AstraZeneca PLC (AZN) 2026 Q2 法說會逐字稿

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  • Operator

    Operator

  • Good morning to those joining from the UK and the US. Good afternoon to those in Central Europe and good evening to those listening in Asia. Welcome to AstraZeneca's half-one and Q2 2026 webinar for investors and analysts.

    早安,向來自英國與美國的各位致意。向中歐的各位道午安,並向在亞洲收聽的各位道晚安。歡迎參加阿斯特捷利康 2026 年上半年及第二季投資人與分析師網路研討會。

  • Before I hand over to AstraZeneca, I'd like to read the Safe Harbour Statement. The company intends to utilize the Safe Harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Participants on this call may make forward-looking statements with respect to the operations and financial performance of AstraZeneca.

    在我把時間交給阿斯特捷利康之前,我想先宣讀「安全港聲明」。本公司擬適用 1995 年《美國私人證券訴訟改革法案》的安全港條款。本次電話會議的與會者可能會就阿斯特捷利康的營運與財務表現發表前瞻性陳述。

  • Although we believe our expectations are based on reasonable assumptions, by their very nature, forward-looking statements involve risks and uncertainties. And may be influenced by factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call.

    雖然我們相信我們的預期係基於合理假設,但前瞻性陳述本質上涉及風險與不確定性,並可能受到各種因素影響,致使實際結果與該等前瞻性陳述所明示或暗示者出現重大差異。本次電話會議中所作的任何前瞻性陳述,均反映本次會議當時可得的知識與資訊。

  • The company undertakes no obligation to update forward-looking statements. Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation and webinar. (Operator Instructions)

    本公司不承擔更新前瞻性陳述之任何義務。亦請仔細閱讀隨本次簡報與網路研討會提供之投影片資料中的前瞻性陳述免責聲明。(接線員指示)

  • And with that, I'd now like to hand the conference over to the company.

    接下來,我將把會議交給公司方。

  • Joris Silon - Head, Investor Relations

    Joris Silon - Head, Investor Relations

  • A warm welcome to AstraZeneca's half-year and second-quarter 2026 presentation conference call and webcast for investors and analysts. I'm Joris Silon, Head of Investor Relations. And before I hand over to Pascal and members of our executive team, I would like to cover some housekeeping items.

    誠摯歡迎各位參加阿斯特捷利康 2026 年上半年及第二季面向投資人與分析師的簡報電話會議與網路直播。我是投資人關係主管 Joris Silon。在我把時間交給 Pascal 與我們的執行團隊成員之前,我想先說明幾項會議事項。

  • Firstly, all of the materials presented today are available on our AstraZeneca Investor Relations website. Please advance slide. This slide contains our forward-looking statements, including the Safe Harbor provisions, which I would encourage you to take the time to read. We will be making comments on our performance using constant exchange rates, our CER, core financial numbers and other non-GAAP measures.

    首先,今天所呈現的所有資料皆可於阿斯特捷利康投資人關係網站取得。請切換投影片。本頁包含我們的前瞻性陳述(含安全港條款),建議各位撥冗閱讀。我們將以固定匯率(CER)、核心財務數字及其他非 GAAP 指標來評論我們的表現。

  • A non-GAAP to GAAP reconciliation is contained within the results announcement. All numbers quoted are in millions of US dollars unless stated otherwise. Please advance slide. This slide shows our agenda for today's call. Following our prepared remarks, we will open the line for questions. As usual, we will try to address as many questions as we can during the allocated time, although please limit the number of questions you asked to allow others a fair chance to participate in the Q&A.

    非 GAAP 與 GAAP 的調節表載於本次業績公告中。除非另有說明,所有引用數字均以百萬美元為單位。請切換投影片。本頁顯示今天電話會議的議程。在我們的預先準備發言後,將開放提問。如同以往,我們會在既定時間內盡可能回答更多問題,但也請限制您提問的數量,讓其他人也能公平參與問答。

  • And with that, please advance to the next slide. And Pascal, I will hand over to you.

    接下來,請切換到下一頁投影片。Pascal,時間交給你。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Joris, and welcome, everyone. I'm really pleased to report that in the first half of '26, we saw strong growth momentum and continued pipeline delivery. Total revenue grew 6%, driven by strong demand for our innovative medicines, excluding the impact of Farxiga and Brilinta, which are affected by generics, as you know. Total revenue grew 11%, that is a clear demonstration of the underlying strengths of our portfolio and our broad geographical footprint.

    謝謝你,Joris,也歡迎各位。我很高興報告,2026 年上半年我們看到強勁的成長動能,且研發管線持續交付成果。總營收成長 6%,主要由我們創新藥品的強勁需求所帶動,並排除如各位所知受學名藥影響的 Farxiga 與 Brilinta。總營收成長 11%,清楚展現我們產品組合的內在實力以及廣泛的全球布局。

  • We also saw strong growth in core EPS, increasing 11%. In the first half, we announced positive results from six key Phase III programs, including three new molecular entities. We secured 30 major market approvals across our diverse portfolio, including the first approvals for two NMEs, ETCAMAH in breast cancer and Baxfendy in hypertension, and increasing our number of approved NMEs to 11 since we outlined our target to achieve 20 by 2030.

    我們也看到核心每股盈餘(core EPS)強勁成長,增加 11%。上半年,我們公布了六項關鍵第三期(Phase III)計畫的正面結果,其中包含三個新分子實體(NME)。我們在多元產品組合中取得 30 項主要市場核准,其中包括兩個 NME 的首次核准:乳癌的 ETCAMAH 與高血壓的 Baxfendy;自我們提出 2030 年達成 20 個 NME 的目標以來,已核准的 NME 數量提升至 11 個。

  • Our confidence in reaching our 2030 target is underpinned by the exceptional quality and momentum of our pipeline, together with our proven track record of successful execution launches. We continue to invest in our pipeline and commercial capabilities to bring innovative medicines to patients around the globe and to support growth through 2030 and beyond.

    我們對達成 2030 年目標的信心,來自於研發管線卓越的品質與動能,以及我們在成功執行上市推進方面的既有實績。我們將持續投資於研發管線與商業化能力,把創新藥物帶給全球患者,並支持 2030 年及其後的成長。

  • So please move to the next slide. There you can see the breadth of our company remains a key competitive strength. Oncology and rare disease delivered strong double-digit growth in the first half, while within biopharmaceuticals, we see continued momentum in respiratory and immunology that helped mitigate the expected impact of loss of exclusivity in CVRM, in particular Farxiga and Brilinta.

    請切換到下一頁投影片。您可看到,我們公司的廣度仍是關鍵競爭優勢。上半年腫瘤與罕見疾病業務實現強勁的雙位數成長;而在生物製藥領域,我們看到呼吸與免疫持續具備動能,有助於抵銷 CVRM 領域因專利到期所帶來的預期影響,特別是 Farxiga 與 Brilinta。

  • We delivered strong growth in the US, in Europe, and in the emerging markets outside of China. Growth in China was impacted by continued effects from volume-based procurement, and we expect the recent [NRDL] additions and new regulatory approval in 2026 to fuel future growth.

    我們在美國、歐洲以及中國以外的新興市場均實現強勁成長。中國的成長受到帶量採購持續影響;我們預期近期納入 [NRDL] 以及 2026 年新的監管核准將推動未來成長。

  • Move to the next slide, please. An important message for today is that, when we set our $80 billion revenue ambition for 2030, we did so based on the strengths of a broad and diversified portfolio, not on a single program. As you know very well, the $80 billion is a risk-adjusted forecast. If everything worked, we would be above the $80 billion. And so we have, of course expected setbacks to happen. Unfortunately, the results of the CARDIO-TTRansform trail were not what we hoped, and they were disappointing for our team, and most importantly for the patients we sought to help. This serves as a reminder that transformative science carries inherent risk and that not every program will succeed.

    請切換到下一頁投影片。今天的重要訊息是:當我們為 2030 年設定 800 億美元營收願景時,是基於廣泛且多元化產品組合的優勢,而非單一計畫。如各位非常清楚,800 億美元是經風險調整後的預測。如果一切都順利,我們將高於 800 億美元。因此,我們當然也預期會出現挫折。很遺憾,CARDIO-TTRansform 試驗的結果並非我們所期望,這對我們團隊而言令人失望,更重要的是,對我們希望幫助的患者而言亦然。這提醒我們,具變革性的科學本就伴隨內在風險,並非每個計畫都會成功。

  • Our pipeline, however, continued to deliver during the first-half with positive results from six high-value Phase III programs, including the first pivotal data for three new molecular entities, tozorakima in COPD which we look forward to presenting at ERS, efzimfotase alfa in HPP. And as announced today, our first wholly owned ADC, Sone-Ve, including 18.2 positive gastric cancer.

    然而,我們的研發管線在上半年仍持續交付成果,六項高價值第三期計畫取得正面結果,其中包括三個新分子實體的首批關鍵性數據:用於 COPD 的 tozorakima(我們期待在 ERS 上發表)、用於 HPP 的 efzimfotase alfa。以及如今日所宣布,我們首個完全自有的 ADC,Sone-Ve,包括 18.2 胃癌的正面結果。

  • We also received eight major market approvals across important indications, including two additional NMEs. We're very happy to see first approvals for Etcamah in first-line hormone receptor positive breast cancer with emergency SR1 mutations in Europe and Japan and a few other countries. These approvals demonstrate the value of this innovative treatment approach, and we continue to have constructive discussions with the US FDA.

    我們也在重要適應症上取得八項主要市場核准,其中包括另外兩個 NME。我們非常高興看到 Etcamah 在歐洲、日本及其他一些國家,獲得用於第一線荷爾蒙受體陽性乳癌(具 emergency SR1 突變)的首次核准。這些核准展現此創新治療方式的價值,我們也持續與美國 FDA 進行具建設性的討論。

  • We also saw US FDA approval for Baxfendy, which has the potential to transform outcomes for patients with uncontrolled or resistant hypertension, and we continue our launch activities at pace. This, together with the more than 20 approvals we've achieved in the first half of this year, support our continued growth trajectory and strengthen our confidence in delivering the 2030 ambition. And as you will hear today, we are also working very hard and making great progress on our post-2030 growth.

    我們也獲得美國 FDA 對 Baxfendy 的核准;該藥物有潛力改變未控制或難治性高血壓患者的治療結果,我們也持續加速推進上市活動。這些成果,加上我們在今年上半年已取得超過 20 項核准,支持我們持續的成長軌跡,並強化我們達成 2030 年願景的信心。而且如各位今天將聽到的,我們也正非常努力並取得重大進展,推動 2030 年後的成長。

  • And with that, I will hand over to Aradhana now to take you through our financials. Please advance to the next slide.

    接下來,我把時間交給 Aradhana,請她帶各位檢視我們的財務表現。請切換到下一頁投影片。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Thank you, Pascal, and good morning and good afternoon, everyone. As usual, I will start with our reported P&L. Next slide, please.

    謝謝你,Pascal,各位早安、午安。如同以往,我將先從我們的申報損益表(P&L)開始。請切換到下一頁投影片。

  • As Pascal has highlighted, we delivered continued top-line momentum in the first half of the year. Total revenue increased by 6% with product revenue also growing by 6%. Alliance revenue increased by 29%, reflecting higher profit shares from our partnered medicines Enhertu, Datroway, and Tezspire in markets where our partners record product sales.

    如 Pascal 所強調的,我們在今年上半年持續展現營收端的動能。總營收成長 6%,產品營收亦成長 6%。聯盟營收成長 29%,反映在合作夥伴記錄產品銷售的市場中,我們自合作藥品 Enhertu、Datroway 與 Tezspire 取得更高的利潤分成。

  • Next slide, please. Turning to our core P&L, core gross margin was 83% in the first half. While the margin improved in the second quarter compared to the first quarter, we expect a lower gross margin in the second-half, consistent with prior years, reflecting seasonal demand patterns for lower margin medicines such as FluMist and Beyfortus. For the full year, we continue to expect a stable to slightly higher core gross margin versus 2025.

    請看下一張投影片。回到我們的核心損益表,上半年核心毛利率為 83%。雖然第二季毛利率較第一季改善,但我們預期下半年毛利率將較低,與過往年度一致,主要反映 FluMist 與 Beyfortus 等較低毛利藥品的季節性需求型態。就全年而言,我們仍預期 2025 年的核心毛利率將維持穩定至略為提高。

  • Core R&D expense increased by 6% in the first half, reflecting continued investment in our pipeline. Following the positive Phase IIb results for oral GLP-1 molecule, elecoglipron, we have now initiated a comprehensive Phase III program in both obesity and type II diabetes, with first patients dosed earlier this month.

    上半年核心研發費用增加 6%,反映我們持續投資於研發管線。在口服 GLP-1 分子 elecoglipron 取得正向的 IIb 期結果後,我們已在肥胖與第二型糖尿病兩個適應症啟動完整的 III 期計畫,本月稍早已完成首位受試者給藥。

  • Core R&D represented 23% of total revenue in the first half, and we continue to expect R&D expenses to be at the upper end of the low 20s percentage range for the full year as we continue to build our pipeline for long-term growth opportunities, including biospecifics, cell therapies, T-cell engagers, in addition to our CVRM portfolio.

    上半年核心研發費用占總營收 23%;隨著我們持續建構研發管線以掌握長期成長機會(包括雙特異性、細胞治療、T 細胞接合劑,並加上我們的 CVRM 產品組合),我們仍預期全年研發費用占比將落在 20% 出頭區間的上緣。

  • Core SG&A expense also increased by 6% in the first half. During this period, we launched Baxfendy in the US, following FDA approval in May, and we continue to make pre-launch investments ahead of the anticipated launch of tozorakimab following positive Phase III data. Both medicines are expected to be important growth drivers, supporting growth to 2030 and beyond, and we are investing accordingly to maximize their potential.

    上半年核心銷售、一般及行政(SG&A)費用亦增加 6%。期間內,我們在 5 月取得 FDA 核准後於美國推出 Baxfendy,並持續在 tozorakimab 於 III 期數據正向後、預期上市前進行上市前投資。預期這兩項藥品將成為重要的成長驅動力,支撐至 2030 年及其後的成長,因此我們正相應投入以最大化其潛力。

  • Other operating income was $341 million in the first six months, consisting of royalties and small regional divestitures, and we anticipate a broadly similar level in the second-half. Our tax rate in the second quarter benefited from a one-time adjustment to deferred tax assets following certain internal legal entity changes. Overall, core EPS grew by both 11% in the first half, in line with our guidance for the full year.

    前六個月其他營業收入為 3.41 億美元,主要由權利金及小型區域性資產處分構成;我們預期下半年大致維持相近水準。第二季稅率受惠於一次性遞延所得稅資產調整,該調整源於若干內部法律實體變更。整體而言,上半年核心每股盈餘(EPS)成長 11%,符合我們對全年指引。

  • (technical difficulty) [$2.2 billion] in the first half, a decline versus comparator period. This primarily reflects the Lynparza milestone received in the first quarter of 2025, skewing comparisons, as well as working capital impact associated with US loss of exclusivity for Farxiga. We expect these working capital effects to persist through the remainder of the year before normalizing.

    (技術問題)上半年為 [22 億美元],較對比期間下降。這主要反映 2025 年第一季收到 Lynparza 里程碑款,使比較基期偏高,以及與 Farxiga 在美國失去獨占權相關的營運資金影響。我們預期這些營運資金效應將持續至今年剩餘期間,之後才會恢復正常。

  • Capital expenditure was $1.5 billion in the first half, underscoring our commitment to investing behind our long-term growth ambitions, and as previously communicated, we anticipate CapEx to increase by around a third in 2026. Key investments include our new ADC manufacturing facility in Singapore, along with several other strategic multi-year projects that will enhance our manufacturing network and support sustainable growth well into the next decade.

    上半年資本支出為 15 億美元,凸顯我們致力於投資以支持長期成長企圖;且如先前所述,我們預期 2026 年資本支出將增加約三分之一。主要投資包括我們在新加坡的新 ADC 製造設施,以及其他數個策略性多年期專案,將強化我們的製造網絡並在未來十年持續支持可持續成長。

  • Deal-related payments totaled $3.3 billion and included in both milestone payments and the $1.2 billion upfront payment for CSBC collaboration, which closed during the second quarter. For the full year, we continue to expect milestone payments of approximately $2.5 billion relating to prior business development transactions. We have announced new BD transactions totaling just over $2 billion in upfront payments year to date, including the most recently announced Dizal transaction.

    與交易相關的付款合計 33 億美元,包含里程碑付款以及 CSBC 合作案的 12 億美元一次性預付款,該合作已於第二季完成交割。就全年而言,我們仍預期與先前業務開發交易相關的里程碑付款約為 25 億美元。截至目前為止,我們已公告新的 BD(業務開發)交易,其一次性預付款合計略高於 20 億美元,其中包括最近公告的 Dizal 交易。

  • Our lease liabilities also increased as we opened our new Kendall Square R&D Center in Cambridge. Our capital allocation priorities remain unchanged. Net debt increased by around $3.5 billion in the first half, primarily reflecting the payment of the second FY 2025 interim dividend in March and the deal payments I just mentioned. We remain comfortable with our level of gross debt, as previously communicated, following refinancing activities earlier in the year, resulting in higher than historic interest rate and lower interest income, we anticipate core finance costs to be higher in the second-half compared to the first-half.

    隨著我們在劍橋啟用新的 Kendall Square 研發中心,我們的租賃負債也有所增加。我們的資本配置優先順序維持不變。上半年淨負債增加約 35 億美元,主要反映 3 月支付 2025 財年第二次期中股利,以及我剛提到的交易付款。如先前所述,經過年初的再融資活動後,我們仍對目前的總負債水準感到安心;由於利率高於歷史水準且利息收入較低,我們預期下半年核心財務成本將高於上半年。

  • Turning to guidance, we are reiterating our outlook for the full year. We expect total revenue to increase by a mid to high single-digit percentage and core EPS to increase by low double-digit percentage at constant exchange rates.

