AstraZeneca PLC (AZN) 2023 Q2 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Good morning to those joining from the U.K. and the U.S. Good afternoon to those in Central Europe, and good evening to those listening in Asia. Welcome, ladies and gentlemen, to AstraZeneca's Half Year and Q2 Results 2023 Webinar for Investors and Analysts.

    英國和美國的聽眾早上好,中歐的聽眾下午好,亞洲的聽眾晚上好。女士們、先生們,歡迎參加阿斯利康為投資者和分析師舉辦的 2023 年半年和第二季度業績網絡研討會。

  • Before I hand over to AstraZeneca, I'd like to read the safe harbor 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.

    在我移交給阿斯利康之前,我想閱讀安全港聲明。該公司打算利用 1995 年美國私人證券訴訟改革法案的安全港條款。本次電話會議的參與者可能會就阿斯利康的運營和財務業績做出前瞻性陳述。

  • 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.

    儘管我們相信我們的預期是基於合理的假設,但就其本質而言,前瞻性陳述涉及風險和不確定性,並且可能受到可能導致實際結果與這些前瞻性陳述明示或暗示的結果存在重大差異的因素的影響。

  • Any forward-looking statements made on this call reflect the knowledge and information available at the time of this call. 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)

    本次電話會議中所做的任何前瞻性陳述均反映了本次電話會議時可獲得的知識和信息。該公司不承擔更新前瞻性陳述的義務。另請仔細閱讀本演示文稿和網絡研討會附帶的幻燈片中的前瞻性聲明免責聲明。 (操作員說明)

  • And with that, I'll now hand you over to the company.

    現在我就把你交給公司了。

  • Andrew P. Barnett - Head of IR

    Andrew P. Barnett - Head of IR

  • Thank you, operator, and welcome, everybody. I'm Andy Barnett, Head of Investor Relations with AstraZeneca, and I'm very pleased to welcome you to AstraZeneca's first half and second quarter 2023 conference call. As usual, all materials presented are on our website.

    謝謝運營商,歡迎大家。我是阿斯利康投資者關係主管安迪·巴尼特 (Andy Barnett),我非常高興地歡迎您參加阿斯利康 2023 年上半年和第二季度的電話會議。與往常一樣,所有提供的材料都在我們的網站上。

  • This slide contains our usual safe harbor statement. We will be making comments on our performance using constant exchange rates, or CER, core financial numbers and other non-GAAP measures. A non-GAAP to GAAP reconciliation is contained within the results announcement, numbers used are millions of U.S. dollars unless otherwise stated.

    這張幻燈片包含我們通常的安全港聲明。我們將使用固定匯率(CER)、核心財務數據和其他非公認會計準則衡量標準對我們的業績進行評論。業績公告中包含非公認會計原則與公認會計原則的調節,除非另有說明,否則使用的數字為數百萬美元。

  • This slide shows our agenda for today's call. Following our prepared remarks, we will open the line for questions. We will try and address as many questions as we can during the allotted time. Although I'd ask that participants to limit the number of questions you ask to allow others a fair chance to participate in the Q&A. (Operator Instructions)

    這張幻燈片顯示了我們今天電話會議的議程。在我們準備好的發言之後,我們將開通提問熱線。我們將盡力在規定的時間內解決盡可能多的問題。儘管我會要求參與者限制提出的問題數量,以便其他人有公平的機會參與問答。 (操作員說明)

  • With that, Pascal, I will hand the call over to you.

    這樣,帕斯卡,我就把電話交給你了。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Thank you. Hello, everyone, and welcome. Please move on to the next slide.

    謝謝。大家好,歡迎光臨。請轉到下一張幻燈片。

  • Total revenue in the first half of the year increased 4% to $22.3 billion, with 16% growth in our non-COVID medicines, offsetting a $2.2 billion decline in our COVID-19 medicines revenue. Core earnings per share increased 21% to $4.04. This increase reflects both our robust business performance as well as a gain following an update to our contractual relationships for Beyfortus in the U.S.

    上半年總收入增長 4%,達到 223 億美元,其中非 COVID 藥品增長 16%,抵消了 COVID-19 藥品收入 22 億美元的下降。每股核心收益增長 21% 至 4.04 美元。這一增長既反映了我們強勁的業務業績,也反映了我們與 Beyfortus 在美國的合同關係更新後的收益。

  • We continue to benefit from our diverse commercial portfolio and our global footprint. Given our strong execution in the first half, we remain confident in our outlook for the remainder of the year, and we have reiterated our 2023 guidance.

    我們繼續受益於我們多元化的商業投資組合和全球足跡。鑑於我們上半年的強勁執行力,我們對今年剩餘時間的前景仍然充滿信心,並重申了 2023 年的指導。

  • Next slide, please. Taking a closer look at the performance of our non-COVID business across our regions in these areas, growth in the emerging markets continue to be strong. In particular, outside of China, emerging markets outside of China collectively grew by 38% in the first half. This growth underscores our confidence that these markets will become increasingly important to our business.

    請下一張幻燈片。仔細觀察我們在這些地區的非新冠疫情業務的表現,新興市場的增長繼續強勁。尤其是在中國以外,上半年中國以外的新興市場合計增長38%。這種增長凸顯了我們的信心,即這些市場對我們的業務將變得越來越重要。

  • We also saw double-digit growth across the EU and Europe in the period. On the right-hand side, you will see that we delivered a robust double-digit growth across oncology, CVRM, R&I and Rare Disease. And as expected, we saw declines in V&I. This growth reflects strong medicines performance across these areas.

    在此期間,我們還看到了整個歐盟和歐洲的兩位數增長。在右側,您將看到我們在腫瘤學、CVRM、R&I 和罕見疾病領域實現了強勁的兩位數增長。正如預期的那樣,我們看到了 V&I 的下降。這一增長反映出這些領域藥品的強勁表現。

  • Please advance to the next slide. When we look at performance across our portfolio in the first half, we had 8 medicines deliver over $1 billion H1 product sales. A broad range of these products are driving our growth, as you can see from this slide.

    請前進到下一張幻燈片。當我們查看上半年我們的產品組合的表現時,我們有 8 種藥物上半年產品銷售額超過 10 億美元。正如您從這張幻燈片中看到的那樣,一系列廣泛的產品正在推動我們的增長。

  • For effective life cycle management, we've seen an acceleration in the rate of growth for several medicines, such as Imfinzi and Farxiga with new indications making important contributions to revenues. Ultomiris growth stood at, once again, and is the result of both successful conversion from Soliris as well as growth in patient numbers.

    在有效的生命週期管理方面,我們看到一些藥物的增長速度加快,例如 Imfinzi 和 Farxiga 的新適應症對收入做出了重要貢獻。 Ultomiris 的增長再次保持不變,這是從 Soliris 成功轉換以及患者數量增長的結果。

  • We've also seen promising global growth from some of our more recently launched medicines including an HER2, Calquence, Breztri, Tezspire and Saphnelo, all of which are helping to change the course of their respective diseases.

    我們還看到,我們最近推出的一些藥物(包括 HER2、Calquence、Breztri、Tezspire 和 Saphnelo)在全球範圍內實現了有希望的增長,所有這些藥物都有助於改變各自疾病的進程。

  • Next slide, please. Confidence in our long-term outlook is supported by our robust late-stage pipeline, which now has well over 120 active projects. Importantly, we maintain a rigorous approach to R&D development, setting a high bar for late-stage trial initiations and advancing only the most promising projects.

    請下一張幻燈片。我們強大的後期研發管線支撐著我們對長期前景的信心,目前該管線擁有超過 120 個活躍項目。重要的是,我們保持嚴格的研發開發方法,為後期試驗啟動設定高標準,並只推進最有前途的項目。

  • We strive to stay at the front of the innovation curve, and we have already progressed 14 unique new molecular entities into late-stage development. We're making good progress towards initiating 30 new pivotal trials this year, having those 9 in the year-to-date with recent additions, including the LITHOS trial for Breztri and asthma and two next generation PROpel trials, which will support the expansion of our pMDI portfolio.

    我們努力保持在創新曲線的前沿,並且已經將 14 個獨特的新分子實體推進到後期開發。今年,我們在啟動 30 項新的關鍵試驗方面取得了良好進展,今年迄今已有 9 項試驗,最近又增加了這些試驗,包括針對 Breztri 和哮喘的 LITHOS 試驗以及兩項下一代 PROpel 試驗,這將支持擴大我們的 pMDI 產品組合。

  • As we indicated last quarter, most of the new pivotal trials are expected to dose in the second half of this year. Our pipeline continues to make exciting progress with 8 positive pivotal oncology trials already this year. These are shown on the right-hand side of this slide. In particular, we are encouraged by the positive results from the TROPION-Lung01 trial of Dato-DXd and are excited to unlock the full potential of this promising medicine.

    正如我們上季度指出的那樣,大多數新的關鍵試驗預計將在今年下半年進行。我們的產品線繼續取得令人興奮的進展,今年已經進行了 8 項積極的關鍵腫瘤學試驗。這些顯示在該幻燈片的右側。特別是,我們對 Dato-DXd 的 TROPION-Lung01 試驗的積極結果感到鼓舞,並很高興能夠釋放這種有前途的藥物的全部潛力。

  • On the next slide, Aradhana can take you through our financial highlights in the first half as well as provide some further insights into how we are embracing the power of artificial intelligence across our manufacturing and supply chain.

    在下一張幻燈片中,Aradhana 可以帶您了解我們上半年的財務亮點,並進一步深入了解我們如何在整個製造和供應鏈中擁抱人工智能的力量。

  • Over to you, Aradhana.

    交給你了,阿拉達納。

  • Aradhana Sarin - Executive Director

    Aradhana Sarin - Executive Director

  • Thank you, Pascal, and good afternoon, everyone. As usual, I'll start with our reported P&L. Please advance to the next slide.

    謝謝帕斯卡,大家下午好。像往常一樣,我將從我們報告的損益表開始。請前進到下一張幻燈片。

  • As Pascal mentioned, total revenue increased by 4% to $2.3 billion in the first half. Total revenue, excluding COVID-19 medicines, increased 16%. Alliance revenue of $627 million includes $475 million of an HER2 profit sharing from geographies, were Daiichi Sankyo books product sales.

    正如 Pascal 提到的,上半年總收入增長了 4%,達到 23 億美元。不包括 COVID-19 藥品的總收入增長了 16%。聯盟收入 6.27 億美元包括 4.75 億美元的 HER2 利潤分成(來自第一三共圖書產品銷售)。

  • Collaboration revenue of $220 million includes $180 million license fee from the Serum Institute of India booked in the second quarter relating to our COVID-19 antibodies license agreement.

    2.2 億美元的合作收入包括第二季度向印度血清研究所預訂的與我們的 COVID-19 抗體許可協議相關的 1.8 億美元許可費。

  • Please advance to the next slide, which shows our core P&L. The core product sales gross margin in the first half was 82.9%, benefiting from lower production cost in prior quarters and certain nonrecurring items in the first quarter. As previously communicated, we expect the product sales gross margin in the second half to be negatively impacted, similar to in prior years by seasonality for FluMist and certain other medicines.

    請前進到下一張幻燈片,其中顯示了我們的核心損益表。上半年核心產品銷售毛利率為82.9%,受益於前季度生產成本下降以及一季度的部分非經常性項目。正如之前所傳達的,我們預計下半年的產品銷售毛利率將受到負面影響,類似於前幾年 FluMist 和某些其他藥品的季節性影響。

  • The mandatory price reduction for Tagrisso in Japan as well as the full impact of inflation. We still expect the product sales gross margin on a full year basis to be slightly higher than pre-COVID-19 levels.

    日本泰瑞沙的強制降價以及通貨膨脹的全面影響。我們仍然預計全年產品銷售毛利率將略高於 COVID-19 之前的水平。

  • Looking ahead beyond 2023, we expect product sales gross margin percentage will be negatively impacted by profit sharing arrangements. While we already see this dynamic with Lynparza, we anticipate the impact to increase as we start seeing higher sales from medicines such as in HER2 and Tezspire in regions where we book product sales and then pay out a portion of profits to our partners through cost of sales.

    展望 2023 年以後,我們預計產品銷售毛利率將受到利潤分享安排的負面影響。雖然我們已經看到 Lynparza 的這種動態,但隨著我們開始看到 HER2 和 Tezspire 等藥品在我們預訂產品銷售的地區的銷售額增加,然後通過成本向我們的合作夥伴支付部分利潤,我們預計影響將會增加。銷售量。

  • Over the long-term, we're focusing on driving productivity improvements to counter the impact on our gross margin from inflation, continued growth in emerging markets and more complex and expensive manufacturing of new modalities we're investing in. Core operating expenses in the half increased by 8%, R&D costs increased by 9%, driven by continued investments in our pipeline.

    從長遠來看,我們致力於推動生產力的提高,以應對通貨膨脹、新興市場的持續增長以及我們投資的新模式的製造更加複雜和昂貴對我們毛利率的影響。在管道持續投資的推動下,一半增長了 8%,研發成本增長了 9%。

  • The increase in SG&A costs partially reflects spend behind new launches such as TOPAZ and HIMALAYA, which are driving the strong growth of Imfinzi and Imjudo, for example, as well as existing brands like Farxiga and Breztri and geographic expansion of the rare disease medicines portfolio. We previously guided for total core operating expenses to increase by low to mid-single-digit percentage in 2023, and we now expect to finish the year towards the upper end of this range.

    SG&A 成本的增加部分反映了 TOPAZ 和 HIMALAYA 等新產品的支出,這些新產品推動了 Imfinzi 和 Imjudo 的強勁增長,以及 Farxiga 和 Breztri 等現有品牌以及罕見疾病藥物組合的地理擴張。我們此前預計 2023 年核心運營支出總額將出現低至中個位數百分比的增長,現在我們預計今年將達到該範圍的上限。

  • Similar to the phasing we observed in 2022, we expect R&D and SG&A spend to be weighted towards the second half. Other operating income of $1.1 billion includes $712 million related to the previously announced updated agreements on Beyfortus, which was booked in the second quarter. The increase in other operating income is in line with the guidance set out at the start of the year where we said that other operating income would be higher versus last year.

