疾病進展;而在 COPD 中,不幸地會造成住院與過早死亡。

  • So what's the solution? Well, start biologics sooner and stay on them for longer. If we were able to move from 24 injections a year to just two and provide sustained coverage and protection, that would surely be the way to achieve this. And that's precisely what our portfolio is designed to do with Exdensur launched in asthma and shown in the graph, how we're approaching COPD, a development program that seeks to sustain persistence, but not just at the conventional point of treatment, but with these unique characteristics of the medicine, we have the confidence to start a third Phase III study, VIGILANCE, enrolling patients after just one exacerbations. That's unprecedented for a biologic.

    那解方是什麼?就是更早開始使用生物製劑,並且維持更長時間。如果我們能把一年 24 次注射降到只要 2 次,並提供持續的涵蓋與保護,那無疑是達成目標的方式。而這正是我們產品組合的設計方向:Exdensur 已在氣喘上市,圖中也顯示我們如何推進 COPD——一個旨在維持治療持續性的開發計畫;而且不僅是在傳統的治療時點,憑藉此藥物的獨特特性,我們有信心啟動第三項第三期研究 VIGILANCE,在患者僅發生一次急性惡化後就納入。這對生物製劑而言是前所未見的。

  • So the prior slide showed how Exdensur achieves greater coverage and clinical benefit in patients with T2 inflammation through earlier management, and that's illustrated in the rubric here by extending across the grid horizontally. But I mentioned that in COPD, we do need more mechanistic innovation to achieve greater coverage across different populations who have different types of inflammation, and that's illustrated by extending vertically up the grid.

    前一張投影片說明 Exdensur 如何透過更早期的管理,在具有 T2 發炎的患者中達到更廣的涵蓋與臨床效益;在此框架中,這體現在沿著橫向延伸。但我也提到,在 COPD 中,我們需要更多機轉創新,才能在不同族群(其發炎型態不同)之間達到更廣的涵蓋;這體現在沿著縱向向上延伸。

  • Nucala was the first biologic to achieve a broader label owing to metrics, which studied lower eosinophil levels, while MATINEE came in and showed efficacy for the most clinically impactful events, emergency department visits. TSLP is a mechanism that by design is able to extend into intermediate T2 inflammation and where data indicates efficacy in those with eosinophils as low as 150 but not lower.

    Nucala 是第一個因為研究較低嗜酸性球水準等指標而取得更廣適應症標示的生物製劑;而 MATINEE 的結果則顯示,對臨床影響最大的事件——急診就醫——具有療效。TSLP 這個機轉在設計上能延伸到中等程度的 T2 發炎;資料顯示,對嗜酸性球低至 150 的患者有效,但再更低則不顯示效益。

  • And that takes us to IL-33, where we probably need to ignore eosinophils altogether as this mechanism cuts COPD in a fundamentally different way, and that's easier to visualize. All patients with COPD have innate immune dysfunction and a propensity to T1 and T17 inflammation. These patients are older than those with asthma, they're sicker and they have a high burden of vascular and metabolic disease represented on the right-hand side of the slide.

    接著來到 IL-33:這裡我們可能需要完全不去看嗜酸性球,因為這個機轉是以根本不同的方式切入 COPD,且更容易視覺化理解。所有 COPD 患者都有先天免疫功能失調,並傾向於 T1 與 T17 發炎。這些患者比氣喘患者年長、病情更重,且合併高負擔的血管與代謝性疾病,如投影片右側所示。

  • A proportion of these patients have truly high T2 risk and a further group have mixed intermediate levels. This is the orange and middle overlap segments of the slide. And this risk is well addressed with IL-5 and TSLP biologics, respectively. But how do we get to the backbone of pathobiology in COPD, the blue plane in the slide?

    其中一部分患者具有真正高的 T2 風險,另有一群則呈現混合的中等程度。這對應到投影片中的橘色與中間重疊區段。而這些風險分別可由 IL-5 與 TSLP 生物製劑良好處理。但我們要如何觸及 COPD 病理生物學的骨幹——也就是投影片中的藍色平面?

  • Well, a single, dual or even triple cytokine approach won't be the answer if they're targeting the wrong biology. This is where we need to get to the tissue, vascular and structural damage that results from repeat injury at the root of COPD.

    如果標的生物學本身就不對,那麼單一、雙重甚至三重細胞激素策略都不會是答案。我們需要直達組織、血管與結構性損傷——這些損傷源自反覆受傷,是 COPD 的根本。

  • IL-33 is expressed primarily on lung epithelial and vascular endothelial cells, the dynamic barrier lining the airways and blood vessels. These are the first tissues to be exposed to and then attempt to respond to inflammatory injury and our translational insights reveal how and when IL-33 governs this therapeutically untapped space. And so we're very excited to have a potentially best-in-class long-acting and Phase III-ready products, which will be deployed with the benefits of this deeper understanding.

    IL-33 主要表達於肺部上皮細胞與血管內皮細胞上,這些細胞構成覆蓋氣道與血管的動態屏障。它們是最先暴露於發炎性損傷、並嘗試做出反應的組織;而我們的轉譯研究洞見揭示了 IL-33 如何以及在何時主導這一尚未被治療性開發的領域。因此,我們對於擁有一項可能同級最佳(best-in-class)、長效且已具備第三期(Phase III)就緒條件的產品感到非常振奮,該產品將在這份更深入理解所帶來的效益下被推進應用。

  • We predicted the early success now shown clinically for anti-IL-33 when stratifying based on mucus score. With the luxury of what we believe to be the most complete set of respiratory data anywhere in the world, over 1,000 randomized controlled trials, several million patients with deep genetic and cellular profiling and of course, clinical interventional data in COPD with our product, we've designed pivotal studies based on patient profiles most likely to respond to IL-33.

    我們在依據黏液評分(mucus score)進行分層時,已預測到如今在臨床上所展現的抗 IL-33 早期成功。憑藉我們所擁有、我們相信是全球最完整的呼吸系統資料集——超過 1,000 項隨機對照試驗、數百萬名患者的深度基因與細胞層級剖析,當然也包括我們產品在 COPD 的臨床介入數據——我們已根據最可能對 IL-33 產生反應的患者特徵設計關鍵性研究。

  • These will include factors related to stage of disease by which I mean lung function, distinct from disease severity defined by exacerbation history and other traits and tested against new clinically important outcomes that can differentiate the product. Without disclosing too much, what I can share is that one of these pivotal study starts includes a cardiorespiratory outcome study, which we will start next year in partnership with a major cardiovascular academic research organization.

    這些研究將納入與疾病分期相關的因素——我指的是肺功能——並與以急性惡化史及其他特徵所定義的疾病嚴重度加以區分,同時以新的、具臨床重要性的結局指標進行檢驗,以便區隔並凸顯產品差異化。在不透露過多細節的前提下,我可以分享的是,其中一項關鍵性研究的啟動內容包含一項心肺結局研究,我們將於明年與一家主要的心血管學術研究機構合作啟動。

  • In parallel, we will complete our Phase II study in non-CF bronchiectasis, an enormous market with no approved biologics and where we're positioned to be best-in-class with IL-33 as well as testing combinations with TSLP, which our AI-enhanced models predict could provide synergistic efficacy. So we're looking forward to coming out of IL-33 stealth with conviction and material differentiation.

    同時,我們將完成非囊性纖維化(non-CF)支氣管擴張症的第二期(Phase II)研究;這是一個龐大市場,目前尚無核准的生物製劑,而我們在 IL-33 上具備成為同級最佳的定位,並將測試與 TSLP 的聯合方案;我們的 AI 強化模型預測該組合可能帶來協同療效。因此,我們期待以堅定信心與實質差異化,走出 IL-33 的「隱身」狀態。

  • Our ultra-long-acting TSLP program has been significantly accelerated by nine months across three indications, now positioning this asset to start six pivotal Phase III studies, the PERSIST program integrating data from a GSK-sponsored Phase II study in asthma, the NASER study, alongside data from our partner, Hengrui, who studied nasal polyps.

    我們的超長效(ultra-long-acting)TSLP 計畫在三個適應症上整體加速了九個月,現已使該資產具備啟動六項第三期關鍵性研究的條件;PERSIST 計畫將整合 GSK 贊助之氣喘第二期研究(NASER 研究)的數據,以及我們合作夥伴恆瑞(Hengrui)在鼻息肉所進行研究的數據。

  • This gives us dosing and pharmacodynamic data to confidently advance the first ultra-long-acting TSLP across all major indications, asthma, nasal polyps and COPD. Our BD strategy to access derisked mechanisms with a high likelihood of success allows us to jump directly to testing for product differentiation rather than mechanistic relevance. And this is reflected in our deal since January.

    這使我們獲得給藥與藥效動力學(pharmacodynamic)數據,得以有信心地推進首個超長效 TSLP,涵蓋所有主要適應症:氣喘、鼻息肉與 COPD。我們的 BD(商務拓展)策略是取得已去風險(derisked)、成功機率高的作用機制,使我們能直接跳到產品差異化的測試,而非僅驗證機制相關性。這也反映在我們自今年一月以來所完成的交易之中。

  • Ozarepubart builds on the proven efficacy of IgE in food allergy and CSU, but provides materially broader eligibility for those 25% of patients contraindicated for Xolair because of their weight or high IgE levels and an optimized solution for all with three monthly dosing. This will be transformative for the prevalent adolescent population and children. This class has had a remarkable first launch within the first two years with Xolair, now Roche's fastest-growing product and ozure is positioned to provide an objectively improved profile whilst benefiting from that momentum.

    Ozarepubart 建立在 IgE 於食物過敏與慢性自發性蕁麻疹(CSU)中已被證實的療效之上,但可為因體重或 IgE 水平過高而不適用 Xolair 的 25% 患者提供顯著更廣的適用性,並以每月三次給藥為所有患者提供更優化的解決方案。這將對高盛行率的青少年族群與兒童帶來變革性影響。該類別在上市前兩年即由 Xolair 取得顯著的首發表現,現已成為羅氏(Roche)成長最快的產品;而 ozure 有望在承接此一動能的同時,提供客觀上更佳的產品特性。

  • This overlooked space has understandably garnered interest and activity since our deal, but Ozure is the most advanced next-generation product with clinical efficacy data in CSU, which importantly included an active arm with Xolair, which didn't perform as well as Ozure. The program is rapidly enrolled in Phase II and has now recruited the sample size necessary to progress to an interim analysis, which will enable Phase III start in both food allergy and CSU by the end of 2027.

    自我們完成交易以來,這個先前被忽視的領域理所當然地吸引了更多關注與投入,但 Ozure 是最先進的下一代產品,且已在 CSU 中取得臨床療效數據;重要的是,該研究包含一個使用 Xolair 的主動對照組,而其表現不如 Ozure。該計畫在第二期(Phase II)快速完成收案,現已招募到足以進行期中分析(interim analysis)的樣本數,這將使我們能在 2027 年底前於食物過敏與 CSU 兩個適應症啟動第三期(Phase III)研究。

  • For HS235, we build on a new and transformative class of activin traps in pulmonary arterial hypertension, but with an improved molecule that can both remove the liabilities of the incumbents in Group 1 PH, namely bleeding, but what's equally exciting is the potential to unlock the full value of the mechanism, which extends to reducing inflammation, insulin resistance and reducing visceral fat, all of which are substantial drivers of risk in Group II and Group III pulmonary hypertension secondary to chronic heart and lung disease.

    針對 HS235,我們以肺動脈高壓(pulmonary arterial hypertension)中一個全新且具變革性的 activin trap 類別為基礎,但採用一個改良分子,既能消除現有產品在第 1 群肺高壓(Group 1 PH)中的負擔(liabilities),亦即出血風險;同樣令人振奮的是,有機會釋放該機制的完整價值,其效益可延伸至降低發炎、改善胰島素阻抗並減少內臟脂肪——這些皆是第 2 群與第 3 群肺高壓(繼發於慢性心肺疾病)的重大風險驅動因子。

  • Whilst this program is relatively earlier than other products being presented, we've seen evidence to support both the safety and efficacy profile described in the Phase Ib study. And I can share today that we've rapidly converted this post deal to Phase IIb starts that have now been initiated for both Group 1 and Group 2 pulmonary hypertension.

    雖然相較於其他正在展示的產品,該計畫仍屬較早期,但我們已在 Ib 期(Phase Ib)研究中看到證據,支持前述的安全性與療效特性。我今天也可以分享的是,我們在交易後迅速將其推進至 IIb 期(Phase IIb)啟動,且目前已針對第 1 群與第 2 群肺高壓皆已開始。

  • And that takes us to our hepatology portfolio. Put succinctly, our portfolio is pointed to the three major causes of liver-related cirrhosis and mortality, chronic hepatitis B, metabolic dysfunction-associated steatohepatitis and alcohol-related liver disease.

    接下來談到我們的肝病(hepatology)產品組合。簡而言之,我們的組合聚焦於造成肝硬化與肝相關死亡的三大主因:慢性 B 型肝炎、代謝功能障礙相關脂肪性肝炎(MASH)以及酒精相關肝病。

  • All of these diseases have poor outcomes and inadequate standard of care. There's no approved treatments for alcohol-related liver disease, one liver-directed treatment for MASH and no therapies that can drive cure in hepatitis B. Let's start with bepirovirsen, our first-in-class ASO for hepatitis B. Our program was ambitious, designed with the primary endpoint of functional cure, the very highest bar. This is best illustrated in the comparator arm in B-well, where what's labeled as placebo actually represents the standard of care, 48 weeks of treatment with a nucleoside or nucleotide analog.

    這些疾病的預後皆不佳,且現行標準治療不足。酒精相關肝病沒有任何核准治療;MASH 僅有一種肝臟導向治療;而 B 型肝炎則沒有能推動治癒(cure)的療法。先從 bepirovirsen 談起,這是我們用於 B 型肝炎、同級首創(first-in-class)的 ASO。此計畫相當具企圖心,將主要終點設為功能性治癒(functional cure),也就是最高門檻。這點在 B-well 的對照組最能說明:標示為安慰劑(placebo)的組別,實際上代表標準治療——以核苷(nucleoside)或核苷酸(nucleotide)類似物治療 48 週。

  • And in that group, we saw 0 patients achieved the primary endpoint, functional cure in the ITT population. 0 patients achieved functional cure in those with baseline surface antigen levels less than 1,000 and 0 patients achieved an effect with surface antigen levels under 100, which will be consistent with the definition of partial cure.

    在該組中,我們看到在 ITT(意向治療)族群中,達成主要終點(功能性治癒)的患者為 0 人;在基線表面抗原(surface antigen)水平低於 1,000 的患者中,達成功能性治癒者亦為 0 人;在表面抗原水平低於 100 的患者中,也有 0 人達到效果,而這一門檻將符合部分治癒(partial cure)的定義。

  • In comparison, bepi achieved 19% cure in the ITT population, 26% in those with surf antigen at baseline less than 1,000. And importantly, when you include partial cure, a response that's been reported in population studies to improve long-term outcomes, almost one in two patients studied in the ITT population received a response that would predict clinical benefits. And that increases to 62% in those with surface antigen levels less than 1,000 at baseline.

    相較之下,bepi 在 ITT 族群中達到 19% 的治癒率;在基線表面抗原低於 1,000 的患者中為 26%。且重要的是,若將部分治癒納入——這種反應在族群研究中已被報告可改善長期預後——在 ITT 族群中,幾乎每兩位受試者就有一位出現可預測臨床效益的反應。而在基線表面抗原低於 1,000 的患者中,該比例提高至 62%。

  • Of note, this opportunity consolidates in three key markets: China, US and Japan. You can see the epi and scale of the opportunity on the slide in the bottom left, which is vast. So a very exciting opportunity reflected in a suite of expedited regulatory designations setting up near-term expected marketing authorizations and product launches. And then efimosfermin, our potentially best-in-class FGF21 analog in an area of major unmet need in steatotic liver disease.

    值得注意的是,這項機會主要集中於三個關鍵市場:中國、美國與日本。你可以在投影片左下角看到該機會的流行病學(epi)與規模(scale),其市場空間非常龐大。因此,這是一個非常令人振奮的機會,也反映在一系列加速審評的監管認定上,為近期可望取得上市許可與產品上市鋪路。接著是 efimosfermin——我們在脂肪性肝病這一重大未滿足需求領域中,可能同級最佳(best-in-class)的 FGF21 類似物。

  • Let's start with the class. On the left, in F2-F3 MASH, you can see greater benefit on improvements in fibrosis with FGF21 analogs when compared indirectly across studies with GLP-1 agonists, such as semaglutide and thyroid hormone agonist, resmetirom.