    接著談指引,我們重申對全年展望。我們預期總營收將以中到高個位數百分比成長,且在固定匯率下核心每股盈餘將以低雙位數百分比成長。

  • So to summarize, we delivered another period of strong financial performance while continuing to invest significantly in both our pipeline and our commercial capabilities. We remain on track to deliver on our priorities in the near term and support growth in the long-term.

    總結而言,我們在持續大幅投資研發管線與商業能力的同時,再次交出強勁的財務表現。我們仍按計畫推進近期優先事項,並支持長期成長。

  • With that, I'll hand over to Dave to take you through the performance of our oncology business. Next slide, please.

    接下來我把時間交給 Dave,帶各位了解我們腫瘤業務的表現。請看下一張投影片。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Thank you, Aradhana. Next slide, please. Oncology total revenues grew 15% in the first half to $14.1 billion, underpinned by double-digit growth in all major regions. Growth in the US and Europe was particularly notable at 18% and 16%, respectively. Focusing in on the quarterly performance of our key medicines, Tagrisso delivered 6% growth in the second quarter to revenues of $1.9 billion, supported by double-digit growth in the US.

    謝謝你,Aradhana。請看下一張投影片。腫瘤業務總營收在上半年成長 15% 至 141 億美元,主要受所有主要地區皆達雙位數成長所支撐。其中美國與歐洲的成長尤為顯著,分別為 18% 與 16%。聚焦我們關鍵藥品的季度表現,Tagrisso 在第二季成長 6%,營收達 19 億美元,並受美國市場雙位數成長所支撐。

  • The share of combination regimens in the first line continues on an upward trajectory in key markets with FLAURA2 remaining the clear preference.

    在主要市場中,一線治療的聯合療法方案占比持續上升,其中 FLAURA2 仍是明確的首選。

  • Turning to Calquence, which grew 16% in the quarter, generating more than $1 billion in revenue for the first time in a single quarter. Calquence maintains its position as the leading BTK inhibitor in frontline CLL across major markets despite intense competition. Within the finite duration class, AMPLIFY continues to gain share in reimbursed markets with encouraging early signs in the US, where it is uniquely positioned as the only BTK inhibitor with both finite and treat-to-progression options. We continue to see AMPLIFY as a significant growth driver through the remainder of 2026, supported by the clear global trend towards adoption of finite duration treatments.

    接著看 Calquence,本季成長 16%,單季營收首次突破 10 億美元。儘管競爭激烈,Calquence 仍在主要市場的一線 CLL 中維持領先的 BTK 抑制劑地位。在有限療程(finite duration)類別中,AMPLIFY 在已納入給付的市場持續提升市占;在美國也出現令人鼓舞的早期跡象,因其具備獨特定位:是唯一同時提供有限療程與治療至疾病進展(treat-to-progression)兩種選項的 BTK 抑制劑。在全球明確朝向採用有限療程治療的趨勢支持下,我們仍視 AMPLIFY 為至 2026 年剩餘期間的重要成長驅動力。

  • Imfinzi and Imjudo delivered growth of 25% in aggregate in the second quarter. Imfinzi growth continues to be driven by a combination of new launches and increasing demand for established indications. Meaningful contributions from MATTERHORN and gastric cancer reflect its rapid establishment as the standard of care in reimbursed markets, and in lung, ADRIATIC continues to be an important additional source of growth. We continue to see strong global momentum for Imfinzi in muscle invasive bladder cancer. And while the US market is evolving with competitive entrants, VOLGA will continue to expand Imfinzi's reach.

    Imfinzi 與 Imjudo 在第二季合計成長 25%。Imfinzi 的成長持續由新上市與既有適應症需求增加的組合所驅動。MATTERHORN 與胃癌的顯著貢獻,反映其在已納入給付的市場中快速建立為標準治療;在肺癌方面,ADRIATIC 也持續成為另一個重要的成長來源。我們持續看到 Imfinzi 在肌層浸潤性膀胱癌的全球強勁動能。雖然美國市場隨競品進入而演變,VOLGA 將持續擴大 Imfinzi 的觸及範圍。

  • Turning to Enhertu, we delivered growth of 31% in the quarter and reported revenues of $888 million. Growth continues to be across all regions and reflects sustained market leadership in the HER2-positive and HER2-low breast cancer indications in major markets. This strong position is complemented by increased adoption and additional launches in emerging markets.

    接著看 Enhertu,本季成長 31%,申報營收為 8.88 億美元。成長遍及所有地區,反映其在主要市場的 HER2 陽性與 HER2 低表現型乳癌適應症中持續維持市場領導地位。此一強勢地位亦因新興市場採用率提升與新增上市而進一步強化。

  • We are seeing encouraging early signs of adoption and growing awareness in the first line DESTINY-Breast09 setting in the United States following its approval late last year. Together with the recent simultaneous US approvals of DESTINY-Breast05 and DESTINY-Breast11 in the curative setting, these growth drivers will become increasingly important through the remainder of the year.

    在美國於去年年底獲准後,我們在第一線 DESTINY-Breast09 治療情境中,已看到令人鼓舞的早期採用跡象與日益提升的認知度。再加上近期 DESTINY-Breast05 與 DESTINY-Breast11 在治癒性治療情境於美國同步獲批,這些成長動能在今年剩餘期間將變得愈發重要。

  • Truqap revenues of $233 million in the quarter represent growth of 37% over the prior year. As we've indicated previously, the majority of this growth is from ex-US markets with the US opportunity at peak in the breast indication. Beyond breast, we are looking forward to bringing Truqap to patients with P10-deficient metastatic hormone-sensitive prostate cancer following the recent approval of CAPItello-281 in the US, and a near-term priority is to establish testing in the setting which today is not common practice.

    本季 Truqap 營收為 2.33 億美元,較去年同期成長 37%。如我們先前所指出,這項成長多數來自美國以外市場,而在乳癌適應症方面,美國的機會已達高峰。除乳癌之外,我們也期待在 CAPItello-281 近期於美國獲批後,將 Truqap 帶給 P10 缺失之轉移性、荷爾蒙敏感性前列腺癌患者;而短期內的優先事項,是在目前尚非普遍常規的臨床情境中建立檢測。

  • Datroway revenues of $55 million in the second quarter demonstrate growing demand in later-line EGFR-mutated lung cancer with signs of increasing utilization in the secondline setting in the US. We're excited for the ongoing launch of Datroway in patients with triple-negative breast cancer who are not candidates for immunotherapy following the US approval of TROPION-Breast02 earlier in the quarter.

    第二季 Datroway 營收為 5,500 萬美元,顯示在後線 EGFR 突變肺癌的需求持續成長,且在美國第二線治療情境中亦出現使用率提升的跡象。在本季稍早 TROPION-Breast02 於美國獲批後,我們對 Datroway 在不適合接受免疫治療的三陰性乳癌患者中的持續上市推進感到振奮。

  • Given its differentiated profile, we see this as a significant opportunity and look forward to additional market launches in the second half. With strong momentum demonstrated across our portfolio in the first half, we are well-positioned for continued growth through the rest of the year as we deliver innovative oncology medicines to more patients.

    鑑於其差異化的特性,我們認為這是一項重要機會,並期待在下半年進一步於更多市場上市。在上半年我們的產品組合展現強勁動能之下,隨著我們將創新腫瘤藥物帶給更多患者,我們已具備良好條件,在今年剩餘期間持續成長。

  • Please advance to the next slide. Focusing in on EGFR-mutated lung cancer, Tagrisso is the number one prescribed third-generation EGFR TKI globally, approved across all stages of disease. This leadership position is underpinned by the breadth of our clinical development plan and our differentiated product portfolio. In the first-line combination setting, we've seen significant global market expansion over the past 12 months with FLAURA2, the clear market leader. In the highly competitive US market, FLAURA2 holds around three-quarters of this growing segment.

    請切換到下一張投影片。聚焦於 EGFR 突變肺癌,Tagrisso 是全球處方量第一的第三代 EGFR TKI,並已獲准涵蓋疾病各期。這一領導地位奠基於我們臨床開發計畫的廣度,以及我們具差異化的產品組合。在第一線聯合治療情境中,過去 12 個月我們看到全球市場顯著擴張,其中 FLAURA2 明顯為市場領導者。在競爭激烈的美國市場,FLAURA2 約占此一成長中區隔的四分之三。

  • We were pleased to announce the in-licensing of Zegfrovy, a novel oral EGFR inhibitor, earlier this month. Zegfrovy is already approved in the US and China for patients whose tumors carry Exon 20 insertion mutations, following progression on or after platinum-based chemotherapy. Based on the WU-KONG28 data presented at ASCO, filings for the first line have been submitted in China and the US.

    我們很高興在本月稍早宣布引進授權(in-licensing)Zegfrovy,一款新型口服 EGFR 抑制劑。Zegfrovy 已在美國與中國獲准用於腫瘤帶有第 20 外顯子插入突變、且在含鉑化療後或期間疾病進展的患者。根據於 ASCO 發表的 WU-KONG28 數據,第一線適應症的申請已在中國與美國遞交。

  • This deal complements our existing EGFR leadership and allows us to bring a differentiated treatment to patients with limited treatment options globally. Importantly, it's also a clear signal of our intent to remain the definitive leader in this space.

    這項交易補強我們既有的 EGFR 領導地位,並使我們得以為全球治療選擇有限的患者帶來具差異化的治療。更重要的是,這也清楚展現我們意圖在此領域持續成為無可爭議的領導者。

  • I'll now hand it over to Susan to discuss some more of the specific near-term pipeline opportunities.

    接下來我將交由 Susan,進一步說明一些近期具體的研發管線機會。

  • Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

    Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

  • Thank you, Dave. Turning to the right-hand side of this slide, our near-term pipeline readouts provide the opportunity to further strengthen our position in EGFR-mutated lung cancer with Tagrisso as the backbone TKI, with two phase III trials due to readout later this year investigating combinations in the sizable post-TKI second-line setting.

    謝謝你,Dave。看向這張投影片右側,我們近期的研發管線讀出結果,提供機會進一步鞏固我們在 EGFR 突變肺癌的地位;以 Tagrisso 作為基礎 TKI,兩項第三期試驗預計於今年稍晚讀出,研究在規模可觀的 TKI 後第二線治療情境中的聯合療法。

  • TROPION-Lung15 evaluates Datroway alone and in combination with Tagrisso, building on the growing position Datroway already has in later line lung cancer based on TROPION-Lung15. Saffron then evaluates Tagrisso combined with Orpathys, offering a differentiated combination approach in patients with MET-driven resistance, supported by the encouraging data we've already seen from SAVANNAH and SACHI.

    TROPION-Lung15 評估 Datroway 單藥以及與 Tagrisso 的聯合治療,並在 Datroway 既已基於 TROPION-Lung15 在後線肺癌建立的日益增長地位之上再進一步。Saffron 則評估 Tagrisso 與 Orpathys 的聯合治療,為具有 MET 驅動抗藥性的患者提供差異化的聯合策略,並由我們已在 SAVANNAH 與 SACHI 看到的令人鼓舞數據所支持。

  • Looking further ahead, TROPION-Lung14 then aims to bring the combination of Datroway and Tagrisso into the first line, building directly on the success of FLUARA2. This represents a significant long-term opportunity to extend our first line leadership and improve outcomes with the next generation combination. Taken together, these opportunities represent a comprehensive strategy to maintain leadership in EGFR mutated lung cancer for years to come.

    展望更長期,TROPION-Lung14 旨在將 Datroway 與 Tagrisso 的聯合治療推進至第一線,並直接建立在 FLUARA2 的成功之上。這代表一項重大的長期機會,可延伸我們在第一線的領導地位,並以新一代聯合療法改善治療結果。綜合而言,這些機會構成一套完整策略,以在未來多年維持我們在 EGFR 突變肺癌領域的領導地位。

  • Next slide, please. I'm also delighted to share with you today the high-level results from two recent Phase III trial readouts. Back in May, we announced positive results from the planned interim analysis of the Phase III VOLGA trial for Imfinzi in patients with muscle invasive bladder cancer who are not candidates for cisplatin. VOLGA builds on our existing presence in this setting, where the Niagara regimen has already established Infinzi as a key treatment option for cisplatin-eligible patients.

    請到下一張投影片。我也很高興今天與各位分享兩項近期第三期試驗讀出的高層次結果。回到 5 月,我們公布了第三期 VOLGA 試驗的期中分析計畫之正向結果,針對不適合使用順鉑的肌層浸潤性膀胱癌患者評估 Imfinzi。VOLGA 建立在我們於此治療情境既有的布局之上;在此情境中,Niagara 方案已使 Infinzi 成為適用順鉑患者的重要治療選項。

  • VOLGA explores whether the combination of Enfortumab vedotin and Infinzi, plus or minus Imjudo, can improve outcomes for the 50% of patients who are not candidates for cisplatin. Importantly, in this regimen, Enfortumab vedotin is only given in the neoadjuvant setting, aiming to optimise outcomes whilst balancing the overall benefit-risk profile.

    VOLGA 探討 Enfortumab vedotin 與 Infinzi 的聯合治療(合併或不合併 Imjudo)是否能改善那 50% 不適合使用順鉑患者的治療結果。重要的是,在此方案中,Enfortumab vedotin 僅於新輔助治療(neoadjuvant)情境給藥,目標是在平衡整體效益—風險特性的同時,最佳化治療結果。

  • Imfinzi, in combination with Enfortumab vedotin, demonstrated statistically significant and clinically meaningful improvements in both event-free survival and overall survival, underscoring the potential of this regimen to meaningfully improve outcomes in bladder cancer. The Imjudo containing arm also demonstrated a statistically significant improvement in event-free survival, with a favorable trend in overall survival.

    Imfinzi 與 Enfortumab vedotin 的聯合治療,在無事件存活期(EFS)與整體存活期(OS)兩者皆展現具統計顯著且具臨床意義的改善,凸顯此方案在實質改善膀胱癌治療結果方面的潛力。含 Imjudo 的治療組亦在無事件存活期上展現統計顯著改善,且整體存活期呈現有利趨勢。

  • VOLGA broadens our presence in bladder cancer, enabling more patients to benefit from an Imfinzi-based regimen, complementing NIAGARA in muscle-invasive bladder cancer and the recently US-approved POTOMAC indication in earlier-stage non-muscle-invasive disease. We also saw positive NILE results this quarter. And whilst the landscape in the first-line setting has evolved significantly since we started this trial, it further reinforces Imfinzi's value across the full spectrum of bladder cancer.

    VOLGA 擴大我們在膀胱癌領域的布局,使更多患者能受益於以 Imfinzi 為基礎的治療方案,並與肌層浸潤性膀胱癌中的 NIAGARA,以及近期於美國獲批、用於更早期非肌層浸潤性疾病的 POTOMAC 適應症相互補強。本季我們也看到 NILE 的正向結果。儘管自我們啟動此試驗以來,第一線治療版圖已顯著演變,但這些結果進一步強化 Imfinzi 在膀胱癌全病程範圍內的價值。

  • Turning now to gastric cancer, we announced today positive results from the Phase III CLARITY-Gastric01 trial, evaluating Sonesitatug vedotin, or sone-ve, in previously treated patients with advanced gastric cancer expressing Claudin 18.2. CLARITY-Gastric01 is the first Phase III trial to demonstrate an overall survival benefit with a Claudin 18.2 targeted antibody drug conjugate in the second line plus setting. This is a population with a particularly poor prognosis.

    接著談到胃癌,我們今天公布第三期 CLARITY-Gastric01 試驗的正向結果;該試驗評估 Sonesitatug vedotin(或稱 sone-ve),用於先前已接受治療、且表現 Claudin 18.2 的晚期胃癌患者。CLARITY-Gastric01 是首個第三期試驗,證實在第二線及後續治療情境中,Claudin 18.2 標靶抗體藥物複合體可帶來整體存活期獲益。這是一個預後特別不佳的族群。

  • Fewer than 20% of patients with advanced gastric cancer survive beyond one year, and at present, there are no targeted options for Claudin 18.2-positive, non-HER2-positive tumors in this second-line plus setting. The trial met its overall survival dual primary endpoint, with sone-ve demonstrating a statistically significant and highly clinically meaningful improvement in overall survival versus investigators' choice of therapy in patients treated with at least two prior therapies.

    晚期胃癌患者中,存活超過一年的比例不到 20%;而目前在第二線及後續治療情境中,對於 Claudin 18.2 陽性且非 HER2 陽性的腫瘤,尚無標靶治療選項。該試驗達成其整體存活期的雙主要終點;在至少接受過兩種既往治療的患者中,sone-ve 相較於研究者選擇的治療,展現具統計顯著且高度具臨床意義的整體存活期改善。

  • There was also a trend to PFS benefit, which did not meet statistical significance. Critically, the trial also met its key secondary endpoint, demonstrating a highly clinically meaningful overall survival benefit in patients treated with at least one prior line, potentially extending the benefits to a broader patient population earlier in their treatment journey.

    無惡化存活期(PFS)亦呈現獲益趨勢,但未達統計顯著。關鍵的是,該試驗也達成其主要次要終點,顯示在至少接受過一線既往治療的患者中,整體存活期具有高度具臨床意義的獲益,可能將效益延伸至更廣泛的患者族群,並在其治療旅程更早期即帶來幫助。

  • Importantly, the survival data were demonstrated in patients with Claudin 18.2 expression as low as 25% at any staining intensity, a lower threshold than that required by other Claudin 18.2 targeted therapies. Meaning that sone-ve could potentially benefit around 50% of patients with second-line-plus gastric cancer, representing more than 180,000 patients across the US, EU5, China, and Japan.