    與我們在 2022 年觀察到的分階段情況類似,我們預計研發和銷售、一般行政費用將集中在下半年。 11 億美元的其他營業收入包括與之前宣布的 Beyfortus 更新協議相關的 7.12 億美元,該協議已在第二季度入賬。其他營業收入的增長與年初制定的指導一致,我們表示其他營業收入將高於去年。

  • The tax rate in the second quarter was lower than our full year guidance due to certain tax incentives and mix of profits and lower tax legal entities. For the full year, we continue to expect this core tax rate will be between 8% and 22%. Core EPS of $4.07 in the first half represents an increase of 21% at constant exchange rates.

    由於某些稅收優惠以及利潤和較低稅收法人實體的組合,第二季度的稅率低於我們的全年指導。對於全年,我們繼續預計核心稅率將在 8% 至 22% 之間。上半年核心每股收益為 4.07 美元,按固定匯率計算增長了 21%。

  • Next slide, please. Our net cash inflow from operating activities increased by $400 million to $4.9 billion, and we continue to see improvement in our cash conversion. Net debt increased by $1 billion to $24 billion, driven by the payment of the second interim dividend in March and $2.4 billion in deal payments, which include the second payment to Acerta made in the first quarter. As a reminder, we will pay the third and final payment in 2024.

    請下一張幻燈片。我們的經營活動現金流入淨額增加了 4 億美元,達到 49 億美元,而且我們的現金轉換率持續改善。由於 3 月份支付第二次中期股息和 24 億美元的交易付款(其中包括第一季度向 Acerta 支付的第二筆付款),淨債務增加了 10 億美元,達到 240 億美元。謹此提醒,我們將於 2024 年支付第三筆也是最後一筆付款。

  • For the full year, we continue to anticipate deal payments related to prior business transactions to be in line with last year, around $2 billion, excluding Acerta. We have paid just under $1 billion in the first half.

    就全年而言,我們繼續預計與之前業務交易相關的交易付款將與去年持平,約為 20 億美元(不包括 Acerta)。上半年我們支付了近 10 億美元。

  • Our net debt-to-EBITDA ratio continues to decrease and is now at 1.9x or 1.7x if excluding the noncash adjustment for the Alexion inventory fair value uplift, which will soon disappear as we have now minimal inventory remaining from the time of the acquisition.

    如果不包括亞力兄庫存公允價值提升的非現金調整,我們的淨債務與 EBITDA 比率繼續下降,目前為 1.9 倍或 1.7 倍,由於我們現在從收購時起所剩餘的庫存很少,因此這種調整很快就會消失。

  • Today, we are reiterating our 2023 total revenue and core EPS guidance. Total revenues are expected to increase by low to mid-single-digit percentage. Excluding COVID-19 total revenue are expected to increase by low double-digit percentage. Growth in the second half will be hampered by patent expiries, including Symbicort in the U.S. and Nexium in Japan, where we saw first generics end of last year.

    今天,我們重申 2023 年總收入和核心每股收益指引。總收入預計將以低至中個位數百分比增長。不包括 COVID-19 的總收入預計將以較低的兩位數百分比增長。下半年的增長將受到專利到期的阻礙,包括美國的 Symbicort 和日本的 Nexium,我們去年年底在日本看到了第一個仿製藥。

  • We now anticipate revenue in China to increase by a low to mid-single-digit percentage. And as I mentioned earlier, we now anticipate total operating expenses on our end of the range, with phasing of SG&A costs towards the second half of the year, similar to prior years. In addition, given that we anticipate starting several new Phase III trials in the second half of the year, R&D and associated clinical and new product costs will be higher in the second half.

    我們現在預計中國的收入將以低至中個位數的百分比增長。正如我之前提到的,我們現在預計總運營費用將在我們的範圍內,SG&A 成本將在今年下半年分階段進行,與往年類似。此外,鑑於我們預計下半年將啟動多項新的三期試驗,下半年的研發及相關臨床和新產品成本將會更高。

  • Based on June average FX rates, we now anticipate a low single-digit adverse FX impact on total revenue, and a low to mid-single-digit adverse impact on core EPS.

    根據 6 月份平均匯率,我們現在預計外匯對總收入的不利影響將為低個位數,而對核心每股收益的不利影響將為低至中個位數。

  • Please advance to the next slide. Continuing with the artificial intelligence team, today, I want to highlight global operations and how we are leveraging AI to accelerate drug development, manufacturing processes and drive supply chain efficiencies.

    請前進到下一張幻燈片。今天,繼續人工智能團隊,我想重點介紹全球運營以及我們如何利用人工智能加速藥物開發、製造流程並提高供應鏈效率。

  • To share three specific examples here. First, in drug development, with our in-house AI-enabled tool, route manager, we have reduced in route synthesis lead times from 9 to 12 months to 5 to 6 months, and we're striving to further reduce lead times to less than 3 months. Additionally, with this tool, we have been able to reduce the number of experimental trials cutting lead times and driving efficiencies in cause, while also providing sustainability benefits through fewer synthetic steps.

    這里分享三個具體例子。首先,在藥物開發方面,借助我們內部的人工智能工具路線管理器,我們將路線合成的交貨時間從 9 至 12 個月減少到 5 至 6 個月,並且我們正在努力進一步將交貨時間縮短至更短3個月以上。此外,借助該工具,我們能夠減少實驗試驗的數量,從而縮短交貨時間並提高效率,同時通過更少的合成步驟提供可持續性效益。

  • Next, with AI-powered visualization of data, our operators are able to improve process performance for synthetic and biologic medicine by identifying critical variables that will affect yields and make real-time optimization adjustments. In the future, advanced continuous process verification will drive further robustness and yield increases.

    接下來,通過人工智能驅動的數據可視化,我們的操作員能夠通過識別影響產量的關鍵變量並進行實時優化調整來提高合成和生物醫學的工藝性能。未來,先進的連續工藝驗證將進一步推動穩健性和產量的提高。

  • Third example, we've implemented AI-enabled enhancements across our supply chain. For example, Sweden is one of our largest global sites, manufacturing over 12 billion tablets and capsules every year. Here, we use AI-powered digital twins that can leverage multiple data sources simultaneously, such as production orders, dispensing stations and cleaning status to optimize production schedules.

    第三個例子,我們在整個供應鏈中實施了人工智能增強功能。例如,瑞典是我們全球最大的工廠之一,每年生產超過 120 億片片劑和膠囊。在這裡,我們使用人工智能驅動的數字孿生,可以同時利用多個數據源(例如生產訂單、分配站和清潔狀態)來優化生產計劃。

  • This technology has already delivered a 90% improvement in scheduling time, meaning we can now develop a dispensing plan in only 4 to 5 minutes where it's used to take 8 hours. Our ambition is to leverage many of these tools and roll them throughout our manufacturing and supply network.

    這項技術已經將調度時間縮短了 90%,這意味著我們現在只需 4 到 5 分鐘即可製定分配計劃,而過去需要 8 個小時。我們的目標是利用其中許多工具並將其推廣到我們的製造和供應網絡中。

  • This is, of course, a journey, but the work is already underway to use technology to drive efficiencies. While our operations team continues to deliver on seamless supply and new product launch delivery.

    當然,這是一個旅程,但利用技術提高效率的工作已經在進行中。我們的運營團隊繼續提供無縫供應和新產品發布交付。

  • With that, please advance to the next slide, and I will hand over to Dave to walk through our oncology business performance.

    接下來,請轉到下一張幻燈片,我將交給戴夫(Dave)介紹我們的腫瘤業務績效。

  • David Fredrickson - Executive Vice-President of Oncology Business Unit

    David Fredrickson - Executive Vice-President of Oncology Business Unit

  • Thank you, Aradhana. Next slide, please. We're pleased to report our oncology medicines delivered total revenues in the first half of $8.8 billion, an increase of 22% versus the prior year. We delivered double-digit product sales growth across all regions.

    謝謝你,阿拉達納。請下一張幻燈片。我們很高興地報告,上半年我們的腫瘤藥物總收入達到 88 億美元,比去年同期增長 22%。我們在所有地區實現了兩位數的產品銷售增長。

  • Turning to individual medicine performance in the second quarter, Tagrisso Global revenues grew 10%, reflecting strong underlying demand for ADAURA and FLAURA across all regions.

    談到第二季度的個別藥品業績,Tagrisso Global 收入增長了 10%,反映出所有地區對 ADAURA 和 FLAURA 的強勁潛在需求。

  • As expected, effective this June, we realized a mandatory price reduction in Japan. And in China, second quarter revenues reflect the first full quarter of NRDL renewal pricing following reenlistment this March.

    正如預期的那樣,從今年 6 月起,我們在日本實現了強制降價。在中國,第二季度收入反映了今年三月重新納入國家醫保目錄後第一個完整季度的續訂定價。

  • Following the ASCO plenary presentation of ADAURA overall survival data last month, we expect expanded use of Tagrisso in the adjuvant setting as well as potential for new reimbursements in certain geographies.

    繼上個月在 ASCO 全體會議上介紹 ADAURA 總體生存數據後,我們預計 Tagrisso 在輔助治療中的使用將得到擴大,並且在某些地區有可能獲得新的報銷。

  • Lastly, as we consider the future impact from IRA, our current interpretation of CMS final guidance supports the potential exclusion for Tagrisso under orphan drug protections.

    最後,當我們考慮 IRA 的未來影響時,我們目前對 CMS 最終指南的解釋支持將 Tagrisso 排除在孤兒藥保護之下。

  • Lynparza remains the leading PARP inhibitor globally and delivered second quarter product sales growth of 9%. In the U.S., we saw sequential demand decline across the PARP inhibitor class following competitor label restrictions in second-line ovarian cancer. We continue to work on opportunities for U.S. demand expansion in ovarian and HR-positive breast cancer, but still expect this to be more challenging.

    Lynparza 仍然是全球領先的 PARP 抑製劑,第二季度產品銷售額增長 9%。在美國,隨著競爭對手對二線卵巢癌的標籤限制,我們發現 PARP 抑製劑類別的需求連續下降。我們繼續致力於擴大美國對卵巢癌和 HR 陽性乳腺癌的需求擴大,但仍然預計這將更具挑戰性。

  • Outside of the U.S., we saw double-digit product sales growth across the EU, Established Rest of World and Emerging Markets. In Q2, Imfinzi total revenues, inclusive of Imjudo surpassed $1 billion in a quarter for the first time, up 58% and largely driven by new launches of TOPAZ, HIMALAYA and POSEIDON. I'll touch on specific Imfinzi growth drivers a bit later, but needless to say, we're excited by what the team has accomplished within a competitive IO class.

    在美國之外,我們看到歐盟、世界其他地區和新興市場的產品銷售額實現了兩位數的增長。第二季度,Imfinzi 的總收入(包括 Imjudo)首次在一個季度內超過 10 億美元,增長 58%,這主要是受到新推出的 TOPAZ、HIMALAYA 和 POSEIDON 的推動。稍後我將談到特定的 Imfinzi 增長驅動因素,但不用說,我們對團隊在競爭激烈的 IO 類別中取得的成就感到興奮。

  • Calquence total revenues increased 34% year-on-year, supported by ex U.S. demand growth, particularly in Europe. And in the U.S., Calquence continues to maintain leadership in frontline CLL with the majority of new patient starts in this setting. However, we continue to see some new patient share loss in the relapsed/refractory segment.

    在美國以外的需求增長(尤其是歐洲)的支持下,Calquence 總收入同比增長 34%。在美國,Calquence 繼續保持在 CLL 一線治療的領導地位,大多數新患者都是在這種情況下開始治療的。然而,我們繼續看到復發/難治性部分的一些新患者份額流失。

  • In HER2 total revenues of $322 million in the second quarter, increased 176% year-on-year. In the U.S. in HER2 new patient share in the HER2 positive metastatic breast cancer setting remains at 50%. And in the hormone receptor positive HER2-low, post-chemo metastatic breast cancer share has now grown to above 50%. Importantly, we're seeing strong continued demand across the globe, particularly in European markets.

    HER2第二季度總營收為3.22億美元,同比增長176%。在美國,HER2 新患者中 HER2 陽性轉移性乳腺癌患者的比例仍為 50%。而在激素受體陽性HER2-低水平中,化療後轉移性乳腺癌的比例現已增長至50%以上。重要的是,我們看到全球範圍內的需求持續強勁,特別是在歐洲市場。

  • Following the exciting approval for DESTINY-Breast03 in China last quarter, we received approval for Enhertu in HER2-low metastatic breast cancer. Also during the period, we received approval for PROpel in the U.S. and anticipate a potential regulatory milestone to be paid in the second half of the year. And finally, we were granted priority review in the U.S. for CAPItello-291.

    繼上季度 DESTINY-Breast03 在中國獲得令人興奮的批准後,我們又獲得了用於治療 HER2 低轉移性乳腺癌的 Enhertu 的批准。同樣在此期間,我們在美國獲得了 PROpel 的批准,並預計將在今年下半年實現潛在的監管里程碑。最後,我們獲得了美國對 CAPtello-291 的優先審查。

  • Next slide, please. We've seen remarkable Imfinzi and Imjudo growth, driven by the recent launches of TOPAZ, HIMALAYA and POSEIDON. We're excited about the current trajectories of these launches and the broader potential of Imfinzi as supported by the suite of ongoing life cycle management programs.