    先從這個類別談起。在左側的 F2-F3 MASH 中,你可以看到,FGF21 類似物在纖維化改善方面的效益更大;若跨研究進行間接比較,其表現優於 GLP-1 促效劑(如 semaglutide)以及甲狀腺荷爾蒙促效劑 resmetirom。

  • Moving to the right in cirrhotic MASH, where currently there's no approved treatments, you can see placebo adjusted changes that are unprecedented with this class, showing the ability to reverse histological fibrosis and move the patient from cirrhotic to non-cirrhotic disease. In contrast, semaglutide showed directionally worse effects versus placebo.

    再看右側的肝硬化型 MASH,目前尚無核准治療;你可以看到此類別在安慰劑校正後的變化幅度前所未見,顯示其具備逆轉組織學纖維化的能力,並可使患者由肝硬化狀態轉為非肝硬化疾病。相較之下,semaglutide 的效果方向上反而較安慰劑更差。

  • And then within the class, we selected efimosfermin over other products, all available at the time of acquisition based on its best-in-class credentials with monthly versus weekly or biweekly dosing regimens. And since the deal, efimosfermin has reported the fastest observed signal for an antifibrotic benefit of any in the class with fibrosis biomarkers improving as soon as four weeks after treatment and for which we've designed our pivotal program to substantiate as a potential additional differentiator.

    而在同一類別中,我們在收購時於當時可取得的其他產品之中選擇了 efimosfermin,原因在於其同級最佳的條件:採每月給藥,而非每週或每兩週的給藥方案。自交易完成以來,efimosfermin 已呈現該類別中目前觀察到最快的抗纖維化效益訊號——纖維化生物標記在治療後最早 4 週即出現改善;我們也據此設計了關鍵性計畫,以驗證其作為潛在額外差異化優勢。

  • For all these reasons, we're committed to realizing the full value of this potentially transformative product, seeing us initiate the ZENITH studies to F2/F3 MASH, both recruiting since earlier this year. And we have now initiated the F4 cirrhotic MASH program, the NEBULA studies only in the last two weeks.

    基於所有這些原因,我們致力於實現這項具潛在變革性的產品之全部價值,因此我們啟動了針對 F2/F3 MASH 的 ZENITH 研究,兩項研究自今年稍早起即已開始招募。而我們也在過去兩週內啟動了針對 F4 肝硬化型 MASH 的計畫,即 NEBULA 研究。

  • And our Phase II study in alcohol-related liver disease, ALL-STAR has just had IND approved and will start this year. So a portfolio of specialty products pointed to serious and prevalent diseases with renewed discipline to truly focus on areas of greatest commercial value and in turn, prioritize and accelerate those programs. Unprecedented data for bepirovirsen, which resets the bar of efficacy in chronic hepatitis B with functional and partial cure where the standard of care fails to achieve either.

    此外,我們在酒精相關肝病的第二期研究 ALL-STAR 也剛獲得 IND 核准,並將於今年啟動。因此,我們建立了一個聚焦於嚴重且常見疾病的專科產品組合,並以重新強化的紀律真正聚焦於商業價值最高的領域,進而優先排序並加速這些計畫。Bepirovirsen 的數據前所未見,將慢性 B 型肝炎的療效門檻重新拉高,達到功能性治癒與部分治癒,而現行標準治療兩者皆無法達成。

  • A portfolio in COPD that will provide modality and mechanistic innovation providing greater coverage and protection for a disease that's the third leading cause of death globally and with material acceleration of programs like ultra-long-acting TSLP and with both molecule and potential evidence and claims differentiation for our best-in-class long-acting IL-33.

    在 COPD 方面,我們的產品組合將帶來治療模式與機轉上的創新,為這個全球第三大死因的疾病提供更廣的涵蓋與保護;同時也將像超長效 TSLP 等計畫實質加速推進,並且我們的同級最佳長效 IL-33 在分子層面以及潛在證據與主張上都具備差異化。

  • Efimosfermin advancing at speed across a comprehensive Phase III program, which will capture the unique breadth and potential for this mechanism across all stages and etiologies of steatotic liver disease, F2 and F3 MASH, cirrhotic F4 MASH, alcohol-related liver disease and actually potentially beyond with a molecule that has best-in-class properties.

    Efimosfermin 正以快速步伐推進一個全面性的第三期計畫,將捕捉此一機轉在脂肪性肝病各分期與各種病因上的獨特廣度與潛力,包括 F2 與 F3 MASH、肝硬化型 F4 MASH、酒精相關肝病,甚至可能延伸至更多領域;而這是一個具同級最佳特性的分子。

  • And a portfolio enhanced by BD deals that bring best-in-class products, derisked mechanisms and which all fits within an axis of disease that physicians recognize that has yet to be applied to drug development. And that's a gap that GSK is uniquely positioned to address.

    此外,我們的產品組合也透過 BD 交易而更為強化,帶來同級最佳產品與已去風險化的機轉,且這些都契合於一條醫師所熟悉、但尚未被應用於藥物開發的疾病軸線。而這正是 GSK 具備獨特優勢、能夠補上的缺口。

  • With that, I will hand over to my colleague, Sanjay, to cover vaccines.

    接下來,我將交棒給我的同事 Sanjay,來介紹疫苗。

  • Sanjay Gurunathan - Head, Global Vaccines & Infectious Disease Unit in R&D

    Sanjay Gurunathan - Head, Global Vaccines & Infectious Disease Unit in R&D

  • Thank you, Kaivan. Good afternoon, everyone. My name is Sanjay Gurunathan. I head the Global Vaccines and Infectious Disease Unit in R&D. Vaccines have a massive impact on public health.

    謝謝你,Kaivan。各位下午好。我叫 Sanjay Gurunathan。我負責研發部門的全球疫苗與感染性疾病事業單位。疫苗對公共衛生有巨大的影響。

  • That's not new. We've known that for decades that preventing disease takes real pressure of health systems. But here's the thing. The science and economics around vaccines are shifting. They are pointing to something much bigger than we give them credit for.

    這並不新鮮。數十年來我們都知道,預防疾病能大幅減輕醫療體系的壓力。但關鍵在於:疫苗相關的科學與經濟學正在轉變。它們指向的價值遠比我們過去給予的評價更大。

  • So let's dig into why this is the case. Here's a stat that always surprises people. Vaccines make up a tiny slice of our health care spending, less than 1% of the health care budget in high-income countries. And yet that investment -- return on investment is roughly 19 times of what you put in. We already know how valuable it is to prevent an infection. What's missing in the economics is the big picture. The benefits that go beyond preventing the disease a vaccine was designed to stop.

    讓我們深入探討為何如此。有一個統計數據總是讓人驚訝。在高收入國家,疫苗僅占醫療支出的一小部分,不到醫療預算的 1%。然而,這項投資——其投資報酬率約為投入的 19 倍。我們早已知道預防感染有多麼有價值。但在經濟評估中缺少的是整體視角。也就是超越疫苗原本設計用來預防之疾病本身的額外效益。

  • And let's think about that. That could be worth a lot. But if it's not on the label, it doesn't count towards how a vaccine gets assessed or reimbursed. The science is starting to catch up. We used to think of an infection as something that happens and then passes. It turns out that's not the whole story. A lot of infections go dormant in the body, and some of them seem to be tied to long-term health effects, even chronic disease down the road.

    我們來想想這件事。那可能非常有價值。但如果沒有寫在標籤上,就不會被納入疫苗的評估或給付(報銷)考量。科學正在開始追上這個問題。我們過去把感染視為發生後就會過去的事件。事實證明,故事並不只有這樣。許多感染會在體內潛伏,而其中一些似乎與長期健康影響相關,甚至在未來導致慢性疾病。

  • So preventing that initial infection might do a lot more than we thought. It could lower your risk of things like heart disease and dementia later in life. So the opportunity here is simple. We need to build the evidence that turns this potential into something that's recognized and reimbursed.

    因此,預防最初的感染可能帶來的效益遠超過我們原先的想像。它可能降低你日後罹患心臟病與失智症等疾病的風險。所以這裡的機會其實很簡單。我們需要建立證據,把這種潛力轉化為能被認可並獲得給付的價值。

  • And GSK is in a great spot to lead on this. We have already a broad, well-established vaccine portfolio, Shingrix, RSV, flu vaccines, a strong meningitis franchise and a deep lineup of pediatric and travel vaccines. But more importantly, there's real room to expand beyond what these vaccines can already achieve. Shingrix is our best example of this. We have a huge amount of real-world experience. Over 116 million adults have been vaccinated with Shingrix since it was launched nearly a decade ago.

    而 GSK 正處於領先的有利位置。我們已擁有廣泛且成熟的疫苗產品組合,包括 Shingrix、RSV、流感疫苗、強大的腦膜炎產品線,以及深厚的兒科與旅遊疫苗布局。但更重要的是,這些疫苗在既有成就之外,仍有實質擴展空間。Shingrix 是我們最好的例子。我們累積了大量真實世界使用經驗。自近十年前上市以來,已有超過 1.16 億名成人接種 Shingrix。

  • This growing body of evidence that herpes viruses, including herpes zoster, the virus that causes shingles can influence cognitive decline. So why would that be the case? Well, the shingles virus doesn't actually go away after a chickenpox infection. It just goes dormant hiding out in the brain neurons. When it wakes back up, it can start local inflammation, and that inflammation seems to play a role in cognitive decline over time.

    越來越多的證據顯示,疱疹病毒(包括帶狀疱疹,即引起帶狀疱疹的病毒)可能影響認知衰退。那為什麼會這樣?其實,帶狀疱疹病毒在水痘感染後並不會真正消失。它只是進入潛伏狀態,藏在腦部神經元中。當它再次被喚醒時,可能引發局部發炎,而這種發炎似乎會隨時間推移在認知衰退中扮演角色。

  • So by keeping the virus from reactivating in the first place, Shingrix may end up slowing down that decline. But there's likely more to the story. We think Shingrix's adjuvant AS01 might be doing some extra work behind the scenes beyond just blocking viral activation. it could possibly be dialing down inflammation more broadly, including the kind of age-related inflammation that builds up in the brain.

    因此,若能一開始就阻止病毒再活化,Shingrix 可能最終有助於放緩這種衰退。但故事很可能不只如此。我們認為 Shingrix 的佐劑 AS01 可能在幕後做了更多工作,不僅僅是阻斷病毒活化;它也可能更廣泛地降低發炎,包括在大腦中逐漸累積的、與老化相關的發炎。

  • If that's right, it could mean Shingrix is nudging the whole trajectory of neuroinflammation in a healthier direction. We've now seen through several observational studies, risk reductions of dementia symptoms up to 50%. This signal is now being put to test in two big pragmatic studies in Finland and Denmark, covering around 200,000 people with results expected from 2029.

    如果這點成立,可能意味著 Shingrix 正在把整體神經發炎的軌跡推向更健康的方向。我們目前已透過多項觀察性研究看到,失智症狀風險最多可降低 50%。這個訊號目前正在芬蘭與丹麥兩項大型務實性研究中接受檢驗,涵蓋約 20 萬人,預計 2029 年出結果。

  • We're not only seeing this as how Shingrix affects neuroinflammation, but as we go to the next slide, when we look at cardiovascular risk, it gets even more interesting on Shingrix's broader protective effects. real-world data from several independent sources, Veterans Affairs, Kaiser, Optum, TrNIDEXX, all point the same way.

    我們不僅從 Shingrix 對神經發炎的影響來看待此事;如同下一張投影片所示,當我們觀察心血管風險時,Shingrix 更廣泛的保護效果就更引人入勝。來自多個獨立來源的真實世界數據——退伍軍人事務部(Veterans Affairs)、Kaiser、Optum、TrNIDEXX——都指向相同方向。

  • Older adults who got Shingrix saw about a 25% drop in major adverse cardiovascular events or MACE. So why should that be? It turns out the shingles virus itself isn't exactly harmless to your blood vessels. It can damage them, spur up inflammation and even trigger clotting, all of which nudge up your risk of stroke and heart attacks. We think Shingrix, thanks to our AS01 adjuvant, might also be doing some quiet work behind the scene, calming inflammation and potentially bending the curve on chronic diseases in older adults.

    接種 Shingrix 的高齡成人,其重大不良心血管事件(MACE)約下降 25%。那為什麼會這樣?事實上,帶狀疱疹病毒對血管並非完全無害。它可能損傷血管、促發發炎,甚至引發凝血,這些都會推升中風與心肌梗塞的風險。我們認為 Shingrix 透過我們的 AS01 佐劑,也可能在幕後悄悄發揮作用,緩和發炎,並可能改變高齡族群慢性疾病的走勢。

  • So what does this all mean? This matters a lot. Cardiovascular disease is expected to nearly double by 2050 with costs in the US alone set to top over $400 billion a year. We believe the real-world evidence you're seeing on this slide is compelling enough that we are launching a formal Phase III randomized controlled trial this year to nail down whether this is actually causal, not just correlation. We expect the study to start soon.

    那這一切代表什麼?這非常重要。預期到 2050 年,心血管疾病幾乎將倍增,而僅美國的成本就可能超過每年 4,000 億美元。我們相信你在這張投影片上看到的真實世界證據具足夠說服力,因此我們將於今年啟動一項正式的第三期隨機對照試驗,以釐清這是否為因果關係,而不只是相關性。我們預期研究將很快開始。

  • Another opportunity to improve outcomes in older adults is to prevent influenza infection. This disease burden of influenza is significant in adults -- in older adults with the majority of hospitalizations occurring in older adults. It's a segment we have not previously competed in. We know from published literature that influenza vaccination reduces cardiovascular disease burden and respiratory complications, underpinning the theme of broadening the protective effects of vaccine, especially in older adults.

    另一個改善高齡成人健康結果的機會,是預防流感感染。流感在成人中的疾病負擔相當顯著——而在高齡成人中更為明顯,因為多數住院病例發生在高齡成人。這是我們過去尚未競爭過的領域。我們從已發表的文獻得知,流感疫苗接種可降低心血管疾病負擔與呼吸道併發症,呼應我們擴大疫苗保護效益的主題,尤其是在高齡成人族群。

  • As you can see from this visual, currently available flu vaccine effectiveness has varied from 20% to 60% over the past 15 flu seasons, illustrating why there's a true unmet need to improve flu vaccine effectiveness. We believe there's an opportunity using our mRNA technology to establish benefit over current standard of care. We can optimally leverage this technology, its differentiating characteristics to develop our next best-in-class flu vaccine.

    如同這張圖所示,目前可用的流感疫苗有效性在過去15個流感季介於20%到60%之間波動,說明為何提升流感疫苗有效性確實存在重大的未被滿足需求。我們相信,運用我們的mRNA技術有機會在現行標準治療之上建立更佳效益。我們可以最佳化運用這項技術及其差異化特性,開發我們下一代同類最佳的流感疫苗。

  • We will present our positive Phase II results at the Options meeting next month, where you'll hear the exciting data. So let me conclude. What's our focus and where is our focus? Our focus is expanding the role of vaccines, the vaccines play in helping older adults living a longer and healthier life. If you can back that up with strong clinical outcome data and a real understanding of the biology behind it, it could support future labels that reflect these broader benefits.

    我們將在下個月的Options會議上發表我們正向的第二期結果,屆時各位將聽到令人振奮的數據。那麼我來做個總結。我們的重點是什麼?我們的重點在哪裡?我們的重點是擴大疫苗在協助高齡成人活得更長、更健康方面所扮演的角色。如果能以強而有力的臨床結局數據以及對其背後生物學的真正理解來支持,將有助於未來的標籤能反映這些更廣泛的效益。

  • And that changes things. It gives health care professionals more confidence to recommend vaccination and give more people reason to get vaccinated no matter what their current health status is. What really excites us is the growing signs connecting infection to chronic disease. It makes an already strong economic case for vaccination even stronger. Opens up new opportunities across our portfolio. And thanks to Shingrix, it gives us a real working example of how to unlock that value and help shift the trajectory of chronic diseases for older adults.

    而這會改變局面。它讓醫療專業人員更有信心推薦接種,也讓更多人無論目前健康狀況如何,都有理由去接種疫苗。真正令我們振奮的是,越來越多跡象顯示感染與慢性疾病之間存在關聯。這讓原本就很強的疫苗接種經濟論證變得更強。也為我們的產品組合開啟新的機會。而且多虧了Shingrix,我們有一個真正可運作的案例,展示如何釋放那個價值,並協助改變高齡成人慢性疾病的發展軌跡。

  • It's now my pleasure to hand over to Charlotte, who will talk to you about our HIV business.