    重要的是,生存數據在Claudin 18.2表達量低至25%(任何染色強度)的患者中亦得到證實,這一門檻低於其他Claudin 18.2標靶療法所要求的門檻。這意味著sone-ve可能可讓約50%的二線及以上胃癌患者受益,涵蓋美國、歐盟五國(EU5)、中國與日本合計超過180,000名患者。

  • CLARITY-Gastric01 represents a landmark milestone for our oncology portfolio. sone-ve is our second ADC to demonstrate an overall survival benefit in gastric cancer following Enhertu, and our third positive phase III readout in this tumor type in just two years, following MATTERHORN for Imfinzi and DESTINY-Gastric04 for Enhertu. It is also the first phase III data from our wholly owned ADC portfolio, marking an important step as we establish our independent position in this space. We look forward to presenting the data later this year.

    CLARITY-Gastric01是我們腫瘤產品組合的一個里程碑式重大進展。sone-ve是繼Enhertu之後,我們第二個在胃癌中證實具整體存活(OS)獲益的ADC,也是我們在短短兩年內於此腫瘤類型取得的第三個第三期(Phase III)正面讀出,前兩者分別為Imfinzi的MATTERHORN與Enhertu的DESTINY-Gastric04。這也是我們全資擁有的ADC產品組合首次公布第三期數據,標誌著我們在建立該領域獨立地位方面邁出重要一步。我們期待在今年稍晚發表這些數據。

  • Together with VOLGA, these data strengthen our conviction and the opportunity to combine IO with ADCs, an approach we believe can be transformative across multiple cancers. And specifically, these two readouts reinforce our confidence in CLARITY-Gastric02, our first-line gastric cancer trial, evaluating sone-ve in combination with cisplatin, with or without rilvegostomig or nivolumab.

    連同VOLGA,這些數據強化了我們的信念與機會:將IO與ADC結合,我們相信此方法可在多種癌症中帶來變革性影響。具體而言,這兩項讀出也進一步增強我們對CLARITY-Gastric02(我們的一線胃癌試驗)的信心;該試驗評估sone-ve與順鉑合併使用,並可合併或不合併rilvegostomig或nivolumab。

  • And with that, please advance to the next slide. And I'll pass over to Ruud to cover biopharmaceuticals performance.

    接下來,請切換到下一張投影片。我將交給Ruud,說明生物製藥業務表現。

  • Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

  • Thank you so much, Susan.

    非常感謝你,Susan。

  • Next slide, please. Our biopharmaceutical business is in a transitional period. And in the first half of 2026, total revenue declined by 5% to $11.2 billion. This reflected the loss of exclusivity headwinds for Farxiga, Brilinta and Roxadustat, which were largely offset by the growth of our respiratory portfolio. The strong momentum in respiratory was supported by our established biologics for severe asthma, which generated over $2 billion of in-market sales in the first half.

    請下一張投影片。我們的生物製藥業務正處於轉型期。2026年上半年,總營收下降5%至112億美元。這反映了Farxiga、Brilinta與Roxadustat專利到期(失去獨占性)帶來的逆風,但在很大程度上被我們呼吸產品組合的成長所抵銷。呼吸領域的強勁動能來自我們既有的重度氣喘生物製劑,上半年在市場銷售額超過20億美元。

  • Focusing in on the quarter, respiratory and immunology total revenue grew by 11%. Fasenra grew 13% to $570 million, driven by its continued leadership of the IL-5 class. In emerging markets, Fasenra grew 75%, thanks to the ongoing success of its launch in China, where it entered the national reimbursement drug list at the start of the year.

    聚焦本季,呼吸與免疫學總營收成長11%。Fasenra成長13%至5.70億美元,主要受其在IL-5類別中持續領先所帶動。在新興市場,Fasenra成長75%,得益於其在中國上市持續成功;該產品於年初納入國家醫保藥品目錄。

  • Tezspire grew by 45% to $390 million, with strong performances in the United States and Europe being supplemented by uptake in the emerging markets. In our [in-health] portfolio, Breztri continued on its positive trajectory with 20% growth to $346 million. Breztri received its first approval for asthma this year in the United States and last week received a positive recommendation for asthma from the CHMP in Europe. We are excited about this important new indication, which will help us bring this therapy to more patients.

    Tezspire成長45%至3.90億美元,美國與歐洲表現強勁,並由新興市場的採用進一步補強。在我們的[in-health]產品組合中,Breztri延續正向走勢,成長20%至3.46億美元。Breztri今年在美國首次獲得氣喘適應症核准,上週亦在歐洲獲得CHMP對氣喘的正面建議。我們對這一重要新適應症感到振奮,這將幫助我們把此療法帶給更多患者。

  • Simicourt revenues of $671 million were down 8% due to the price pressure in the United States, reflecting a new generic competitor entering the market. Saphnelo revenues increased 24% to $209 million, driven by share gains in the intravenous segment for SLE patients. The new subcutaneous formulation is now available in the US and some European markets, which broadens Saphnelo's reach to patients who favor self-administration.

    Simicourt營收為6.71億美元,下降8%,原因是美國價格壓力,反映有新的學名藥競爭者進入市場。Saphnelo營收成長24%至2.09億美元,主要由其在SLE患者靜脈注射(IV)細分市場的市占提升所帶動。新的皮下(SC)劑型目前已在美國及部分歐洲市場上市,擴大了Saphnelo對偏好自我給藥患者的覆蓋。

  • As expected, generic competition for Farxiga entered the US at the start of the quarter. And this, along with loss of excessivity in some other markets and VBP in China, saw Farxiga decline by 90% overall, resulting in $1.8 billion of revenue for the quarter.

    如預期,Farxiga的學名藥競爭於本季初進入美國市場。再加上其他部分市場的獨占性到期以及中國的VBP(帶量採購),Farxiga整體下滑90%,使本季營收為18億美元。

  • Navigating these expected lifecycle transitions is a natural part of our business, and we remain confident in the long-term strength of our broader portfolio and pipeline. In May, we secured the approval and launch of Baxfendy in the US, and we are now building early market access through affordability programs. We anticipate commercial access for Baxfendy will broaden over the next few quarters in anticipation of Medicare Part D reimbursement from 2028.

    因應這些可預期的產品生命週期轉換是我們業務的自然一環,我們仍對更廣泛的產品組合與研發管線的長期實力充滿信心。5月,我們在美國取得Baxfendy的核准並完成上市,目前正透過可負擔性方案建立早期市場可近性。我們預期Baxfendy的商業可近性將在未來幾季逐步擴大,並為2028年起Medicare Part D給付做準備。

  • We're also making an early start on our launch preparations for Tozorakimab. We are encouraged by the data which showed highly clinical meaningful benefits in the OBERON and TITANIA trials, representing a broad COPD population, and we are looking forward to bringing this innovation to patients around the world as soon as possible.

    我們也已提前啟動Tozorakimab的上市準備。我們受到數據鼓舞:OBERON與TITANIA試驗顯示具高度臨床意義的獲益,涵蓋廣泛的COPD人群;我們期待盡快將這項創新帶給全球患者。

  • I will now hand over to Sharon to take us through the latest developments in the biopharmaceuticals R&D pipeline.

    我現在把時間交給Sharon,帶大家了解生物製藥研發管線的最新進展。

  • Sharon Barr - Executive Vice President - Bio Pharmaceuticals Research and Development

    Sharon Barr - Executive Vice President - Bio Pharmaceuticals Research and Development

  • Thank you, Ruud. Next slide, please.

    謝謝你,Ruud。請下一張投影片。

  • I'd like to start by acknowledging the Phase III CARDIO-TTRansform trial for Wainua in transthyretin-mediated amyloid cardiomyopathy. This trial was conducted in a contemporary ATTR cardiomyopathy patient population designed to examine the role of Wainua, a gene silencer treatment, on top of today's standard of care in reducing recurrent cardiovascular events and CV mortality.

    我想先談第三期(Phase III)CARDIO-TTRansform試驗,該試驗評估Wainua用於轉甲狀腺素蛋白(TTR)介導的類澱粉心肌病變。此試驗在當代ATTR心肌病變患者族群中進行,旨在檢視在現行標準治療基礎上加入Wainua(基因沉默療法),對降低反覆心血管事件與心血管(CV)死亡率的影響。

  • In this contemporary patient population treated with standard of care, including 57% on a stabilizer, adding Wainua did not provide a statistically significant benefit on the composite outcome of CV mortality and recurrent CV events. However, in a pre-specified subgroup analysis of patients treated with Wainua monotherapy as compared to placebo, fewer primary composite events were observed, and this result was nominally significant. In patients who were on stabilizer therapy at baseline, no treatment effect was observed.

    在這一接受標準治療的當代患者族群中(其中57%使用穩定劑),加入Wainua在CV死亡與反覆CV事件的複合終點上未達統計學顯著獲益。然而,在預先指定的亞組分析中,與安慰劑相比,接受Wainua單藥治療的患者觀察到較少的主要複合事件,且該結果名目上達到顯著。在基線即使用穩定劑治療的患者中,未觀察到治療效果。

  • Although the trial did not meet its primary endpoint, we believe these results contribute meaningfully to the greater scientific understanding of treatment approaches for the hundreds of thousands of patients worldwide suffering from this progressive and often fatal condition. AstraZeneca and Ionis will analyze the full dataset to further understand the results, and we look forward to presenting these data at the European Society of Cardiology Congress in August.

    儘管試驗未達主要終點,我們相信這些結果對於加深科學界對治療策略的理解具有重要貢獻,因為全球有數十萬名患者正受此進行性且常致命疾病所苦。AstraZeneca與Ionis將分析完整資料集以進一步理解結果,並期待於8月的歐洲心臟病學會(ESC)大會上發表這些數據。

  • Turning now to elecoglipron, where we are building strong momentum into Phase III. At the American Diabetes Association meeting in June, we presented results from our Phase IIB VISTA and SOLSTICE trials, which demonstrated the potential of elecoglipron as a multi-blockbuster asset for AstraZeneca.

    接著談elecoglipron,我們正建立強勁動能邁向第三期(Phase III)。在6月的美國糖尿病學會(ADA)會議上,我們發表了第二期b(Phase IIB)VISTA與SOLSTICE試驗結果,顯示elecoglipron有潛力成為AstraZeneca的多重重磅資產。

  • In VISTA, we observed a clinically meaningful and statistically significant weight loss of up to 11.8% at week 36, importantly without evidence of a plateau. In SOLSTICE, there was an up to 1.9% reduction in HbA1c at week 26, with the vast majority of patients with type-2 diabetes reaching their glycemic goals. Elecoglipron demonstrated a favorable safety profile with no unexpected safety signals, low discontinuation rates, and tolerability consistent with the GLP-1 receptor agonist class.

    在VISTA中,我們於第36週觀察到最高達11.8%的具臨床意義且具統計學顯著的體重下降,且重要的是未見平台期跡象。在SOLSTICE中,第26週HbA1c最高下降1.9%,且絕大多數第二型糖尿病患者達到其血糖控制目標。elecoglipron展現良好的安全性概況,未出現非預期安全性訊號、停藥率低,且耐受性與GLP-1受體致效劑類別一致。

  • It is worth emphasizing that elecoglipron is an oral small molecule. This once-daily treatment requires no fasting or fluid restrictions and critically can be combined with other oral small molecules to treat interconnected chronic diseases. Based on the strength of these data, we are advancing an ambitious phase III program. EMBOLD is studying elecoglipron monotherapy in patients with obesity or overweight with or without type-2 diabetes. The ILLUMINATE program, which includes five phase III trials, evaluates elecoglipron both as monotherapy and in combination with dapagliflozin across broad patient populations with type-2 diabetes.

    值得強調的是,elecoglipron 為口服小分子藥物。此每日一次的治療不需要禁食或限制飲水,且關鍵在於可與其他口服小分子藥物合併使用,以治療彼此相互關聯的慢性疾病。基於這些數據的強勁表現,我們正推進一項具雄心的第三期計畫。EMBOLD 正在研究 elecoglipron 單藥治療,用於肥胖或過重患者,無論是否合併第二型糖尿病。ILLUMINATE 計畫包含五項第三期試驗,評估 elecoglipron 作為單藥以及與 dapagliflozin 聯合治療,涵蓋廣泛的第二型糖尿病患者族群。

  • I am pleased to say that we achieved first subject in for both the EMBOLD and ILLUMINATE programs. Beyond these, we also plan to initiate ELEVATE, an indication-seeking outcomes program designed to demonstrate the value of elecoglipron in heart failure with preserved ejection fraction and chronic kidney disease on the background of dapagliflozin and other standard of care.

    我很高興地表示,EMBOLD 與 ILLUMINATE 兩個計畫都已完成首位受試者入組。此外,我們也計畫啟動 ELEVATE,這是一項以取得適應症為目標的結局研究計畫,旨在於以 dapagliflozin 及其他標準治療為背景治療下,證明 elecoglipron 在射血分率保留型心衰竭與慢性腎臟病中的價值。

  • Finally, I want to highlight a few additional advancements in our biopharmaceuticals pipeline during the second quarter. [Staying] and weight management, the phase II APRICUS trial studying AZD6234, our selective amylin receptor agonist, read out this quarter, and we are now initiating a phase III monotherapy trial. We look forward to sharing the phase II data with the medical community at EASD later this year.

    最後,我想重點說明我們在第二季於生物製藥研發管線的幾項額外進展。在[Staying]與體重管理方面,研究 AZD6234(我們的選擇性胺淀素受體致效劑)的第二期 APRICUS 試驗於本季讀出,我們目前正啟動第三期單藥試驗。我們期待在今年稍晚於 EASD 與醫學界分享第二期數據。

  • In dyslipidaemia, we look forward to the Phase III readout of our oral PCSK9, laroprovstat, in the first half of 2027 and are advancing our first fixed-dose combination of laroprovstat with rosuvastatin into Phase III, bringing together the benefits of a statin and a PCSK9 inhibitor in a single tablet.

    在血脂異常方面,我們期待於 2027 年上半年取得口服 PCSK9 藥物 laroprovstat 的第三期讀出,並正推進首個 laroprovstat 與 rosuvastatin 的固定劑量複方進入第三期,將他汀類與 PCSK9 抑制劑的效益整合於單一錠劑中。

  • Moving to our respiratory portfolio, we are excited to present the highly clinically meaningful results from the OBERON and TITANIA Phase III studies for Tozorakimab in COPD at the European Respiratory Society Congress in September, highlighting the compelling profile we have seen for this potential first and best-in-class asset.

    接著談到呼吸產品組合,我們很期待在 9 月的歐洲呼吸學會年會上,發表 Tozorakimab 用於 COPD 的 OBERON 與 TITANIA 第三期研究之高度具臨床意義的結果,凸顯我們對此一潛在同類首創且同類最佳資產所觀察到的強勁特性。

  • We have also made exciting progress in other areas of our respiratory portfolio this quarter. Our inhaled TSLP, Sunakiment, which was formerly referred to as AZD8630, read out its Phase II study, and we are discussing plans for Phase III with our partner, Amgen.

    本季我們在呼吸產品組合的其他領域也取得令人振奮的進展。我們的吸入型 TSLP——Sunakiment(先前稱為 AZD8630)已完成第二期研究讀出,我們正與合作夥伴安進(Amgen)討論第三期計畫。

  • Additionally, we entered into an exclusive license agreement with CTTQ, a subsidiary of Sino Biopharmaceuticals, for the development, manufacturing, and commercialization of TQC3721, an inhaled small molecule PDE3/4 inhibitor currently in phase III trials in China for COPD. This licensing agreement strengthens our respiratory portfolio with a novel inhaled option for people living with COPD, a disease with continued patient need, particularly for those who remain symptomatic despite existing treatment options.

    此外,我們與 CTTQ(中國生物製藥旗下子公司)簽訂獨家授權協議,取得 TQC3721 的開發、製造與商業化權利;TQC3721 為吸入型小分子 PDE3/4 抑制劑,目前在中國針對 COPD 進行第三期試驗。此授權協議以一項新穎的吸入治療選擇強化了我們的呼吸產品組合,服務 COPD 患者——這是一種仍存在持續未滿足需求的疾病,特別是對於在既有治療選項下仍有症狀者。

  • And with that, please proceed to the next slide, and I'll pass over to Marc to cover rare disease.

    接下來請切到下一張投影片,我將交給 Marc 來說明罕見疾病。

  • Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

    Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

  • Thank you, Sharon. Can I get the next slide, please? Rare disease total revenues grew by 11% in the first half to $4.9 billion, underpinned by double-digit growth access all key medicines. This is driven by increased patient demand and continued global expansion following launches.

    謝謝你,Sharon。可以請切到下一張投影片嗎?罕見疾病總營收在上半年成長 11% 至 49 億美元,主要受所有關鍵藥品的雙位數成長所支撐。這主要由患者需求增加,以及產品上市後持續的全球擴張所帶動。

  • In the second quarter, Ultomiris grew 12%, driven by patient demand across indications, including the competitive MG and PNH markets. Soliris revenues continued to decline due to successful conversion to Ultomiris as well as biosimilar pressure. Strensiq grew 36% year-on-year, reflecting strong patient demand. Strensiq remains one of AstraZeneca's fastest-growing blockbuster medicines, supported by ongoing investment in commercial capabilities, infrastructure, and disease awareness.

    在第二季,Ultomiris 成長 12%,由各適應症的患者需求所驅動,包括競爭激烈的 MG 與 PNH 市場。Soliris 營收因成功轉換至 Ultomiris 以及生物相似藥競爭壓力而持續下滑。Strensiq 年增 36%,反映強勁的患者需求。Strensiq 仍是阿斯特捷利康成長最快的重磅藥物之一,並受持續投入商業能力、基礎設施與疾病認知推廣所支持。

  • These investments are driving continued growth today, while also laying the foundation for the potential launch of the efzimfotase alfa and future franchise growth Koselugo continues to deliver strong global momentum, supported by expansion in adult patients with NF1PN and uptake of the granule formulation in recently launched market. Koselugo remains the market leader for pediatric patients with NF1PN.