    請下一張幻燈片。在最近推出的 TOPAZ、HIMALAYA 和 POSEIDON 的推動下,我們看到了 Imfinzi 和 Imjudo 的顯著增長。我們對這些產品的當前發展軌跡以及 Imfinzi 在一系列持續的生命週期管理計劃的支持下所具有的更廣泛的潛力感到興奮。

  • First, HIMALAYA in unresectable hepatocellular carcinoma has established a clear foothold for Imfinzi on GI cancers. Last month at ESMO World GI, we presented unprecedented 4-year overall survival data, the longest follow-up to date in unresectable HCC.

    首先,HIMALAYA在不可切除的肝細胞癌領域為Imfinzi在胃腸道癌症領域奠定了明確的立足點。上個月,我們在 ESMO World GI 上展示了史無前例的 4 年總體生存數據,這是迄今為止不可切除的 HCC 中最長的隨訪數據。

  • This sustained benefit, coupled with strong safety will continue to support rapid adoption and the establishment of a new standard of care. The launch of TOPAZ represents a step change innovation in biliary tract cancer, and the strength of this data demonstrates the transformative benefit of IO in this setting.

    這種持續的益處加上強大的安全性將繼續支持快速採用和建立新的護理標準。 TOPAZ 的推出代表了膽道癌領域的重大創新,這些數據的強度證明了 IO 在這一領域的變革性優勢。

  • In the U.S., TOPAZ has become the undisputed standard of care within months, and the EU and Japan launches are already outpacing the U.S. trajectory. We're making progress with POSEIDON in the U.S. and in Europe with a crowded and competitive setting.

    在美國,TOPAZ 在幾個月內已成為無可爭議的護理標準,歐盟和日本的推出速度已經超過了美國。我們正在美國和歐洲的 POSEIDON 項目上取得進展,在擁擠和競爭激烈的環境中。

  • This bunch together with our efforts with PACIFIC and CASPIAN continue to solidify a strong leadership position within lung cancer. In the first half of this year, we delivered 4 positive Phase III trials of novel Imfinzi combinations across lung, GI and GYN settings.

    這群人與我們與 PACIFIC 和 CASPIAN 的努力一起繼續鞏固在肺癌領域的強大領導地位。今年上半年,我們針對肺部、胃腸道和婦科領域的新型 Imfinzi 組合進行了 4 項積極的 III 期試驗。

  • MATTERHORN in gastric and gastroesophageal junction cancer was the first global Phase III trial of IO plus FLOT to demonstrate statistically significant pathologic complete response. In endometrial cancer, we are excited to report that DUO-E showed Imfinzi plus Lynparza and Imfinzi alone significantly improved progression-free survival, and Susan will cover these trials in more detail shortly.

    胃癌和胃食管交界癌的 MATTERHORN 是第一個 IO 加 FLOT 的全球 III 期試驗,證明具有統計學意義的病理完全緩解。在子宮內膜癌中,我們很高興地報告,DUO-E 顯示 Imfinzi 聯合 Lynparza 和單獨使用 Imfinzi 顯著改善無進展生存期,Susan 將很快更詳細地介紹這些試驗。

  • Over the balance of the year, we look forward to additional Phase III readouts with PACIFIC-2 in lung cancer and EMERALD-1 in GI. Building on HIMALAYA, EMERALD-1 and EMERALD-2 will enable our leadership in HCC. Finally, we'll continue to advance our next wave of IO with our novel bispecifics, volrustomig and rilvegostomig and sabestomig.

    在這一年餘下的時間裡,我們期待著針對肺癌的 PACIFIC-2 和針對胃腸道的 EMERALD-1 的更多 III 期數據。以 HIMALAYA、EMERALD-1 和 EMERALD-2 為基礎,將使我們在 HCC 領域處於領先地位。最後,我們將繼續利用新型雙特異性藥物 volrustomig、rilvegostomig 和 sabestomig 推進下一波 IO 浪潮。

  • With that, please advance to the next slide, and I'll hand over to Susan to cover key R&D highlights in the quarter.

    接下來,請轉到下一張幻燈片,我將由 Susan 介紹本季度的主要研發亮點。

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • Thank you, Dave. Next slide, please. It's been an exciting first half of the year with 8 positive pivotal trial readouts. We had a large presence at ASCO with more than 130 abstracts featuring 22 approved and potential medicines, highlighting the momentum of our pipeline.

    謝謝你,戴夫。請下一張幻燈片。今年上半年令人興奮,有 8 項積極的關鍵試驗結果。我們在 ASCO 上展示了 130 多篇摘要,涵蓋 22 種已批准的藥物和潛在藥物,凸顯了我們的研發管線的勢頭。

  • ASCO highlights include the final overall survival data from the Tagrisso ADAURA trial, demonstrating unprecedented survival in early-stage EGFR mutated lung cancer, as well as the first data from the DUO-O trial, highlighting the potential of PARP inhibition plus immunotherapy in advanced ovarian cancer.

    ASCO 亮點包括 Tagrisso ADAURA 試驗的最終總生存數據,證明了早期 EGFR 突變肺癌中前所未有的生存率,以及 DUO-O 試驗的第一個數據,強調了 PARP 抑制加免疫治療在晚期卵巢癌中的潛力癌症。

  • Additionally, interim data from the DESTINY-Pantumor02 trial and Enhertu to be the first therapy to show broad activity across a range of HER2 expressing advanced solid tumors. Since ASCO, updated data showed Enhertu resulted in clinically meaningful progression-free survival and overall survival. And I'm pleased to share that our initial interactions with the FDA have been encouraging.

    此外,來自 DESTINY-Pantumor02 試驗和 Enhertu 的中期數據顯示,Enhertu 是第一個在一系列表達 HER2 的晚期實體瘤中顯示出廣泛活性的療法。自 ASCO 以來,更新的數據顯示 Enhertu 實現了具有臨床意義的無進展生存期和總生存期。我很高興地告訴大家,我們與 FDA 的最初互動令人鼓舞。

  • As mentioned previously, we reported high-level results for 8 pivotal trials this quarter. I'll touch on three of those readouts now. First, FLAURA2 demonstrated a strong clinically meaningful improvement in progression-free survival of patients with EGFR-mutated non-small cell lung cancer.

    如前所述,我們本季度報告了 8 項關鍵試驗的高水平結果。我現在將討論其中的三個讀數。首先,FLAURA2 證明對 EGFR 突變非小細胞肺癌患者的無進展生存期有顯著的臨床意義改善。

  • Considering the EGFR mutated lung cancer landscape as a whole, we believe Tagrisso monotherapy will remain standard of care in first-line, but see the opportunity for FLAURA2 to become a valuable regimen for patients with higher tumor burden. We're delighted that these data have been selected for a presidential plenary presentation at the World Conference on Lung Cancer in September.

    考慮到 EGFR 突變肺癌的整體情況,我們相信 Tagrisso 單藥治療仍將是一線治療的標準,但我們看到 FLAURA2 有機會成為腫瘤負荷較高患者的有價值的治療方案。我們很高興這些數據被選為 9 月份世界肺癌大會主席全體會議的報告。

  • DUO-E is the first Phase III trial of immunotherapy plus PARP inhibition to demonstrate clinical benefit in advanced endometrial cancer. More than 400,000 patients are diagnosed with endometrial cancer each year and in advanced disease, survival remains poor, with only 1 in 5 patients living beyond 5 years.

    DUO-E 是首個免疫療法加 PARP 抑制的 III 期試驗,旨在證明對晚期子宮內膜癌的臨床益處。每年有超過 400,000 名患者被診斷患有子宮內膜癌,在晚期疾病中,生存率仍然很低,只有五分之一的患者存活超過 5 年。

  • In DUO-O, both Imfinzi plus Lynparza and Imfinzi alone significantly improves progression-free survival when added to chemotherapy. With the greatest clinically meaningful benefit observed with the combination of Imfinzi and Lynparza as maintenance treatment.

    在 DUO-O 中,Imfinzi 加 Lynparza 和單獨使用 Imfinzi 與化療聯合使用均可顯著改善無進展生存期。 Imfinzi 和 Lynparza 聯合作為維持治療觀察到了最大的臨床意義獲益。

  • Finally, over 1 million patients are diagnosed with gastric cancer each year. 45% of whom are eligible for perioperative chemotherapy. An early read from Matterhorn demonstrated a statistically significant and clinically meaningful improvement with Imfinzi plus FLOT versus FLOT chemotherapy alone in the key secondary endpoint of pathologic complete response, which we hope to see translate into an improvement in event-free survival over time.

    最後,每年有超過100萬患者被診斷患有胃癌。其中 45% 適合接受圍手術期化療。 Matterhorn 的一份早期報告表明,在病理完全緩解的關鍵次要終點上,Imfinzi 加 FLOT 與單獨使用 FLOT 化療相比,在統計學上具有顯著且具有臨床意義的改善,我們希望看到隨著時間的推移,這會轉化為無事件生存率的改善。

  • Please advance to the next slide. We recently announced waited high-level results from the first Phase III trial for Dato-DXd, the TROPION-Lung01 trial. This trial investigated Dato-DXd versus docetaxel in second and third-line non-small cell lung cancer, and demonstrated a statistically significant improvement in progression-free survival and an early trend in overall survival.

    請前進到下一張幻燈片。我們最近宣布了 Dato-DXd 的第一個 III 期試驗 TROPION-Lung01 試驗的高水平結果。該試驗研究了 Dato-DXd 與多西紫杉醇治療二線和三線非小細胞肺癌的療效,並證明了無進展生存期的統計學顯著改善和總生存期的早期趨勢。

  • The adverse event profile of Dato-DXd was overall consistent with previous trials, including rates of all grade ILD. Whilst there were some cases of Grade 5 ILD observed in the trial, we are confident in the positive benefit risk profile for Dato-DXd. These data reinforce our view that Dato-DXd will be an important potential medicine in multiple cancers, including lung cancer.

    Dato-DXd 的不良事件概況與之前的試驗總體一致,包括所有級別 ILD 的發生率。雖然試驗中觀察到一些 5 級 ILD 病例,但我們對 Dato-DXd 的積極效益風險狀況充滿信心。這些數據強化了我們的觀點,即 Dato-DXd 將成為治療多種癌症(包括肺癌)的重要潛在藥物。

  • Initial interactions with the FDA have been encouraging, and we are proceeding to file TROPION-Lung01. In addition to TROPION-Lung01, we have 3 active Phase III trials in the frontline setting, investigating Dato-DXd in combination with immune checkpoint inhibitors.

    與 FDA 的初步互動令人鼓舞,我們正在著手提交 TROPION-Lung01。除了 TROPION-Lung01 之外,我們還在一線開展了 3 項活躍的 III 期試驗,研究 Dato-DXd 與免疫檢查點抑製劑的組合。

  • TROPION-Lung07, 08 and AVANZAR outcomes in these settings remain poor, less than half of patients treated the initial IO plus chemotherapy living past 2 years. Combination Dato-DXd plus IO has already demonstrated encouraging clinical efficacy in the TROPION-Lung02 trial with durable objective response rates of 50% for Dato-DXd plus pembrolizumab, and 57% for the Dato-DXd plus pembrolizumab and platinum-based chemotherapy across first-line patients.

    TROPION-Lung07、08 和 AVANZAR 在這些環境中的結果仍然很差,只有不到一半接受初始 IO 加化療的患者存活了過去 2 年。 Dato-DXd 加 IO 組合已在 TROPION-Lung02 試驗中證明了令人鼓舞的臨床療效,Dato-DXd 加 pembrolizumab 的持久客觀緩解率為 50%,Dato-DXd 加 pembrolizumab 和鉑類化療的持久客觀緩解率為 57%線患者。

  • We will have further data to support the combination in lung cancer from TROPION-Lung04, which is a late-breaking abstract at the World Conference on Lung Cancer.

    我們將從 TROPION-Lung04 獲得進一步的數據來支持肺癌的聯合治療,TROPION-Lung04 是世界肺癌大會上的最新摘要。

  • The combination has also shown benefit in breast cancer with BEGONIA, where we saw a 91% disease control rate with durable responses in first-line triple-negative breast cancer. These results support stronger benefit of the combination of Dato-DXd and immune checkpoint inhibition.

    該組合還顯示了 BEGONIA 對乳腺癌的益處,我們在一線三陰性乳腺癌中看到了 91% 的疾病控制率和持久的反應。這些結果支持 Dato-DXd 和免疫檢查點抑制組合的更大益處。

  • Moving now on to breast cancer. Our first Phase III trial is due to read out later this year. TROPION-Breast01 investigates Dato-DXd versus chemotherapy in patients with hormone receptor-positive, HER2-negative metastatic breast cancer that have received at least one prior line of chemotherapy.

    現在轉向乳腺癌。我們的第一個三期試驗將於今年晚些時候公佈。 TROPION-Breast01 研究了 Dato-DXd 與化療在激素受體陽性、HER2 陰性轉移性乳腺癌患者中的比較,這些患者之前至少接受過一種化療。

  • Our confidence in this trial is twofold. First, we saw encouraging signals from the HR-positive cohort of TROPION-PanTumor01, with a disease control rate of 85% and a median PFS of 8.3 months, in a more heavily pretreated population compared with TB01. Second, we already have proof of concept for HER2-directed treatment in this space. Phase III data for another compound demonstrating efficacy in a late-line HR-positive population.

    我們對這次試驗的信心是雙重的。首先,我們從 TROPION-PanTumor01 的 HR 陽性隊列中看到了令人鼓舞的信號,與 TB01 相比,在經過更嚴格預處理的人群中,疾病控制率為 85%,中位 PFS 為 8.3 個月。其次,我們已經在該領域獲得了針對 HER2 的治療的概念證明。另一種化合物的 III 期數據證明了對晚期 HR 陽性人群的功效。

  • We also have 2 Phase III focused on triple-negative breast cancer. TROPION-Breast02 investigates where the Dato-DXd can replace chemotherapy in first-line patients not eligible to PD-1 or PD-L1 inhibition. And TROPION-Breast03 investigates the role of adjuvant Dato-DXd with or without Imfinzi in early triple-negative disease.