    現在我很高興把時間交給Charlotte,她將向各位介紹我們的HIV業務。

  • Charlotte Allerton - Head, R&D & CSO for ViiV Healthcare

    Charlotte Allerton - Head, R&D & CSO for ViiV Healthcare

  • Thank you, Sanjay. I am Charlotte Allerton, Head of R&D and CSO for ViiV Healthcare at GSK. Despite decades of progress, HIV remains a major unmet public health challenge. More than 40 million people are living with HIV globally. And in the US, around 30% of people diagnosed with HIV are not virally suppressed, equating to approximately 400,000 people, the majority of whom are still taking daily oral antiretroviral medications as their standard of care.

    謝謝你,Sanjay。我是Charlotte Allerton,GSK旗下ViiV Healthcare的研發負責人暨首席科學官(CSO)。儘管數十年來取得進展,HIV仍是一項重大的未被滿足公共衛生挑戰。全球有超過4,000萬人與HIV共存。在美國,約有30%的HIV確診者未達到病毒抑制,約等於40萬人,其中多數仍以每日口服抗反轉錄病毒藥物作為其標準治療。

  • Real-world barriers such as adherence and stigma continue to negatively affect health outcomes, quality of life and transmission risk, reinforcing the need for long-acting medicines that address these challenges while delivering public health benefits and significant revenue growth. Treatment represents 90% of the current HIV market, the largest unmet medical need and remains our priority. By 2035, we expect this market to be worth approximately GBP25 billion, with growth driven by uptake of new long-acting regimens despite daily oral generics entry and pricing pressure.

    真實世界的障礙(如用藥依從性與汙名)持續對健康結果、生活品質與傳播風險造成負面影響,強化了對長效藥物的需求:這些藥物在帶來公共衛生效益的同時,也能解決上述挑戰並推動顯著的營收成長。治療占目前HIV市場的90%,也是最大的未被滿足醫療需求,並仍是我們的優先事項。我們預期到2035年,該市場規模約為250億英鎊,成長動能來自新型長效療法的採用,儘管每日口服學名藥進入市場並帶來定價壓力。

  • For prevention, we expect this market to be worth approximately GBP6 billion by 2035. Across both treatment and prevention, long-acting injectables are the fastest-growing segment, and we are leading this market transformation from daily oral to long-acting HIV care that improves patient experience, supports adherence and drive sustained competitive growth. We have been at the forefront of HIV innovation for nearly four decades, leading transformational changes in patient care through the first two drug oral therapies and then Cabenuva and Apretude, the first-to-market long-acting injectables for treatment and prevention.

    在預防方面,我們預期到2035年該市場規模約為60億英鎊。在治療與預防兩個領域中,長效注射劑是成長最快的區隔;我們正引領市場從每日口服轉向長效HIV照護的轉型,改善病患體驗、支持依從性,並推動可持續的競爭性成長。近四十年來,我們一直站在HIV創新的最前線,透過首批兩種口服藥物療法,以及Cabenuva與Apretude——分別為治療與預防的首款上市長效注射劑——引領病患照護的變革性改變。

  • Our current portfolio and future pipeline are built on the foundation of integrase strand transfer inhibitors, or INSTIs, which are trusted by health care providers worldwide due to their superior efficacy, long-term tolerability, high barrier to resistance, and they form the basis of over 80% of treatment regimens globally.

    我們目前的產品組合與未來研發管線,建立在整合酶鏈轉移抑制劑(integrase strand transfer inhibitors,INSTIs)的基礎之上;由於其卓越療效、長期耐受性、對抗藥性的高屏障,INSTIs受到全球醫療照護提供者的信賴,並構成全球超過80%治療方案的基礎。

  • Today, we will focus on our near-term growth drivers, 3 times a year treatment, 2 times a year treatment and 3 times a year prevention. However, as you can see beyond these transformational opportunities, we will continue to innovate to address the health of people impacted by HIV for many years to come. This includes best-in-class long-acting orals, which we see as an opportunity to reach the around 30% of patients who our market research suggests may not choose injectable treatment.

    今天我們將聚焦於近期成長驅動因素:一年三次的治療、一年兩次的治療,以及一年三次的預防。不過,正如各位所見,除了這些具變革性的機會之外,我們也將持續創新,在未來多年持續改善受HIV影響人群的健康。這也包括同類最佳的長效口服藥物;我們認為這是觸及約30%病患的機會——我們的市場研究顯示,這些病患可能不會選擇注射治療。

  • We have initiated a Phase I study for VH359, a capsid inhibitor and have multiple potential weekly oral INSTIs and capsid inhibitors in preclinical development. Our leadership in long-acting will continue to fuel our growth with each innovation building on our expertise to shape the future standard of care and reach more people impacted by HIV. Given our lead, we will have launched our second and potentially third long-acting injectable treatment before anyone else enters the market.

    我們已啟動VH359的第一期研究;VH359是一種衣殼抑制劑(capsid inhibitor)。此外,我們也有多個潛在的每週口服INSTI與衣殼抑制劑正處於臨床前開發。我們在長效領域的領導地位將持續推動成長;每一項創新都建立在我們的專業之上,以塑造未來的照護標準並觸及更多受HIV影響的人。憑藉我們的領先優勢,在其他競爭者進入市場之前,我們將已推出第二款、甚至可能第三款長效注射治療。

  • Cabenuva is the first and only complete long-acting injectable HIV treatment. More than five years' worth of real-world and clinical evidence continues to validate the strength of Cabenuva, showing robust antiviral effectiveness and barrier to resistance comparable to daily oral medications with strong persistence out to two years and substantial patient preference compared to oral therapy.

    Cabenuva是第一款也是唯一一款完整的長效注射型HIV治療方案。超過五年的真實世界與臨床證據持續驗證Cabenuva的強勁實力,顯示其具穩健的抗病毒有效性與可比於每日口服藥物的抗藥性屏障,且治療持續性可達兩年,同時相較口服治療展現出顯著的病患偏好。

  • In addition, Cabenuva demonstrated superiority over oral standard of care in the LATITUDE study, delivering nearly 2 times lower regimen failure and 4 times lower virological failure, leading to early study termination due to overwhelming efficacy in this suppressed high-risk HIV population with adherence challenges. The real-world data in viremic patients is also compelling, and we look forward to seeing data from our CROWN study in the second half of '26, assessing Cabenuva in viremic patients with adherence challenges to daily oral therapy.

    此外,在LATITUDE研究中,Cabenuva相較口服標準治療展現優越性:治療方案失敗率降低近2倍、病毒學失敗率降低4倍;由於在這個已達病毒抑制、但具高風險且面臨依從性挑戰的HIV族群中療效壓倒性,研究因此提前終止。在病毒未抑制(viremic)病患中的真實世界數據同樣令人信服;我們也期待在'26年下半年看到CROWN研究的數據,該研究評估Cabenuva在病毒未抑制且對每日口服治療有依從性挑戰的病患中的表現。

  • The entirety of this data shows the power of Cabenuva to lead the -- to lead the market growth in long-acting injectables through addressing preference, stigma, adherence and reducing the burden of daily oral therapies, supported by a robust IP strategy with cabotegravir NCE patent protection into 2031 and addition no patent protection now granted into 2040.

    這些完整數據顯示Cabenuva的力量:透過回應偏好、汙名與依從性問題,並降低每日口服治療負擔,帶動長效注射劑市場成長;同時有強健的智慧財產權策略支持,cabotegravir的新化學實體(NCE)專利保護延續至2031年,且另有新增的專利保護已獲核准延伸至2040年。

  • As the first mover in long-acting treatment, we have built the market from the ground up, establishing the evidence, infrastructure, provider experience and patient confidence needed to accelerate the adoption of future long-acting injectable innovations. We are now focused on franchise growth, continuing to address stigma and adherence challenges while meeting patients and health care provider preference for less frequent administration.

    作為長效治療的先行者,我們從零開始建立市場,奠定證據、基礎設施、醫療提供者經驗與病患信心,為未來長效注射創新加速採用所需的一切打下基礎。我們目前聚焦於產品線(franchise)成長,持續解決汙名與依從性挑戰,同時滿足病患與醫療照護提供者對更低給藥頻率的偏好。

  • The profile of our 3 times a year treatment constituting novel formulations of cabotegravir and rilpivirine is compelling. It builds on the proven efficacy and trust experience with Cabenuva, takes 365 oral daily treatment days down to just three injection visits per year, doubling provider capacity compared to Cabenuva, enabling clinics to serve more patients without increasing infrastructure. And this competitive profile is underpinned by a robust IP strategy with additional patent protection pending into 2047.

    我們一年三次治療的產品特性——由cabotegravir與rilpivirine的新型配方所構成——相當具吸引力。它建立在Cabenuva已證實的療效與信賴使用經驗之上,將一年365天的每日口服治療,降至每年僅三次注射回診;相較Cabenuva可使醫療提供者的服務量能加倍,讓診所無需增加基礎設施即可服務更多病患。而此一競爭性產品特性也由強健的智慧財產權策略支撐,另有新增專利保護申請中,預計可延伸至2047年。

  • I am pleased to share that QUATTRO, our 3 times a year Phase III registrational study in suppressed switch patients has begun, supporting potential approval in 2028. We remain confident that 3 times a year treatment will be transformational, not incremental, making long-acting treatment easier to choose, deliver and sustain, unlocking substantial switch opportunity from both oral therapy and existing Cabenuva, which will drive long-acting injectable market growth.

    我很高興分享,QUATTRO——我們針對已達病毒抑制、由其他療法轉換(switch)的病患所進行的一年三次治療第三期註冊性研究——已經開始,支持在2028年取得潛在核准。我們仍然有信心,一年三次治療將是變革性的,而非僅是漸進式改良;它將使長效治療更容易被選擇、更容易提供並更容易維持,從口服治療與現有Cabenuva中釋放出可觀的轉換機會,進而推動長效注射劑市場成長。

  • Having set a high bar with our 3 times a year treatment, we are driven to keep innovating for people living with HIV by delivering a 2 times a year long-acting injectable treatment. Our preferred regimen is the combination of our third-generation INSTI, VH184, with our novel capsid inhibitor, VH499, a combination with NCE patent protection into at least 2040 and additional patents pending into at least 2047.

    在我們每年 3 次治療已樹立高標準之後,我們仍持續以創新驅動,為 HIV 感染者提供每年 2 次的長效注射治療。我們的首選療程為第三代 INSTI VH184 與新型衣殼抑制劑 VH499 的組合;該組合享有 NCE 專利保護至少至 2040 年,並另有追加專利申請中,至少延伸至 2047 年。

  • We believe this regimen can set a new standard of care for a broad HIV population, bringing confidence in efficacy and a high barrier to resistance while further addressing adherence challenges. VH184 is currently in a Phase IIb clinical study, where we have seen rapid patient recruitment, reflecting the community's interest in its third-generation INSTI profile.

    我們相信此療程可為廣泛的 HIV 人群建立新的照護標準,在提升療效信心與高抗藥性屏障的同時,進一步解決用藥依從性挑戰。VH184 目前正處於 IIb 期臨床研究,我們已看到病患招募迅速,反映社群對其第三代 INSTI 特性的高度興趣。

  • Our differentiated capsid inhibitor, VH499, will commence its Phase IIb study in the second half of 2026. And we have a bold plan to get to Phase III in 2028 and approval by the end of the decade, combining operational insights from our ongoing 3 times a year QUATTRO study and utilizing the entirety of our Phase I and II data to select optimal doses and formulations to achieve what we believe will be a practice-changing profile.

    我們具差異化的衣殼抑制劑 VH499 將於 2026 年下半年啟動其 IIb 期研究。我們也制定了大膽計畫,目標在 2028 年進入 III 期並於本十年末前獲批;我們將結合正在進行的每年 3 次 QUATTRO 研究所累積的營運洞見,並運用全部 I 期與 II 期數據來選擇最佳劑量與劑型,以達成我們認為將改變臨床實務的產品特徵。

  • The data on this slide represents a subset of evidence of that practice-changing profile. The chart on the left shows VH184 retains superior potency over second-generation INSTI bictegravir against the majority of second-generation INSTI resistance mutations from the DAWNING clinical study. Its high potency and enhanced resistance profile positions it to transform HIV treatment, and we plan to determine its clinical efficacy in an in resistant population to further inform our Phase III plans.

    本投影片上的數據呈現了該「改變臨床實務」特徵的一部分證據。左側圖表顯示,針對 DAWNING 臨床研究中多數第二代 INSTI 抗藥性突變,VH184 相較第二代 INSTI bictegravir 仍保有更優異的效力。其高效力與增強的抗藥性特徵使其具備改變 HIV 治療的潛力;我們計畫在具抗藥性的人群中評估其臨床療效,以進一步支持我們的 III 期規劃。

  • The graph on the right shows VH499 does not cause the CYP3A-mediated drug-drug interactions that can lead to safety concerns for patients taking common concomitant medications or recreational drugs. It shows that VH499 had no effect on the pharmacokinetic profile of midazolam, the FDA recommended probe for exploring CYP3A drug-drug interactions.

    右側圖表顯示,VH499 不會引發由 CYP3A 介導、可能導致同時使用常見併用藥物或娛樂性藥物之患者出現安全疑慮的藥物—藥物交互作用。結果顯示 VH499 對 midazolam 的藥物動力學特徵沒有影響;midazolam 為 FDA 建議用於探索 CYP3A 藥物—藥物交互作用的探針藥物。

  • This data, combined with 499 and 184's strong efficacy and encouraging tolerability gives us a combination that is not just less frequent, but clinically and commercially differentiated, maximizing patient reach and transforming options for people living with HIV once again.

    這些數據,加上 VH499 與 VH184 的強勁療效與令人鼓舞的耐受性,使我們擁有一個不僅給藥頻率更低、且在臨床與商業上具差異化的組合,能最大化病患覆蓋並再次改變 HIV 感染者的治療選擇。

  • Now moving to HIV prevention. The unmet need is significant. Despite the 2.2 million people in the US that could benefit from prevention, only 25% use it. Daily oral persistence remains low, creating a major opportunity for long-acting options that better fit people's lives.

    接著談 HIV 預防。未被滿足的需求相當顯著。儘管美國有 220 萬人可能可從預防中受益,但實際使用者僅 25%。每日口服的持續使用率仍偏低,為更貼近人們生活型態的長效選項帶來重大機會。

  • Our 3 times a year prevention candidate, which contains a new formulation of cabotegravir builds on Apretude's greater than 99% efficacy and extensive real-world experience and is protected by a robust IP strategy with additional patents pending into 2045. Six months after a single dose of cabotegravir and lenacapavir in our CLARITY study, follow-up data reinforced cabotegravir's highly preferred injection profile with fewer, less visible and shorter-lasting injection site reactions, whereas 90% of participants continue to report lenacapavir-associated modules at six months with 20% being reported as severe over that time period.

    我們每年 3 次的預防候選方案,採用 cabotegravir 的新劑型,建立在 Apretude 超過 99% 的療效與廣泛的真實世界使用經驗之上,並透過強健的智慧財產策略加以保護,另有追加專利申請中,延伸至 2045 年。在我們的 CLARITY 研究中,單次給予 cabotegravir 與 lenacapavir 後 6 個月的追蹤數據,進一步支持 cabotegravir 更受偏好的注射特徵:注射部位反應更少、更不明顯且持續時間更短;相較之下,90% 的受試者在 6 個月時仍回報 lenacapavir 相關的結節,其中 20% 在該期間被回報為嚴重。

  • Delivered through a single intramuscular injection, our 3 times a year prevention has the potential to combine strong tolerability, a favorable drug-drug interaction profile, a dosing schedule aligned to routine sexual health visits and the fewest maintenance injections per year, reducing treatment burden and supporting long-term persistence. With registrational study data from EXTEND4M anticipated in the second half of 2026 and approval in 2027, we remain confident it represents the optimal prevention option for both patients and providers. To close, HIV remains a significant, persistent and unresolved public health challenge.

    透過單次肌肉注射給藥,我們每年 3 次的預防方案有潛力結合良好耐受性、有利的藥物—藥物交互作用特徵、與例行性性健康就診相一致的給藥時程,以及每年最少的維持注射次數,從而降低治療負擔並支持長期持續使用。隨著 EXTEND4M 的註冊性研究數據預計於 2026 年下半年取得並於 2027 年獲批,我們仍有信心其將成為病患與醫療提供者的最佳預防選擇。最後,HIV 仍是一項重大、持續且尚未解決的公共衛生挑戰。

  • The market is moving towards long acting the innovation we have built and lead with Insti at the core to drive the market transformation. Cabenuva demonstrates the power of long-acting treatment and creates the foundation for continued innovation and a pipeline that keeps raising the standard of care. Our near-term long-acting injectable growth drivers are clear. 3 times a year treatment to unlock the next wave of growth targeted for '28 approval, 2 times a year treatment, novel molecules designed for differentiation plan for Phase III start in '28 and 3 times a year prevention optimized based on patient and provider feedback targeted for '27 approval.