    這些投資不僅推動當前的持續成長,也為 efzimfotase alfa 的潛在上市以及未來產品線成長奠定基礎。Koselugo 亦持續展現強勁的全球動能,受惠於 NF1PN 成人患者的擴展,以及在近期上市市場中顆粒劑型的採用提升。Koselugo 仍是 NF1PN 兒科患者的市場領導者。

  • Overall, we continue to see great momentum across the rare disease portfolio, and please advance to the next slide. Turning to our rare disease pipeline, we have continued to build momentum with Phase III data presentation across rare disease indications, highlighting the breadth of our portfolio and the strength of our late-stage execution.

    整體而言,我們持續看到罕見疾病產品組合的強勁動能,請切到下一張投影片。談到罕見疾病研發管線,我們持續透過多個罕見疾病適應症的第三期數據發表來累積動能,凸顯我們產品組合的廣度以及後期臨床執行的實力。

  • In IgAN nephropathy, Phase III data from the I CAN trial for Ultomiris showed a 43% reduction in proteinuria, with significant proteinuria reduction seen as early as 10 weeks. Importantly, treatment effects were consistent across patient groups, including those at higher risk of progression and with more inflammatory disease. While IgAN is becoming an increasingly competitive treatment landscape, the heterogeneity of the disease underscores the importance of multiple treatment approaches and the data we presented at ERA further support the role of complement in disease pathophysiology.

    在 IgAN 腎病變方面,Ultomiris 的 I CAN 第三期試驗數據顯示蛋白尿降低 43%,且在第 10 週即觀察到顯著的蛋白尿下降。重要的是,治療效果在各患者族群間一致,包括進展風險較高及發炎程度較高的患者。儘管 IgAN 的治療版圖正變得愈加競爭,疾病的異質性凸顯多元治療策略的重要性,而我們在 ERA 發表的數據亦進一步支持補體在疾病病理生理中的角色。

  • The IgAN opportunity represents an important step in the continued expansion and development of our C5 franchise, building on Ultomiris established leadership across multiple complement-mediated diseases. We have now filed in both the US and Japan. For efzimfotase alfa, in Hypophosphatasia, data from our phase III pediatric trials, MULBERRY and CHESTNUT were presented at the International Conference on Children's Bone Health in June.

    IgAN 的機會代表我們持續擴展與發展 C5 產品線的重要一步,並建立在 Ultomiris 於多種補體介導疾病中已確立的領導地位之上。我們目前已在美國與日本提出申請。至於 efzimfotase alfa,在低磷酸酶症方面,我們的第三期兒科試驗 MULBERRY 與 CHESTNUT 的數據已於 6 月在國際兒童骨骼健康會議上發表。

  • MULBERRY demonstrated clinically meaningful improvement in bone health, function, and quality of life. In her single-arm switch safety study, CHESNUT, showed efzimfotase alfa was well tolerated and demonstrated a favorable safety profile in pediatric patients. In a pooled analysis of the Phase III MULBERRY and EcoRI trials, including pediatric, adolescent, and adult patients, treatment with efzimfotase alfa resulted in a median of 361 days per year, free from injection site reactions. And injection site reactions rates were 5 times lower than with Strensiq.

    MULBERRY 顯示在骨骼健康、功能與生活品質方面具有臨床上具意義的改善。在其單臂轉換安全性研究 CHESNUT 中,結果顯示 efzimfotase alfa 耐受性良好,並在兒科患者中展現良好的安全性特徵。在第三期 MULBERRY 與 EcoRI 試驗的合併分析中(涵蓋兒科、青少年與成人患者),efzimfotase alfa 治療使每年中位數達 361 天可免於注射部位反應。且注射部位反應發生率較 Strensiq 低 5 倍。

  • Data from [MICORI] trial will be presented at the American Society for Bone and Mineral Research in October. We are progressing filings across major markets to support a broad SPP patient population.

    [MICORI] 試驗數據將於 10 月在美國骨與礦物質研究學會(ASBMR)發表。我們正推進在主要市場的申請,以支持更廣泛的 SPP 患者族群。

  • Also data from the CALYPSO Phase III trial was presented in May at ECE. Eneboparatide demonstrated maintenance of serum calcium within the target range. Normalization of urinary calcium and restoration of normal bone turnover in patients with Hypoparathyroidism. And anselamimab in kappa light-chain amyloidosis patients results from the CARES program demonstrated a 62% reduction in all-cause mortality and a 71% reduction in cardiovascular hospitalization with an overall survival benefit observed even in patients with advanced mild-stage disease.

    另外,CALYPSO 第三期試驗數據已於 5 月在 ECE 發表。Eneboparatide 顯示可維持血清鈣於目標範圍內。並在甲狀旁腺功能低下症患者中達到尿鈣正常化及恢復正常骨代謝週轉。此外,在 κ 輕鏈類澱粉沉積症患者中,anselamimab 的 CARES 計畫結果顯示全因死亡率降低 62%,心血管住院降低 71%,且即使在晚期輕度分期疾病患者中亦觀察到整體存活獲益。

  • Taken together, this program illustrates the strengths of our rare disease pipeline with multiple, near, and mid-term catalysts with potential approvals and future launches across several high-value rare disease indications.

    綜合而言,該計畫展現我們罕見疾病研發管線的優勢,具備多項近期與中期的關鍵催化事件,並有望在多個高價值罕見疾病適應症上取得核准與未來上市。

  • And finally, an update on our Ultomiris phase III trial in adults with thrombotic microangiopathy after ECT, high-level results showed that Ultomiris did not achieve statistical significance for the primary endpoint of even-free survival through 26 weeks compared to placebo in adults and adolescents aged 12 years older with HSCT/TMA. Ultomiris showed a trend towards treatment benefit and discussion with health authorities ongoing regarding the interpretation of this data including in the context of real-world evidence.

    最後,更新我們 Ultomiris 用於 ECT 後血栓性微血管病變之成人第三期試驗:高層級結果顯示,與安慰劑相比,Ultomiris 在 26 週內的主要終點「事件無發生存活」(event-free survival)未達統計顯著性,研究對象為 12 歲以上的成人與青少年 HSCT/TMA 患者。Ultomiris 顯示出治療獲益的趨勢,我們正與衛生主管機關持續討論對此數據的解讀,包括在真實世界證據脈絡下的解釋。

  • In pediatric patients with HSCT-TMA, we are advancing regulatory filings based on data from the open-label Phase III trial reported in 2025 and data from an external control study. As pioneers in complement biology, we continue to explore and advance treatment approaches in disease where complement is believed to play a central role in disease pathophysiology. With limited treatment option available today, it reflects our ongoing commitment to bringing innovative therapies to patients with severe complement-mediated disease.

    在兒科 HSCT-TMA 患者方面,我們正基於 2025 年報告的開放標籤第三期試驗數據,以及一項外部對照研究的數據,推進監管申報。作為補體生物學的先驅,我們持續探索並推進在補體被認為於疾病病理生理中扮演核心角色之疾病的治療策略。在目前治療選項有限的情況下,這反映了我們持續致力於為嚴重的補體介導疾病患者帶來創新療法。

  • And with that, please advance to the next slide and I will hand back to Pascal.

    接下來,請切換到下一張投影片,我會把時間交還給 Pascal。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Marc. Next slide, please.

    謝謝你,Marc。請下一張投影片。

  • As the slide shows you, we carried strong momentum into the first half, six positive program readouts already delivered, and a rich catalyst path ahead. Over the next 18 months, we have 25 key phase III trial readouts that are planned, giving us multiple opportunities to add further value and conviction to our trajectory. We expect pivotal data readouts for six new molecular entities in 2027 alone across our portfolio. Some of them are really important. As you can see here, and for instance, (inaudible) is a big one, but there are many other very important readouts over the next 18 months or so.

    如投影片所示,我們在上半年延續了強勁動能,已交付六項正面的專案讀出,且未來仍有豐富的催化事件路徑。在接下來 18 個月內,我們規劃將有 25 項關鍵第三期試驗讀出,為我們提供多次機會,進一步為我們的發展軌跡增添價值與信心。我們預期僅在 2027 年,我們的產品組合中就會有六個新分子實體的關鍵性數據讀出。其中有些非常重要。如你在此所見,例如(聽不清)是一個重點,但在未來約 18 個月內還有許多其他非常重要的讀出。

  • So move to the next slide. Our growth ambition extends well beyond 2030, and we continue to invest behind the transformative technologies that we believe will redefine how many diseases are treated. If you remember back in May 2024. We identified platforms that we said would drive our growth post 2030, what we called at the time the day after tomorrow. And I'm pleased to say that we have made very good progress across many of these platforms. As you can see here, the slide highlights the momentum we're building in our next wave of innovation.

    那麼請到下一張投影片。我們的成長企圖心遠超過 2030 年,我們也持續投資於我們相信將重新定義多種疾病治療方式的變革性技術。如果你還記得 2024 年 5 月。我們辨識出一些平台,並表示它們將驅動我們 2030 年後的成長,我們當時稱之為「後天」。我很高興地說,我們在其中許多平台上都取得了非常好的進展。如你所見,這張投影片突顯了我們在下一波創新上正在累積的動能。

  • So if we start with weight management and cut a risk factor. As [Sharon] mentioned, we expect the first phase III data for Laroprovstat in the first half of 2027. And we have now initiated five phase III trials for elecoglipron. So you can see here our portfolio is building both scale and optionality and focused on not only weight management, but the risk factors that accompany excess obesity and varicular abdominal obesity.

    如果我們先從體重管理與降低風險因子談起。如 [Sharon] 所提到,我們預期 Laroprovstat 的首批第三期數據將於 2027 年上半年出爐。而我們目前也已啟動 elecoglipron 的五項第三期試驗。因此你可以看到,我們的產品組合正在同時建立規模與選擇性,且不僅聚焦於體重管理,也聚焦於伴隨過度肥胖以及內臟型腹部肥胖的風險因子。

  • In ADC and radio conjugates, we continue to make strong progress. As highlighted today, we've just had the first positive Phase III readouts for sone-ve, and we anticipate Phase III data for our second wholly owned ADC, puxi-sam, next year. We also continue to advance our broader program, having those patients in our first Phase III trials for torvu-sam and also for zada-gu this quarter, so very good progress across ADCs, and radioligands.

    在 ADC 與放射性偶聯藥物方面,我們持續取得強勁進展。如今天所強調,我們剛獲得 sone-ve 的首個正面第三期讀出,並預期明年將取得我們第二個完全自有 ADC——puxi-sam——的第三期數據。我們也持續推進更廣泛的專案,本季已在 torvu-sam 的首批第三期試驗以及 zada-gu 的試驗中納入患者,因此在 ADC 與放射性配體方面都取得了非常好的進展。

  • For our next generation IU bispecifics, we now have 16 phase III trials across eight tumor types, including five in combination with our ADCs. This supports our ambition to replace the current generation of checkpoint inhibitors. Our cell therapy and T-cell engager portfolios are also advancing very rapidly. AZD0120 and surovatamig, both have multiple phase III trials underway across hematology.

    在我們下一代 IU 雙特異性抗體方面,目前已在八種腫瘤類型中展開 16 項第三期試驗,其中包含五項與我們 ADC 聯合使用的試驗。這支持了我們取代現有一代免疫檢查點抑制劑的企圖心。我們的細胞治療與 T 細胞接合劑產品組合也在非常快速地推進。AZD0120 與 surovatamig 兩者皆在血液腫瘤領域有多項第三期試驗進行中。

  • And importantly, both now have extended into autoimmune diseases, underscoring the broader therapeutic potential of these platforms, very exciting program -- progress, sorry, across those two products. Beyond these lead programs, we're also investing behind off the shelf and in vivo cell therapies, which we believe will enable us to reach more patients across more disease areas.

    而且重要的是,兩者現在也已延伸至自體免疫疾病,凸顯這些平台更廣泛的治療潛力;在這兩項產品上都取得了非常令人振奮的進展——抱歉,是進展。除了這些領先專案之外,我們也在投資現成型(off-the-shelf)與體內(in vivo)細胞治療,我們相信這將使我們能在更多疾病領域觸及更多患者。

  • These programs continue to advance and are key components of our deep lead stage pipeline of multiple blockbuster opportunities that will underpin our next wave of growth.

    這些專案持續推進,並且是我們深度領先階段研發管線的重要組成部分,該管線包含多個具備重磅藥物潛力的機會,將支撐我們下一波成長。

  • So move to the next slide. The strength of that opportunity is reflected in this slide. We have three recent launches, Datroway, Etcamah, Baxfendy, each with peak year revenue potential of more than $5 billion. Beyond these launches, we have a broad portfolio of late-stage assets that are expected to deliver pivotal data before 2030, including multiple programs with multi-blockbuster potential.

    那麼請到下一張投影片。這張投影片反映了這項機會的強度。我們有三個近期上市產品:Datroway、Etcamah、Baxfendy,每一個的峰值年度營收潛力都超過 50 億美元。除了這些上市產品之外,我們還有廣泛的後期資產組合,預期在 2030 年前交付關鍵性數據,其中包含多個具備多重重磅潛力的專案。

  • Together, these assets provide a strong foundation for growth into the next decade. It really is important to remember that our $80 billion is risk-adjusted. If everything worked 100%, we would be much above the $80 billion, of course. But we've also assumed some projects would not work and other projects would work. And a good example of this is the strong data we obtained for Tozorakimab, a product that very few people thought was going to work. We ourselves had a low probability of success for it. We tried because we thought we have a different mechanism of action and we have a chance and it actually worked. You will see the data very soon.

    合在一起,這些資產為未來十年的成長提供了堅實基礎。非常重要的一點是要記得,我們的 800 億美元是經風險調整後的。如果所有項目都 100% 成功,當然會遠高於 800 億美元。但我們也假設有些專案不會成功,而另一些專案會成功。一個很好的例子是我們為 Tozorakimab 取得的強勁數據,這是一個很少人認為會成功的產品。我們自己對它的成功機率評估也很低。我們之所以嘗試,是因為我們認為它有不同的作用機轉,且我們有機會,而它確實成功了。你很快就會看到這些數據。

  • As a result, we have increased our peak revenue expectation to more than $5 billion. In addition, with a positive readout for sone-ve today, we estimate that this ADC could reach peak revenue between $3 billion and $5 billion. This is an example of the strengths and the diversification in our pipeline. The likelihood that there will be puts and takes is part of how we plan, and we've taken this into account in our growth ambition beyond 2030 as well. We have built what we believe is one of the most exciting pipelines in the industry, one that can now more than offset losses of exclusivity and fuel AstraZeneca growth well into the next decade.

    因此,我們已將其峰值營收預期上調至超過 50 億美元。此外,隨著今天 sone-ve 的正面讀出,我們估計這款 ADC 的峰值營收可達 30 億至 50 億美元之間。這就是我們研發管線優勢與多元化的例證。在我們的規劃中,出現利多與利空的可能性本就是一部分,我們也已將此納入我們 2030 年後的成長企圖心之中。我們打造了我們認為是業界最令人振奮的研發管線之一,現在它不僅能抵消專利到期帶來的影響,還能推動阿斯特捷利康在未來十年持續成長。

  • In closing, as we move to the next slide, I'd like to say that we delivered strong growth in the first half. Again, 11% excluding Farxiga and Brilinta shows you the strengths of the pipeline and the geographical footprint. 6% growth overall. So strong growth in the first half. The breadth and depth of our pipeline remain exceptional and our confidence in reaching $80 billion revenue by 2030 is intact.

    最後,在我們切換到下一張投影片時,我想說我們在上半年交出了強勁成長。再次強調,若排除 Farxiga 與 Brilinta,11% 的成長顯示了研發管線與地理布局的優勢;整體成長為 6%。因此,上半年表現強勁。我們研發管線的廣度與深度依然卓越,我們對於在 2030 年達成 800 億美元營收的信心依舊不變。

  • But what excites me most is what comes next. With multiple waves of blockbuster assets that are progressing through each stage development and transformative technology platforms scaling rapidly. We're building a company that will not just deliver on its 2030 ambition but continue to grow well into the next decade. We have the science, we have the pipeline, and we have the team to make that happen.

    但最讓我興奮的是接下來的發展。隨著多波重磅資產在各開發階段持續推進,以及變革性技術平台快速擴張。我們正在打造一家不僅能實現 2030 年企圖心,且能在未來十年持續成長的公司。我們有科學實力、有研發管線,也有團隊來實現這一切。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • And with that, please advance to the next slide and we'll move to the Q&A. As Joris mentioned at the start of the call, please limit the number of questions you asked to allow others a fair chance to participate. Please use the raised hand function on Zoom.

    那麼接下來,請切換到下一張投影片,我們將進入問答環節。如 Joris 在電話會議一開始所提到,請限制你提問的數量,讓其他人也有公平的參與機會。請使用 Zoom 的舉手功能。

  • Rajan Sharma, Goldman Sachs.

    Rajan Sharma,高盛。

  • Rajan Sharma - Analyst

    Rajan Sharma - Analyst

  • Hi, thanks for taking my question. Firstly, just on the oral PCSK9, which you highlighted there, could you just outline your expectations ahead of the data next year? And how do you expect this to compare relative to Merck's Lipfendra? And maybe you could just comment on your expectations for pricing in that market, given we now have a list price for your competitor?

    嗨,謝謝讓我提問。首先,關於你們剛才提到的口服 PCSK9,你能否概述一下你們對明年數據公布前的預期?以及你們預期它相較於默克的 Lipfendra 會如何表現?另外,鑑於我們現在已看到競品的定價(標價),也請你談談你們對該市場定價的預期。

  • And then secondly, on sone-ve, you're going to $3 billion to $5 billion in peak sales. Can you just help us understand how much of that is in the first line versus the data that you've disclosed today? And maybe could you just talk about geographical split of patients and potential revenues? Thank you.

    其次,關於 sone-ve,你們預期峰值銷售額將達到 30 億至 50 億美元。能否協助我們理解,其中有多少來自一線治療,多少來自你們今天披露的數據?另外,能否談談患者的地理分布以及潛在營收的區域拆分?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • That's great. Thank you very much, Rajan. Maybe Ruud could take the first question and, Dave, the second one.