    我們還有 2 個針對三陰性乳腺癌的 III 期臨床試驗。 TROPION-Breast02 研究 Dato-DXd 在哪些方面可以替代不適合 PD-1 或​​ PD-L1 抑制的一線患者的化療。 TROPION-Breast03 研究了佐劑 Dato-DXd 聯合或不聯合 Imfinzi 在早期三陰性疾病中的作用。

  • We are on track to deliver on the promise of Dato-DXd in lung and breast cancer and TROPION-PanTumor01 and 03 are generating the data needed to support further investments in the future.

    我們有望兌現 Dato-DXd 在肺癌和乳腺癌方面的承諾,TROPION-PanTumor01 和 03 正在生成支持未來進一步投資所需的數據。

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

    接下來,請轉到下一張幻燈片,我將由 Ruud 介紹生物製藥的業績。

  • Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit

  • Thank you, Susan. Next slide, please. BioPharmaceuticals delivered total revenue of $9.1 billion in the first half with both CVRM and R&I posting double-digit growth. Within global CVRM, Farxiga total revenue grew 41% to $1.5 billion in the quarter, driven by continued uptake in CKD and heart failure.

    謝謝你,蘇珊。請下一張幻燈片。生物製藥業務上半年總收入達 91 億美元,其中 CVRM 和 R&I 均實現兩位數增長。在全球 CVRM 中,受 CKD 和心力衰竭治療持續增長的推動,Farxiga 本季度總收入增長 41%,達到 15 億美元。

  • Farxiga is now approved in 62 countries for patients with heart failure with preserved ejection fraction. And this quarter, we were pleased to gain approval in the United States for deliver, which means heart failure patients cannot benefit from Farxiga regardless of the left ventricular eject infection status.

    Farxiga 現已在 62 個國家獲批用於治療射血分數保留的心力衰竭患者。本季度,我們很高興在美國獲得分娩批准,這意味著無論左心室射血感染狀態如何,心力衰竭患者都無法從 Farxiga 中受益。

  • Fasenra, Tezspire and Saphnelo continued their strong momentum, delivering combined growth of 48% in the first half. These brands are becoming a larger driver of our overall performance. In the second quarter, these brands made up 46% of our R&I total revenue, up from 36% in the first quarter. Next year, we will add another innovative medicine to our portfolio with the launch of Airsupra in 2024.

    Fasenra、Tezspire 和 Saphnelo 繼續保持強勁勢頭,上半年綜合增長 48%。這些品牌正在成為我們整體業績的更大推動力。第二季度,這些品牌占我們研發總收入的 46%,高於第一季度的 36%。明年,我們將在 2024 年推出 Airsupra,為我們的產品組合增添另一種創新藥物。

  • In the second quarter, Fasenra grew 16% to $406 million, driven by strong demand in the U.S. and Europe as well as some favorable inventory movements in the quarter. We recently filed Fasenra for its first approval in China following positive high-level results from the MIRACLE trial.

    在美國和歐洲的強勁需求以及本季度一些有利的庫存變動的推動下,Fasenra 第二季度增長了 16%,達到 4.06 億美元。繼 MIRACLE 試驗取得積極的高水平結果後,我們最近在中國申請了 Fasenra 的首次批准。

  • Tezspire delivered $81 million in total revenue in the second quarter, up from just $13 million last year. When we look at the combined global sales for AstraZeneca and our partner, Amgen, Tezspire reached $257 million in the half, an impressive achievement in only 1 year since launch. Tezspire is now available in 11 markets and has enjoyed notable early success in the U.S., Japan and Germany, with more European launches to come later this year.

    Tezspire 第二季度總收入為 8100 萬美元,而去年僅為 1300 萬美元。當我們看看阿斯利康和我們的合作夥伴安進的全球合併銷售額時,Tezspire 在上半年就達到了 2.57 億美元,這是自推出以來僅一年內取得的令人印象深刻的成就。 Tezspire 現已在 11 個市場上市,並在美國、日本和德國取得了顯著的早期成功,今年晚些時候還將在歐洲推出更多產品。

  • Silico total revenue in the second quarter remained stable. However, we still anticipate the entry of generic competition in the United States in the back half of the year. In V&I, we saw the first product sales for Beyfortus, which is now approved in the United States following a unanimous vote by the FDA Antimicrobial Drugs Advisory Committee supporting Beyfortus benefit risk profile.

    Silico第二季度總營收保持穩定。然而,我們仍然預計下半年仿製藥競爭將進入美國。在 V&I 中,我們看到了 Beyfortus 的首次產品銷售,在 FDA 抗菌藥物諮詢委員會一致投票支持 Beyfortus 的效益風險概況後,該產品現已在美國獲得批准。

  • AstraZeneca manufactures Beyfortus and then supplies product to Sanofi for distribution, and we record our sales to Sanofi as product sales. We also booked Alliance revenue on Sanofi's Beyfortus sales outside the U.S., where we share profits with Sanofi. We're looking to make Beyfortus available to protect infants in the U.S. and Europe ahead of the 2023 RSV season.

    阿斯利康生產 Beyfortus,然後將產品供應給賽諾菲進行分銷,我們將向賽諾菲的銷售額記錄為產品銷售額。我們還記錄了賽諾菲 Beyfortus 在美國境外銷售的聯盟收入,我們與賽諾菲分享利潤。我們希望在 2023 年 RSV 季節到來之前,讓 Beyfortus 能夠保護美國和歐洲的嬰兒。

  • Next, please. The continued growth of Farxiga is a result of a decade long development plan to broaden its use from diabetes to chronic kidney disease and heart failure patients. Our pioneering research has led to Farxiga becoming the leading medicine in its class, bringing its mortality benefits to millions of patients globally.

    下一位。 Farxiga 的持續增長是長達十年的開發計劃的結果,該計劃將其用途從糖尿病擴大到慢性腎病和心力衰竭患者。我們的開創性研究使 Farxiga 成為同類藥物中的領先藥物,為全球數百萬患者帶來了死亡益處。

  • We see further opportunities to come for the Dato molecule and other combination therapies, giving us the potential to address additional unmet needs among cardiorenal patients and other indications. Our Farxiga combinations remain on track with plans for Phase III decisions later this year.

    我們看到了 Dato 分子和其他聯合療法的更多機會,使我們有可能解決心腎患者和其他適應症中其他未滿足的需求。我們的 Farxiga 組合仍按計劃在今年晚些時候進行第三階段決策。

  • With that, please advance to the next slide, and I wind over to Mene.

    接下來,請前進到下一張幻燈片,然後我轉到梅內。

  • Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board

    Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board

  • Thanks, Ruud. This slide and -- we are on the right slide. This slide outlines our participation at recent medical congresses where we showcased data for tozorakimab, our anti-IL33 monoclonal antibody. We also highlighted the importance of real-world data and patient outcomes across R&I and CVRM.

    謝謝,路德。這張幻燈片——我們在右邊的幻燈片上。這張幻燈片概述了我們參加最近的醫學大會,在會上我們展示了我們的抗 IL33 單克隆抗體 tozorakimab 的數據。我們還強調了 R&I 和 CVRM 中真實世界數據和患者結果的重要性。

  • Firstly, the American Thoracic Society Congress, lung tissue samples taken from patients with COVID-19 were stained and analyzed. And the images I'm showing, here show localization of higher levels of IL-33 in the airway tissues providing further scientific rationale for targeting IL-33 in severe viral infections in our Phase III TILIA trial.

    首先,美國胸科學會大會對從COVID-19患者身上採集的肺組織樣本進行了染色和分析。我在這裡展示的圖像顯示了氣道組織中較高水平的 IL-33 的定位,為我們的 III 期 TILIA 試驗中針對嚴重病毒感染的 IL-33 提供了進一步的科學依據。

  • Also at ATS, real-world data highlighted the importance of prompt intervention with Breztri, initiating treatment within 30 days following a moderate or severe COPD exacerbation decrease the risk of future exacerbations by 24% versus delaying treatment by 6 months, and by 34% versus the delaying treatment 6 months to 1 year.

    ATS 的真實數據也強調了立即使用 Breztri 進行干預的重要性,即在中度或重度 COPD 惡化後 30 天內開始治療,與推遲治療 6 個月相比,未來病情惡化的風險降低了 24%,與延遲治療相比,未來病情惡化的風險降低了 34%。推遲治療6個月至1年。

  • At the European Renal Association, we presented real-world evidence underscoring the importance of early diagnosis of CKD. Multinational study, REVEAL-CKD, demonstrated that 85% to 95% of Stage 3 CKD remains undiagnosed. Data also showed that delaying diagnosis by just 1 year, resulted in an increased risk of deterioration, kidney transplant or long-term dialysis treatment.

    在歐洲腎臟協會,我們提出了現實世界的證據,強調了早期診斷 CKD 的重要性。跨國研究 REVEAL-CKD 表明,85% 至 95% 的 3 期 CKD 仍未確診。數據還顯示,僅僅延遲診斷一年就會導致病情惡化、腎移植或長期透析治療的風險增加。

  • The ZORA study supported continued concomitant use of potassium binders in RAASi patients who experience hyperkalemia. In response, we've already seen updates to a number of CKD and heart failure treatment guidelines.

    ZORA 研究支持對患有高鉀血症的 RAASi 患者繼續同時使用鉀結合劑。作為回應,我們已經看到了許多 CKD 和心力衰竭治療指南的更新。

  • Please advance to the next slide. I wanted to also take the opportunity to highlight the broad modalities and technologies we now have in our armory. Over the past decade, we have built these capabilities to provide our scientists with access to the most relevant biological pathways and targets. And as you can see, these are starting to mature and gain momentum.

    請前進到下一張幻燈片。我還想藉此機會強調我們現在擁有的廣泛模式和技術。在過去的十年中,我們建立了這些能力,為我們的科學家提供最相關的生物途徑和目標。正如您所看到的,這些正在開始成熟並獲得動力。

  • We have a portfolio of antisense oligonucleotides across amyloidosis, NASH and CKD in clinical development. These are precision medicine approaches that target the underlying biology of the disease in specific patient subpopulations.

    我們擁有一系列處於臨床開發階段的反義寡核苷酸產品組合,涵蓋澱粉樣變性、NASH 和 CKD。這些是針對特定患者亞群疾病的基礎生物學的精準醫學方法。

  • For example, our PNPLA3 AZD2693 dosed in Phase IIb in NASH this quarter, following promising Phase I data, which showed a steatosis reduction and positive gene knockdown at 12 weeks.

    例如,我們的 PNPLA3 AZD2693 在本季度在 NASH 的 IIb 期中給藥,此前 I 期數據顯示出良好的前景,該數據顯示 12 週時脂肪變性減少和陽性基因敲除。

  • In advanced biologics, AZD8630 is a human anti-TSLP fragment antibody formulated for inhaled dry powder delivery. AZD8630 is currently in Phase I in patients with poorly controlled asthma with data expected later this year. Also later this year, we're expecting dates from our NGF/TNA (sic) [(NGF/TNF] bispecific monoclonal antibody currently in Phase II for the treatment of OA pain and neuropathic pain.

    在先進的生物製劑中,AZD8630 是一種人抗 TSLP 片段抗體,專為吸入乾粉輸送而配製。 AZD8630 目前正處於哮喘控制不佳患者的 I 期臨床試驗中,預計將於今年晚些時候獲得數據。同樣在今年晚些時候,我們預計 NGF/TNA(原文如此)[(NGF/TNF] 雙特異性單克隆抗體目前處於 II 期,用於治療 OA 疼痛和神經性疼痛。

  • In autoimmune disease, we recently announced a collaboration with Quell Therapeutics to develop engineered Treg-based cell therapies for autoimmune combined with our own expertise in this space, we can accelerate the development of this novel therapeutic approach with the potential to be curative in Type-1 diabetes and in inflammatory bowel disease.

    在自身免疫性疾病方面,我們最近宣布與 Quell Therapeutics 合作,開發基於 Treg 的工程化自身免疫細胞療法,結合我們在該領域的專業知識,我們可以加速這種新型治療方法的開發,並有可能在類型- 1 糖尿病和炎症性腸病。

  • With the acquisition of Alexion, our gene therapy ambitions have also accelerated significantly, utilizing our proprietary CRISPR gene editing platform to address challenging rare diseases where together building an approach, we hope we will offer better safety margins.

    隨著收購 Alexion,我們的基因治療目標也顯著加快,利用我們專有的 CRISPR 基因編輯平台來解決具有挑戰性的罕見疾病,我們希望共同構建一種方法,提供更好的安全裕度。

  • We're also working with Alexion teams to optimize the therapeutic window through the use of novel tissue-directed capsids and tissue-specific promoters. The possibility of curative treatment for rare genetic disease becomes achievable when combined with the Alexion rare disease expertise.

    我們還與 Alexion 團隊合作,通過使用新型組織定向衣殼和組織特異性啟動子來優化治療窗口。當與 Alexion 罕見病專業知識相結合時,罕見遺傳病的治愈性治療成為可能。

  • With that, I'll now hand over to Marc, who will cover the Rare Disease genome strategy in more detail, along with rare disease highlights in the period. Please advance to the next slide.

    現在,我將把任務交給 Marc,他將更詳細地介紹罕見疾病基因組策略,以及該時期的罕見疾病亮點。請前進到下一張幻燈片。

  • Marc Dunoyer - CEO of Alexion & Chief Strategy Officer

    Marc Dunoyer - CEO of Alexion & Chief Strategy Officer

  • Thank you, Mene. Can I see the next slide. In the first half, Rare Disease total revenue grew 12%, contributing $3.8 billion. Growth in the period was driven by increased demand and benefited from timing of tender market orders, slightly offset by the onetime pricing adjustment in the international region recognized in the second quarter of last year.