    市場正朝向長效化發展;我們以 INSTI 為核心所建立並領先的創新,將推動市場轉型。Cabenuva 展現長效治療的力量,並為持續創新與不斷提高照護標準的研發管線奠定基礎。我們近期的長效注射成長驅動因素清晰可見:每年 3 次治療以開啟下一波成長、目標於 2028 年獲批;每年 2 次治療、以差異化為目標設計的新分子,計畫於 2028 年啟動 III 期;以及依據病患與醫療提供者回饋優化的每年 3 次預防方案,目標於 2027 年獲批。

  • As HIV care continues to evolve, we are uniquely positioned to shape where the market goes next, combining scientific leadership, long-acting innovation and deep patient insight to deliver the next generation of treatment and prevention options.

    隨著 HIV 照護持續演進,我們具備獨特優勢來塑造市場下一步走向,結合科學領導力、長效創新與深度病患洞察,提供下一代治療與預防選項。

  • That brings us to the end of the R&D part of the presentation, and I will now hand over to Julie to share more on the funding of accelerate growth and our outlook.

    以上即為本次簡報中研發(R&D)部分的結尾,接下來我將交棒給 Julie,分享更多關於加速成長的資金來源與我們的展望。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Thank you very much, Charlotte, and also to all my R&D colleagues. So as you've seen, GSK has a broad and rich portfolio of opportunities. And the purpose of this section is to show you how we plan to fund it. Moving on to the next one. So one of our three priorities is to simplify the way we work.

    非常感謝你,Charlotte,也感謝我所有研發同仁。如各位所見,GSK 擁有廣泛且豐富的機會組合。本段落的目的,是向各位說明我們計畫如何為其提供資金。我們看下一頁。我們三大優先事項之一,是簡化我們的工作方式。

  • And this will be enabled by the Accelerate growth program. We've identified GBP1.9 billion of cumulative annual benefits to be delivered by 2029. And the majority of these will fund the investment opportunities outlined by Tony and his team today, accelerating 7 assets across 18 indications, and we have more than 20 Phase III trial starts in 2026.

    這將透過「加速成長(Accelerate growth)」計畫來實現。我們已識別出至 2029 年可實現的累計年度效益達 19 億英鎊。其中大部分將用於資助 Tony 與其團隊今日所概述的投資機會,加速 7 項資產、涵蓋 18 個適應症的推進;且我們在 2026 年將有超過 20 項 III 期試驗啟動。

  • Now, a proportion of the savings will also drop through, strengthening the margin through the dolutegravir loss of exclusivity period, which is 28 to 30. The program will deliver incremental sales from 2030 -- it has a very strong IRR, and it will be implemented with financial discipline as usual, ensuring we retain capacity for business development.

    此外,部分節省也將直接反映於損益,於 dolutegravir 專利到期(失去獨占)期間(2028 至 2030 年)強化利潤率。該計畫將自 2030 年起帶來增量銷售——其 IRR 非常強勁,並將一如既往以財務紀律推動落地,確保我們保有進行業務開發的能力。

  • Turning to the details of the program. We expect 90% of the cumulative annual savings to be delivered by 2028. And we have undertaken an enterprise-wide review to identify opportunities with processes redesigned and enabled by tech and AI. Support functions and key processes across the organization will be streamlined for efficiency and impact. Procurement will be enhanced further to deliver maximum value.

    接著說明計畫細節。我們預期至 2028 年可實現累計年度節省的 90%。我們已進行全企業範圍的檢視,以找出機會,並透過科技與 AI 促成流程再設計。組織內的支援功能與關鍵流程將被精簡,以提升效率與影響力。採購也將進一步強化,以創造最大價值。

  • And we will also be reallocating resources from mature brands towards the key specialty growth drivers. And finally, there will be further automation and simplification of the supply chain and the network to align with the evolution of our portfolio. The program will cost GBP2.4 billion to be reflected in adjusting items, of which GBP2.1 billion is cash and the payback is 2.5 years before the reinvestment. We have a compelling track record of deploying cash in line with our capital allocation framework. First, invest for growth; and second, shareholder distributions, all underpinned, as you know, by a strong investment-grade balance sheet.

    我們也將把資源自成熟品牌重新配置至關鍵的專科成長驅動因素。最後,供應鏈與網路將進一步自動化與簡化,以配合我們產品組合的演進。該計畫成本為 24 億英鎊,將反映於調整項目(adjusting items)中,其中 21 億英鎊為現金支出;在再投資之前的回收期為 2.5 年。我們在依循資本配置框架部署現金方面,擁有令人信服的往績。第一,投資以促進成長;第二,回饋股東;而這一切都如各位所知,以強健的投資級資產負債表為基礎。

  • Since the start of 2021, we have delivered more than GBP40 billion of cash generated from operations. We've deployed GBP18 billion to invest for growth by way of capital expenditure and business development. We have distributed GBP16 billion to shareholders through the dividends and the buyback. And we've reduced net debt through this period by GBP6 billion, decreasing net debt to core EBITDA to 1.3 times.

    自 2021 年初以來,我們已實現超過 400 億英鎊的營運現金流入。我們已投入 180 億英鎊用於成長投資,包括資本支出與業務開發。我們透過股利與庫藏股回購向股東分配了 160 億英鎊。同時,我們在此期間將淨負債降低了 60 億英鎊,使淨負債對核心 EBITDA 的倍數降至 1.3 倍。

  • This represents a considerable transformation of GSK and considerably improved cash generation and a significant reduction in net debt has led to the strengthening of our balance sheet, affording us the optionality to execute BD and further strengthen the pipeline, as you've recently seen through the acquisition of Nuvalent.

    這代表GSK的一次重大轉型;現金創造能力大幅提升以及淨負債顯著下降,已促使我們的資產負債表更為強健,讓我們具備執行BD並進一步強化研發產品線的選擇權,正如你們近期透過收購Nuvalent所看到的。

  • We also have a strong track record of delivering profitable growth and increasing returns whilst continuing to increase the investment we've placed in R&D. So from '21 to '26, we are on track to deliver yearly sales growth of 8%, operating profit growth of 13% and more than 540 basis points improvement in the margin. Now this is all whilst R&D investment has stepped up, increasing more than 50% to now more than GBP7 billion and supporting a doubling of the Phase III starts in 2026, as Tony outlined.

    我們也有強勁的往績,能在持續提高我們對研發(R&D)投資的同時,實現獲利性成長並提升回報。因此,從2021年到2026年,我們正按計畫實現每年8%的銷售成長、13%的營業利益成長,以及超過540個基點的利潤率改善。而這一切是在研發投資同步提升的情況下達成:研發投資增加超過50%,目前已超過70億英鎊,並如Tony所述,支援在2026年第三期(Phase III)啟動數量倍增。

  • So looking ahead to our longer-term outlook and the impact to accelerate growth. We remain committed to our outlook of more than GBP40 billion of sales in 2031, with more than 50% of our business in Specialty Medicines.

    接著展望更長期的前景,以及加速成長所帶來的影響。我們仍然堅守2031年銷售額超過400億英鎊的展望,其中超過50%的業務來自專科藥物(Specialty Medicines)。

  • Our operating margin is now expected to be stable to improving through the dolutegravir, a loss of exclusivity period, supported by a number of things. First, specialty continues to grow as a proportion of the portfolio. Second, we were driving increased productivity gains across the business. And third, part of the savings from the program overall will drop through to the margin in that three-year period. Growth is then expected to accelerate from 2031 onwards, given the portfolio of products and the opportunity for further BD, the latter of which would be incremental to our commitments. This program allows GSK to build on the strong foundations we've laid over the past five years and accelerate growth from 2031 onwards.

    我們目前預期,在dolutegravir專利到期(失去獨占權)的期間,營業利潤率將維持穩定至改善,並由多項因素支撐。第一,專科藥物在產品組合中的占比持續提升。第二,我們正推動全公司範圍的生產力提升。第三,整體計畫中的部分節省將在該三年期間反映至利潤率。之後,預期自2031年起成長將加速,原因在於產品組合以及進一步BD的機會;後者將是在我們既有承諾之上的增量。此計畫使GSK能在過去五年奠定的堅實基礎上再接再厲,並自2031年起加速成長。

  • Thank you, and I will now hand back to Luke for final words.

    謝謝,我現在把時間交回Luke做最後結語。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Thanks, Julie. Next slide, please. So today, I open by saying that our focus was on products and growth. And this slide here shows the pathway we are building with our products to drive growth and with it, delivering long-term value. So the presentations from the team today were designed to give you greater insight into how we're actually going to make that happen.

    謝謝,Julie。請看下一張投影片。所以今天我一開始就說,我們的重點在產品與成長。而這張投影片展示了我們正以產品打造的成長路徑,並藉此交付長期價值。今天團隊的簡報旨在讓各位更深入了解我們將如何真正把這件事做成。

  • And to reanchor you, at the start of the day, I outlined that we would demonstrate to you the following: Firstly, confidence in our ability to drive the business now and beyond to 2031 by showcasing our late-stage pipeline and our focus on defined value propositions and by providing some detail on how we are reallocating capital and resources to change and invest in R&D. With that, I think we're going to go to questions. I'll ask, Guys are quick. I wouldn't want me get a gunfight with you. So we'll bring the team up.

    再讓各位重新聚焦:在今天一開始,我提到我們將向各位展示以下幾點:第一,透過展示我們後期研發產品線、聚焦於明確的價值主張,並提供我們如何重新配置資本與資源以推動變革並加大研發投資的細節,來展現我們有信心在當下以及到2031年乃至更遠的未來推動業務成長。接下來我想我們要進入問答。我會請——各位動作很快。我可不想跟你們來一場槍戰。那我們請團隊上台。

  • So Julie, Nina, Charlotte, Kaivan and I think Sanjay as well. And as we said earlier, raise your hand, you guys clearly remember that. So Zain, I think you were -- do you want to go first? And then I'll just wait while everyone sits down. Zain over to you.

    所以Julie、Nina、Charlotte、Kaivan,我想還有Sanjay。如同我們先前說的,請舉手——你們顯然都還記得。Zain,我想你剛才——你要先開始嗎?我先等大家都坐好。Zain,交給你。

  • Zain Ebrahim - Analyst

    Zain Ebrahim - Analyst

  • Zain over from JPMorgan. First question is just on the 2031 target and beyond. I think Julie sort of ended with a comment on it in terms of 2031 now sounds like it's organic, but just to confirm that Nuvalent included in the 2031 are greater than $40 billion. And then the target or ambition for accelerating growth beyond 2031, you mentioned that it's organic in terms of delivery on your commitments, but how much of that is dependent on BD in terms of the ambition beyond 2031. That's the first question.

    我是來自摩根大通(JPMorgan)的Zain。第一個問題是關於2031年的目標以及之後。我想Julie最後提到,2031年現在聽起來是有機成長,但想確認一下:2031年超過400億美元的目標是否已包含Nuvalent?另外,關於2031年之後加速成長的目標或企圖,你提到在履行承諾方面是有機的,但在2031年之後的企圖中,有多少是取決於BD?這是第一個問題。

  • The second question is just a follow-up on 2027 margins because I think the path on 28% to 30% is relatively clear. And you have the cost savings that will help offset some of the dolutegravir. But next year, you've got the Gilead royalty going in Q4 IRA impact potentially and R&D, you've mentioned will significantly outgrow sales. So just how should we think about '27 in terms of margins? I think consensus has got margin expansion. So what are the other drivers that could get towards margin expansion?

    第二個問題是關於2027年利潤率的追問,因為我認為28%到30%的路徑相對清楚。而你們也有成本節省可用來抵消部分dolutegravir的影響。但明年第四季你們會有Gilead權利金(royalty)進來,可能還有IRA的影響,以及你們提到研發將顯著快於銷售成長。所以我們應該如何看待2027年的利潤率?我想市場共識是利潤率擴張。那麼還有哪些其他驅動因素可以推動利潤率擴張?

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Okay. So in terms of the first question related to Nuvalent and so we've emphasized that we are totally committed to more than 40%. Obviously, the Nuvalent acquisition happened recently, and we've now got accelerate growth. Accelerate growth for sales start in 2030, but they're quite minor in 2030. It's more of a longer-term play.

    好的。就第一個與Nuvalent相關的問題而言,我們已強調我們完全致力於「超過40%」。顯然,Nuvalent的收購是近期才發生,而我們現在也具備加速成長的動能。加速成長對銷售的貢獻會從2030年開始,但在2030年的貢獻相當小。這更偏向一個長期布局。

  • But net-net, we just -- we'd like to emphasize that we are saying we will deliver and we will deliver more than 40 but we didn't want to get into minor increments each way along. I think as Luke mentioned, it is a portfolio. We obviously had the camlipixant news just over a week ago, but it is a portfolio, and we believe we will deliver more than 40% overall when you take it asset by asset. Everything we do as well. I think as most people know, is PTRS adjusted probability of technical and regulatory success.

    但總體而言,我們想強調的是:我們說會交付,而且會交付「超過40%」,但我們不想去細談一路上每個小幅增減。我想如Luke所提,這是一個產品組合。我們當然在一週多前才有camlipixant的消息,但這是一個組合;我們相信逐一以資產來看,整體將交付超過40%。我們所做的一切也都是如此。我想多數人都知道,這是以PTRS(技術與法規成功機率)調整後的結果。

  • But inevitably, you get movements in the portfolio now that we've built to build that optionality. And then none of it at all is dependent on what you might call new BD. So if we do further deals, which we do intend to do, we've got capacity to do them, as Luke outlined, they would be incremental on top, if that answers that question. And then in terms of the margins, I got this question in the break actually from quite a few people. So we have guided the margin to the end of 2026, which is more than 31% at 25 average exchange rates.

    但不可避免地,隨著我們建立起這個產品組合以形成選擇權,組合內會出現變動。而這完全不依賴你所稱的「新的BD」。因此,如果我們進一步進行交易——我們確實打算這麼做,而且如Luke所述我們也有能力去做——那將是在既有基礎之上的增量;希望這回答了你的問題。至於利潤率,我其實在休息時間也被不少人問到這題。我們已指引到2026年底的利潤率,在以2025年平均匯率計算下將超過31%。

  • We then guided the dolutegravir period because we knew and appreciated that investors were quite concerned about that period because of the profitability of HIV. So we did an extensive amount of work as a team to basically understand how we could underpin that margin through that period. But we did not want to get into guiding a margin every year.

    接著我們也對dolutegravir期間做了指引,因為我們知道並理解投資人對那段期間相當擔憂,原因在於HIV業務的獲利能力。因此我們團隊做了大量工作,基本上是為了理解我們如何在那段期間支撐利潤率。但我們不想進一步做到逐年指引利潤率。

  • So we gave the assurance based on a whole series of factors that we could hold the margin stable through the dolutegravir loss of exclusivity. What we're now seeing because this program then generates the additional savings, which total GBP1.9 billion by 2029, it allows us to drop through some of those benefits to give not just a stable margin, but the optionality to also have an improving margin through that period. And it builds 28 to 30. So the period when dolutegravir hits the most, it's most protective.

    因此,我們基於一系列因素給出保證:在dolutegravir失去獨占權的期間,我們可以讓利潤率維持穩定。而我們現在看到的是,因為此計畫帶來額外節省——到2029年合計達19億英鎊——使我們能將部分效益反映到利潤率上,讓我們不僅能維持穩定利潤率,也具備在那段期間改善利潤率的選擇權。並且它支撐28%到30%的區間。因此在dolutegravir影響最明顯的期間,它提供了最大的保護。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • I'm trying to pick the rest of you. Have you had a question before? And then we'll go to James and then anyone in the back.

    我想再挑一下其他人。你之前有問過問題嗎?然後我們會到James,接著再到後排的各位。

  • Naresh Chouhan - Analyst

    Naresh Chouhan - Analyst

  • Naresh Chouhan from Intron Health. Just one on vaccines. It seems that the pharma business and the vaccines business are going to have increasingly different outlook in terms of innovation growth rates, capital requirements. So how wedded are you to continuing to own vaccines, which presumably, if they are separated would unlock quite a lot of value and would further simplify the business.

    Intron Health 的 Naresh Chouhan。我有一個關於疫苗的問題。看起來製藥業務與疫苗業務在創新成長率、資本需求等方面的前景將愈來愈不同。那麼你們對於持續持有疫苗業務的承諾有多深?據推測,如果將其分拆,將能釋放相當多的價值,並進一步簡化業務。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Short answer is very wedded. I mean the capital intensity really is in Regis' shop. I think the main challenge with vaccines, frankly, is the paucity of novel targets of innovation. But again, we're trying to capitalize on that and some of the signals that we've observed there. But I mean, it's a fantastic business.