    很好。非常感謝你,Rajan。也許 Ruud 可以回答第一個問題,Dave 回答第二個。

  • Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

  • Yes, of course, Pascal. Overall, I think we are excited about our oral PCSK9. We will see the first data reading out in the first half of 2027. I think we will have -- and hopefully we will have a competitive profile versus the compounds of Merck, but I think the breadth of our portfolio for cholesterol-lowering medicines is broader than only the oral PCSK9, as Sharon has mentioned, we have started the first combination with rosavastin.

    好的,當然可以,Pascal。整體而言,我想我們對我們的口服 PCSK9 感到振奮。我們將在 2027 年上半年看到第一批數據讀出。我認為我們將會——並且希望——相較於默克的化合物具備具競爭力的特性;但如 Sharon 提到的,我們的降膽固醇藥物產品組合不僅僅只有口服 PCSK9,我們已經啟動了與 rosavastin 的首個聯合用藥。

  • I think we have a unique opportunity because it's a true oral medicine in order to combine that with all the other products in our portfolio and hence that will increase the level of competitiveness. Regarding the pricing, we have seen the official first list price of our competitors in the United States. It will not change dramatically our own outlook. Of course, I'm not going to disclose our pricing strategy moving forward. It also depends. We are going to see in our clinical trials.

    我認為我們有一個獨特的機會,因為這是一款真正的口服藥物,可以與我們產品組合中的其他所有產品進行搭配,因此將提升競爭力。關於定價,我們已看到競品在美國的官方首個掛牌價格。這不會大幅改變我們自身的展望。當然,我不會披露我們未來的定價策略。這也取決於——我們將在臨床試驗中看到。

  • But overall, I think we are well on track in order to develop a very competitive oral PCSK9 moving forward.

    但總體而言,我認為我們正按計畫推進,以開發一款非常具競爭力的口服 PCSK9。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Thanks, Ruud. So, just picking up on the question about sone-ve and CLARITY-Gastric, and after I'm done, turn it over to Susan, who can talk a bit more about the life cycle plan beyond CGL-1. But we're very excited about these results and look forward to getting an opportunity to presenting them soon, specifically the CGL-1 opportunity as potential to be a blockbuster indication.

    謝謝,Ruud。接著回到關於 sone-ve 與 CLARITY-Gastric 的問題;我講完後會交給 Susan,她可以再多談一些 CGL-1 之外的全生命週期規劃。我們對這些結果非常振奮,也期待能很快有機會正式發表,特別是 CGL-1 的機會,作為潛在的重磅適應症。

  • Now, some of that will depend obviously on indications that we are able to achieve, but the data set looks good. We look forward to sharing it. I think a couple of important points first, we will pursue discussions across all major markets, US, Europe, China, Japan, and throughout the emerging markets. This data set we think supports those discussions.

    當然,其中一部分取決於我們最終能取得哪些適應症,但這套數據看起來不錯。我們期待分享。我想先強調幾個重點:第一,我們將在所有主要市場推進討論,包括美國、歐洲、中國、日本,以及各新興市場。我們認為這套數據支持這些討論。

  • Secondly, as you saw, overall survival being an absolute gold standard within this setting, we think well positions sone-ve for uptake upon approval, and we expand the definition of CLAUDIN 18.2 positivity with the cutoff that we're using in this study. And that cutoff is greater than 25%. And that represents about half of the patients with gastric GEJ cancer. So it's a great opportunity and one that we're really looking forward to getting an opportunity to launch as quickly as possible.

    第二,如你所見,在此治療情境中,總生存期是絕對的黃金標準;我們認為這使 sone-ve 在獲批後的採用上具備良好定位,同時我們也透過本研究所使用的切點擴大了 CLAUDIN 18.2 陽性的定義。該切點為大於 25%。這大約涵蓋一半的胃癌/胃食道交界(GEJ)癌患者。因此這是一個很好的機會,我們也非常期待能盡快有機會上市。

  • Susan, do you want to talk a little bit about the life cycle plan beyond CGL-1?

    Susan,你要不要談談 CGL-1 之後的全生命週期規劃?

  • Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

    Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

  • Yes. So, obviously, in the first line, there's an opportunity to combine with IR agents, as I've discussed with both rilvegostomig plus backbone of capecitabine. And the CLARITY-Gastric02 study has two cohorts, one in the PD-L1 greater than 1%, but also has a cohort in the less than 1% where we're looking at sone-ve plus 5FU-based regimen versus the standard of care as well.

    好的。很明顯,在一線治療上,有機會與免疫療法(IO)藥物合併,如我先前提到的 rilvegostomig,再加上 capecitabine 的基礎治療。而 CLARITY-Gastric02 研究有兩個隊列:一個是 PD-L1 大於 1%;同時也有一個小於 1% 的隊列,我們在其中比較 sone-ve 加上以 5FU 為基礎的方案,對照標準治療。

  • So, I think that gives us an opportunity to have a broad first line opportunity to have that IO and ADC combination in the relevant patient population. And it is a big segment in gastric cancer. And then again, I think there are opportunities to consider based on the data that we've got with MATTERHORN, whether there's an opportunity to go into the earlier stage setting.

    因此,我認為這讓我們有機會在相關患者族群中,於一線治療取得更廣泛的機會,形成 IO 與 ADC 的聯合治療。而這在胃癌中是一個很大的族群。另外,我也認為,基於我們在 MATTERHORN 所取得的數據,或許有機會進一步拓展到更早期的治療情境。

  • Plus, Claudin 18.2 is not just expressed on gastric cancer, but also on some pancreatic cancers and biliary tract cancers. And we're exploring those in our ongoing phase I, and we're encouraged by the data that we've seen to date. So I think this can be a broad programme for sone-ve across all of these GI-based cancers.

    此外,Claudin 18.2 不僅在胃癌表達,也在部分胰臟癌與膽道癌中表達。我們正在進行中的第一期試驗中探索這些適應症,且截至目前看到的數據令人鼓舞。因此我認為,這可以成為 sone-ve 橫跨所有這些以腸胃道為主的癌症的廣泛計畫。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Suzanne, Dave, and Rude. Maybe one thing I could add to the PCSK9 is that another fixed dose combo we are developing is together with elecoglipron or glipron oral, cause if you have high elevated cholesterol, typically you also need to lose a bit of weight. This is a good example of how we can differentiate our PCS scan, but also differentiate our glipran by providing convenient formulations to patients who are typically polymedicated in these circumstances.

    謝謝你,Suzanne、Dave 和 Rude。關於 PCSK9,我或許可以補充一點:我們正在開發的另一個固定劑量複方,是與 elecoglipron 或口服 glipron 併用,因為若膽固醇偏高,通常也需要減一些體重。這是我們如何讓 PCS scan 具差異化、同時也讓 glipran 具差異化的一個好例子:為在這些情況下通常需要多重用藥的患者,提供更便利的劑型。

  • So next question is, I think, Richard.

    下一個問題,我想是 Richard。

  • Richard Vosser - Analyst

    Richard Vosser - Analyst

  • Thanks, Pascal. One question, please, on camizestrant. Just now we've seen the persevERA data in detail ASCO, I don't think when we last spoke we'd seen it. Could you give us your latest thoughts around how SERENA-4 could differ in terms of patients enrolled and how that impacts your thinking around potential benefit of Cami, what it could deliver in the trial?

    謝謝,Pascal。我有一個關於 camizestrant 的問題。我們剛在 ASCO 看到了更完整的 persevERA 數據細節,我想上次我們通話時還沒看到。你能否分享你們最新的看法:SERENA-4 在入組患者方面可能有哪些不同,以及這如何影響你們對 Cami 潛在效益的判斷、以及它在試驗中可能帶來的結果?

  • And does the data you've seen change your view of the importance of endocrine sensitivity for generating a benefit and how endocrine sensitive do you think you have in the trial? Thanks very much.

    另外,你們看到的數據是否改變了你們對「內分泌敏感性」在產生療效上的重要性的看法?以及你們認為試驗中患者的內分泌敏感性大概有多高?非常感謝。

  • Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

    Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

  • So, thanks for the question. So, as you said, the goal for SERENA-4 is to enrich for endocrine sensitivity. Again, as a reminder, we have a larger sample size, 1370 patients enrolled compared to the SERENA. And I think, what you've seen with the persevERA data is evidence of activity which varies across the different subgroups there. I can't comment on the exact subgroups today. Obviously, we're anticipating the trial readout in the second-half of this year, and obviously we have to wait for that readout to really see.

    謝謝你的問題。如你所說,SERENA-4 的目標是富集內分泌敏感的患者。再提醒一下,我們的樣本數更大,入組 1,370 名患者,相較於 SERENA。而你在 persevERA 數據中看到的是活性證據,但在不同亞組之間有所差異。我今天無法評論具體的亞組。很明顯,我們預期在今年下半年讀出結果,而我們也必須等到讀出後才能真正了解。

  • But again, we have striven to enrich for that endocrine sensitive population with the design of those subgroups. And again, I think what we're happy with the SERENA-6 data is the overall tolerability profile that we've seen with camrizestrant, low rates of GI side effects that are seen, and a very low discontinuation rate with good tolerability overall in that trial. So I think we have to wait and see at this point. That's why we run phase III trials, and we're very happy to share the data with you as soon as we have them.

    但同樣地,我們透過這些亞組的設計,努力富集內分泌敏感族群。另外,我們對 SERENA-6 數據感到滿意的是:camrizestrant 的整體耐受性表現良好,觀察到的腸胃道副作用比例偏低,且停藥率非常低,整體耐受性佳。所以我認為目前只能等待並觀察。這也是我們進行第三期試驗的原因;一旦我們拿到數據,也會很樂意盡快與各位分享。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Susan.

    謝謝,Susan。

  • Simon Baker, Redburn.

    Simon Baker,Redburn。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Thank you, Pascal. One, if I may, on osimertinib. The profile based on the data we've seen so far looks very impressive indeed against the competition. But just wanted to get your perspectives on how you see the profile of osimertinib in that setting, and also the significance or otherwise of the far loop versus near loop mutation performance. It appears to be particularly differentiated on far loop. Is that a significant factor or is that less important than perhaps it might seem? Thanks so much.

    謝謝你,Pascal。如果可以的話,我有一個關於 osimertinib 的問題。就目前我們看到的數據而言,這個特性相較於競品看起來確實非常令人印象深刻。但我想請教你們如何看待 osimertinib 在該治療情境中的特性,以及遠環(far loop)相較於近環(near loop)突變表現的意義或重要性。看起來它在遠環上特別具差異化。這是一個重要因素,還是其重要性其實沒有看起來那麼大?非常感謝。

  • Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

    Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

  • Okay, so you're talking about, Zegfrovy, Prascal, do you want me to take this one?

    好的,所以你是在談,Zegfrovy、Prascal,你要我來回答這題嗎?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Yes, please. Yes, if you don't mind, please go ahead.

    是的,麻煩你。是的,如果你不介意的話,請繼續。

  • Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

    Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

  • Okay, so Zegfrovy is obviously the asset that we've licensed from Dizal for exon 20 mutations, but also has activity in a group of mutations that are non-classical as well, which is about a similar size patient population. So I think what the profile is that we see overall -- first of all, it's potent against the exon 20. It's delivering this high and durable response rate there and really has differentiated activity in that second line setting, which has already provided the label that we've got in the US and China.

    好的,所以 Zegfrovy 顯然是我們從 Dizal 授權取得、用於 exon 20 突變的資產,但它同時也對一組非典型突變具有活性,而那一組的病患族群規模也大致相當。所以我認為我們整體看到的特徵是——首先,它對 exon 20 具有很強的效力。它在那裡帶來高且持久的反應率,並且在二線治療情境中確實展現出差異化的活性,而這也已經支撐了我們在美國與中國取得的適應症標籤。

  • In the first line setting, the data were presented at ASCO. So there was an oral presentation at ASCO if people want to have a look at that. And that will form the basis of the filing in the first line setting. So, we look forward to having discussions with the regulatory authorities given the high response rate that we've seen and really good progression-free survival, which was obviously the primary endpoint in that randomized trial.

    在一線治療情境中,數據已在 ASCO 發表。因此如果大家想看,ASCO 上有口頭報告。而這將構成我們在一線治療情境申報的基礎。所以,鑑於我們看到的高反應率以及非常好的無惡化存活期(PFS)——而那顯然是該項隨機試驗的主要終點——我們期待與監管機關展開討論。

  • So yeah, I think if you look at that compared with the other competitors in this space, it's oral, easy to administer at home. The tolerability profile, I think is competitive with other agents and the potency is also competitive. So again, we're excited to have this as another agent to build on our legacy in each of our mutant lung cancer.

    所以是的,我想如果你把它與這個領域的其他競品相比,它是口服、在家就能方便使用。我認為其耐受性概況與其他藥物相比具有競爭力,而效力也同樣具競爭力。因此,我們也很興奮能把它作為另一個藥物,延續並強化我們在各類突變型肺癌領域的既有基礎。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Susan. Maybe good to hear also from. Dave telling you about what we're trying to do to solidify the Tagrisso franchise, because we are under, of course, two major competitive threats, one in China, which is the multiplicity of EGFR in the market and very competitive market. We're doing well, but it's competitive. And the second is, of course, the Mariposa regimen, which again we are still doing well, as Dave mentioned before market share is still very strong for Tagrisso. But beyond that, we are actually trying to build a variety of ways to differentiate Tagrisso. So maybe, Dave, if you can give us the whole picture again, that would be useful.

    謝謝你,Susan。也許也很適合聽聽 Dave 的說法。Dave 來跟大家說明我們正在做什麼,以鞏固 Tagrisso 的產品版圖,因為我們當然正面臨兩個主要的競爭威脅:第一個在中國,也就是市場上 EGFR 藥物眾多、競爭非常激烈。我們表現不錯,但競爭確實激烈。第二個當然是 Mariposa 方案;同樣地,正如 Dave 先前提到的,我們目前仍表現良好,Tagrisso 的市占仍然非常強勁。但除此之外,我們其實也在建立多種方式來讓 Tagrisso 更具差異化。所以 Dave,如果你能再把整體全貌跟我們說一次,會很有幫助。

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Yeah, it'd be my pleasure. And let me use this as just an opportunity also to comment that the strength of FLAURA2 is really laying the foundation right now for the expansion of the clinical development plan to build off of the combination approach to a Tagrisso backbone in order to improve outcomes in EGFR mutated lung cancer. And as Susan quite nicely articulates, Zegfrovy adds to the group of patients that we now have an opportunity to be able to engage physicians about and offer a new therapy.

    好的,我很樂意。也讓我藉此機會補充一下:FLAURA2 的強勁表現,正在為擴大臨床開發計畫奠定基礎;我們將以 Tagrisso 作為骨幹,延伸組合治療策略,以改善 EGFR 突變肺癌的治療結果。而如同 Susan 很清楚地闡述,Zegfrovy 也擴大了我們現在能與醫師溝通、並提供新療法的病患族群。

  • I think just very importantly, we're seeing double-digit volume growth. And in fact double-digit revenue growth in the US in the face of the competition with Tagrisso right now. What that's allowing us also then to do is get ready for both the Dato and the Orpathys combinations, which we're looking forward to. I think that with Dato, obviously, we've got TROPION Lung15 in the later lines and also TROPION Lung14 in the frontline setting.

    我認為非常重要的是,我們看到用量呈現雙位數成長。事實上,在目前 Tagrisso 面對競爭的情況下,我們在美國也看到營收雙位數成長。這也讓我們能為 Dato 與 Orpathys 的組合療法做好準備,我們非常期待。我想在 Dato 方面,顯然我們有後線治療的 TROPION Lung15,以及一線治療情境的 TROPION Lung14。

  • I think relative to what we see with the other Trope2 class players, this is a very differentiated position of having the Tagrisso combination as a way of bringing this set of therapies into these settings. We've got SAFFRON on the horizon, and that's with the Orpathys combination. And we are very enthusiastic about Tagrisso continuing to be an important driver of growth and contributing meaningfully to the 2030 ambition that we've laid out.

    相較於我們看到的其他 TROP2 類別競品,我認為我們的差異化優勢非常明確:以 Tagrisso 的組合作為方式,把這一組療法帶入這些治療情境。我們也有即將到來的 SAFFRON,那是與 Orpathys 的組合。我們對 Tagrisso 持續成為重要的成長驅動力、並對我們所提出的 2030 年目標做出實質貢獻,感到非常振奮。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Dave. So this is a very good example of what we've told you before. The ability we have to combine products through our portfolio to defend our various franchises and build beyond where we are. And then we see addition of Zegfrovy, we are also addressing a gap in our coverage of this EGFR market. So you can see we are really reducing the space where the competition could actually have an impact over time.

    謝謝你,Dave。所以這是一個很好的例子,呼應我們之前跟各位說過的。我們能夠透過產品組合把不同產品進行搭配,以捍衛我們各個產品版圖,並在現有基礎上再往前拓展。此外,隨著 Zegfrovy 的加入,我們也在補足我們在 EGFR 市場覆蓋上的一個缺口。所以你可以看到,我們確實在縮小競爭對手隨時間推移可能產生影響的空間。

  • Sarita Kapila, Morgan Stanley.

    Sarita Kapila,Morgan Stanley。

  • Sarita Kapila - Analyst

    Sarita Kapila - Analyst

  • Thanks, Pascal, for taking my questions. On advance, we noticed it has the PFS and OS endpoints in both TROP2 positive and ITT populations. Could you give us any more color on the testing hierarchy? So for example, are you looking at PFS and then OS in TROP2, followed by PFS and OS and ITT? And what is the minimum outcome that would be filing enabling? So for example, would a PFS win in TROP2 positive patients be sufficient without a clear OS benefit?

    謝謝你,Pascal,讓我提問。關於 advance,我們注意到它在 TROP2 陽性與 ITT 族群中都設有 PFS 與 OS 終點。你能否就檢定階層(testing hierarchy)提供更多說明?例如,你們是否會先看 TROP2 的 PFS 再看 OS,接著再看 ITT 的 PFS 與 OS?以及,能夠支持申報(filing enabling)的最低結果是什麼?例如,若在 TROP2 陽性病患中 PFS 勝出,但沒有明確的 OS 受益,是否就足夠?