    謝謝你,梅內。我可以看下一張幻燈片嗎?上半年,罕見疾病總收入增長12%,貢獻38億美元。這一時期的增長是由需求增加推動的,並受益於招標市場訂單的時機,但被去年第二季度確認的國際地區的一次性定價調整所略微抵消。

  • Across the portfolio, our global patient numbers continue to grow. And notably, this is the first quarter Ultomiris patients exceeded those of Soliris. Ultomiris grew 60% in the second quarter driven by continued naive patient growth in generalized myasthenia gravis, new market launches and successful conversion from Soliris across the shared indications. As a consequence of this dynamic, Soliris declined 19%.

    在整個產品組合中,我們的全球患者數量持續增長。值得注意的是,這是 Ultomiris 患者數量首次超過 Soliris 患者數量。 Ultomiris 在第二季度增長了 60%,這得益於全身性重症肌無力患者的持續增長、新市場的推出以及 Soliris 在共享適應症上的成功轉換。由於這種動態,Soliris 下降了 19%。

  • So I'm excited by our performance. As I mentioned in the first quarter, we expect some headwinds in the second half of the year. These include pricing pressure related to renegotiations as Ultomiris launches in large neurological indications and potential for Soliris biosimilar entry in Europe.

    所以我對我們的表現感到興奮。正如我在第一季度提到的,我們預計下半年會出現一些阻力。其中包括隨著 Ultomiris 在大型神經系統適應症中推出而與重新談判相關的定價壓力以及 Soliris 生物仿製藥進入歐洲的潛力。

  • Also, as a reminder, we benefited from tender market order timing in the second half of last year. Timing of these orders are variable throughout the course of the year, impacting growth versus prior periods. Beyond C5 both Strensiq and Koselugo grew 25% and 30%, respectively, reflecting underlying patient demand and expansion into new markets.

    另外,提醒一下,我們受益於去年下半年的招標市場訂單時機。這些訂單的時間在一年中各不相同,影響了與之前時期相比的增長。除了 C5 之外,Strensiq 和 Koselugo 分別增長了 25% 和 30%,反映了潛在的患者需求和新市場的擴張。

  • Please advance to the next slide. During the quarter, ALXN2220 Phase I data were presented at the European Society of Cardiology in patients with transthyretin amyloid cardiomyopathy. As a reminder, ATTR-CM is a progressive and fatal disease caused by misfolding transthyretin depositing in heart tissue. The safety and pharmacokinetic profiles of ALXN2220 were assessed and cardiac imaging studies were performed.

    請前進到下一張幻燈片。本季度,歐洲心髒病學會公佈了 ALXN2220 在轉甲狀腺素蛋白澱粉樣心肌病患者中的 I 期數據。提醒一下,ATTR-CM 是一種進行性致命疾病,由沉積在心臟組織中的甲狀腺素運載蛋白錯誤折疊引起。評估了 ALXN2220 的安全性和藥代動力學特徵,並進行了心臟成像研究。

  • As shown, the images detailed remarkable reduction in cardiac amyloid deposition over 4 and 12 months. The observations were supported by change in level of cardiac biomarkers as well as functional measures. ALXN2220 is the first and only medicine to clear amyloid deposition, and it has the potential to reverse the course of disease both as a complementary therapy with other modalities, but also as a monotherapy.

    如圖所示,圖像詳細顯示了 4 個月和 12 個月內心臟澱粉樣蛋白沉積的顯著減少。這些觀察結果得到了心臟生物標誌物水平變化以及功能測量的支持。 ALXN2220是第一個也是唯一一個清除澱粉樣蛋白沉積的藥物,它有可能逆轉病程,既可以作為其他療法的補充療法,也可以作為單一療法。

  • We are excited by this Phase Ib data, and as previously shared, we plan to initiate a Phase III trial later this year. Across AstraZeneca and Alexion, we are looking to transform the care of prostrate amyloidosis through multiple therapy modalities. Our broader amyloidosis portfolio includes Silencer eplontersen and Stabiliser, acoramidis, which we have rights in Japan.

    我們對這一 Ib 期數據感到興奮,正如之前分享的那樣,我們計劃在今年晚些時候啟動 III 期試驗。在阿斯利康和亞力兄,我們希望通過多種治療方式來改變前列腺澱粉樣變性的治療。我們更廣泛的澱粉樣變產品組合包括 Silencer eplontersen 和穩定劑 acoramidis,我們在日本擁有這些產品的權利。

  • Recently, we saw positive 30 months Phase III data for acoramidis. We've demonstrated a 50% relative risk reduction in cardiovascular-related hospitalization, building confidence in the meeting ability to stabilize disease progression. Eplontersen met its primary endpoint in hereditary transthyretin amyloid polyneuropathy, and we have ongoing fast trials in LCM. We believe this portfolio of medicine this differentiating mechanism of action, will address the full spectrum of disease severity.

    最近,我們看到了 acoramidis 的 30 個月 III 期積極數據。我們已經證明,心血管相關住院治療的相對風險降低了 50%,增強了人們對會議穩定疾病進展能力的信心。 Eplontersen 在遺傳性轉甲狀腺素蛋白澱粉樣多發性神經病中達到了主要終點,我們正在進行 LCM 的快速試驗。我們相信,這種藥物組合和這種差異化的作用機制將解決所有疾病的嚴重程度。

  • Next slide, please. As you may have seen, we have done a series of small to medium-sized business development deals, expanding our technologies and platform in research. I wanted to take the opportunity to highlight some of these and affirm our long-term ambition to be an industry leader in genomic medicine.

    請下一張幻燈片。正如您可能已經看到的,我們已經完成了一系列中小型企業發展交易,擴展了我們的技術和研究平台。我想藉此機會強調其中的一些內容,並確認我們成為基因組醫學行業領導者的長期雄心。

  • Approximately 80% of rare diseases are genetic driven by inherited or acquired gene mutations. By leveraging AstraZeneca technologies in non-viral delivery systems and nucleases, such as CRISPR, LogicBio, GeneRide and sAAVy platforms, this year, (inaudible) cargo for delivery to the central system or CNS as well as our own operated platforms, we aim to address a number of genetic diseases across liver, kidney, heart and muscle and CNS.

    大約 80% 的罕見疾病是由遺傳或獲得性基因突變引起的。通過利用阿斯利康在非病毒遞送系統和核酸酶方面的技術,例如 CRISPR、LogicBio、GeneRide 和 sAAVy 平台,今年,(聽不清)貨物將運送到中央系統或 CNS 以及我們自己運營的平台,我們的目標是解決肝臟、腎臟、心臟、肌肉和中樞神經系統的多種遺傳疾病。

  • The agreement announced this morning to acquire a portfolio of gene therapy program for Rare Disease from Pfizer, accelerate our time frame to bring this potentially transformative and curative treatment to patients. We look forward to welcoming Pfizer employees who have been driving this program forward, increasing our gene therapy team to over 80 specialists.

    該協議於今天上午宣布,將從輝瑞收購罕見病基因治療項目組合,加快我們為患者帶來這種潛在變革性和治愈性治療的時間框架。我們期待著歡迎輝瑞員工,他們一直在推動這一項目的發展,使我們的基因治療團隊增加到 80 多名專家。

  • Together with all my colleagues at Alexion, we are excited to continue our work developing enhanced platform and technologies, leveraging the expertise across a larger group to deliver life-changing medicines to patients, where there are limited or no long-term treatment option.

    我們很高興能與 Alexion 的所有同事一起繼續開發增強的平台和技術,利用更大團隊的專業知識,為長期治療選擇有限或沒有長期治療選擇的患者提供改變生活的藥物。

  • And with that, please advance to the next slide, and I will hand over the call to Pascal for closing remarks.

    接下來,請前進到下一張幻燈片,我將把會議轉交給帕斯卡進行結束語。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Thank you, Marc. Next slide, please. Before I make my concluding remarks, I would like to take a minute to recognize the important steps we are taking to tackle the climate crisis, in particular, our Ambition Zero Carbon program is on track, and we have made significant steps towards achieving our science-based targets.

    謝謝你,馬克。請下一張幻燈片。在我做總結髮言之前,我想花一點時間來認識一下我們正在採取的應對氣候危機的重要步驟,特別是我們的零碳雄心計劃正在步入正軌,並且我們已經在實現我們的科學目標方面邁出了重要的一步基於目標。

  • Firstly, we announced our partnership with Vanguard Renewables allowing us to deliver renewable natural gas, a source of clean heat to all our U.S. sites, manufacturing and R&D sites by the end of 2026. We also significantly expanded our AZ Forest program with a commitment of $400 million to plant and maintain 200 million trees across 6 continents by 2030.

    首先,我們宣布與 Vanguard Renewables 建立合作夥伴關係,使我們能夠在 2026 年底之前向我們所有的美國工廠、製造和研發工廠提供可再生天然氣,這是一種清潔熱源。我們還大幅擴展了我們的 AZ 森林計劃,並承諾到 2030 年,將投入 4 億美元在六大洲種植和維護 2 億棵樹。

  • The expanded program with sequester carbon supported by diversity and deliver benefits to local communities positively impacting an estimated 80,000 livelihoods. Lastly, our Transition Plan is verified by the science-based initiative, which focuses on deep decarbonization, allowing for only 10% residual emissions removals by 2045.

    擴大後的計劃通過多樣性支持固碳,為當地社區帶來好處,對大約 80,000 人的生計產生了積極影響。最後,我們的過渡計劃得到了基於科學的舉措的驗證,該計劃的重點是深度脫碳,到 2045 年僅允許清除 10% 的殘餘排放量。

  • Scope 3 remains to be our largest challenge, and we are committed to partnering with our suppliers. Last week, private sector members of the SMI Health Systems task force, which I convened, sent an open letter calling on supplier to commit to join minimum climate and sustainability targets that contribute to decarbonizing the health care value chain.

    範圍 3 仍然是我們最大的挑戰,我們致力於與供應商合作。上週,我召集的 SMI 衛生系統工作組的私營部門成員發出了一封公開信,呼籲供應商承諾加入有助於醫療保健價值鏈脫碳的最低氣候和可持續發展目標。

  • We're playing a leading role in this space, doing our part to limit the impact on climate change while unlocking opportunities to deliver more sustainable health care system.

    我們在這一領域發揮著主導作用,儘自己的一份力量限制對氣候變化的影響,同時釋放機會以提供更可持續的醫療保健系統。

  • Please move to the next slide. We have an exciting second half of the year ahead with a number of important pivotal trial readouts, including 2 trials in breast cancer, TROPION-Breast01 and CAPItello-290. 2 trials -- we also have 2 trials of Imfinzi and non-small cell lung cancer in HCC.

    請移至下一張幻燈片。我們將迎來令人興奮的下半年,我們將公佈多項重要的關鍵試驗數據,其中包括 2 項乳腺癌試驗:TROPION-Breast01 和 CAPtello-290。 2 項試驗——我們還有 2 項 Imfinzi 和非小細胞肺癌治療 HCC 的試驗。

  • We have a trial with Fasenra in EGP as well as the first results of our next-generation COVID-19 antibody AZD3152. We also have a rich catalyst pass in 2024, which given current even production rates will now include DESTINY-Breast03 and CTx FLAURA results from both of which we are now -- which both of which are now expected in the first half of 2024.

    我們在 EGP 中進行了 Fasenra 試驗,以及我們的下一代 COVID-19 抗體 AZD3152 的初步結果。我們在 2024 年還有豐富的催化劑通過,考慮到目前的均勻生產率,現在將包括我們現在的 DESTINY-Breast03 和 CTx FLAURA 結果 - 現在預計這兩個結果將在 2024 年上半年實現。

  • The progress that we are making in our pipeline overall is inspiring, and I'm excited for when we have the opportunity to share data -- to share the full data from the many studies we have showcased during this call -- at upcoming medical congresses.

    總體而言,我們在管道中取得的進展是鼓舞人心的,當我們有機會在即將召開的醫學大會上分享數據時(分享我們在本次電話會議中展示的許多研究的完整數據),我感到很興奮。

  • Now please advance to the next slide. Finally, before we turn to Q&A. Earlier today, we announced that Mene Pangalos will retire after almost 14 years with the company and a great 35-year career. Mene will be succeeded by Sharon Barr, currently Head of Research and Product Development at Alexion. And Alexion joined AstraZeneca 2 years ago, a key priority was ensuring that our shared organization would benefit from the world-class talent as Alexion brings.

    現在請前進到下一張幻燈片。最後,在我們進行問答之前。今天早些時候,我們宣布 Mene Pangalos 將在公司工作了近 14 年並擁有 35 年的偉大職業生涯後退休。 Mene 將由 Sharon Barr 接任,她現任 Alexion 研究和產品開發主管。 Alexion 於兩年前加入阿斯利康,首要任務是確保我們共同的組織能夠從 Alexion 帶來的世界級人才中受益。

  • From day 1 Sharon stood as an exceptional scientific leader. Sharon brings tremendous experience that we prove essential to advancing a pharmaceutical pipeline, along with a strong track record for driving productivity and fostering innovation. This experience coupled with our leadership style and passion for developing people, places how perfectly to take over the reins from Mene and help us to write the next chapter of success.

    從第一天起,沙龍就是一位傑出的科學領袖。莎倫帶來了豐富的經驗,我們證明這些經驗對於推進製藥管道至關重要,並且在提高生產力和促進創新方面擁有良好的記錄。這段經歷加上我們的領導風格和對人才培養的熱情,使我們能夠完美地接替梅內的領導權,並幫助我們譜寫成功的下一個篇章。

  • Over the coming months, Mene and Sharon will complete an extensive handover, supporting a smooth transition of responsibility and ensuring there are no delays to the advancements of projects.

    在接下來的幾個月中,梅內和沙龍將完成廣泛的交接,支持職責的順利過渡,並確保項目的進展不會受到延誤。

  • Which brings me to Mene, someone who's always quick to praise others, but must take credit himself for all he has done to transform how we approach R&D, delivering a greater than fivefold improvement in productivity, driving deeper collaborations with academic, biotech and peer organizations, pioneering programs to promote open innovation and championing the use of new technologies and modalities.