    簡短回答:非常堅定。我的意思是,資本密集度其實主要在 Regis 的部門。我認為疫苗最大的挑戰,坦白說,是創新新靶點的匱乏。但同樣地,我們正嘗試把握這一點,以及我們在那裡觀察到的一些訊號。不過我的意思是,這是一門很棒的生意。

  • It's very hard to get into. Okay, it's under short-term pressure, frankly, because of politics in some locations and post-COVID hangover. But frankly, I think if you look at the medium to longer term, it's a very durable business with very high barriers to entry. The question is what can we do to be more operationally effective? How do we make this plant more productive?

    非常難進入。好吧,短期內確實承受壓力,坦白說,因為某些地區的政治因素以及 COVID 之後的後遺效應。但坦白說,我認為若看中期到長期,這是一門非常耐久的生意,且進入門檻非常高。問題是我們能做什麼來提升營運效率?我們如何讓這座工廠更具生產力?

  • And then when we do see innovation, how do we make sure that we're participating in it faster and more aggressively than others. So yes, long story short, we like the business. But again, the hierarchy for us in terms of capital allocation, you can see is specialty. And again, that's why we're highlighting that from 2031 plus. And then James, and then I think Sean will go to you.

    然後當我們確實看到創新時,我們如何確保比其他人更快、更積極地參與其中。所以是的,長話短說,我們喜歡這門生意。但同樣地,就我們的資本配置優先順序而言,你可以看到是專科(specialty)。而且這也是為什麼我們強調 2031 年以後。接著 James,然後我想 Sean 會輪到你。

  • Is that Sean up there? I think Yes, Sean and then I promise we'll get to everyone.

    上面那位是 Sean 嗎?我想是的,Sean,然後我保證我們會輪到每一位。

  • James Gordon - Equity Analyst

    James Gordon - Equity Analyst

  • So James Gordon at Barclays. Two on HIV and one quick one on R&D. So on HIV, I think the previous plan was to have a six-monthly prevention product. I think it was in 2028, but I couldn't see it on the slide. So are you not doing six monthly prevention anymore?

    我是巴克萊的 James Gordon。兩個關於 HIV 的問題,另外一個快速問 R&D。先談 HIV,我記得先前的計畫是要有一個每六個月一次的預防產品。我想是在 2028 年,但我在投影片上沒看到。所以你們不再做每六個月一次的預防了嗎?

  • And on treatment, I think it was six month treatment, 28 to 30. So I could see that you're -- I think starting the Phase III in '28, but when do you think that launch is that beyond '29 so post dolutegravir LOE is when you'd have a six-monthly treatment? And then also just a clarification on orals, I think you also talked about, but when do you think you could have a weekly oral or a monthly oral in the market, please?

    再談治療,我記得是每六個月一次的治療,時間在 28 到 30 年。所以我看到你們——我想是在 2028 年啟動第三期,但你們認為上市時間是什麼時候?是否會晚於 2029 年,也就是在 dolutegravir 專利到期(LOE)之後,才會有每六個月一次的治療?另外也想釐清口服藥,你們也提到過:你們認為每週一次口服或每月一次口服,何時可能在市場上推出?

  • And then the final one, just squeeze R&D spend. I think before you said R&D would grow faster than sales is the way you put it. Should we assume that's the assumption that effectively you spend less on SG&A, but R&D keeps on growing faster than sales? How should we model that, please?

    最後一個,把 R&D 支出擠一擠。我記得你們之前說過 R&D 會比銷售成長更快。我們是否應該假設你們實際上會在 SG&A 上花得更少,但 R&D 仍持續比銷售成長更快?我們應該如何建模,麻煩說明?

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Yes. Sure. I mean, long story short, yes, we want to drive R&D as the portfolio changes. When I joined GSK, we launched Trelegy and a few thousand people in the US. You look at zidesamtinib, we're talking 10, 20 people.

    是的。當然。我的意思是,長話短說,是的,隨著產品組合變化,我們希望推動 R&D。我加入 GSK 時,我們推出 Trelegy,在美國需要幾千人。你看 zidesamtinib,我們談的是 10、20 個人。

  • So Charlotte, over to you. And then, Julie, if you want to add anything on that one as well, if I May.

    所以 Charlotte,交給你。然後 Julie,如果你也想在這題補充一些的話,如果可以。

  • Charlotte Allerton - Head, R&D & CSO for ViiV Healthcare

    Charlotte Allerton - Head, R&D & CSO for ViiV Healthcare

  • Great. Thank you for the questions. I'll start with the 2 times year prevention. So our market research and prevention says to us that really 3 times yearly is the optimal. I updated on the 3 times yearly today with -- we hope data in the latter part of this year to support approval next year.

    很好。謝謝你的問題。我先從一年兩次的預防開始。我們的市場研究與預防端告訴我們,一年三次其實是最理想的。我今天也更新了一年三次的進展——我們希望在今年稍晚取得數據,以支持明年獲批。

  • It aligns very well with Medic's preference in terms of bringing people into the clinic and wellness checks and sexually transmitted disease checks. That said, we know there will be a subset of the market that we'll still seek for twice yearly. And so we remain committed to that as a line extension. And we have actually a prodrug of cabotegravir that will take into the clinic during the latter part of this year. We will look to develop that using PK bridging approaches, and we'll update on time lines on that more in due course.

    這也非常符合醫療端(Medic)的偏好:把人帶回診所做健康檢查與性傳染病檢查。話雖如此,我們知道市場上仍會有一部分人會尋求一年兩次。因此我們仍承諾把它作為一個延伸適應症/產品線延伸(line extension)。而且我們確實有一個 cabotegravir 的前藥,會在今年稍晚帶入臨床。我們會用 PK 橋接的方法來開發,並會在適當時候更新其時間表。

  • the twice yearly treatment, you asked about potential time lines for that. We have a bold plan. We have a bold plan looking to get to approval in the latter part of 2030. And we have a bold plan because we like the profile of it, and we want to take it out to the community as quickly as possible. It's too soon to be getting the details of our Phase III plans.

    至於一年兩次的治療,你問到可能的時間表。我們有一個大膽的計畫。我們的大膽計畫是希望在 2030 年下半年取得核准。我們之所以大膽,是因為我們喜歡它的特性,並希望盡快把它帶到社群端。現在談我們第三期計畫的細節還太早。

  • We need to keep working those through and obviously discuss them with the agency. But I can tell you how we're thinking about it, which is, firstly, we're very focused on Phase III start in 2028. That will be using the entirety of our Phase I data on different formulations as well as our Phase II data for 184 and 499. For the Phase IIbs, as you heard, 184 is underway, 499, we will start soon.

    我們需要持續把這些工作推進,並且當然要與主管機關討論。但我可以告訴你我們的思路:第一,我們非常聚焦在 2028 年啟動第三期。那將會使用我們第一期在不同劑型上的全部數據,以及 184 與 499 的第二期數據。至於第二期 b(Phase IIb),如你所聽到的,184 已在進行中,499 我們很快會啟動。

  • And then for the Phase IIIs, what I would say is that we're going to learn a great deal from our 3 times a year treatment trial, QUATTRO that we have started. We started mid-'26. We're looking to gain approval in 2028. And we will be taking those learnings into the Phase III development of our twice yearly. Your last question was on -- Orals.

    然後對於第三期,我想說的是:我們會從已啟動的一年三次治療試驗 QUATTRO 中學到很多。我們在 2026 年年中啟動。我們希望在 2028 年取得核准。而我們會把這些學習帶入一年兩次方案的第三期開發。你最後一個問題是——口服藥。

  • And the markets that we're leading in, and we just talked about one long-acting injectables. We know 70% of patients from our market research are saying they prefer a long-acting injectable, but we definitely want to cater to those who would rather avoid the injections, and we know others have been leading in that space.

    在我們領先的市場中,我們剛談到一個長效注射劑。我們從市場研究得知,有 70% 的病人表示偏好長效注射劑,但我們也確實想照顧那些希望避免注射的人,而且我們知道其他公司在那個領域一直走在前面。

  • However, there remains a strong opportunity for a long-acting oral weekly that's in based, and I've talked about why today in terms of the superior efficacy barrier to resistance and also it's so familiar and highly trusted by patients and providers. So we will be focusing on a true best-in-class INSTI-based oral weekly and moving at pace. We have VH359, which we believe has the potential to be a best-in-class oral weekly capsid inhibitor in Phase I.

    不過,仍然存在一個強勁機會:以 INSTI 為基礎的長效每週一次口服藥;我今天也談到原因,包括更優的療效、較高的抗藥性屏障,而且對病人與醫療提供者而言非常熟悉且高度信任。因此我們會聚焦於真正同級最佳(best-in-class)、以 INSTI 為基礎的每週一次口服藥,並加速推進。我們有 VH359,我們相信它在第一期中具備成為同級最佳每週一次口服衣殼抑制劑(capsid inhibitor)的潛力。

  • And we have multiple other INSTI and capsid inhibitors in preclinical development. And I would also say we have a long relationship in INSTI design with our other stakeholders, Shionogi. And so we will update more on time lines regarding the oral weekly in due course.

    此外,我們還有多個 INSTI 與衣殼抑制劑處於臨床前開發。我也想說,我們在 INSTI 設計方面與其他利害關係人——塩野義(Shionogi)——有長期合作關係。因此,我們會在適當時候進一步更新每週一次口服藥的時間表。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Great. So we do Sean, Sarita and then Sam. How about that? So Sean, have you got a microphone up there --

    很好。那我們先 Sean、Sarita,然後 Sam。這樣可以嗎?Sean,你那邊有麥克風嗎--

  • Sean Conroy - Analyst

    Sean Conroy - Analyst

  • Sean Conroy from Shore Capital. Just firstly, I will pick on the one Phase III trial in vaccines that you announced of the 34 that you're planning. Is the ambition with this MAYA study to ultimately get a labeling change for Shingrix? And could you give us some idea of what that might ultimately mean for progressing the pricing over time? And then maybe for you, Julie, in terms of this restructuring program and this steer of capital into specialty medicines, is there a risk -- you've talked about this being for mature products.

    Shore Capital 的 Sean Conroy。首先,我想先挑你們宣布、在規劃的 34 項疫苗第三期試驗中,那 1 項第三期試驗來問。這個 MAYA 研究的目標,是否是最終要讓 Shingrix 的標示(label)變更?以及你們能否給我們一些概念,這最終可能對未來逐步推進定價意味著什麼?另外也想請教 Julie,關於這個重整計畫以及把資本導向專科藥物,是否存在風險——你們談到這是針對成熟產品。

  • So presumably, the bulk of this is coming from GenMed. Is there a risk that you end up underinvesting in some of these brands and this general medicines becomes diluted to the growth story? And if so, how open would you be to divesting some of these brands in the future?

    所以推測這大部分會來自 GenMed。是否有風險會導致你們對其中一些品牌投資不足,讓一般藥品(general medicines)在成長敘事中被稀釋?如果是這樣,未來你們對於出售(divest)其中一些品牌會有多開放?

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Thank -- so Sanjay, and maybe Kaivan, feel free to give any color around some of the signal finding work and just the basic hypothesis that is there. I mean I think with MACE, clearly, the regulatory pathway is more robust than dementia, and that's why that's being prioritized. But Sanjay, do you want to get into that and then we'll come to you, Julie.

    謝——所以 Sanjay,也許 Kaivan,你們也可以就一些訊號探索(signal finding)的工作,以及背後的基本假設補充一些說明。我的意思是,我認為就 MACE 而言,監管路徑顯然比失智症更明確、更健全,所以才會被優先推進。不過 Sanjay,你要不要先談這部分,然後我們再請 Julie 回答。

  • Sanjay Gurunathan - Head, Global Vaccines & Infectious Disease Unit in R&D

    Sanjay Gurunathan - Head, Global Vaccines & Infectious Disease Unit in R&D

  • Yes. So the answer is the ambition to get a label is an emphatic yes, right? So how do we get there? And why are we so confident? So first, I showed you seven studies, real-world studies where what is remarkable about the effect size, it's fairly consistent across these seven studies.

    是。所以答案是:我們的目標是取得標示(label),非常明確地是肯定的。那我們要怎麼達成?以及為什麼我們這麼有信心?首先,我給你們看了七項真實世界研究;值得注意的是,效果量(effect size)在這七項研究中相當一致。

  • So despite all the limitations you have with real-world studies, the fact that the signal is so consistent gives us a lot of confidence. Second, we have some unique insights into biology that we're exploring that might give a little bit of credibility to the biology and the mechanism of action.

    所以儘管真實世界研究有各種限制,但訊號如此一致,讓我們非常有信心。第二,我們對正在探索的一些生物學有獨特洞見,這可能會讓生物學基礎與作用機轉更具可信度。

  • So if you take these two things together, the confidence that we are going to be successful in this study remains high, and that's why we're embarking on this. We are in discussion with regulators and the reception so far has been very favorable. So we are progressing and hope to finalize those discussions over the next few months to really move forward with the MACE study.

    把這兩點合在一起,我們對於這項研究能成功的信心仍然很高,這也是我們啟動這項研究的原因。我們正在與監管機關討論,目前的回饋非常正面。因此我們正持續推進,並希望在接下來幾個月內完成這些討論,真正往前推動 MACE 研究。

  • And as Luke said, the pathway and the road map for MACE is relatively well established. The endpoints are fairly standardized, and I think Kaivan can speak to them the way we conduct these studies and the benchmarks are available already. It's much more of a difficult discussion with dementia, which is a much more heterogeneous condition, and we are in discussions with the regulators to try to solve that.

    而且如 Luke 所說,MACE 的路徑與路線圖相對已建立得很完善。終點指標(endpoints)相當標準化,我想 Kaivan 可以談談我們如何執行這些研究,以及既有的基準也已經可用。相較之下,失智症的討論要困難得多,因為那是一個更異質的疾病狀態;我們也正在與監管機關討論,嘗試解決這個問題。

  • Kaivan Khavandi - Head of R&D

    Kaivan Khavandi - Head of R&D

  • Yes. Just to add that my organization has significant experience in cardiovascular outcomes trials. And so the design that's being implemented for Shingrix is adequate and well controlled to support a registrational label. But as Sanjay said, this is a fairly unique setting where clearly, the data in support of Shingrix's cardiovascular benefit appears to be working through inflammatory mechanisms rather than through lipids, blood sugar or blood pressure.

    是。補充一下,我的團隊在心血管結局試驗方面有相當豐富的經驗。因此,針對 Shingrix 所採用的研究設計是充分且控制良好,足以支持註冊用(registrational)的標示。但如 Sanjay 所說,這是一個相當獨特的情境:支持 Shingrix 具心血管效益的數據,顯示其作用似乎是透過發炎機制,而不是透過血脂、血糖或血壓。

  • And so we've done a lot of work to ensure that there's understandable mechanistic plausibility that would go in concert with that large outcomes trial, and we've engaged the appropriate experts to make sure that's an integrated package.

    因此我們做了大量工作,確保有可理解的機轉合理性(mechanistic plausibility),能與大型結局試驗相互呼應;同時也邀請了適當的專家,確保這是一個整合性的方案。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Can I suggest for George, maybe just --

    我可以建議 George 也許就--

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Pricing. I didn't --

    定價。我沒有--

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • The impact on the physicians and patients --

    對醫師與病患的影響--

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Willing population.

    願意接種的人口。

  • Nina Mojas - President - Global Product Strategy

    Nina Mojas - President - Global Product Strategy

  • Yes. Maybe to talk a little bit more broader about what we think the benefit of such an indication would be. Just to take a step back, when you get an additional indication for a vaccine like Shingrix, it's not to get a license for a broader population, but to increase the motivation of people to be vaccinated. And we've got extensive research that shows that when there is a strong recommendation from a physician, the willingness to be vaccinated increases from 40% to 8%. And we also know from research that an indication such as MACE or dementia for that matter, increases the confidence of the physician to provide a strong recommendation from 50% to 90%.

    是。也許更廣泛地談談,我們認為這類適應症的效益會是什麼。先退一步說,像 Shingrix 這樣的疫苗取得額外適應症,目的不是為了讓核准涵蓋更廣的人群,而是為了提高人們接種疫苗的動機。我們有大量研究顯示,當醫師給出強烈建議時,接種意願會從 40% 提升到 8%。我們也從研究得知,像 MACE 或(就此而言)失智症這樣的適應症,會把醫師提供強烈建議的信心從 50% 提升到 90%。

  • So that gives you, I think, a very good understanding of what the benefit is of such an indication. But also, it's a major driver in the short and midterm ahead of such an indication of why we are focusing so much on comorbidities and comorbid patients to be considered for vaccinations for Shingrix. And in fact, more than 70% of the 50-plus population that Shingrix is indicated for are suffering from these comorbidities. Obviously, Sanjay spoke about how this proposition improves the economics. And if the study is positive and we have the data, we will be looking obviously at what that means in terms of price.