  • And this is just a quick one, taking a step back. How should we think about [DATUADES] profile versus Sat-TMT, particularly post the positive OptiTROP-Lung06 data and ahead of the PD-L1-BHF data in 2027? Thank you.

    另外這是一個快速的問題,退一步來看。在 OptiTROP-Lung06 數據為正、且 2027 年 PD-L1-BHF 數據出爐之前,我們應該如何看待 [DATUADES] 的特徵相較於 Sat-TMT?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Sarita. Two good questions for you, Susan.

    謝謝你,Sarita。兩個很好的問題,交給你了,Susan。

  • Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

    Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

  • Okay, thanks, Pascal. Thanks for the question. So as a reminder, what we previously said about AVANZAR is that we have both the ITT and the biomarker positive patient populations at the top of the multiple testing procedure. So it is possible to get a positive study with success in either the ITT or in the biomarker positive group. So I hope that answers your first question. Obviously. Regulators will be interested in the effect size and the meaningfulness of the differentiation between those groups in discussions.

    好的,謝謝你,Pascal。謝謝你的問題。提醒一下,我們先前對 AVANZAR 的說法是:在多重檢定程序的最上層,我們同時放入 ITT 與生物標記陽性的病患族群。因此,無論是在 ITT 或在生物標記陽性族群中達成成功,都有可能使研究結果為正。希望這回答了你的第一個問題。當然,監管機關在討論時會關注效應量,以及兩個族群之間差異的臨床意義。

  • In terms of differentiation from the competitors. I think we have a best in class TROP2 based ADC based on the design, which is based on the stable linker. And you can see that based on the half-life of the molecule and also the lower rate of bone marrow toxicity because you see higher rates of bone marrow toxicity with ADCs that have less stable linkers and so more exposure to the free payload.

    至於與競品的差異化。我認為我們擁有同級最佳(best in class)的 TROP2 ADC,這是基於其設計——採用穩定的連接子(stable linker)。你可以從分子的半衰期,以及較低的骨髓毒性發生率看出來;因為連接子較不穩定的 ADC 會有較高的骨髓毒性發生率,原因是游離載荷(free payload)暴露更高。

  • That, I think, underpins the data that we've seen in the triple-negative breast cancer where we saw differentiated activity with a higher response rate, progression-free survival, and leading to overall survival in that first-line triple-negative breast cancer. So that underpins our confidence in the design of this ADC. I do think that the data that's been seen from the OptiTROP trials in lung cancer underpin the potential for TROP2-based ADCs in this first-line setting in combination with IO. But I think given the design that we have of the molecule and the design that we have of the AVANZAR study with that ability to look in the ITT and the biomarker, we have the ability to be first into first line and to be best based on those combinations and that differentiation.

    我認為這也支撐了我們在三陰性乳癌中看到的數據:在一線三陰性乳癌中,我們看到更高的反應率、無惡化存活期,並進一步帶來整體存活期(OS)的改善,呈現出差異化的療效。因此,這也支撐了我們對這個 ADC 設計的信心。我確實認為,在肺癌的 OptiTROP 試驗中所見到的數據,支持以 TROP2 為基礎的 ADC 在一線治療情境、與 IO 聯合使用的潛力。但我認為,考量到我們分子的設計,以及 AVANZAR 試驗的設計——能同時在 ITT 與生物標記族群中進行評估——我們有能力在一線領域率先進入,並且基於這些組合與差異化而成為最佳。

  • So we look forward to seeing the results. And again, I should just caveat as we do with all of our Phase IIIs, whilst we're confident in the hypothesis that we've got, we obviously have to wait for the Phase III trials and nobody is keener than I am to see the data and as soon as we got it, we'll share it with you.

    因此我們期待看到結果。再重申一次,我必須像我們對所有第三期試驗一樣加以保留:儘管我們對目前的假設有信心,但顯然仍需等待第三期試驗的結果;沒有人比我更迫切想看到數據,一旦我們拿到數據,就會立即與各位分享。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Susan.

    謝謝你,Susan。

  • Gonzalo Artiach, Danske.

    Danske 的 Gonzalo Artiach。

  • Gonzalo Artiach Castanon - Analyst

    Gonzalo Artiach Castanon - Analyst

  • Hi, and thank you for taking my question, Gonzalo Artiach from Danske Bank.

    嗨,謝謝讓我提問,我是來自 Danske Bank 的 Gonzalo Artiach。

  • I have one for Sharon and one for Marc. For Sharon, on cliramitug, ATTR depleter, I know the first three study with cliramitug monotherapy keeps moving as planned, but could you give us some color on how you are seeing this drug moving forward in case the phase III hits the line? Is it something that you could put out as monotherapy or the ideal case would be to give it in combination with now, for example, Amvuttra given the failed cardio transform studies? I'm just trying to figure out what you're thinking on this molecule from today.

    我有一題要問 Sharon,另一題要問 Marc。先問 Sharon,關於 cliramitug(ATTR 清除劑,depleter),我知道 cliramitug 單藥治療的前三項研究仍按計畫推進,但能否請你多分享一些:如果第三期試驗達標,你們如何看待這個藥物後續的發展方向?它是否可能以單藥方式推出?或理想情況是與現有療法合併使用,例如在 cardio transform 研究失敗之後,與 Amvuttra 併用?我只是想釐清你們目前對這個分子的想法。

  • And a second question on Strensiq for Marc. You guys are confident on these $3 billion to $5 billion peak sales for Efzimfotase alfa, based on the results presented so far. But I was wondering if you could give us some color on the dynamics across commercial regions expected between Strensiq and Efzimfotase alfa. How should we expect those to play out in the market? Thank you so much.

    第二個問題是問 Marc,關於 Strensiq。你們基於目前已呈現的結果,對 Efzimfotase alfa 30 億到 50 億美元的峰值銷售額很有信心。但我想請你談談在各個商業區域中,Strensiq 與 Efzimfotase alfa 之間預期的動態會是如何?我們應該如何預期它們在市場上的演變?非常感謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks, Gonzalo. It's probably two questions for Marc, actually, because cliramitug is developed by (inaudible) Over to you, Marc?

    謝謝你,Gonzalo。其實可能兩題都要問 Marc,因為 cliramitug 是由(聽不清)開發的。Marc,交給你?

  • Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

    Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

  • Thank you for the two questions. So, let me take the first one. So, to your question on the add-on design, so cliramitug is -- the trial we're doing on cliramitug is as an add-on to either stabilizer, FMED or Acoramidis, and silencers. So, the trial is not done as a monotherapy. What is very important to understand is the difference of mechanism as the class indicates, the cliramitug is a depleter and therefore depletes the amyloid burden in the tissues -- the amyloid plaque in the tissues. This has been confirmed during our phase 1B studies over one year for cliramitug.

    謝謝這兩個問題。我先回答第一題。關於加用(add-on)設計:cliramitug——我們正在進行的 cliramitug 試驗,是在穩定劑(stabilizer,FMED 或 Acoramidis)以及沉默劑(silencers)的基礎上加用。因此,這項試驗並不是以單藥治療方式進行。非常重要的一點是要理解其作用機轉的差異:如同其類別所示,cliramitug 是一種清除劑(depleter),因此會清除組織中的類澱粉負荷——也就是組織中的類澱粉斑塊。這點已在我們針對 cliramitug 的 1B 期、為期一年的研究中獲得確認。

  • We have also read across from another product that -- another depleter that we are developing in another disease called the light-chain amyloidosis, and the product is called oleclumab. We have seen on this product a very clear outcome benefit both on mortality as well as cardiovascular event following cardiac remodeling as well as improvements of many cardiac functions. So, it's not the sudden disease exactly, but we have reasonably good read across of the depleter mechanism in the treatment of amyloidosis.

    我們也從另一個產品進行了類推——也就是我們在另一種疾病(輕鏈型類澱粉沉積症,light-chain amyloidosis)中開發的另一個清除劑,其產品名為 oleclumab。我們在這個產品上看到非常明確的結局(outcome)效益,包括死亡率以及心血管事件的改善,並伴隨心臟重塑(cardiac remodeling),以及多項心臟功能的改善。因此,雖然不是完全相同的疾病,但我們對於清除劑機轉在治療類澱粉沉積症上的效果,有相當不錯的類推依據。

  • So, for cliramitug, we are expecting the results in the future, and we look forward to demonstrating, again the sudden benefit or improvement of cardiac model improvement. And outcome benefit in both full-post mortality and cardiovascular hospitalization, and we look forward to these results.

    因此,對於 cliramitug,我們預期未來會取得結果,也期待能再次證明其明確效益,或心臟模型改善(cardiac model improvement)的提升。以及在全因死亡率(all-cause mortality)與心血管住院(cardiovascular hospitalization)兩方面的結局效益;我們期待這些結果。

  • To the second question on Strensiq, so Strensiq today has been on the market since 2015. We do not have a very wide coverage, and I think this is what efzimfotase is going to bring us, is going to have a much wider coverage in terms of countries. Possibly, we would have a wider label than Strensiq, but this remains to be discussed with regulatory authorities.

    第二題關於 Strensiq:Strensiq 自 2015 年起已上市。我們目前的覆蓋範圍並不算非常廣,我認為 efzimfotase 將帶給我們的,就是在國家覆蓋面上更廣。此外,我們可能會取得比 Strensiq 更廣的適應症標籤(label),但這仍需與監管機關討論。

  • What -- the big difference between those two products is the greater tolerability of efzimfotase, which is, remind you, administered every two weeks instead of administered either daily or every other day for strensiq. So there are a big difference for the patient's utilization. And in terms of tolerability, just to give you some numbers, patients who are on efzimfotase alfa basically have five days of injection site reaction on average in a given year. And this is many times low -- many times lower than what is experienced with Strensiq. We also know that the retention of Strensiq is often impacted by this issue of tolerability.

    這兩個產品之間最大的差異,是 efzimfotase 的耐受性更佳;提醒各位,efzimfotase 是每兩週給藥一次,而 Strensiq 則是每日或隔日給藥。因此在病患使用便利性上有很大的差異。就耐受性而言,給各位一些數字:使用 efzimfotase alfa 的病患,在一年之中平均只有 5 天會出現注射部位反應。這比 Strensiq 的經驗低很多倍。我們也知道,Strensiq 的治療留存率(retention)常常會受到耐受性問題的影響。

  • So, that's why we are -- we remain confident that efzimfotase will grow in terms of number of countries in the breadth of patients and also in the retention of patients once they're on therapy.

    因此,我們仍有信心 efzimfotase 將在國家數量、病患覆蓋廣度,以及病患一旦開始治療後的留存率等方面帶來成長。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Marc. And maybe going back to cliramitug, Gonzalo, you see from Marc's response that cliramitug can be used as monotherapy, but it can be used on top of -- [Vutrisiran] can be used on top of stabilizers. Of course, we'll have to show that it adds something, but that's potentially a broad use for this agent.

    謝謝你,Marc。另外回到 cliramitug,Gonzalo,從 Marc 的回覆你可以看出,cliramitug 可以作為單藥使用,但也可以在——[Vutrisiran] 可以在穩定劑之上加用。當然,我們必須證明它能帶來額外效益,但這可能會讓這個藥物有更廣泛的使用情境。

  • Sachin Jain, Bank of America.

    美國銀行的 Sachin Jain。

  • Sachin Jain - Analyst

    Sachin Jain - Analyst

  • Hi, there. Thanks for taking my questions. One financial, one pipe.

    嗨。謝謝讓我提問。一題財務、一題管線。

  • So financial, can you talk about balancing the investment in pipe and launches that are adding to talk to versus delivering margin expansion? So as we think about 2H '26 and '27 cost growth, is 1H R&D/SG&A cost growth of 6% a good proxy? Or should we think about acceleration into second-half this year and into next year?

    先談財務:你們能否談談如何在加大對研發管線與新產品上市(launches)的投資(這些都會推升成本)與實現利潤率擴張之間取得平衡?因此,當我們思考 2026 年下半年與 2027 年的成本成長時,上半年研發/銷售與管理費用(R&D/SG&A)6% 的成本成長是否是一個好的代理指標?或者我們應該預期今年下半年以及明年會加速?

  • And then quick hits on one-on-one biopharma '27 pipe. So CAMBRIA1 the switch study due next year. Perhaps Susan, you could just talk to how you think about the probability of success in that study relative to SERENA-4 and where it sits on the endocrine sensitivity continuum.

    接著快速問幾個 2027 年一對一生物製藥(one-on-one biopharma)管線的重點。CAMBRIA1 的轉換(switch)研究預計明年出結果。也許 Susan 你可以談談:相較於 SERENA-4,你如何看待該研究的成功機率?以及它在內分泌敏感性(endocrine sensitivity)連續譜上的位置?

  • And then one Ruud. Farxiga lifecycle management, just a simple question. You've got substantial peak sales of almost $10 billion across the various fixed dose combos consensus basically it has nothing. Where do you think consensus is missing on these assets? Thank you.

    再來一題給 Ruud。關於 Farxiga 的產品生命週期管理(lifecycle management),一個簡單問題:在各種固定劑量複方(fixed dose combos)上,你們的峰值銷售額接近 100 億美元,但市場共識基本上認為幾乎沒有。你認為共識在這些資產上忽略了什麼?謝謝。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • That's great. Sachin, thank you. You are very ambitious with many questions, but we lack ambition. So maybe Aradhana could cover the first one, then Susan and then Ruud. Is that okay? Aradhana, will you start?

    很好。Sachin,謝謝你。你的問題很多、很有企圖心,但我們也不缺企圖心。所以也許先由 Aradhana 回答第一題,接著 Susan,再來 Ruud。可以嗎?Aradhana,你先開始?

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Great. Thank you, Sachin. So for 2026, we've given, obviously, a revenue and EPS, and we give enough detail on other line items as you've seen, whether it's on R&D or some of the other moving parts on gross margin and other income, et cetera. So I think for 2027, we will obviously give guidance for 2027. At the beginning of 2027, we will start our annual budgeting process later this year. So we start that in a few months.

    好的。謝謝你,Sachin。關於 2026 年,我們已提供營收與每股盈餘(EPS)指引,並且如你所見,也對其他損益項目提供了足夠細節,不論是研發(R&D)或毛利率、其他收入等其他變動因素。至於 2027 年,我們當然也會提供 2027 年的指引。在 2027 年初,我們會開始 2027 年的年度預算流程,而今年稍晚我們就會啟動年度預算編列。也就是幾個月後就會開始。

  • And as there's a lot more readouts still to come and investments still to make, whether it's on TOZO or we'll see how some of the other events read out. So all of that is going to be part of our planning and we base our guidance for 2027 or any year we base our guidance on our budget and on our planning process. So we'll give more view on that. When we do that early next year.

    而且由於後續還會有更多讀出結果、也仍有投資需要進行,不論是在 TOZO 上,或是我們將觀察其他一些事件的讀出情況。因此,這些都會納入我們的規劃之中;我們對 2027 年或任何年度所提供的指引,都是以我們的預算與規劃流程為基礎。所以我們會就此提供更多看法。在明年年初我們進行相關說明時。

  • Susan?

    Susan?

  • Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

    Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

  • Okay, thank you. So thanks for the question about CAMBRIA-1. Just as a reminder, CAMBRIA-1 is an extended adjuvant trial in patients with intermediate to high risk hormone receptor positive and HER2 negative breast cancer. So it's already been well established that extension of duration of endocrine therapy in this adjuvant setting improves outcomes.

    好的,謝謝。謝謝你關於 CAMBRIA-1 的提問。提醒一下,CAMBRIA-1 是一項延長輔助治療試驗,對象為中度至高風險、荷爾蒙受體陽性且 HER2 陰性的乳癌患者。因此,延長此輔助治療情境下的內分泌治療療程可改善結果,這點早已被充分證實。

  • By taking patients who've completed two to five years of adjuvant endocrine therapy, with or without a CDK4/6 inhibitor, which is this switch design, and randomizing them into continuation of Tamoxifen, or to camizestrant, we're actually taking what is an endocrine sensitive patient population. The patients that have got higher risk factors will likely have progressed through that initial period of adjuvant treatment. And by focusing on the intermediate or high risk, we're taking out those patients with low-risk disease who are likely already cured with current standard of care.

    透過納入已完成 2 至 5 年輔助性內分泌治療(可合併或不合併 CDK4/6 抑制劑)的患者(這是一種切換設計),並將其隨機分派為繼續使用 Tamoxifen,或改用 camizestrant,我們實際上是在選取一個對內分泌治療敏感的患者族群。具有較高風險因子的患者,很可能在最初那段輔助治療期間就已經出現進展。而透過聚焦於中度或高風險,我們也排除了那些低風險疾病患者——他們很可能已在現行標準治療下被治癒。

  • So, I think it does select for an endocrine-sensitive patient population in a setting where endocrine intensification has already been proven with other trials. So, I think from that perspective, and given the profile that we've seen with camizestrant in terms of tolerability. And efficacy within the SEVENA-6 study, I think it has a good probability of success together with the data that we've seen from a competitor in the adjuvant setting.

    所以,我認為這確實是在一個已被其他試驗證實「加強內分泌治療」有效的情境中,篩選出對內分泌治療敏感的患者族群。因此,從這個角度來看,再加上我們目前看到 camizestrant 在耐受性方面的特徵,以及在 SEVENA-6 研究中所見的療效,我認為它有相當不錯的成功機率;同時也呼應了我們在輔助治療領域從競品所看到的數據。

  • Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

  • Okay, thanks, Susan. So, let me quickly address the question of Sachin regarding the combinations. We have currently three combinations in development. All those combinations are addressing patient populations where there's a high risk and where there is almost no current treatment. So if I take [Zebodepa] as one example, it's in phase III. It has recruited very fast. Clearly showing the high medical needs in proteinuric CKD.