    這讓我想到了梅內,他總是很快地讚揚別人,但他自己必須為自己為改變我們的研發方式所做的一切負責,將生產力提高五倍以上,推動與學術、生物技術和同行組織的更深入合作,促進開放式創新並倡導使用新技術和模式的開創性計劃。

  • And last but not least, leading our contribution to the U.K. life sciences sector and in particular, building a very important presence in Cambridge in the U.K. Mene, thank you for your contribution to our company, and I wish you only the best in your retirement.

    最後但並非最不重要的一點是,領導我們對英國生命科學領域的貢獻,特別是在英國梅內劍橋建立非常重要的影響力,感謝您對我們公司的貢獻,祝您退休後一切順利。

  • Personally, I will miss your wonderful sense of humor and your intellectual with. But the quality of the medicines you brought to patients and the pipeline and capabilities you've built will be your legacy for many years to come.

    就我個人而言,我會懷念你美妙的幽默感和你的知識分子。但您為患者提供的藥品質量以及您所建立的管道和能力將成為您未來許多年的遺產。

  • With that, I will hand the call back to Andy for our Q&A session.

    這樣,我會將電話轉回給安迪,以進行我們的問答環節。

  • Andrew P. Barnett - Head of IR

    Andrew P. Barnett - Head of IR

  • We will now go to the Q&A with all of our executive members participating shown here. (Operator Instructions) And with that, we'll move to the first question.

    我們現在將進入問答環節,所有執行成員都參與其中。 (操作員說明)接下來,我們將討論第一個問題。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Sachin Jain, Bank of America.

    薩欽·賈恩 (Sachin Jain),美國銀行。

  • Sachin Jain - MD & Research Analyst

    Sachin Jain - MD & Research Analyst

  • Sachin Jain from Bank of America. Two topics. Firstly, Dato in first-line lung, if I may. So part of the reaction to TROP Lung01 was investor fading confidence in first-line on both efficacy and safety. So I wonder if you could touch on that.

    美國銀行的薩欽·賈恩 (Sachin Jain)。兩個話題。首先,請允許我介紹一下肺一線的拿督。因此,投資者對 TROP Lung01 的部分反應是對一線藥物的功效和安全性信心減弱。所以我想知道你是否可以談談這一點。

  • Could you remind us how you interpret the 8 months of PFS we saw from TL02 at ASCO just the competitor [KEYNOTE-189] 9 months. And as Susan, you could frame expectations of what our focus should be into TL04 that you flagged at World Lung?

    您能否提醒我們您如何解釋我們在 ASCO 的 TL02 中看到的 8 個月的 PFS,而競爭對手 [KEYNOTE-189] 9 個月。作為 Susan,您可以對我們在 World Lung 上標記的 TL04 的重點應該放在哪裡提出期望嗎?

  • And then the second question is on breast cancer, a lot of news flow in breast cancer in the next 12 months. We've been particularly vocal. I wonder if you could just touch on 2 reads. Firstly, TB01, which you talked about, but the potential for that to be better than TROPiCS, 02 you noted the 8-month PFS. Are you confident that can repeat and better the trade by 5.5 months?

    第二個問題是關於乳腺癌的,未來 12 個月將會有很多關於乳腺癌的新聞。我們特別發聲。我想知道你是否可以只談兩篇讀物。首先是 TB01,您談到了它,但它有可能比 TROPiCS 更好,您注意到 02 的 8 個月 PFS。您有信心能夠重複並改善 5.5 個月的交易嗎?

  • And then secondly, you didn't mention DB09, but you pulled that forward into '24. So again, just talk to the confidence you've got there? Prior data suggest potential for double the PFS comparator receptive data?

    其次,你沒有提到 DB09,但你把它提前到了 24 年。再說一遍,談談你的信心?先前的數據表明 PFS 比較器接受數據有可能翻倍嗎?

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Thanks, Sachin. So easy question for you, Susan?

    謝謝,薩欽。蘇珊,這個問題對你來說很簡單嗎?

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • Thanks for the question, Sachin. So let's start with data in first-line lung.

    謝謝你的提問,薩欽。讓我們從一線肺部的數據開始。

  • First of all, I would say that given the TLO1 is a positive study, there were things that we can learn from that. The first-line lung studies are ongoing. We've obviously got TROPION-Lung07, 08 and AVANZAR, which are complementary trials in first-line and predominantly in patients without genomic alterations versus the respective standard of care.

    首先,我想說,鑑於 TLO1 是一項積極的研究,我們可以從中學到一些東西。一線肺部研究正在進行中。顯然,我們已經有了 TROPION-Lung07、08 和 AVANZAR,它們是一線的補充試驗,主要針對沒有基因組改變的患者,而不是各自的護理標準。

  • AVANZAR is investigating patients regardless of PD-L1 status of gene histology. So they're complementary segments of first-line lung. What I would say is that we've now treated across all of these studies, together with TLO2 and TLO4 over 200 patients on the Dato-DXd plus immune checkpoint inhibitor combination. And we're comfortable with the safety profile that we've seen across that patient population.

    AVANZAR 正在對患者進行研究,無論 PD-L1 基因組織學狀態如何。所以它們是一線肺的互補部分。我想說的是,我們現在已經在所有這些研究中,連同 TLO2 和 TLO4 一起,使用 Dato-DXd 加免疫檢查點抑製劑組合治療了 200 多名患者。我們對在該患者群體中看到的安全狀況感到滿意。

  • So I think it's important to just remember that from an ILD perspective. We know that some tumor types have a higher risk of ILD than others and that later line patients, you've had multiple prior lines of chemotherapy at high risk of ILD. And so I think it's important that, that ongoing safety profile that in first-line lung is underpinning our confidence there.

    所以我認為從 ILD 的角度記住這一點很重要。我們知道,某些腫瘤類型比其他腫瘤類型具有更高的間質性肺病風險,並且對於後期接受過多種化療的患者來說,發生間質性肺病的風險很高。因此,我認為重要的是,一線肺部持續的安全狀況支撐著我們的信心。

  • When you look at TROPION-Lung02 data that you highlighted, we're encouraged both by the response rate and the durability of response that we've seen from TROPION-Lung02 for both the combination with the doublet of Dato-DXd plus pembro and also the triplet when platinum-based chemotherapy is added.

    當您查看您強調的 TROPION-Lung02 數據時,我們對 TROPION-Lung02 與 Dato-DXd 加 pembro 的雙聯體組合的響應率和響應持久性感到鼓舞。添加鉑類化療時的三聯體。

  • What you'll see in TROPION-Lung04 that's a Phase Ib study that also looks at the combination of Dato plus immune checkpoint inhibition in cancer, it's an additional data set to TROPION-Lung02. And again, we're happy to talk to you after the data we presented at a World Congress on lung cancer.

    您將在 TROPION-Lung04 中看到一項 Ib 期研究,該研究還著眼於癌症中 Dato 與免疫檢查點抑制的組合,它是 TROPION-Lung02 的附加數據集。再次,我們很高興在世界肺癌大會上公佈數據後與您交談。

  • For breast cancer, you asked 2 questions. One is about TROPION-Breast01. Again, the confidence in TROPION-Breast01 is based on the data that we've seen that you've already highlighted, and you've already mentioned. I mean I'll just say that for the design of Dato-DXd, we think is a best-in-class ADC. It's got an excellent stable linker and a proven roll head already.

    對於乳腺癌,您問了 2 個問題。其中之一是關於 TROPION-Breast01。同樣,對 TROPION-Breast01 的信心是基於我們所看到的您已經強調和提到的數據。我的意思是,我只想說,對於 Dato-DXd 的設計,我們認為它是一流的 ADC。它已經具有出色的穩定連接器和經過驗證的滾頭。

  • And so when we look across cross-trial comparisons with all the caveats those have, we've seen numerically higher response rates across a number of different settings. And that really underpins our potential to have better efficacy and have a best-in-class profile in that setting. But obviously, we have to wait for the actual readout of the trial.

    因此,當我們對交叉試驗與所有註意事項進行比較時,我們發現在許多不同的環境中,響應率在數字上更高。這確實支撐了我們在該環境中獲得更好功效並擁有一流形象的潛力。但顯然,我們必須等待審判的實際結果。

  • For DESTINY-Breast09, I think actually, the readout time is not, it's hugely shifted here. Obviously, all of the -- and HER2 trials are accruing rapidly and that helps with the time lines, but these are also event-driven trials that we look for the outcome. So I don't think there's anything more than that to insert in the shift in the timeline. I hope that addresses all your questions.

    對於DESTINY-Breast09,我認為實際上,讀出時間不是,它在這裡發生了巨大的變化。顯然,所有 HER2 試驗都在迅速進行,這有助於縮短時間,但這些也是我們尋找結果的事件驅動試驗。所以我認為沒有什麼比這更需要在時間軸的轉變中插入的了。我希望這能解決您的所有問題。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Thanks, Susan. Tim Anderson. Go ahead, Tim.

    謝謝,蘇珊。蒂姆·安德森.繼續吧,蒂姆。

  • Unidentified Analyst

    Unidentified Analyst

  • So just sitting on the top Dato-DXd in the light of wood TROPION-Lung01 is shown. I know you guys say you're enthusiastic about the program. Is your enthusiasm less or tempered at all by how TLO1 readout because the benefit -- I mean, you guys pretty much said is modest. So I'm wondering if that those kind of temporary expectations for that program overall, and what that could deliver in other tumor types or even other settings for lung cancer?

    因此,只需坐在 Dato-DXd 頂部,在木頭燈光下即可顯示 TROPION-Lung01。我知道你們說你們對這個計劃充滿熱情。你的熱情是否因 TLO1 讀數的方式而減弱或減弱,因為好處 - 我的意思是,你們幾乎說是適度的。所以我想知道是否對整個計劃有這種暫時的期望,以及在其他腫瘤類型甚至其他肺癌環境中可以帶來什麼?

  • And then a second question, where are you with the retrospective biomarker analysis of TLL1. Is there anything you can say yet within results by TROP2 expression levels?

    然後是第二個問題,TLL1 的回顧性生物標誌物分析進展如何?對於 TROP2 表達水平的結果,您還有什麼可以說的嗎?

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • Okay. Thank you, Tim. So let me just reiterate that we're confident in the data that we've seen for TROPION-Lung01. As we've shared already, we've had initial conversations with the FDA, which have been encouraging, and we're moving to file.

    好的。謝謝你,蒂姆。因此,讓我重申一下,我們對 TROPION-Lung01 所看到的數據充滿信心。正如我們已經分享的,我們已經與 FDA 進行了初步對話,這是令人鼓舞的,我們正在提交文件。

  • So we're looking forward to sharing the full data, which I think will be helpful for everybody at an upcoming conference. And that will obviously provide a more complete picture.

    因此,我們期待分享完整的數據,我認為這將對即將舉行的會議上的每個人都有幫助。這顯然會提供更完整的情況。

  • We're confident that the data that we've seen really, really enforces that Dato-DXd is going to be an important potential medicine in multiple cancer types, but also including in lung cancer.

    我們相信,我們所看到的數據確實、確實證實了 Dato-DXd 將成為治療多種癌症類型的重要潛在藥物,但也包括肺癌。

  • In terms of the biomarker analysis, work is, as you say, ongoing. And obviously, one important source of data is going to be the TROPION-Lung01 data set. So I look forward to updating you with data once we've had the chance to complete that analysis.

    正如您所說,就生物標誌物分析而言,工作正在進行中。顯然,一個重要的數據來源將是 TROPION-Lung01 數據集。因此,一旦我們有機會完成該分析,我期待向您提供最新數據。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Thanks, Susan. The next question is from Andrew Baum at Citi.

    謝謝,蘇珊。下一個問題來自花旗銀行的安德魯·鮑姆。

  • Andrew Simon Baum - Global Head of Healthcare Research and MD

    Andrew Simon Baum - Global Head of Healthcare Research and MD

  • So couple of questions. One for Susan and one for Marc.

    有幾個問題。一份給蘇珊,一份給馬克。

  • So you filed or you plan to file the TROPION-Lung01 data with the FDA. Can I ask which population presumably, given you've got modest PFS, the OS is a mature one would imagine that the sub-group in the second-line that is persuadable third-line for the FDA. So could you just comment on which indication you are picking, which population is a third-line, second-line histology, I ask knowing the likely response, but I'm interested anyway.

    因此,您已提交或計劃向 F​​DA 提交 TROPION-Lung01 數據。我能否問一下,考慮到您的 PFS 適中,OS 是成熟的,哪些人群可能會想像二線中的亞組可以說服 FDA 作為三線藥物。那麼,您能否評論一下您選擇的適應症,哪些群體是三線、二線組織學,我問知道可能的反應,但無論如何我很感興趣。

  • And then second to Marc in relation your amyloid monoclonal where you share your enthusiasm. When we think about the outcome trial, are you going to mirror that that -- the bridge bio with a serve embedded 6-minute walk as well as an outcome for mortality or modality or do you think you can get it approved solely on 6-minute walk in order to expedite Imfinzi market?

    然後是關於你的澱粉樣蛋白單克隆抗體的第二位,你分享你的熱情。當我們考慮結果試驗時,您是否會反映這一點 - 帶有嵌入 6 分鐘步行服務的橋樑生物以及死亡率或模式的結果,或者您認為您可以僅在 6 分鐘內獲得批准嗎?步行分鐘以加快 Imfinzi 市場?

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Susan, do you want to start?

    蘇珊,你想開始嗎?

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • Yes, sure. Thanks for the question, Andrew. So obviously, in the top line results, we've not specified performance by patient subsets, that's entirely in line with our normal practice. And TLO1 was stratified by the most immediate prior therapy, including anti-PD-L1 and PD-1 immunotherapy, geographical region and histology, squamous versus non-squamous, it includes patients with actionable genomic alterations so that was a later protocol amendment, and it's a minority of the patients that are included. I can't really comment on ongoing dialogue with the FDA at this point.