    所以我認為,這能讓你非常清楚地理解這類適應症的效益。同時,這也是為什麼在取得該適應症之前的短中期,我們會如此聚焦於共病(comorbidities)以及有共病的病患,將其納入 Shingrix 疫苗接種的考量。事實上,Shingrix 適用的 50 歲以上族群中,有超過 70% 正在承受這些共病。當然,Sanjay 已談到這個主張如何改善經濟性。如果研究結果為正且我們取得數據,我們也會進一步評估這對價格意味著什麼。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Julie?

    Julie?

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Yes. Okay. GenMed, the GenMed question. The GenMed business is an invaluable part of our portfolio. A number of reasons for that. But one of them is that it's synergistic with the other parts where we sell respiratory. So vaccines, obviously, with Arexvy, together with specialties such as Nucala Exdensur. And so there's an ability to use the field force across multiple parts, GenMed vaccines and specialty. The other point about GenMed is that although it's under some degree of pressure, it is significantly a cash-generative business. So it's part of the portfolio overall.

    是。好的。GenMed,關於 GenMed 的問題。GenMed 業務是我們產品組合中極其重要的一部分。原因有很多。其中之一是:在我們銷售呼吸產品的領域,它與其他部分具有協同效應。因此疫苗(顯然包括 Arexvy)與專科產品(例如 Nucala Exdensur)可以搭配。因此我們能在多個領域共用前線團隊:GenMed、疫苗與專科。關於 GenMed 的另一點是,雖然它面臨一定程度的壓力,但它仍是一個顯著能產生現金流的業務。所以它是整體產品組合的一部分。

  • Very importantly, the reason we're choosing to invest behind specialty more so -- and it's actually of the seven major assets that have been chosen to be accelerated, specialty is six of them. It's just because of the longevity, the future of that business and the growth and the profitability from that business as time moves on, as you go out of the investment phase into major launch and thereafter. Oncology, in particular, people probably know the margins that you get in oncology products. So that's essentially why.

    非常重要的是,我們之所以選擇更偏重投資在專科領域——而且在被選定要加速推進的七個主要資產中,有六個是專科——主要是因為該業務的長期性、未來性,以及隨著時間推進,當你從投資期進入主要上市(launch)及其後階段時,所帶來的成長與獲利能力。尤其是腫瘤領域,大家可能都知道腫瘤產品的毛利水準。基本上就是這個原因。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Yes. And we've signed a series of deals in emerging markets across multiple geographies with companies like Zuellig, where there's basically revenue targets and profit sharing to obviously put some ballast with that. So I think, Theresa, your hand was up and then session.

    是。而且我們已在新興市場、跨多個地理區域,與像 Zuellig 這樣的公司簽署了一系列交易,其中基本上包含營收目標與利潤分成,以便在這方面提供一些支撐。所以我想 Theresa,你剛才舉手了,然後接著是 session。

  • Unidentified Participant 1

    Unidentified Participant 1

  • It's Theresa from Morgan Stanley. So the later-stage pipeline appears to be weighted to assets as you've highlighted that are derisked mechanistically and clinically. But how should we think about the commercial risk of entering markets with potentially entrenched competitors? And are the convenience advantages alone, so for example, with IL-33 wrapped enough to drive meaningful share? And then just a quick one on Neladalkib and ALK+ lung frontline.

    我是摩根士丹利的Theresa。所以如你所強調的,後期管線似乎更偏向於在機轉與臨床上已去風險(derisked)的資產。但我們應該如何看待進入可能已有根深蒂固競爭者的市場時所面臨的商業風險?另外,僅靠便利性優勢——例如IL-33的長效包覆——是否足以推動有意義的市占?最後再快速問一下Neladalkib以及ALK+肺癌一線治療。

  • Is it possible to get an earlier look versus 2030? So could it come at interim in '28? And what percentage of the overall value or peak sales opportunity is contingent on frontline?

    有可能比2030年更早看到結果嗎?也就是說,是否可能在2028年的期中分析就出來?以及整體價值或峰值銷售機會中,有多少比例取決於一線治療?

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Sure. Okay. So Nina, do you want to cover that? I'll resist adding to my because we hear from the team today, and then we'll go to Hesham.

    當然。好。Nina,你要不要來回答這題?我先忍住不補充,因為今天我們會聽團隊說明,然後再請Hesham。

  • Nina Mojas - President - Global Product Strategy

    Nina Mojas - President - Global Product Strategy

  • Yes. Let's -- just with the last one, is it possible to read out early? Yes, it's possible. It's event-driven. So events will determine how early we get there.

    是的。先就最後一題:有可能提早讀出嗎?是的,有可能。這是事件驅動(event-driven)的。所以會由事件發生的情況決定我們能多早走到那一步。

  • In terms of competing with long-acting specifically, I think I want to be Kaivan can definitely add, but I want to be very specific. Long-acting is the first thought that comes to mind is it's convenience. It's actually not -- it is convenience, but it's a feature of the drug that ends up in better persistence or longer persistence and earlier use. So it's a feature of a drug that changes potentially benefit for patients and the willingness of the physicians to prescribe the drug earlier. So that -- both of those things are translating into patient benefit and outcome.

    至於與長效藥物競爭這件事,我想——Kaivan當然也可以補充——但我想講得很具體。談到長效,第一個想到的是便利性。它確實是便利性,但不僅如此——它是藥物的一個特性,最終會帶來更好的治療持續性(persistence)或更長的持續性,並且更早被使用。因此,這是一種可能改變病人獲益、也提高醫師願意更早開立該藥的藥物特性。所以——這兩點都會轉化為病人獲益與治療結果。

  • And I think one core component of success of long-acting formulations is to position it like that and profile it like that rather than just convenience. And then on Nella, I'll --

    我認為長效劑型成功的一個核心要素,是以這樣的方式來定位與呈現其特性,而不只是把它當作「便利」。至於Nella,我會——--

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • First line is the bulk of the value, as you'd imagine. But we did an enormous amount of due diligence with physicians who are empirically exposed to the drug, and it's recruiting incredibly well. So -- that's always a good sign. Hesham, anything you want to add?

    如你所想,一線治療佔了大部分的價值。但我們也對已在實務上接觸過這個藥的醫師做了大量盡職調查,而試驗招募表現非常好。所以——這通常是個好跡象。Hesham,你有什麼要補充的嗎?

  • Hesham Abdullah - Global Head of Oncology R&D

    Hesham Abdullah - Global Head of Oncology R&D

  • And maybe just Sachin and I were actually talking about this a little bit at the break as well, too. Just a few points to highlight. The first, of course, is as we think about the comparator in the study, of course, different comparator versus the lorlatinib trial. So this is against a second-gen TKI. So just something at least to take into account.

    另外,Sachin和我在休息時間也稍微聊到這點。我想強調幾個重點。第一,當我們思考研究中的對照組時,這當然與lorlatinib試驗的對照不同。這次是對上第二代TKI。所以至少這是一點需要納入考量。

  • The second, of course, to Luke's point, recruitment rates are really important in terms of how these event-driven studies actually read out as well, too. And then the third, of course, is how early does that separation actually take place. I mean when we look at the data with Nella, especially in the TKI-naive patient population, we look at these 12-month duration of response, 91% versus 70% with lorlatinib, the response rate, 86% versus 76% as well too. So I think these are all variables that we have to take into account. But in addition, we're always going to be opportunistic in the context of how the trial was designed.

    第二,正如Luke提到的,招募速度對於這類事件驅動研究何時讀出也非常重要。第三,則是曲線分離(separation)究竟會多早出現。我的意思是,當我們看Nella的數據,特別是在未使用過TKI(TKI-naive)的病人族群中,我們看到12個月反應持續時間(duration of response)為91%對比lorlatinib的70%,反應率(response rate)也為86%對比76%。所以我認為這些都是我們必須納入考量的變數。此外,在試驗設計的框架下,我們也會隨時把握機會、採取更具彈性的作法。

  • And specifically, again, like I said, how early that at least separation occurs and possibly when certain interim analyses could potentially read out as well, too.

    而且具體來說,就像我說的,關鍵在於那個分離點有多早出現,以及某些期中分析是否可能更早讀出。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Yes. And I'd just add -- just to build out on the commercial differentiation. I mean, use the example of the WAP transaction. I mean we had been following Xolair for multiple years. And I can remember back at Roche, this product was expected to be finished, kept growing.

    是的。我再補充一下——延伸談商業差異化。以WAP交易為例。我們追蹤Xolair已經好幾年了。我還記得在羅氏時,大家原本以為這個產品會走到尾聲,但它卻持續成長。

  • And initially, we thought it might have been driven in asthma, of course, it's not. It's being ablated in that population. Then we identified Chris' team identified RAPT and then we started to do market research and talk to physicians using it. And it was pretty clear the barriers there in terms of dosing, the 25% population with obesity, etc, and just the frequency of having to treat children in particular. Then we characterized the BTKs and the safety profile of BTKs.

    一開始我們以為成長可能是由氣喘帶動,當然事實並非如此。在那個族群中它其實正在被淘汰(被取代)。接著我們辨識出——Chris的團隊辨識出RAPT——然後我們開始做市場研究並與實際使用的醫師交流。很明顯地,障礙在於劑量給藥、25%的肥胖族群等等,以及特別是治療兒童時必須頻繁處置的問題。然後我們也評估了BTK抑制劑(BTKs)及其安全性特徵。

  • And it was pretty clear from pediatricians that they would be reluctant to use those drugs in kids, plus the half-life is pretty short. So how much coverage if they're away, away from supervision, etc. So it's always a combination. And then you had the target, obviously, derisk and the learning from Novartis there. So it's always -- it's a combination of things that we do.

    從小兒科醫師那裡很清楚,他們會不太願意在孩子身上使用那些藥物,而且其半衰期相當短。所以如果病人外出、缺乏監督等情況下,能有多少覆蓋(coverage)?因此這永遠是多因素的組合。再加上標的本身顯然已去風險,以及我們從諾華那邊得到的學習。所以我們做的事情一向——都是多種因素的組合。

  • So thanks, Theresa. Sachin?

    所以謝謝你,Theresa。Sachin?

  • Sachin Jain - Analyst

    Sachin Jain - Analyst

  • Sachin Jain, Bank of America. A few questions, please. So firstly, on Bepi. I know we've got a bit of time post these. I wonder if you could just update us on your thoughts as to how you think about the speed of launch. So two deltas. Any sense on speed of payer uptake, both commercially and in government channels given the government is a big section? And then you commented to a bolus of patients. Again, I wonder if you got a better sense of that. So you listed today 50,000 patients in the US, less than 1,000.

    我是美國銀行的Sachin Jain。我有幾個問題。首先,關於Bepi。我知道在這些之後我們還有一些時間。想請你更新一下你們對上市推進速度(speed of launch)的看法。有兩個差異點。對於付款方(payer)採用速度,你們有沒有概念——不論是商業保險或政府通路,尤其政府端占比很大?另外你提到會有一波(bolus)的病人。我也想知道你們是否對此有更清楚的掌握。你今天提到美國有50,000名病人,少於1,000名。

  • Of that population, do you have a sense how many could be fast adopters? So just to sort of start thinking about the cadence of launch as we think about the back end of this year, early next year. On the IL-33, do you have a target exacerbation reduction profile that sort of puts together all of your sort of internal data, mucus, etc, relative to existing biologics of 20% to 25% that sort of builds on the just duration?

    在那個族群中,你們覺得有多少人可能會是快速採用者(fast adopters)?也就是說,當我們看今年下半年到明年初時,想開始思考上市節奏(cadence of launch)。關於IL-33,你們是否有一個目標的急性惡化降低(exacerbation reduction)表現輪廓,把你們內部所有數據(黏液等)整合起來,並相對於現有生物製劑約20%到25%的水準,作為在「持續時間」之外的提升?

  • And then just one follow-on for Hesham, which we didn't get to touch on earlier. Just it's the first disclosure of 35% of patients recruited in the study, which I know you said it's in line, but given, I don't know, the 300 KOLs or whatever you've spoken to are very excited. It seems to me that maybe a little bit slower than anticipated given the study has been running for a year, but just any sense there? And can you accelerate it?

    最後再追問Hesham一題,我們先前沒有談到。這是首次揭露研究已招募35%的病人;我知道你說這符合預期,但考量到你們跟大約300位KOL或你們所說的那些人交流後都非常興奮,在我看來,研究跑了一年才到這個進度似乎可能比原先預期慢一些;你們怎麼看?以及能否加速?

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Great. Do you want to cover that one first Hesham? Then I'll go on IL-33 and then we'll do Bepi. And Pedro, feel free to add in anything as well. Pedro has joined us from AbbVie has quite a bit of experience in that area.

    很好。Hesham,你想先談那個嗎?然後我會接著講 IL-33,之後我們再談 Bepi。Pedro,你也可以隨時補充。Pedro 是從 AbbVie 加入我們的,在那個領域有相當多的經驗。

  • Hesham Abdullah - Global Head of Oncology R&D

    Hesham Abdullah - Global Head of Oncology R&D

  • Thank you, Luke. I'll start off first maybe Sachin by saying, of course, that recently at ASCO, we just saw the first-line TKI-naive data for Nella as well too. And prior to that, I'd probably say the data that had been communicated was probably relatively limited in its scope.

    謝謝你,Luke。我先開始,Sachin,當然要先說,最近在 ASCO,我們也剛看到 Nella 的一線、TKI-naive(未接受 TKI 治療)數據。在那之前,我會說已對外溝通的數據範圍相對有限。

  • So I think we're starting to see now, certainly in terms of recruitment picking up quite significantly, especially with the communication around the data, the potential of the asset itself. And of course, how we're seeing the -- not only the medicinal chemistry design of the drug itself, but also the pharmacology playing out especially the fact that it has this activity against both single ALK mutations and compound ALK mutations as well, too.

    所以我認為我們現在開始看到,尤其是在招募方面明顯加速,特別是在數據溝通之後,市場對這個資產本身的潛力有更清楚的認識。當然,我們也看到——不只是藥物本身的藥物化學設計,還有藥理特性如何展現,尤其是它同時對單一 ALK 突變與複合 ALK 突變都具有活性。

  • Getting to the question specifically around recruitment. What I would say is, no doubt, are there opportunities to accelerate it? There is. We're actually engaging and Nuvalent has been engaging, of course, with patient advocacy groups, certainly investigators. There's a lot of excitement about the drug itself.

    回到招募這個問題本身。我會說,毫無疑問,是否有機會加速?是有的。我們正在投入,Nuvalent 也一直在投入,當然包括與病友倡議團體合作,以及與研究者互動。大家對這個藥本身非常興奮。

  • And I think when you add to it the potential in terms of scale that GSK brings in terms of clinical operations and execution as well, we see a lot of potential for that. I mean, Luke talked about and touched on the fact that as well, too, that we're seeing at least with Neladalkib, more than 200% ahead of recruitment on our second-line study. So we see the same potential here, especially in these areas of high unmet need. And we think that certainly, that could pick up, especially over the next 6 to 12 months.

    而且我認為,再加上 GSK 在臨床營運與執行方面所帶來的規模潛力,我們看到很大的可能性。Luke 也提到並觸及這點:至少在 Neladalkib 的二線研究上,我們的招募進度已超前 200% 以上。所以我們也在這裡看到同樣的潛力,特別是在這些高度未被滿足的需求領域。我們認為,這確實可能加速,尤其是在接下來 6 到 12 個月。

  • Kaivan Khavandi - Head of R&D

    Kaivan Khavandi - Head of R&D

  • Yes. So I think the question was effectively the product profile we'd be targeting with IL-33. And as Nina said, per the entire portfolio, long or ultra-long acting, we don't have to trust our intuition. That's a good thing. Exdensur is going to qualify and substantiate why that translates to clinical benefits in a real-world setting.

    是的。所以我想這個問題實際上是在問,我們針對 IL-33 會鎖定什麼樣的產品特性(product profile)。如 Nina 所說,整個產品組合都朝向長效或超長效,我們不必只憑直覺判斷。這是好事。Exdensur 將會驗證並佐證,為什麼這能在真實世界情境中轉化為臨床效益。

  • With IL-33, we additionally have a mix of mechanistic and trial innovation. And so exacerbation reduction target sizes, we're accustomed to seeing those for T2 elevated disease. In T2 low disease, there's no approved therapies. So the types of reductions we've seen with Nucala, for example, I think, would be transformative in T2-agnostic target medicine profiles. But what I would say about IL-33 is very different from the mechanisms we've seen previously.