    好的,謝謝你,Susan。那我快速回應 Sachin 關於合併療法的問題。我們目前有三個合併療法正在開發中。這些合併療法都鎖定高風險、且幾乎沒有現有治療選項的患者族群。以 [Zebodepa] 為例,它正在第三期。收案非常快速。這清楚顯示蛋白尿型 CKD(慢性腎臟病)存在高度未被滿足的醫療需求。

  • Those patients are very ill, the kidney function is declining, and we know the beneficial effects of dapagliflozin. And on top of that, we hope to see a beneficial effect of an endothelium receptor antagonist. The other one is [BelCDEPA] in heart failure patients with a low EGFR where mortality is very high. Normally twice as you see normally in a heart failure patient and there is no data available. So again, it's a highly, highly risky patient population. The estimates of the epi data has shown that more than 12 million patients in the top eight markets are eligible for a treatment like this. So it clearly shows the potential if the study is reading out.

    這些患者病情非常嚴重,腎功能持續下降,而我們也知道 dapagliflozin 的有益效果。在此基礎上,我們希望能看到內皮素受體拮抗劑帶來額外的效益。另一個是 [BelCDEPA],用於 EGFR 偏低的心衰竭患者,其死亡率非常高。通常大約是一般心衰竭患者的兩倍,而且目前沒有可用的數據。所以同樣地,這是一個高度、高度高風險的患者族群。流行病學資料的估算顯示,在前八大市場中,超過 1,200 萬名患者符合此類治療的適用條件。因此,如果研究讀出結果良好,這清楚顯示其潛力。

  • Both of those fix-dose combinations, we are expecting to see data in the first half of 2027. And then last but not least, bexostat in the combination with dapagliflozin. Also, that is in a high-risk population in chronic kidney disease and hypertension. We know that hypertension is a very important risk factor for the development of chronic kidney disease, and we hope to see a slowdown of the progression of kidney disease. So again, a high-risk patient, and I think not everyone is addressing and seeing the potential of those new combinations. Those are really new molecular entities if they are successful.

    這兩個固定劑量合併製劑,我們預期在 2027 年上半年看到數據。最後但同樣重要的是,bexostat 與 dapagliflozin 的合併。這同樣是在慢性腎臟病與高血壓的高風險族群中進行。我們知道高血壓是慢性腎臟病發展的一個非常重要的風險因子,而我們希望能看到腎病進展速度放緩。所以同樣是高風險患者族群;我認為並不是每個人都在關注並看見這些新合併療法的潛力。如果成功,這些將是真正的新分子實體。

  • So I think building on the massive experience we are having with dapagliflozin, 60 million patients are currently treated with dapagliflozin. I think it's the backbone of heart failure and chronic kidney disease patients, and adding those new mechanisms hopefully will lead to a much more beneficial effect, both from a mortality perspective, but also from a kidney disease progression perspective.

    因此,我認為在我們對 dapagliflozin 的龐大經驗基礎上——目前已有 6,000 萬名患者正在接受 dapagliflozin 治療——我認為它是心衰竭與慢性腎臟病患者治療的骨幹;而加入這些新機轉,期望能帶來更顯著的效益,不僅在死亡率面向,也在腎臟疾病進展面向。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you. I had not realized we had many more questions in the line. So if we can stick to one question per person, it would be great.

    謝謝。我沒有意識到線上還有這麼多問題。所以如果我們能夠每位提問者只問一個問題,那就太好了。

  • Graham Parry, Citi. Are you on mute maybe?

    Graham Parry,花旗。你是不是在靜音?

  • Graham Parry - Analyst

    Graham Parry - Analyst

  • So I had one on simpatico you said your filing for a broad label. Can you confirm that, that does include adults? And was that based on any discussion with regulators to date is the acceptability of the HIRI trial and the trend benefit in the pediatric on cell adult population. And does the $3 billion to $5 billion sales outlook include the adult population? Or is that just in pediatrics?

    我有一個關於 simpatico 的問題:你提到你們將以廣泛適應症標籤進行申報。你能確認這包含成人嗎?另外,這是否是基於迄今與監管機構的任何討論——例如 HIRI 試驗的可接受性,以及在小兒起病成人族群中所見的趨勢性獲益?以及 30 億到 50 億美元的銷售展望是否包含成人族群?還是僅限於兒科?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Marc?

    Marc?

  • Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

    Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

  • Thank you very much for the question. So the broad population, so the filings will be above two years of age for a broad population, as I said in my prepared remarks, this has been done in discussion with regulatory authorities. But obviously, they will need to look at the detail of the three studies that we have completed and submitted.

    非常感謝你的提問。關於廣泛族群,我們的申報將涵蓋兩歲以上的廣泛族群;如同我在事先準備的發言中所說,這是在與監管機構討論後所進行的。但顯然,他們仍需要檢視我們已完成並提交的三項研究的細節。

  • To your second question on the -- so the adult population is segmented into two parts, adult with pediatric onset, which is in several countries already obtained with Strensiq in adult with adult onset where Strensiq is not approved today. Your second question on the $3 billion to $5 billion, even if we get less than the totality of available that we have filed for, we expect to be within the range of $3 billion to $5 billion.

    至於你的第二個問題——成人族群可分成兩部分:小兒起病的成人,這在多個國家已透過 Strensiq 取得;以及成人起病的成人族群,而 Strensiq 目前尚未核准用於此族群。你第二個問題關於 30 億到 50 億美元:即使我們最終取得的適應症範圍少於我們所申報的全部範圍,我們仍預期會落在 30 億到 50 億美元的區間內。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • James Gordon, Barclays.

    James Gordon,巴克萊。

  • James Gordon - Equity Analyst

    James Gordon - Equity Analyst

  • Pascal called out Saruparib, so the selective PARP in prostate cancer where we're getting data next year, and this has been described as a $5 billion-plus product. There was some excitement about the asset a few years ago than it wasn't pine with Merck and maybe there was a thinking that Lynparza is a pretty high bar to beat. So how big could it be if it works next year? Is the $5 billion, a lot of that is derisked by the date of next year? Or does that need a lot of other trials to work? And how excited are you by that readout?

    Pascal 提到了 Saruparib,也就是前列腺癌中的選擇性 PARP,我們明年會拿到數據,而且這被描述為一個 50 億美元以上的產品。幾年前市場對這個資產有些興奮,但後來它沒有與默克合作推進,可能也有人認為 Lynparza 是一個很難超越的高門檻。所以如果明年結果成功,它的規模可能有多大?這個 50 億美元的預期,有多少會在明年的數據出來時就已經去風險(derisked)?還是說還需要很多其他試驗也成功才行?你們對這次讀出有多期待?

  • And then if I could just squeeze in a quick clarification. So other operating income or OOI. So the updated 2026 guidance implies higher OI and higher OpEx and then you're reiterating the guide because you're reinvesting in higher ROI. But how much of this year's ROI is ongoing versus one-off? So is that going to create a headwind next year when you don't have the ROI? Or is most of this year is going to repeat again next year from an ongoing source?

    另外如果我可以再擠一個快速釐清。關於其他營業收入(other operating income,OOI)。更新後的 2026 年指引意味著更高的營業利益(OI)與更高的營運費用(OpEx),而你們重申指引是因為你們正在把資金再投資到更高投資報酬(ROI)的項目。但今年的 ROI 有多少是持續性的、又有多少是一次性的?也就是說,明年在沒有這些 ROI 的情況下,是否會形成逆風?或者今年大部分的內容其實會在明年以持續性來源再度出現?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, James. Susan, do you want to cover the Seraparib question. I mentioned it, James, just as an example of many projects in our pipeline that nobody talks about. We seem to be facing from most an obsessive focus on two readouts that are important, of course, I don't want to underestimate the but I just wanted to highlight the fact that we have many, many more projects. And what we showed you today are only the most important ones, and Seroparib is certainly one of the most important ones as well.

    謝謝你,James。Susan,你要不要回應一下 Seraparib 的問題。我提到它,James,只是作為我們研發管線中許多沒有人談論的專案之一的例子。我們似乎正面臨外界對兩個讀出結果的過度聚焦;當然它們很重要,我不想低估其重要性,但我只是想強調,我們還有非常、非常多的專案。而我們今天向各位展示的只是最重要的那些,Seroparib 當然也是其中最重要的之一。

  • Susan, over to you.

    Susan,交給你。

  • Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

    Susan Galbraith - Executive Vice President - Oncology Haematology Research and Development

  • So as you have seen from the clinical trials appendix, there's a significant effort that we've got with sorafrub in prostate cancer. One of the key trials is the Evapostate01, which is a metastatic common sensitive prostate cancer, including both the HRM and non-HRM cohorts. So we already have seen from the PROPEL study in a later line that we do have activity for PARP inhibition in combination with anti receptor inhibitors. And what we've done is taken the learnings from the PROPEL study and move this into an earlier line setting and power the study for both our HRM and non-HRM. And of course, having seen the data for the talazoparib and enzalutamide data sets coming out.

    如同你們從臨床試驗附錄所看到的,我們在前列腺癌的 sorafrub 上投入了相當大的努力。其中一項關鍵試驗是 Evapostate01,針對轉移性去勢敏感性前列腺癌,涵蓋 HRM 與非 HRM 兩個隊列。因此,我們已經從較後線治療的 PROPEL 研究看到,PARP 抑制與抗受體抑制劑合併使用是有活性的。我們所做的是把 PROPEL 研究的學習帶到更前線的治療情境,並讓研究在 HRM 與非 HRM 兩群都具備足夠的統計力。當然,我們也看到了 talazoparib 與 enzalutamide 的資料集陸續公布。

  • I think there's significant opportunity in this setting to improve the tolerability profile, increase the potency of inhibition on PARP and see benefits in both those subgroups. You will recall that we did see a positive effect on PFS in the non-HRM in the PROPEL data set. But there was a lot of discussion at the time of the We've addressed those concerns with the design of this study, and I think that's a significant opportunity. But it's also backed up by other studies in other segments in prostate cancer and also in the Evaparbreast opportunity as well. So when you look at the totality of the sort of prove opportunity, it is significant and definitely in the $5 billion range, and we're excited to see these data read out.

    我認為在這個治療情境中有很大的機會:改善耐受性表現、提升對 PARP 的抑制效力,並在這兩個亞群都看到獲益。各位會記得,在 PROPEL 的資料集中,我們確實在非 HRM 人群看到 PFS 的正向效果。但當時也有很多討論;我們已透過本研究的設計回應了那些疑慮,我認為這是一個重要機會。此外,這也有其他在前列腺癌不同分段的研究支持,並且在 Evaparbreast 的機會上亦然。因此,當你從整體來看這個 sorafrub 的機會總量,它相當可觀,確實在 50 億美元的量級,我們也很期待看到這些資料讀出。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Let's park this one and revisit it at the end. So we give everybody a chance to ask one question, and we may have a chance to cover it as part of another financial question. And next is Christopher Uhde.

    我們先把這題放一放,最後再回來談。這樣可以讓每個人都有機會問一個問題,而且我們也可能在另一個財務相關問題中一併涵蓋。下一位是 Christopher Uhde。

  • Christopher Uhde - Analyst

    Christopher Uhde - Analyst

  • I guess this one would be on Bexendi, noting that you have the primary aldosteronism trial reading out next year now. So today, screening for aldosteronism is not really or active. So what are you doing to try to ensure as rapid a rollout that would not be a break on your launch?

    我想問的是 Bexendi,注意到你們的原發性醛固酮增多症試驗現在將在明年讀出。但就目前而言,對醛固酮增多症的篩檢其實並不普遍或積極。那你們正在做些什麼,以確保能夠快速推廣,避免篩檢不足成為你們上市推進的阻力?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Sharon, do you want to cover this?

    Sharon,你要不要回應這題?

  • Sharon Barr - Executive Vice President - Bio Pharmaceuticals Research and Development

    Sharon Barr - Executive Vice President - Bio Pharmaceuticals Research and Development

  • Sure. So first, I'll say thank you for noticing the potential for Baxter stat in primary aldosteronism. This is a really important and unmet medical need. It's really a group of disorders in which aldosterone production is unusually high for sodium status, and it is relatively autonomous of the normal regulators. So this is a major unmet medical need and a key driver of cardiovascular damage and is the leading cause of secondary hypertension. We think it could affect as many as 5% to 10% of all hypertensives and up to 20% of resistant hypertension.

    好的。首先,謝謝你注意到 Baxter stat 在原發性醛固酮增多症上的潛力。這是一個非常重要且未被滿足的醫療需求。它其實是一組疾病,特徵是在鈉狀態下醛固酮產生異常偏高,且相對不受正常調節因子控制。因此,這是重大的未滿足醫療需求,也是心血管損傷的重要驅動因素,並且是繼發性高血壓的首要原因。我們認為它可能影響所有高血壓患者中的 5% 到 10%,而在難治性高血壓中甚至可達 20%。

  • And you're right, relatively few of those patients today are being streamed because there hasn't been a therapy to give them. Now we have the first approved aldosterone synthase inhibitor with an excellent treatment profile, our target product profile. And we think that this is going to be pivotal in helping to drive uptake now that there is a recognized therapy that addresses aldosteronism. So we're running that study. And as we have disclosed, it is -- it has accrued very rapidly.

    而你說得對,目前真正被篩檢出來的患者相對少,因為過去並沒有可提供的治療。現在我們有了第一個已核准的醛固酮合成酶抑制劑,且治療特性非常好,符合我們的目標產品特性(TPP)。我們認為,既然已有被認可、可直接處理醛固酮增多症的療法,這將成為推動使用量提升的關鍵。因此我們正在進行那項研究。而如同我們已揭露的,它——它的入組速度非常快。

  • So we're accelerating that time line for primary aldosteronism, and excited to see the interest around as a leading molecule. So increasing uptake will, I think, follow through naturally from what we hope will be a positive data set. And the rapid recruitment that we're seeing for our studies really speaks to the major unmet medical need and the general enthusiasm of the clinical community for this mechanism.

    因此我們正在加速原發性醛固酮增多症的時程,也很高興看到外界對它作為領先分子的關注。我認為,提高使用量將會很自然地隨著我們希望看到的正向資料集而發生。而我們研究中所看到的快速招募,也確實反映了這個重大未滿足醫療需求,以及臨床社群對此一機轉的普遍熱忱。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Peter Verdult, BNP.

    BNP 的 Peter Verdult。

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Peter, BNP. Two quick ones, Pascal, one for Ruud on IL Phase III and $5 billion target for Tazo. Are you anticipating any competition here? And the reason for the question is we're hearing Sanofi and the part of Regeneron might not undertake the third Phase III study for itepekimab that will be required for approval in light of your data and probably the fact you now enjoy a three year head start. So first, a quick question on Tazo.

    我是 BNP 的 Peter。Pascal,兩個快問:一個給 Ruud,關於 IL 第三期以及 Tazo 的 50 億美元目標。你們是否預期會有任何競爭?我之所以這樣問,是因為我們聽說 Sanofi 以及 Regeneron 方面,可能不會進行 itepekimab 為取得核准所需的第三項第三期研究,考量到你們的數據,以及你們現在可能已經有三年的領先優勢。所以先快速問一下 Tazo。

  • And then secondly, the obligatory sort of MF pricing question. When you think about approved in Europe, hopefully will get approved in the US. How have your thoughts on pricing strategy evolve if we compare it to historical presents like Calquence and Tagrisso?

    第二個則是例行的 MF 定價問題。當你們考量已在歐洲獲批、也希望能在美國獲批時,若與過往的案例(例如 Calquence 與 Tagrisso)相比,你們對定價策略的想法有何演變?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thanks. Ruud, do you want to cover the question, and I'll return to the pricing at the end?

    謝謝。Ruud,你要不要先回應這個問題?我會在最後再回到定價的部分。

  • Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

  • Yeah, for sure. Now I think, Peter, it's a fair question, but it's so difficult for me to answer this one because I simply don't know what Roche or Sanofi are planning to do. What I can tell you is that the data set, hopefully, you will see at the year is very convincing. And we get many questions about why do we think that our IL-33 was successful in those pivotal trials. And we truly believe that the mechanism of action is very specific to our anti-IL-33. It's inhibiting the anti-inflammatory pathway, but equally the mucus pathway. And I think that combination makes this a quite unique molecule. So let's see how the competition is going to react to the data. But of course, we keep a close eye on it.

    好的,當然。Peter,我認為這是個合理的問題,但我很難回答,因為我真的不知道 Roche 或 Sanofi 計畫怎麼做。我能告訴你的是,希望你們在今年稍晚看到的那份資料集會非常有說服力。我們也常被問到,為什麼我們認為自家的 IL-33 能在那些關鍵性試驗中成功。我們確實相信,這個作用機轉對我們的抗 IL-33 來說非常特異。它抑制的是發炎相關路徑,但同時也抑制黏液路徑。我認為這樣的組合使它成為相當獨特的分子。所以就看看競爭對手會如何回應這些數據。當然,我們也會密切關注。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Stephen Scala, TD Cowen.

    TD Cowen 的 Stephen Scala。

  • Steve Scala - Analyst

    Steve Scala - Analyst

  • Pascal, you have been bullish on China for years, although headwinds were clear in the quarter. All things considered, are you as confident as you have been in the past? And how threatening are the local companies on the global stage? And just a very brief question. Should we view it as possible that SERENA-4 and Avanza are presented at ESMO?

    Pascal,你多年來一直看好中國,儘管本季逆風很明顯。綜合各項因素,你現在還像過去一樣有信心嗎?本土公司在全球舞台上的威脅有多大?另外一個非常簡短的問題:我們是否可以認為 SERENA-4 和 Avanza 有可能在 ESMO 發表?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Stephen. So I'll cover the first question, and we'll return to the S-4 question at the end. China, still very bullish for reasons that have evolved, I must say. I mean the potential in China is still large. But on top of it, the innovation potential is also enormous, as you've seen from the various deals we have made but also other companies have made.