    是的,當然。謝謝你的提問,安德魯。顯然,在最重要的結果中,我們沒有指定患者子集的表現,這完全符合我們的正常做法。 TLO1 按最近的先前治療進行分層,包括抗 PD-L1 和 PD-1 免疫治療、地理區域和組織學、鱗狀細胞與非鱗狀細胞,它包括具有可操作基因組改變的患者,因此這是後來的方案修訂,並且這只是所包括的患者中的一小部分。目前我無法對與 FDA 正在進行的對話發表評論。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Maybe the one thing that we could add here is that from what we've seen, we think this agent is going to be useful in a large population of lung cancer patients. Marc, do you want to cover the second question?

    也許我們可以在這裡補充的一件事是,從我們所看到的情況來看,我們認為這種藥物將對大量肺癌患者有用。馬克,你想回答第二個問題嗎?

  • Marc Dunoyer - CEO of Alexion & Chief Strategy Officer

    Marc Dunoyer - CEO of Alexion & Chief Strategy Officer

  • Yes. Thank you, Andrew, for your interest in 2220. So we are planning this Phase III, and we are in ongoing discussion with the FDA to confirm the protocol. You ask a very precise question on whether we were going to include the 6-minute walking test in our endpoints. And the answer is no. We are probably going to finalize the endpoints on mortality and cardiovascular morbidity, possibly with the addition of the third-tier endpoint, but it won't include 6-minute walking distance.

    是的。感謝 Andrew 對 2220 的興趣。因此,我們正在計劃第三階段,並且我們正在與 FDA 進行持續討論以確認該方案。您提出了一個非常精確的問題,即我們是否要將 6 分鐘步行測試納入我們的終點。答案是否定的。我們可能會最終確定死亡率和心血管發病率的終點,可能會增加第三級終點,但不會包括 6 分鐘步行距離。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Mark Purcell, Morgan Stanley.

    馬克·珀塞爾,摩根士丹利。

  • Mark Douglas Purcell - Equity Analyst

    Mark Douglas Purcell - Equity Analyst

  • A couple of questions. Firstly, on Calquence and one for Dave. Dave, could you help us understand the sales split for Calquence and for the BTK market in CLL between first-line and second-line to refractory patients? And if you can help us on the second-line side to understand the sort of share dynamics there that could be really useful.

    有幾個問題。首先是卡爾昆斯,還有戴夫。 Dave,您能否幫助我們了解 Calquence 和 BTK 市場在 CLL 一線和二線難治性患者之間的銷售分配情況?如果您能幫助我們在二線方面了解那裡的股票動態,那可能會非常有用。

  • Secondly, on the TROPION-Breast01 market opportunity, obviously, a large number of patients, I guess, in the -- just the third line setting or maybe 5,000 patients in the G8. Could you help us understand how these fits within HER2 and the HER2 low setting as well? So trying to think about the market opportunity before you get the data themselves.

    其次,關於 TROPION-Breast01 的市場機會,我猜顯然有大量患者處於第三線環境,或者可能有 5,000 名 G8 患者。您能否幫助我們了解這些如何適合 HER2 以及 HER2 低設置?因此,在獲取數據本身之前,請嘗試考慮市場機會。

  • And then lastly, for Susan, just to follow-on towards the TROP2 testing questions. Can you help us understand going forward, the importance of TROP2 testing for TROP2 ADCs? And from a regulatory standpoint, the acceptance of retrospective data on TROP2 expression and the potential to incorporate TROP2 testing into trials, which have recently started such as TL07 and TL08?

    最後,Susan 繼續討論 TROP2 測試問題。您能否幫助我們了解 TROP2 測試對於 TROP2 ADC 的重要性?從監管的角度來看,是否接受 TROP2 表達的回顧性數據以及將 TROP2 測試納入最近開始的試驗(例如 TL07 和 TL08)的可能性?

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Dave, you want to?

    戴夫,你願意嗎?

  • David Fredrickson - Executive Vice-President of Oncology Business Unit

    David Fredrickson - Executive Vice-President of Oncology Business Unit

  • Thank you, Mark for the question. So starting first with your Calquence question. In terms of just the overall new patient starts within the BTKi class, we see about half of new patient starts of total BTKi starts are happening in CLL in the front-line. And then you have about half of those starts that are happening in the relapsed/refractory setting.

    謝謝馬克提出的問題。首先從你的 Calquence 問題開始。就 BTKi 類別中的總體新患者開始而言,我們發現 BTKi 總開始新患者中約有一半發生在一線 CLL 中。然後大約有一半的開始發生在復發/難治性環境中。

  • And then you can split that half in the relapsed/refractory setting into about half of those, so 25% are in patients who are naive. And the other balance of that is in patients that have been pretreated with BTKi. So that gives you a general sense for how the class splits out.

    然後,您可以將復發/難治性環境中的那一半分成大約一半,因此 25% 屬於幼稚患者。另一個平衡點是接受過 BTKi 預處理的患者。這樣你就可以大致了解班級是如何分裂的。

  • In terms of our share of those classes, I've been very pleased with the U.S. performance in the second quarter as we've seen in the front-line setting. Our share position has held strong as we've seen the entrance of new competition within the class.

    就我們在這些課程中所佔的份額而言,我對美國第二季度的表現非常滿意,正如我們在前線環境中看到的那樣。隨著我們看到該類別中新競爭的出現,我們的股票地位一直保持堅挺。

  • In the second-line setting, as I mentioned in my prepared remarks, we have seen erosion of our share in that relapsed/refractory setting, particularly within the naive. We remain, as we see it, still the leaders within this space. That said, it is a pretty tight share split among the 3 players as we see it within that space.

    在二線環境中,正如我在準備好的發言中提到的,我們已經看到我們在復發/難治性環境中的份額受到侵蝕,特別是在幼稚的環境中。正如我們所見,我們仍然是這個領域的領導者。也就是說,正如我們在該領域內看到的那樣,這三個參與者之間的份額分配相當緊張。

  • In terms of -- now switching to the commercial opportunity for TROPION-Breast01, I think that maybe the primary thing that I'd lay out here is that I think what we're really seeking on this is category leadership within breast cancer.

    就現在轉向 TROPION-Breast01 的商業機會而言,我認為也許我在這裡要闡述的首要內容是,我認為我們真正尋求的是乳腺癌領域的類別領導地位。

  • I think that as you quite rightly point out, across the G7 countries, there are a large number, over 35,000 fourth line and beyond patients treated across the G7 in hormone receptor positive and HER2-negative disease. And I think that what we'll really be looking to do is understanding how patient selection and sequencing can create opportunities both for in HER2 as well as for Dato-DXd.

    我認為,正如您所指出的,在 G7 國家中,有大量超過 35,000 名四線及以上的患者在激素受體陽性和 HER2 陰性疾病中接受治療。我認為我們真正要做的是了解患者選擇和測序如何為 HER2 和 Dato-DXd 創造機會。

  • And I think that an important part of the approach that we're taking is to try to have an AstraZeneca medicine that is appropriate for patients with various different subtypes. And also in various different sequence over time. And I think that I would look at the opportunity to replace chemotherapy across late-line breast cancer as a category is how we're thinking about the portfolio of medicines.

    我認為我們正在採取的方法的一個重要部分是嘗試開發一種適合各種不同亞型患者的阿斯利康藥物。而且隨著時間的推移,也會以各種不同的順序出現。我認為我會將晚期乳腺癌替代化療的機會視為我們對藥物組合的思考方式。

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • And so to answer the question about biomarker development for Dato-DXd.

    因此回答有關 Dato-DXd 生物標誌物開發的問題。

  • So in principle, antibody-drug conjugates are targeted medicines. And I think as a general principle, we want biomarkers to identify the right patients for targeted medicines across that class.

    因此原則上,抗體藥物偶聯物是靶向藥物。我認為作為一般原則,我們希望生物標誌物能夠識別出適合該類別靶向藥物的患者。

  • And so as we've indicated, we are in -- working on a biomarker for the TROP2 program, and we will use the data that we've got from TLL1, and to help with that effort, and we can update you on that one, once those analysis are completed.

    正如我們所指出的,我們正在為 TROP2 項目開發生物標誌物,我們將使用從 TLL1 獲得的數據來幫助完成這項工作,我們可以向您通報最新情況一,一旦這些分析完成。

  • I think your comment about retrospective versus prospective. Obviously, in an ideal world, you want prospective selection in order to make sure that you've got a balance and you often stratify for that presence in such trials, but there are multiple examples of retrospective analysis based on the prospect of definition of that have enabled an approval in that setting.

    我認為你對回顧性與前瞻性的評論。顯然,在理想的世界中,您希望進行前瞻性選擇,以確保獲得平衡,並且您經常在此類試驗中針對這種情況進行分層,但是有多個基於該定義的前景進行回顧性分析的例子已在該設置中啟用批准。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • The next question is from Gonzalo Artiach at ABG.

    下一個問題來自 ABG 的 Gonzalo Artiach。

  • Gonzalo Artiach Castañón - Research Analyst

    Gonzalo Artiach Castañón - Research Analyst

  • Yes. Can you hear me?

    是的。你能聽到我嗎?

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Yes, we can hear you now.

    是的,我們現在可以聽到你的聲音。

  • Gonzalo Artiach Castañón - Research Analyst

    Gonzalo Artiach Castañón - Research Analyst

  • Okay, great. So first one, it's regarding your yesterday's news on DESTINY-Pantumor02. And with the data presented yesterday, improved PFS and OS in line with what you showed at ASCO. How much does this help for a potential tumor-agnostic approval? And here, what is your view on this debate of the use of HER2 grades or different expression levels as by market for potential treatment approach? And specifically in pancreas, where you didn't see any major improvements in terms of ORR, but could you share anything on how does this new parameters, PFS and OS look like?

    好的,太好了。第一個是關於您昨天在 DESTINY-Pantumor02 上看到的新聞。根據昨天提供的數據,PFS 和 OS 得到改善,與您在 ASCO 上展示的結果一致。這對於潛在的腫瘤不可知的批准​​有多大幫助?在這裡,您對關於使用 HER2 等級或不同表達水平作為潛在治療方法市場的爭論有何看法?特別是在胰腺中,您沒有看到 ORR 方面有任何重大改進,但您能否分享一下有關新參數、PFS 和 OS 的情況?

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • Okay. Thank you for the question. So as we shared at ASCO, what we've seen with Enhertu in the Pantumor02 study is impressive response rate and durability of response across multiple tumor types, particularly impressive in the gynecologic cancers of endometrial cancer, ovarian and cervical but also encouraging data across multiple other tumors. And of course, what we saw in that study with an enhanced response rate in the IHC 3+ compared with the IHC 2+ populations. So it's important just to remember that there's a mix nature in this trial, you've got multiple different genotypes with different lines of therapy, but generally heavily pretreated patient population. And what you saw there was a response rate -- durability response, which is beyond what you would reasonably expect and certainly in the IHC3+ population for a standard of care chemotherapy in that setting.

    好的。感謝你的提問。因此,正如我們在 ASCO 上分享的那樣,我們在 Pantumor02 研究中使用 Enhertu 看到的是在多種腫瘤類型中令人印象深刻的緩解率和緩解持久性,尤其是在子宮內膜癌、卵巢癌和宮頸癌等婦科癌症中令人印象深刻,而且在多種腫瘤類型中也取得了令人鼓舞的數據其他腫瘤。當然,我們在該研究中看到,與 IHC 2+ 人群相比,IHC 3+ 人群的緩解率有所提高。因此,重要的是要記住,這項試驗具有混合性質,有多種不同的基因型和不同的治療方案,但通常是經過大量預處理的患者群體。你看到的是反應率——持久性反應,這超出了你的合理預期,當然在 IHC3+ 人群中,在這種情況下進行標準護理化療也是如此。

  • So I think it's encouraging now that we've got the progression-free survival and overall survival to back up that response rate and durability of response. And I do think there are differences in this setting between IHC 3+ and IHC 2+, which is something we've also seen in other settings as well. And that, if you like, establishes the differentiation from the standard of care. I also think should you say, though, that there are patients beyond the IHC3+ that are clearly benefiting beyond what you might expect from that standard of care chemotherapy. So what I would say is that a conversations with regulatory authorities, including the FDA, are ongoing. As we said, initial discussions are encouraging. And as those develop, we can provide more details.

    因此,我認為現在令人鼓舞的是,我們已經獲得了無進展生存期和總生存期來支持緩解率和緩解持久性。我確實認為 IHC 3+ 和 IHC 2+ 之間在這種設置上存在差異,這也是我們在其他設置中也看到的。如果你願意的話,這也確立了與護理標準的區別。不過,我也認為您應該說,除了 IHC3+ 之外,還有一些患者明顯受益於您從標準護理化療中獲得的益處。所以我想說的是,與包括 FDA 在內的監管機構的對話正在進行中。正如我們所說,初步討論令人鼓舞。隨著這些的發展,我們可以提供更多細節。

  • Operator

    Operator

  • Next question is from Richard Parkes from Exane.

    下一個問題來自 Exane 的 Richard Parkes。

  • Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team

    Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team

  • Yes, just a couple of questions. Firstly, just to push a little bit more on TROPION-Lung01. Just help me understand the difference in level of optimism at the time of the press release and what you're communicating now. Because as you'll know, your mission of the words clinically meaningful is what's caused nervousness. But clearly, given the decision to [borrow] your optimism today, you do see the overall benefit as meaningful. So can you just help us understand a little better the context for that contradiction somewhat in the communication? Is it additional analysis you've done since the readout? Or was there some other reason why you thought you couldn't include that word in the press release? Second question, simple just could you update us on progress for us to make to Phase III, I know we're waiting for the durability of response data at the lower dose to be presented. And I just wonder, will that be an ESMO World Lung?