    在 IL-33 上,我們另外也結合了機轉創新與試驗設計創新。因此,在急性惡化(exacerbation)降低的目標效果量方面,我們習慣在 T2 升高的疾病中看到這些。在 T2 低的疾病中,目前沒有核准療法。所以像 Nucala 例如所看到的那種降低幅度,我認為若能用在不受 T2 限制(T2-agnostic)的標的藥物產品特性上,將會是具變革性的。但我想說的是,IL-33 與我們先前看到的機轉非常不同。

  • So I wouldn't expect it necessarily to work on spirometry, but you might see an enhanced effect on severe events, hospitalizations, -- and as I've described, the biology also potentially is having a direct effect that's protective on the vasculature. And so for us, the types of effect sizes you've seen previously, but extending into all types of COPD, additionally, in particular, for severe events and the cardiopulmonary hard endpoints, I think, will materially differentiate our program.

    所以我不會預期它一定會在肺量計(spirometry)上有作用,但你可能會看到它對嚴重事件、住院——以及如我所描述,其生物學也可能對血管具有直接的保護作用——帶來更強的效果。因此對我們而言,若能達到先前見過的效果量,但延伸到各類型 COPD,並且特別是在嚴重事件與心肺硬終點(cardiopulmonary hard endpoints)上,我認為將會在實質上讓我們的計畫具備明顯差異化。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Nina, take bolus.

    Nina,談一下 bolus。

  • Nina Mojas - President - Global Product Strategy

    Nina Mojas - President - Global Product Strategy

  • Yes, definitely. So on Bepi and then Pedro, please, as Luke mentioned, Pedro has history of working in hep C, so a pretty good idea of where we might go. So bolus, yes, we expect basically that patients who are currently on treatment, and you know that these patients are on lifelong treatment are the first patients who will start therapy. When we talk to the physicians and centers that treat hep B patients, they will quote frequently number of patients that they expect. They will start on therapy as soon as available.

    好的,當然。所以先談 Bepi,然後 Pedro 也請補充;如 Luke 提到,Pedro 有做過丙肝(hep C)的經驗,所以對我們可能的走向很有概念。所以關於 bolus,是的,我們基本上預期目前正在治療中的病人——而你也知道這些病人是終身治療——會是第一批開始用藥的病人。當我們與治療乙肝(hep B)病人的醫師與中心交流時,他們常會提到他們預期的人數。他們會在藥物一旦可用時就立即開始治療。

  • Testing in different geographies is at different stages. So in Asia, testing is very present and part of routine care. As it doesn't determine diagnosis or treatment in the US, it's definitely less present. It's a relatively simple test. It's just not used because it doesn't help at the moment in the treatment pathway.

    不同地理區域的檢測推行處於不同階段。所以在亞洲,檢測非常普遍,且是常規照護的一部分。在美國,因為它不決定診斷或治療,所以確實較不普及。這是一個相對簡單的檢測。只是因為目前在治療路徑上沒有幫助,所以沒有被使用。

  • We are working on that as well, supporting centers to implement or start having testing available. What we -- we have pretty good idea on price. where -- what is going to be acceptable. And obviously, we will see the price once the drug is approved. I think we made the comment before, we do expect to be in the scale of hep C.

    我們也正在處理這件事,支持各中心導入或開始提供檢測。我們——對於價格有相當清楚的概念:在哪個區間——什麼樣的價格會被接受。當然,一旦藥物獲批,我們就會看到實際價格。我想我們之前也提過,我們預期會落在丙肝(hep C)的價格量級。

  • Now that has been quite some time ago. We will see where we end up. Pricing then negotiations and specifically enabling access will happen as after the approval, so end of '26 and '27 discussions with the payers in the US, which we expect to then unlock. In terms of barriers, we do expect the testing will be required for -- as part of prior authorization. I don't know, Pedro, if there is anything else you want to add.

    不過那已經是相當久以前的事了。我們會看看最後會落在哪裡。定價、後續談判以及特別是促進可近性(access)的工作,會在核准之後才進行,也就是 2026 年底到 2027 年與美國付款方(payers)的討論,我們預期屆時會逐步打開。就障礙而言,我們確實預期檢測會被要求——作為事前授權(prior authorization)的一部分。Pedro,我不確定你是否還想補充其他內容。

  • Unknown ExecutiveExecutive

    未知 高階主管高階主管

  • Yes, to add to that -- Just to add to that one that there was like in the ACV space, there was kind of a bolus of patients, and that's what everyone has in mind. With Bepi, we are expecting a different approach. We are very pleased with the way the medical society has taken the data in the functional cure, but also beyond functional cure. But what was driven the ACV uptake was mainly the cirrhotic patients that were waiting to get that cure.

    是的,補充一下——就像在 ACV 領域,曾經出現一波病人湧入(bolus),這也是大家腦中所想的情境。但對 Bepi,我們預期會是不同的方式。我們對醫學界對功能性治癒(functional cure)以及超越功能性治癒的數據反應感到非常滿意。不過,當時推動 ACV 採用的主要是那些等待治癒的肝硬化病人。

  • Here, the treatment is not on the cirrhotic patients. So we are expecting the patients really to be willing to be treated. Actually, there is a segment, quite sizable segment that in the market research are coming really willing to start the treatment as soon as possible. But that will be basically going to the doctor when they need to go. We are not expecting what happened in ACV that basically there was a massive pressure to the doctors, but also to the payers to get the product reimbursed, mainly because the cirrhotic status.

    在這裡,治療並不是針對肝硬化病人。所以我們預期病人會真正願意接受治療。事實上,有一個相當可觀的族群,在市場研究中顯示他們非常願意盡快開始治療。但那基本上會是他們在需要時去看醫師時才會發生。我們不預期像 ACV 那樣,出現對醫師、也對付款方施加巨大壓力以取得給付的情況,主要是因為肝硬化狀態所致。

  • So -- but we are expecting really a fast uptake in that population that is really willing to be treated. Medicare, these patients basically are all over the commercial and Medicare. So we are expecting Medicare to come a little bit later due to access situation, but there is a lot of these patients that are with the commercial.

    所以——但我們確實預期,在那群非常願意接受治療的人口中,會有很快的採用速度。就 Medicare 而言,這些病人基本上分布在商業保險與 Medicare 之間。因此我們預期 Medicare 會因為可近性狀況而稍晚一些,但也有很多病人是在商業保險之下。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • And relatively high geographical concentration in the US, typically vertical, as you'd imagine. other questions, we'll do around and then we'll go online. Michael?

    而且在美國的地理分布相對集中,通常是垂直型的集中,如你所想像。還有其他問題嗎?我們先繞一圈,然後再轉到線上。Michael?

  • Michael Leuchten - Analyst

    Michael Leuchten - Analyst

  • It's Michael Leuchten from Jefferies. Two questions, please. Just on HIV, the IP for cabotegravir up to 2040, maybe longer. What are you assuming in your revenue estimate? So when we look at your indicative revenue chart, what's in those assumptions? And then just maybe, Kaivan or Nina, back to IL-33. If I heard it right, you're going to do the cardiometabolic endpoint with a partner. I think you said academic. Is that not going to slow you down given that this is going to be a competitive space?

    我是來自 Jefferies 的 Michael Leuchten。請問兩個問題。先談 HIV,cabotegravir 的智慧財產權保護到 2040 年,可能更久。你們在營收估算中假設了什麼?所以當我們看你們的指引性營收圖表時,那些假設包含了哪些內容?另外也許 Kaivan 或 Nina,回到 IL-33。如果我沒聽錯,你們會與合作夥伴一起做心代謝終點。我想你說的是學術單位。鑑於這將是一個競爭激烈的領域,這樣不會拖慢你們的進度嗎?

  • Operator

    Operator

  • Do you want to go with that one first, and then we'll come to Julia and Deborah on the assumptions.

    你想先回答這題嗎?然後我們再請 Julia 和 Deborah 談談那些假設。

  • Kaivan Khavandi - Head of R&D

    Kaivan Khavandi - Head of R&D

  • Yes. To be clear, it's not an academic alliances with a professional ARO, which are the organizations responsible for running most cardiovascular outcome trials. So the opposite. We're going to be partnering with an established entity that has delivered multiple MACE-like studies over the last 20 years. You can imagine there's a list of them that are familiar in the Boston area and beyond.

    是的。先說清楚,這不是與學術單位結盟,而是與專業 ARO 合作;ARO 是負責執行多數心血管結局試驗的機構。所以正好相反。我們將與一家成熟的機構合作,該機構在過去 20 年已完成多項類似 MACE 的研究。你可以想像,在波士頓地區及其他地方,有一份大家都熟悉的名單。

  • Nina Mojas - President - Global Product Strategy

    Nina Mojas - President - Global Product Strategy

  • And maybe just to clarify, that's not the only outcome we would look at -- so yes, if that's your question about slowing us down. We will have the --

    另外再澄清一下,那並不是我們唯一會看的結局——所以是的,如果你的問題是會不會拖慢我們。我們會有--

  • Kaivan Khavandi - Head of R&D

    Kaivan Khavandi - Head of R&D

  • Sorry, apologies. in terms of the study time lines. Yes. So this will be additional to a more conventional exacerbation endpoint study. And you're right, it won't be dramatically shifted exacerbation studies and this type of cardiopulmonary composite endpoint.

    抱歉,不好意思。就研究時程而言。是的。所以這會是額外加做的,並行於較傳統的急性惡化終點研究。你說得對,急性惡化研究與這類心肺複合終點研究的時程不會被大幅改變。

  • It might be that study is a year later than the exacerbation study, which obviously we would file off the exacerbation study if it came sooner.

    可能那項研究會比急性惡化研究晚一年;而如果急性惡化研究更早完成,我們當然會先以急性惡化研究來申報。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Logically, we're trying to aggressively exploit differentiation and disrupt the targets been derisked for us. Okay. Julie and then Deborah? -- and then we'll take one online.

    從邏輯上,我們是想積極利用差異化優勢,並在已為我們去風險化的標的上做出突破。好。Julie 然後 Deborah?——接著我們再接一個線上提問。

  • Julie Brown - Chief Financial Officer, Executive Director

    Julie Brown - Chief Financial Officer, Executive Director

  • Yes. So in terms of cabotegravir, the new chemical entity patent protection is into 2031. Obviously, three-year patents, 3 times a year patents are then pending, and they would take you into the mid-2040s. I mean just in the way in terms of how we take these things into our forecast. Until we get an extension or until we get a new combination, we would always -- in the forecast we do, we would use the earlier date of expiry until we have extensions available to us, etc.

    是的。就 cabotegravir 而言,新化學實體(NCE)的專利保護到 2031 年。當然,三年期專利、每年三次的相關專利目前仍在申請中,若核准可延伸到 2040 年代中期。也就是說,就我們如何把這些納入預測而言,在我們取得延展或取得新的組合之前,我們在做預測時一律會先採用較早的到期日,直到有可用的延展等為止。

  • Deborah?

    Deborah?

  • Deborah Waterhouse - Chief Executive Officer - ViiV Healthcare and President - GSK Global Health

    Deborah Waterhouse - Chief Executive Officer - ViiV Healthcare and President - GSK Global Health

  • Yes. Just to build a little bit on how we're thinking about this. So we've got patents granted for the 6 times yearly, so current Cabenuva to 2040, and we've got a number pending. So there is a robust intellectual property strategy that's playing out. The other way I think about it is how quickly can we cannibalize one product into another.

    是的。我再補充一下我們的思考方式。我們已取得每年 6 次給藥的專利核准,因此現行 Cabenuva 可到 2040 年,另外也有多項仍在申請中。所以我們正在推進一套強健的智慧財產權策略。我看待這件事的另一個角度是:我們能多快把一個產品的需求轉移(蠶食)到另一個產品上。

  • So it took us 12 months to cannibalize the once monthly into twice monthly, about 70% in the first year and then everything else pretty rapidly afterwards. Our expectation is that we would rapidly cannibalize the 6 times yearly into the 3 times yearly. And obviously, that's coming in 2028. And then we would rapidly cannibalize a big chunk of the 3 times yearly into the 2 times yearly because in treatment, there is a really strong value proposition for the twice yearly because of the unique assets, VH184 and 499 in the way that Charlotte's described.

    我們花了 12 個月把每月一次的用藥轉移到每兩月一次:第一年就轉移了約 70%,之後其餘也很快完成。我們預期會很快把每年 6 次的用藥轉移到每年 3 次。而那會在 2028 年推出。接著我們也會很快把每年 3 次中的很大一部分轉移到每年 2 次,因為在治療端,每年兩次的價值主張非常強,這來自於 Charlotte 所描述的獨特資產 VH184 與 499。

  • So in our model, we are modeling a very rapid cannibalization in treatment product by product as you get further and further through the pipeline. PrEP is a little bit different. It's a much smaller opportunity for us market size-wise, but also we absolutely prioritize treatment.

    因此在我們的模型中,隨著管線愈往後推進,我們會逐一在治療產品之間假設非常快速的蠶食轉移。PrEP 則有些不同。就市場規模而言,對我們來說機會小得多,但我們也絕對優先聚焦治療。

  • So in PrEP, I think you will find a coexistence of the 3 times yearly and the 2 times yearly because some physicians really, as Charlotte described, really want that 3 times yearly. They want people to come in and have their sexual health kind of dialogue rather than just leaving people unprotected for too long. So I think it's the way of thinking about it would be IP and cannibalization. And as you bring it together, the pipeline really is very, very sustainable from a value perspective.

    所以在 PrEP 上,我想你會看到每年 3 次與每年 2 次並存,因為有些醫師確實如 Charlotte 所說,真的希望採每年 3 次。他們希望病人回診並進行性健康方面的對話,而不是讓病人處於無保護狀態太久。所以我認為思考方式會是:智慧財產權加上蠶食轉移。而把這些整合起來後,從價值角度看,這條管線確實非常、非常可持續。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Thanks, Deborah. Okay. Last question is a phone one. We've got three on phone. Okay.

    謝謝你,Deborah。好。最後一題是電話提問。我們有三位在線上。好。

  • Is there three people with three questions or okay -- three people. All right. Well --

    是三個人各有三個問題,還是——好,是三個人。好。那麼--

  • Operator

    Operator

  • Seamus Fernandez, Guggenheim.

    Guggenheim 的 Seamus Fernandez。

  • Seamus Fernandez - Equity Analyst

    Seamus Fernandez - Equity Analyst

  • So I wanted to ask a little bit more about the accelerated approach on the respiratory side, particularly with the long-acting TSLP. It says on clinicaltrials.gov right now that there is an ongoing kind of formulation study, but you are planning to move forward in the second half of this year.

    我想再多問一些關於呼吸領域加速推進的做法,特別是長效型 TSLP。clinicaltrials.gov 目前顯示有一項正在進行的配方研究,但你們計畫在今年下半年往前推進。

  • I just wanted to get a little bit more color on your confidence that this formulation will have a true kind of full six-month coverage all the way through the sort of end of treatment. And then the second question is just your conviction in the TSLP mechanism having a robust result in COPD. I think that's one where I think there's still some questions and whether or not TSLP should be targeted to patients with elevated eosinophils.

    我想更了解一下,你們對這個配方能真正提供完整六個月覆蓋、一路維持到治療期末的信心來源。第二個問題是,你們對 TSLP 機轉在 COPD 中能產生強勁結果的信念。我認為這方面仍有一些疑問,包括 TSLP 是否應該鎖定嗜酸性球偏高的病人。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Great. Thanks, Seamus. I mean I would start the answer and then we'll go to Kaivan. We looked at every long-acting TSLP out there. And this was one that we clearly had the most confidence in, in terms of its durability.

    很好。謝謝你,Seamus。我先開頭回答,然後交給 Kaivan。我們看過市面上所有長效型 TSLP。而這一個在持久性方面,顯然是我們最有信心的。

  • Programs and context, Kaivan?

    Kaivan,談談計畫與背景?

  • Kaivan Khavandi - Head of R&D

    Kaivan Khavandi - Head of R&D

  • Yes. So very confident indeed because we've run a Phase II study. We now have interim pharmacodynamic data that supports the Q6M profile in asthma. And as I said earlier, we also have data in nasal polyps from our partner, Hengrui, which has allowed us to have confident discussions with regulatory authorities for end of Phase II. We've actually now submitted all three Phase III indications under the IND, and we will be starting those six studies by the end of the year.