    謝謝你,Stephen。我先回答第一個問題,S-4 的問題我們最後再回來談。對中國,我仍然非常看好,但我必須說,看好的理由已經有所演變。我的意思是,中國的市場潛力仍然很大。除此之外,創新潛力也非常龐大,正如你從我們做過的各種交易、以及其他公司做過的交易中所看到的。

  • Today, Chinese companies are innovating at great speed and tend to partner with global companies like Harvest to globalize the development and the commercialization. But it's reasonable to expect that over time, they will expand globally.

    如今,中國企業正以極快的速度創新,並傾向與像 Harvest 這樣的全球公司合作,以推動研發與商業化的全球化。但合理的預期是,隨著時間推移,他們將在全球範圍內擴張。

  • Expanding globally is not that simple, right? I mean, because the profitability in China is not that high. Prices are low. So if you don't have a very strong domestic business from a profit viewpoint, it's not that simple to globalize, but you have to assume they will at some point. So what we're doing is collaborating, but we're also competing.

    全球擴張沒那麼簡單,對吧?我的意思是,因為在中國的獲利能力並不那麼高。價格很低。所以如果你在國內從獲利角度沒有非常強的業務基礎,要走向全球並不容易,但你也必須假設他們終究會在某個時間點走出去。所以我們正在做的是合作,但同時也在競爭。

  • You saw the competition in the Tagrisso market. It's very, very intense. And in the ADC market, very intense too. So we learned to compete with them and something we'll take those learnings globally when they become global companies, if they do.

    你在 Tagrisso 市場看到了競爭。那是非常、非常激烈的。而在 ADC 市場,也同樣非常激烈。所以我們學會了如何與他們競爭;當他們成為全球性公司時(如果他們真的成為的話),我們也會把這些經驗帶到全球。

  • We're also learning from them in terms of how they develop products and how fast they operate. And we've made some changes in the way we operate. And for instance, that we announced this morning is a good example of the role our Chinese team has played in the speedy development of this product. So I think being present in China very present and strong enables us to collaborate with companies, learn from them and plan to compete as well.

    我們也在學習他們在產品開發方式以及運作速度方面的做法。而我們也在營運方式上做了一些調整。例如,我們今天早上宣布的事項,就是一個很好的例子,說明我們中國團隊在這項產品快速開發中扮演的角色。所以我認為,在中國保持非常深入且強勢的布局,使我們能與企業合作、向他們學習,同時也規劃好競爭。

  • Colin White, UBS.

    Colin White,瑞銀(UBS)。

  • Colin White - Equity Analyst

    Colin White - Equity Analyst

  • I had a quick question on the C5 franchise. I was wondering if you could talk about how much you expect to may be impacted by longer-acting C5 inhibitors like Regeneron cemdisiran? And then just quickly, if you could comment on the Fortis arbitration in the US, the time lines possible outcomes of that, that would be helpful.

    我有一個關於 C5 產品線的簡短問題。我想請你談談,你們預期會在多大程度上受到像 Regeneron 的 cemdisiran 這類長效型 C5 抑制劑的影響?另外也想快速請你評論一下美國的 Fortis 仲裁案,包括可能的時間表與結果,這會很有幫助。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you. Marc, do you want to cover the C5 question, and we'll cover a little later.

    謝謝。Marc,你要先回答 C5 的問題嗎?仲裁的部分我們稍後再談。

  • Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

    Marc Dunoyer - Chief Executive Officer - Alexion, Chief Strategy Officer - AstraZeneca

  • Yeah. So obviously, there have been a number of competitors against the C5 franchise, we continue to grow. But obviously, other mechanism or similar products on the C5, complement biology also will compete with us. What we have been doing with Temeris since the acquisition of Alexion was also to explore and pioneer in new indications, and we are going to continue doing that. I mentioned today, IgAN.

    好的。很明顯,針對 C5 產品線已經出現了不少競爭者,但我們仍在持續成長。不過,其他機制或在 C5/補體生物學上相近的產品也會與我們競爭。自從收購 Alexion 之後,我們在 Temeris 所做的,也包括在新適應症上探索並率先開拓,而我們會持續這麼做。我今天提到了 IgAN。

  • We saw the results in We have other trials such as the delayed graft function. And then we will be developing several other areas in the renal rare disease, but also in -- with other modules of the nodes of the of the complement biology to propose answers to disease that have no response today. So we are continuing to compete in the C5, but also outside of the C5 from within the complement biology.

    我們看到了相關結果。我們還有其他試驗,例如延遲移植物功能(delayed graft function)。接著我們也會在腎臟罕見疾病的數個其他領域進行開發,同時也會在補體生物學的其他模組/節點上提出解方,以回應目前仍無有效治療的疾病。因此,我們會持續在 C5 領域競爭,但也會在 C5 之外、從補體生物學的其他面向來競爭。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Marc. And as you can see, I mean nonacting could have a place, of course, but you have to develop every single one of those indications. So takes time and it takes money.

    謝謝你,Marc。而且如你所見,我的意思是,非長效型當然可能有其位置,但你必須把每一個適應症都開發出來。所以這需要時間,也需要資金。

  • Michael Leuchten, Jefferies.

    Michael Leuchten,Jefferies。

  • Michael Leuchten - Analyst

    Michael Leuchten - Analyst

  • Pascal, maybe if I could just go back to rate on the other operating income question that we have to covered. How much of that is sustainable going forward? How much does the higher run rate cost and a higher base that makes 27 a little bit more challenging?

    Pascal,也許我可以回到我們剛才談到的「其他營業收入」的年化水準(run rate)問題。其中有多少在未來是可持續的?更高的年化水準成本與更高的基期,會在多大程度上讓 2027 年變得更具挑戰?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • That's great. Aradhana, you got your question.

    很好。Aradhana,你來回答這個問題。

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • So again, we don't provide the split of other income, but there is a portion of that. Obviously, that is relating to royalties and some milestones that we get. And then there's a portion for this year that also relates to, like I said, smaller regional divestitures we've done, again, as we clean up the portfolio, again, all of these are small legacy products that we continue to sell and monetize those. But there is a portion of that, that is consistent and will likely continue into 2027.

    所以再次說明,我們不提供其他收入的拆分。但其中有一部分,顯然與我們取得的權利金以及一些里程碑款項有關。另外,今年也有一部分如我所說,與我們做的一些較小的區域性資產剝離有關;我們在整理產品組合時,這些都是我們仍在銷售的較小型歷史產品,我們會持續將其變現。不過其中有一部分是相對穩定的,且很可能會延續到 2027 年。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Aradhana. So if we return to the -- sorry, there is a question from Seamus.

    謝謝你,Aradhana。那我們回到——抱歉,Seamus 那邊有個問題。

  • Zach Dunn - Analyst

    Zach Dunn - Analyst

  • This is Zach Dunn on for Seamus Fernandez. I just want to touch on BD. More specifically, is the current Phase III pipeline sufficient to deliver a stable profile during the main patent expiration period in 2032 plus? It seems to us that the current pressure on the multiple has much less to do with 2030 and much more to do with 2032 and beyond and the larger BD may be necessary to drive growth in that time frame?

    我是代 Seamus Fernandez 提問的 Zach Dunn。我想稍微談一下 BD(業務開發)。更具體地說,目前的第三期(Phase III)研發管線是否足以在 2032 年左右及之後的主要專利到期期間,維持穩定的業績輪廓?我們看起來,目前估值倍數(multiple)的壓力與 2030 年關係較小,更多是與 2032 年及之後有關;而在那個時間框架內,可能需要更大規模的 BD 才能推動成長?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Well, I think on this one, I can be very clear. The answer is no, we don't need mobility to deliver. But of course, to deliver this growth post 2030. But again, it assumes that the aggregate probability of success across our pipeline of new products will be at least as we plan it. because again, there's no one or two projects. It's the aggregate view of the pipeline.

    嗯,我想這一題我可以講得很清楚。答案是否,我們不需要靠併購(M&A)來交付。當然,是指在 2030 年之後交付這個成長。但同樣地,這也假設我們新產品研發管線的整體成功機率,至少會如我們規劃的那樣;因為這不是一兩個專案的問題。而是對整體管線的綜合判斷。

  • And then if you look at that, -- the average probability of success across Phase III for the industry, 60%, 65%. I think Aradhana mentioned it earlier. The probity -- the aggregate probability of success that we use across our pipeline, and we looked at it again recently, it's around 60%. So we are more or less planning as if we were going to develop the industry average, in fact, a little bit lower. But we have consistently developed higher now mentioned 75% plus has been our record.

    再來,如果你看產業在第三期的平均成功機率,大約是 60%、65%。我想 Aradhana 先前也提過。我們用於整體管線的成功機率假設——而且我們最近又重新檢視過——大約在 60% 左右。所以我們的規劃大致上是以產業平均來開發,事實上還略低一些。但我們過去一貫的實際表現更高,如先前提到,我們的紀錄是 75% 以上。

  • So if we deliver what we have in our plan is a profitive success -- And then we have -- actually, we don't need more BD. So the reason we don't -- we need is really to continue planning long term and continuously strengthen our franchises. The most recent one we just talked about is how do we strengthen the -- sorry, the Tagrisso franchise? So net-net is, no, we don't need new bid to achieve this goal. I don't know where this side it comes from probably from people who haven't analyzed the pipeline in detail, I have to say.

    所以如果我們能交付計畫中的成功機率——然後我們其實不需要更多 BD。因此,我們不需要的原因在於,我們真正需要的是持續做長期規劃,並不斷強化我們的產品線(franchises)。我們剛才談到的最新例子就是:我們要如何強化——抱歉——Tagrisso 產品線?所以總結來說,答案是否,我們不需要新的 BD 來達成這個目標。我不知道這種說法從哪裡來,可能是來自沒有深入分析管線的人,我必須這麼說。

  • Luisa, Berenberg, do you want to go ahead?

    Luisa,Berenberg,你要繼續嗎?

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • Pascal, so at the start of the year, you highlighted over $10 billion combined and risk-adjusted peak sales from the 2026 readouts. And today, we see a couple of increases in too and then the and also hearing consistent messages from Susan on Serena and Avanza are kind of balanced and consistent. So does that guidance still stand? Or have there been some risk adjustment changes maybe that were negative for the cohort?

    Pascal,在年初時,你提到 2026 年讀出(readouts)所對應、合併後且經風險調整的峰值銷售額(peak sales)超過 100 億美元。而今天我們看到其中有幾項上調,另外也聽到 Susan 對 Serena 和 Avanza 的訊息是相對平衡且一致的。所以那個指引仍然成立嗎?或者在風險調整上是否有一些變動,可能對這一批(cohort)是偏負面的?

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • No, the -- when you're talking about the 2030 targets, right?

    沒有——你是在談 2030 年的目標,對嗎?

  • Luisa Hector - Analyst

    Luisa Hector - Analyst

  • No, the $10 billion peak sales potential from the readout this year 2026 was a slide you had at the full year '25 results. Yeah.

    不是,這個 100 億美元的峰值銷售潛力,是你們在 2025 全年業績簡報中提到、來自今年(2026 年)讀出的那張投影片。對。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Okay. Aradhana, do you want to cover this one?

    好的。Aradhana,你想要說明這一題嗎?

  • Aradhana Sarin - Chief Financial Officer, Executive Director

    Aradhana Sarin - Chief Financial Officer, Executive Director

  • Sorry. So the $10 billion was the peak year estimates with the risk unwind. So what that means is as risk unwinds for the 2026 cohort, we were still -- we would say $10 billion. Now some of them have unwound in a positive manner like a too. Some of them have unwound in not so positive manner like the Venua. But I think, again, all of those being probability adjusted, I still think we'll unwind close to $10 billion. Now that $10 billion is not a 2030 number, that's a peak year sales number and the peak for some of these products may hit beyond 2030.

    抱歉。所以這 100 億美元是風險回沖下的峰值年度估算。這表示,隨著 2026 年隊列的風險回沖,我們仍然——我們會說是 100 億美元。現在其中一些以正向方式回沖,例如 Toso。有些則以不那麼正向的方式回沖,例如 Venua。但我認為,再次強調,將所有這些按機率調整後,我仍然認為我們會回沖到接近 100 億美元。另外,這 100 億美元不是 2030 年的數字,而是峰值年度銷售額;而其中一些產品的峰值可能會在 2030 年之後才出現。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Maybe the one thing I would add to this is that our probability of success in our risk-adjusted overall forecast, the probity of success we gave to Toso was on the low side, and I'm sure you would agree with that nobody thought it was going to work. We thought it had a good chance, but we still give it a low PTS. And then we had a higher sort of a good PTS for Venua and more industry standard because we had good reasons to believe based on what the entire cardiology community was saying, a good the reason it was going to work. So the net result is we've unlocked Toso, and so the uplift in sales is much higher than the downlift in sales from Venua. If you consider the low PTS we had for Toso. That's one.

    也許我想補充的一點是,在我們風險調整後的整體預測中,我們給 Toso 的成功機率(PTS)偏低,我相信你也會同意,因為沒有人認為它會成功。我們覺得它有不錯的機會,但仍給了較低的 PTS。而對 Venua,我們給了較高、較好的 PTS,更接近業界標準,因為基於整個心臟科社群的看法,我們有充分理由相信它會成功。因此最終結果是,我們解鎖了 Toso,所以銷售上調的幅度遠大於 Venua 帶來的銷售下調幅度。如果你考慮到我們對 Toso 給的低 PTS。這是第一點。

  • And two is the profitability of Toso is higher. We own this product 100%, whereas with we were going to share it with our partners at Ionis. So clearly, we gained more with Toso than we lost with I think maybe we'll take -- that was the last question. So we'll take the questions we left sideways. And maybe, Dave, you could cover both the MFN impact on the pricing of and also the question about S4 and will it be at ESMO?

    第二點是,Toso 的獲利能力更高。我們 100% 擁有這個產品;而原本我們要與 Ionis 的合作夥伴分享。所以很明顯,我們從 Toso 得到的多於我們因為——我想——那是最後一個問題而失去的。所以我們會回答先前擱置的問題。也許 Dave,你可以同時說明 MFN 對定價的影響,以及關於 S4、它是否會在 ESMO 發表的問題?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Thanks, Pascal. Well, on the second question, we will present it when we have our high-level results at whatever Congress we can make it to. So we're not going to be able to comment any more specifically than that in terms of where we'll see the presentation of that.

    謝謝你,Pascal。關於第二個問題,我們會在拿到高層次結果後,於我們能參加的任何大會上進行發表。因此,就會在哪裡看到該項發表而言,我們無法再更具體評論。

  • On MFN, we don't give brand-specific pricing commentary on MFN and don't plan to. That said, our pricing approach across all of launches now has really evolved in response to MFN. And with the US now referencing a basket of countries and setting its price, we are seeing productive engagement with payers and the wealthy nations within that context. With it Cama specifically, we're still early in the commercial life cycle in the markets where we have approvals, but the early negotiations are reflecting this new reality that funding for innovation needs to rise in line with a country's GDP per capita.

    關於 MFN,我們不會就 MFN 提供特定品牌的定價評論,也沒有這樣的計畫。不過,我們目前在所有新產品上市的定價策略,確實已因應 MFN 而演進。隨著美國現在參考一籃子國家並據此設定價格,我們在此脈絡下,與支付方以及其中的富裕國家看到具建設性的互動。就 Cama 而言,我們在已取得核准的市場仍處於商業化生命週期的早期,但初期談判已反映這個新現實:對創新的資金支持需要隨著一國人均 GDP 同步提高。

  • We do anticipate that these will be discussions that are going to take more time than perhaps sometimes in the past. But we do think that -- so far, the objective that was set by the US for prices in wealthy nations to come up and US prices to come down a bit, we think is the direction of travel.

    我們確實預期,這些討論將比過去某些時候需要更長的時間。但我們也認為——到目前為止——美國所設定的目標,也就是讓富裕國家的價格上升、而美國價格略為下降,我們認為這就是目前的趨勢方向。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • And S4 at ESMO?

    那 S4 在 ESMO 呢?

  • David Fredrickson - Executive Vice President - Oncology Business Unit

    David Fredrickson - Executive Vice President - Oncology Business Unit

  • Yeah, I commented on that at the beginning and said we will share when we have the data, what the timing of the Congress will be.

    是的,我在一開始已經評論過,並表示我們會在有數據時分享,屆時也會說明大會時程。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Okay. And the last question for Ruud about be Fortis.

    好的。最後一個問題是問 Ruud,關於 be Fortis。

  • Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

    Ruud Dobber - Executive Vice President - Bio Pharmaceuticals Business Unit

  • Yeah. Pascal, there's not so much I can comment on this one. As we mentioned in our legal disclosures, we started an arbitration process regarding be Fortis in the United States. And as we normally do, we are not commenting on either an arbitration or legal procedure.

    是的。Pascal,這題我沒有太多可以評論的。如同我們在法律揭露中提到的,我們已在美國就 be Fortis 啟動仲裁程序。而如同我們一貫作法,我們不會評論任何仲裁或法律程序。

  • Pascal Soriot - Chief Executive Officer, Executive Director

    Pascal Soriot - Chief Executive Officer, Executive Director

  • Thank you, Ruud. So we'll close the Q&A here. Thank you so much for all your great questions. And being closing or thank you for joining us, for your interest in our company and also restate that we are firmly on track for our 2030 goal, but also on track with our post 2030 goal ambition. And again, we don't need additional bid. It doesn't mean we will not do additional bidding, but we don't need additional bid if we continue delivering as we expect to across the pipeline.

    謝謝你,Ruud。那我們就在此結束問答。非常感謝大家提出的精彩問題。在結束之前,也謝謝各位加入我們,感謝你們對本公司的關注;並再次重申,我們正穩健朝 2030 年目標前進,同時也在朝 2030 年後的目標願景前進。而且再次強調,我們不需要額外的併購。這不代表我們不會進行額外併購,但如果我們能如預期在整體研發管線上持續交付成果,我們就不需要額外併購。

  • Again, thank you, and have a good day.

    再次感謝,祝各位有美好的一天。