    是的。我們確實非常有信心,因為我們已完成一項第二期研究。目前也有期中藥效動力學資料支持在氣喘中每 6 個月一次(Q6M)的特徵。而且如我先前所說,我們也有合作夥伴恆瑞(Hengrui)在鼻息肉上的資料,使我們能在第二期結束(End of Phase II)時與監管機關進行有把握的討論。我們其實已在 IND 之下提交了三個第三期適應症,並將在年底前啟動那六項研究。

  • So very confident in terms of our ability to select dose confidently across all three indications, which I think is unique in the ultra-long-acting space for TSLP. Mechanism-wise, I think that the data we saw with Tezspire demonstrates a best-in-disease profile for nasal polyps. In asthma, clearly, the differentiator is that it's truly eosinophil-agnostic in asthma. But you're right, in COPD, we don't expect it to work in true T2 low disease in contrast to what I described for IL-33. So the COPD study will enrich based on either eosinophils, pheno or a combination thereof so that we're in that sort of intermediate high T2 space.

    因此,就我們在三個適應症中都能有把握地選擇劑量而言,我們非常有信心;我認為這在TSLP超長效領域是獨一無二的。就作用機轉而言,我認為我們在Tezspire上看到的數據,顯示其在鼻息肉方面具備同類最佳(best-in-disease)的特徵。在氣喘方面,顯然其差異化在於:在氣喘中它確實不受嗜酸性球狀態影響(eosinophil-agnostic)。但你說得對,在COPD方面,我們不預期它會在真正的T2低型疾病中奏效,這點不同於我對IL-33所描述的情況。因此,COPD研究將會依據嗜酸性球、表型或兩者的組合來進行富集(enrich),以便讓我們落在那種介於中度到偏高的T2區間。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Next question?

    下一個問題?

  • Operator

    Operator

  • Kerry Holford, Berenberg.

    Kerry Holford,Berenberg。

  • Kerry Holford - Analyst

    Kerry Holford - Analyst

  • Thank you for the full review of everything today. The one thing that stood out to me, I think, is very clear, business development is increasingly central to your pipeline. And the commentary today suggests it will remain so going forward.

    謝謝你們今天對所有內容做了完整回顧。有一點我覺得特別突出、也很清楚的是:商務發展(BD)在你們的研發管線中正變得愈來愈核心。而今天的評論也顯示,未來它仍將持續如此。

  • So really, my question is, following the failure of camlipixant that we saw recently, are there any key learnings that you can now take from the BELLUS acquisition? Anything you would highlight here, particularly in the context of more recent business development decision-making post that deal with BELLUS thinking about your recent round of BD, but also your decision-making when you are looking at future targets going forward?

    所以我的問題是:在我們最近看到camlipixant失敗之後,你們是否能從BELLUS收購案中汲取任何關鍵教訓?有沒有什麼你們會特別強調的,尤其是在該交易之後、你們近期一輪BD以及未來尋找標的時的BD決策脈絡之下?

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Right. Thanks. I mean I think and feel free to add guys or Tony as well. And I think with BELLUS, again, we approached it, we tried to integrate the lessons from Jeff Dupixent in terms of target selectivity, dysgusia, taste disturbance, the cough counter, all of these elements. And in the end, we had one study that worked and one that didn't.

    好的。謝謝。我的意思是——也歡迎各位或Tony補充。我想在BELLUS這件事上,我們的做法是嘗試把Jeff在Dupixent上的經驗教訓整合進來,包括標的選擇的選擇性、味覺異常(dysgusia)、味覺干擾、咳嗽計數器等所有這些要素。而最後,我們有一項研究成功、另一項沒有。

  • But then we looked at the totality of the data, we just thought, okay, this is not going to shift care. And so we took that decision to reallocate the resources. I'm not sure what else we could have done different. I mean, in the effect -- the effect was disrupted by a Hawthorne effect. Obviously, people changing their behavior when observed. And that's always a challenge. We knew that was a challenge in that program. So I'm not sure it would drive a main shift, but you are correct. I mean, we are very committed to BD. We're very active with BD.

    但接著我們看了整體數據後,認為:好吧,這不會改變臨床照護。因此我們做出決定,把資源重新配置。我不確定我們還能做出哪些不同的事。就效果而言——效果被霍桑效應(Hawthorne effect)干擾了。顯然,人們在被觀察時會改變行為。而這一直都是挑戰。我們也知道那個計畫中這會是個挑戰。所以我不確定這是否會驅動主要的轉變,但你說得沒錯。我們對BD非常投入。我們在BD上非常積極。

  • We see it as an integral part of the strategy. But again, disciplined. And the deals that you've seen us done this year already, I think, are a good framework to employ for the types of transactions that we would be looking to execute in the future. And at the end of the day, this is drug development. We have a portfolio for a reason. Typically Phase III programs, 75% probability. So you are going to have situations like we had. I don't know, Tony, do you want to add anything else?

    我們把它視為策略中不可或缺的一部分。但同樣地,要有紀律。而你們今年已經看到我們做的那些交易,我認為為我們未來要執行的交易類型提供了一個很好的框架。歸根結底,這就是藥物開發。我們之所以有投資組合,是有原因的。通常第三期計畫的成功機率是75%。所以你會遇到像我們這次這樣的情況。我不知道,Tony,你還想補充什麼嗎?

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • Yes. Just to report, Hi Kerry, by the way. Look, for camlipixant, we took it on because we saw a significant unmet need in an area of adjacency. If we learn anything from it, and you can now see it entirely reflected in the portfolio that you've seen this afternoon, which is where we can. We're focusing on hard endpoints.

    是的。先回報一下,Kerry,你好。你看,camlipixant我們之所以接手,是因為我們看到在一個相鄰領域存在顯著未被滿足的需求。如果說我們從中學到什麼,而你現在也能在今天下午看到的整個投資組合中完全反映出來,那就是:在可行之處,我們正聚焦在硬終點(hard endpoints)。

  • You heard that in the MACE versus dementia conversation that was going on around Shingrix as well. But again, I mean, let me just reinforce, this is an area that we saw was an adjacency for us. It had high unmet need. Obviously, we're disappointed and particularly disappointed the patients with refractory chronic cough. They have no medications. The study read out in the three dimensions that we were anticipating, the Hawthorne effect overwhelmed the outcome to a greater extent than we anticipated.

    你們也在Shingrix相關、關於MACE對比失智症的討論中聽到了這點。但我再強調一次:這是我們認為與我們相鄰的一個領域。它有高度未被滿足的需求。顯然我們很失望,尤其是對於難治性慢性咳嗽的患者更是如此。他們沒有藥物可用。研究結果在我們原先預期的三個面向上讀出,而霍桑效應對結果的壓過程度比我們預期更大。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Thanks, Kerry. Was that your only question?

    謝謝你,Kerry。這是你唯一的問題嗎?

  • Kerry Holford - Analyst

    Kerry Holford - Analyst

  • Well, if I can squeeze another quick one in, as I have been online for two hours I promise. HIV, I wonder if you can just talk briefly to how Apretude is faring in that PrEP market. I know you referenced it being less important than the treatment. But how is that faring in PrEP relative to Gilead? And what do you expect for market share evolution in that space if Merck succeeds with a once monthly pill?

    嗯,如果我可以再塞一個很快的問題——我已經在線上兩個小時了,我保證。關於HIV,我想請你們簡要談談Apretude在PrEP市場的表現如何。我知道你提到它的重要性不如治療。但在PrEP方面,相較於Gilead,它的表現如何?如果Merck成功推出每月一次的口服藥,你們預期該領域的市占率演變會如何?

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Great. Thanks, Kerry. So Deborah, over to you.

    很好。謝謝你,Kerry。那麼Deborah,交給你。

  • Deborah Waterhouse - Chief Executive Officer - ViiV Healthcare and President - GSK Global Health

    Deborah Waterhouse - Chief Executive Officer - ViiV Healthcare and President - GSK Global Health

  • Thanks, Kerry. So I think what you're seeing is a reshaping of the PrEP market. It's continuing to grow rapidly. And as more options come in, less optimal daily treatments are being replaced by longer-acting ones. And I think the Merck once monthly, our own long-acting injectables and obviously, our competitor long-acting injectables are all going to serve patients and protect them from acquiring HIV in a way that the daily orals had not done because people just did not adhere to them in the way that they needed to.

    謝謝你,Kerry。我想你看到的是PrEP市場正在被重新塑造。它仍在快速成長。隨著更多選項進入市場,較不理想的每日治療正被更長效的方案所取代。我認為Merck的每月一次方案、我們自己的長效注射劑,以及當然我們競爭對手的長效注射劑,都將以每日口服藥未能做到的方式來服務並保護患者免於感染HIV,因為人們就是無法以所需的方式遵從每日口服用藥。

  • So I think that it's a really good story for innovation. In terms of what's happening at the moment, so you will have seen that we grew Apretude 39%. The market continues to grow. We're holding share in a fast-growing market. And you will see YoY has had a relatively good uptake.

    所以我認為這是一個關於創新的非常好的故事。就目前正在發生的情況而言,你們也看到我們的Apretude成長了39%。市場持續成長。我們在一個快速成長的市場中維持住了市占。而你們也會看到,年對年(YoY)有相對不錯的採用成長。

  • Long-acting injectables are growing fast in the segment. But I think we're holding our own, and I'm really delighted that versus our competitor, we're holding our own, and we're continuing to grow in this part of the HIV market. But as I say, more choice is good when what's there today is suboptimal. That's why only 25% of people who could benefit from PrEP are currently taking PrEP. So I think it's going to be a good news story for those that are involved in that market.

    長效注射劑在這個細分市場成長很快。但我認為我們維持得不錯;而且我很高興的是,相較於競爭對手,我們也守住了陣地,並且在HIV市場的這一部分持續成長。但如我所說,當現有方案並不理想時,更多選擇是好事。這也是為什麼目前只有25%本可受益於PrEP的人正在使用PrEP。所以我認為,對於參與這個市場的人而言,這會是一個好消息的故事。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Great. We'll take one more question, and then I think we'll close because it's very sunny outside.

    很好。我們再接一個問題,然後我想我們就結束,因為外面陽光非常好。

  • Operator

    Operator

  • Steve Scala, TD Cowen.

    Steve Scala,TD Cowen。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • And I have two questions. First, given that GSK seems to be an industry leader in organizing decades of in-house data, why was the term AI spoken, I think, only twice today and certainly wasn't a focus? And then secondly, I'm curious, why is enlarging R&D presence in a country that is so difficult on pharma and you might not launch new drugs, some new drugs in the future anyway.

    我有兩個問題。第一,鑑於GSK似乎是業界在整理數十年內部數據方面的領導者,為什麼我覺得今天「AI」這個詞只被提到兩次,而且顯然不是重點?第二,我很好奇,為什麼要在一個對製藥業如此嚴苛、而且你們未來可能也不會在那裡上市某些新藥的國家,擴大研發(R&D)據點?

  • Why is that a good idea? As one example, GSK employees won't even have access to the latest innovation. Is there some aspect that we're not seeing? I think you'll answer that the talent is so rich in Cambridge, but there are certainly other parts of the world where that's the case as well.

    為什麼那是個好主意?舉例來說,GSK 員工甚至無法接觸到最新的創新。是不是有什麼我們沒看到的面向?我想你會回答說劍橋的人才非常豐富,但世界上當然也有其他地方同樣如此。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Thanks, Steve. So I mean, on the AI one, my rule of thumb is the more people talk about it, the less they're doing. So we are very, very active. But again, I think we're quite selective in terms of what we disclose because I think it is so fluid right now and these people are very difficult to attract and retain. We're quite cautious about how much we disclose.

    謝謝你,Steve。所以我的意思是,就 AI 這件事而言,我的經驗法則是:越多人在談,實際在做的就越少。所以我們非常、非常積極。但再說一次,我們在揭露哪些內容方面相當有選擇性,因為我認為現在變化非常快,而且這些人才非常難以招募並留任。我們對於要揭露多少相當謹慎。

  • But clearly, the effort we're putting is really on the frontier of Tony's organization. I mean, do you want to provide a little bit of color? And then I think, Steve, your second question is very fair. And you will hear the answer for Tony exactly as you've just suggested it may be, but I'll let Tony answer and then we'll close.

    但很明顯,我們投入的努力其實是在 Tony 組織的最前沿。我是說,你要不要補充一些說明?然後我想,Steve,你的第二個問題非常合理。而你也會從 Tony 那裡聽到答案,正如你剛才所暗示的那樣;不過我先讓 Tony 回答,然後我們就結束。

  • Tony Wood - Chief Scientific Officer

    Tony Wood - Chief Scientific Officer

  • So look, AI is at the center of everything we do. We don't talk about it so much because of what we feel is a competitive position. It's pointless without data. So we focus very heavily on the acquisition of data, and that really underpins the approach that we've taken. I'll tell you more about it, Steve, when we talk about early R&D and how we're applying AI, not just to the idea of matching targets and patients and opportunity, but designing molecules and ultimately making clinical trial execution more effective.

    所以你看,AI 是我們所做一切的核心。我們不太談它,是因為我們認為這涉及競爭優勢。沒有資料就毫無意義。所以我們非常專注於資料的取得,而這確實支撐了我們採取的方法。Steve,等我們談到早期研發以及我們如何應用 AI 時,我會再多告訴你一些——不只是用在把標的、病患與機會做匹配的概念上,還包括分子設計,並最終讓臨床試驗的執行更有效率。

  • We've got 150 people in our AI group. These folks have PhDs in maths. We don't unwrap other people's shrinkwrapped AI products. We have access to token windows through our collaborations with Cerebrus, for example, that leave us stable for the coming two to three years where GPU utilization is going to be a really big question. But I'm keeping what we do pretty close to my chest.

    我們的 AI 團隊有 150 人。這些人有數學博士學位。我們不會去拆封別人封裝好的 AI 產品來用。例如,透過與 Cerebrus 的合作,我們可以取得 token windows 的資源,讓我們在未來兩到三年保持穩定——屆時 GPU 的使用率會是一個非常大的問題。但我會把我們在做的事情相當保密。

  • We'll share more of it. But as I say, it's all about the data. And in fact, indeed, just -- Steve, I don't want you to misinterpret. We are continuing to underpin our presence in the UK. I don't think we said we were increasing it in terms of -- and again, there again, it's all about a focus on data, the relationships that we have with Cambridge University that I mentioned.

    我們會分享更多。但如我所說,一切都在於資料。而且事實上,Steve,我不希望你誤解。我們會持續鞏固我們在英國的布局。我不認為我們說過要在——就……而言增加;而且再說一次,這同樣是聚焦在資料,以及我提到的我們與劍橋大學之間的關係。

  • We also have relationships with Oxford University and with King's College. And we'll continue to deepen that type of relationship elsewhere in the world as well. I mentioned in the deck that we'll be looking to do more on the East Coast of the US. You'll hear more from us on that in the near term and indeed in China.

    我們也與牛津大學以及 King's College 有合作關係。我們也會在世界其他地方持續深化這類型的合作關係。我在簡報裡提到,我們會尋求在美國東岸做更多布局。你們在近期會聽到我們更多相關訊息,當然也包括在中國。

  • So I'd say what we focus on is where we can access unique patient-related data that helps us make the sorts of decisions that you've heard illustrated throughout the afternoon. And we apply AI/ML where it enables those decisions in an effective way based on the nature of the data and the iteration that's available within it.

    所以我會說,我們聚焦的是那些能讓我們取得獨特、與病患相關資料的地方,這些資料能幫助我們做出你們今天下午一路聽到的那類決策。而我們會在 AI/ML 能夠基於資料的特性以及其中可用的迭代,讓這些決策以有效方式被支持時,才加以應用。

  • Luke Miels - Chief Executive Officer, Executive Director

    Luke Miels - Chief Executive Officer, Executive Director

  • Great. Thanks, Tony. So I think we should close now. Firstly, I wanted to thank you all for participating. Again, very thoughtful and fair and challenging questions. So I appreciate that. Thank you to the IR team -- well, firstly, thank you to the presenters. I mean, yes, I personally couldn't be more proud, and there's a massive amount of thought and effort that's gone into this. And it's a privilege on my part, frankly, to moderate this today. For the IR teams, thank you.

    很好。謝謝你,Tony。所以我想我們現在應該結束了。首先,我想感謝各位的參與。再次感謝你們提出非常周到、公允且具挑戰性的问题。所以我很感激。也謝謝 IR 團隊——嗯,首先,謝謝各位講者。我是說,是的,我個人再自豪不過了,這當中投入了大量的思考與努力。坦白說,今天能由我來主持是我的榮幸。也謝謝 IR 團隊。

  • There's a huge amount of work, particularly to Joanna, who had to pull all these slides together and also the LSE Group and the Conn's Group, India has been coordinating it and everyone else that helped out. So thank you. It concludes it. If you're in the room and you would like a drink --

    這背後有非常大量的工作,特別要感謝 Joanna,她必須把所有這些投影片整合起來,還有 LSE Group 與 Conn's Group,India 一直在協調,以及所有其他提供協助的人。所以謝謝。到此結束。如果你在現場,並且想喝一杯——