    是的,只有幾個問題。首先,稍微推動一下 TROPION-Lung01。請幫助我了解新聞稿發佈時的樂觀程度與您現在所傳達的內容之間的差異。因為正如你所知,你對這些詞的臨床意義的使命是導致緊張的原因。但顯然,鑑於今天決定[借用]你的樂觀態度,你確實認為整體收益是有意義的。那麼您能否幫助我們更好地理解溝通中存在的矛盾的背景?這是您自讀數以來所做的額外分析嗎?或者是否有其他原因導致您認為不能在新聞稿中包含該詞?第二個問題,很簡單,您能否告訴我們第三階段的進展情況,我知道我們正在等待較低劑量反應數據的持久性。我只是想知道,這會是 ESMO World 肺嗎?

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • So the definition of clinically meaningful in terms of what clinicians are looking for will take into account not only the difference in mediums but shape of the KM curves. Obviously, the hazard ratio, which is what the trial is often designed to power together with the response rate, durability response and the safety profile as well as the patient population that's included. So I think -- what I would just reiterate really is that when we look at the data, and we find out in that, it's encouraging, and we've had discussions with the FDA and on the basis of encouraging response we are proceeding to file. I can't go into more details today, but we'd be happy to have more conversations when we've actually the opportunity to present the data in upcoming Medical Congress.

    因此,臨床醫生所尋找的臨床意義的定義不僅要考慮介質的差異,還要考慮 KM 曲線的形狀。顯然,風險比是試驗通常設計的目的,與反應率、持久性反應和安全性以及所包括的患者群體一起提供動力。所以我認為——我想重申的是,當我們查看數據時,我們發現這是令人鼓舞的,我們已經與 FDA 進行了討論,在令人鼓舞的反應的基礎上,我們正​​在繼續文件。我今天無法透露更多細節,但當我們實際上有機會在即將召開的醫學大會上展示這些數據時,我們很樂意進行更多對話。

  • With regards to your question on (inaudible), the program is advancing at pace and we have indicated that we've got a number of Phase III trials in planning. We're proceeding again at pace with those. And as we initiate those. And as we have more mature data, we will share those data, but not necessarily on the time lines that you're asking for. So at the appropriate time, we will share the data in the public Congress.

    關於您提出的問題(聽不清),該計劃正在快速推進,我們已經表示,我們已經計劃進行一些 III 期試驗。我們將再次按照這些步伐進行。當我們發起這些活動時。由於我們擁有更成熟的數據,我們將共享這些數據,但不一定按照您要求的時間線共享。所以在適當的時候,我們會在公眾大會上分享這些數據。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • I mean, Richard, just to add, I mean, our partner, Daiichi Sankyo and us, actually, we have a policy of only disclosing high-level results, as you know, and not the details. So what you saw is the announcement relative to the high level results. What we have seen is the detailed results and not probably also explain some of the discrepancies, but you'll understand better when you see the results of future Congress. And the next question is from Christopher Uhde at SEB.

    我的意思是,理查德,我想補充一點,我的意思是,我們的合作夥伴第一三共和我們,實際上,我們的政策是只披露高水平的結果,正如你所知,而不是細節。所以你看到的是與高層結果相關的公告。我們看到的是詳細的結果,可能無法解釋一些差異,但當你看到未來國會的結果時,你會更好地理解。下一個問題來自 SEB 的 Christopher Uhde。

  • Christopher Winston Uhde - Analyst

    Christopher Winston Uhde - Analyst

  • Christopher Uhde, SEB. So I have a question on SUPERNOVA and the COVID antibody update in general. So obviously -- so I saw that the time line seems to be reiterated. But we're moving toward the latter part of the half, not so much time to get it to patients before the end of the year. So perhaps could you just remind us a little bit about the factors determining the time from topline to EUA? And can you also talk a little bit about how you're planning to brand it? It seems that it won't be -- have you shelled, but I guess that has advantages and disadvantages. So perhaps you could talk about that. And then in terms of Fasenra, the growth levers going forward and also thinking about -- I saw GSK has an ultra extended half-life -- so what are your thoughts around competition?

    克里斯托弗·伍德,SEB。我有一個關於 SUPERNOVA 和新冠病毒抗體更新的問題。很明顯——所以我看到時間線似乎被重申了。但我們正朝著下半年的方向發展,在年底之前沒有太多時間將其交付給患者。那麼您能否提醒我們一些決定從頂線到 EUA 的時間的因素?你能談談你打算如何打造它的品牌嗎?看來不會——你炮轟了,但我想這有利有弊。所以也許你可以談談這個。然後就 Fasenra 而言,未來的增長槓桿以及思考 - 我看到葛蘭素史克的半衰期超長 - 那麼您對競爭有何看法?

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Thank you, Christopher. (inaudible), do you want to take the first one? And Ruud, you take the next one?

    謝謝你,克里斯托弗。 (聽不清),你想拿第一個嗎?路德,你選下一張嗎?

  • Unidentified Company Representative

    Unidentified Company Representative

  • Christopher, thanks for the question and also thanks for your continuous interest in this area. So we continue to rapidly advance AZD3152, which is a new long-acting monoclonal antibody for prevention and treatment of COVID-19 for immunocompromised patients. And I'm pleased to say that SUPERNOVA trial is on track. As you are mentioning, we did update the trial, and that was a result of the trial design. And that was a result of the consultation and agreement with FDA because we believe that is the fastest way how to achieve emergency approval for the patients in U.S. And currently, the trial is updated with the sub-study or immuno-bridging data. As a reminder, this is a precedent study design and will allow us to have the data late this year. Obviously, as we are moving from the beginning with at pace, we will do our best to deliver AZD3152 to the immunocompromised patients in U.S. by end of this year.

    克里斯托弗,感謝您提出問題,也感謝您對這一領域的持續關注。因此,我們繼續快速推進AZD3152,這是一種新型長效單克隆抗體,用於預防和治療免疫功能低下患者的COVID-19。我很高興地說 SUPERNOVA 試驗已步入正軌。正如您所提到的,我們確實更新了試驗,這是試驗設計的結果。這是與 FDA 協商並達成協議的結果,因為我們相信這是為美國患者獲得緊急批准的最快方式。目前,該試驗已使用子研究或免疫橋接數據進行更新。提醒一下,這是一個先例研究設計,將使我們能夠在今年晚些時候獲得數據。顯然,隨著我們從一開始就快速前進,我們將盡最大努力在今年年底前將 AZD3152 交付給美國的免疫功能低下患者。

  • Equally, we are continuing the SUPERNOVA trial with efficacy endpoint, and we believe that efficacy data readout will happen in the first quarter of next year. That will allow us to have the approval globally outside of U.S. On your branding question, thanks for that. I do agree they are not having Evusheld brand name for our new next-generation monoclonal antibody has its good and bad side. We are currently in discussion both with FDA and EMA, and we will provide the update on the brand name as soon as we get agreement from those agencies.

    同樣,我們正在繼續進行具有功效終點的 SUPERNOVA 試驗,我們相信功效數據的讀出將在明年第一季度進行。這將使我們能夠在美國以外的全球範圍內獲得批准。關於您的品牌問題,謝謝。我確實同意他們沒有使用 Evusheld 品牌名稱,因為我們新的下一代單克隆抗體有其好的一面和壞的一面。我們目前正在與 FDA 和 EMA 進行討論,一旦獲得這些機構的同意,我們將立即提供品牌名稱的最新信息。

  • Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit

    Ruud Dobber - Executive Vice-President of BioPharmaceuticals Business Unit

  • Chris, quickly, the growth drivers for Fasenra in the foreseeable future. there are 3 big ones. First of all, by far, the biggest 1 is still bio-penetration is at the low side for biologics in severe uncontrolled asthma, depending on where you are, it's everything between 15% and 25%. So there's still a huge room to maneuver in a positive way. The second one, what I said in my remarks is that China is an important growth driver. We have filed in China based on the outstanding MIRACLE trial. So hopefully, next year, we will see the results. And last but not least, later this year, we will see the outcome of Fasenra and EGPA which is another very important growth driver for the brand. So all in all, we truly believe that there's still a very bright future for Fasenra. Quickly, your remark about long-acting, of course, we have our own Fasenra with every 2 months. So we don't foresee a major impact of our molecules. The class is very competitive. But once again, bio-penetration across the board is still at a very low level. So more competitors will also make -- grow the market in an acceptable and good way.

    Chris,很快,Fasenra 在可預見的未來的增長動力。有3個大的。首先,到目前為止,最大的一個問題是生物製劑在嚴重不受控制的哮喘中的生物滲透率仍然偏低,具體取決於您所在的地區,在 15% 到 25% 之間。因此,積極的操作空間仍然很大。第二個,我在講話中講的是,中國是重要的增長動力。我們已根據未完成的 MIRACLE 試驗在中國提出申請。所以希望明年我們能看到結果。最後但並非最不重要的一點是,今年晚些時候,我們將看到 Fasenra 和 EGPA 的成果,這是該品牌的另一個非常重要的增長動力。總而言之,我們堅信 Fasenra 的未來仍然非常光明。很快,您關於長效的評論,當然,我們每兩個月就有自己的 Fasenra。所以我們預計我們的分子不會產生重大影響。班級競爭非常激烈。但再次強調,生物滲透率仍然處於非常低的水平。因此,更多的競爭對手也將以可接受的良好方式擴大市場。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • James Gordon, JPMorgan.

    詹姆斯·戈登,摩根大通。

  • James Daniel Gordon - Senior Analyst

    James Daniel Gordon - Senior Analyst

  • James Gordon, JPMorgan. Firstly, a question on at Dato, which would be, is the plan to change anything on the back of the recent Dato update? And what might change? For instance, could you tweak any of the trials to enroll patients that you think are going to show stronger efficacy in some sort of subpopulation? And is it tough too, is it something more sophisticated that you're actually looking at? Because a TROP2 expression is like a pillow on the slide laying out the Dato program. This something else where you might end up stratifying? And will you kick off any more data Phase III trials from now? Or are you going to wait until you've got a bit more data from other trials to work how was the strongest efficacy is going to be generated? And then just one other question, which is Imfinzi, so very strong growth today. But is there anything one-off there that help performance? Or actually, if we put Dato aside, is Imfinzi and HER2 really going to be the 2 key growth drivers from now and to the end of decade. Can we really extrapolate the strong growth forward for Imfinzi today?

    詹姆斯·戈登,摩根大通。首先,拿督提出的一個問題是,最近拿督更新後,計劃是否會改變任何事情?什麼可能會改變?例如,您是否可以調整任何試驗來招募您認為在某種亞群中表現出更強療效的患者?它也很難嗎?你實際上正在考慮的是更複雜的東西嗎?因為 TROP2 表達式就像幻燈片上的一個枕頭,展示了 Dato 程序。這是您最終可能會分層的其他內容嗎?從現在開始您會啟動更多的數據三期試驗嗎?或者您是否要等到從其他試驗中獲得更多數據後才知道如何產生最強的功效?然後還有一個問題,那就是 Imfinzi,今天的增長非常強勁。但是有沒有什麼一次性的東西可以幫助提高性能呢?或者實際上,如果我們把 Dato 放在一邊,Imfinzi 和 HER2 真的會成為從現在到十年末的兩個關鍵增長動力嗎?我們真的可以推斷 Imfinzi 今天的強勁增長嗎?

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Susan?

    蘇珊?

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • Okay. All right. So in terms of Dato-DXd trial, let me start with that one. Yes, we are continuing to plan new Phase III trials with Dato-DXd. As we had indicated at the end of last year and continue to be excited about the potential for this molecule in multiple different settings. In terms of the biomarker, TROP2 is highly expressed across many different tumor types, including lung cancer. I think in general, about ADCs and prediction of outcome, receptor expression is one element, receptor internalization is another element and sensitivity to warhead is a third element. So there were multiple elements to consider about predicting the patients that are most likely to respond and of course, we are looking at those different elements in what we're looking on from a biomarker perspective.

    好的。好的。因此,就 Dato-DXd 試驗而言,讓我從那個開始。是的,我們正在繼續計劃與 Dato-DXd 進行新的 III 期試驗。正如我們在去年年底所指出的,我們繼續對該分子在多種不同環境中的潛力感到興奮。就生物標誌物而言,TROP2 在許多不同的腫瘤類型中高表達,包括肺癌。我認為總的來說,關於 ADC 和結果預測,受體表達是一個要素,受體內化是另一個要素,對彈頭的敏感性是第三個要素。因此,在預測最有可能做出反應的患者時,需要考慮多個因素,當然,我們正在從生物標誌物的角度看待這些不同的因素。

  • David Fredrickson - Executive Vice-President of Oncology Business Unit

    David Fredrickson - Executive Vice-President of Oncology Business Unit

  • James, on Imfinzi. I mean I think the first thing I'd note is that we double-clicked into it into the prepared remarks because we think that the opportunity for Imfinzi going forward is an important one. We've made a series of investments into the life cycle plan and the clinical development plan for Imfinzi. And those now are paying off in terms of positive readouts, and we're commercially taking advantage of that. I think that to go a little bit more specifically, somewhere between 20% and 30% of the Imfinzi growth that we're seeing is coming from the established portfolio, so the PACIFIC and CASPIAN indications where we're seeing strength in PACIFIC across the globe as we kind of get further away from some of the COVID-19 challenges.

    詹姆斯,關於伊姆芬齊。我的意思是,我認為我要注意的第一件事是我們雙擊進入準備好的評論,因為我們認為 Imfinzi 前進的機會是一個重要的機會。我們對 Imfinzi 的生命週期計劃和臨床開發計劃進行了一系列投資。現在這些都在積極的讀數方面得到了回報,我們正在商業上利用這一點。我認為更具體地說,我們看到的 Imfinzi 增長的 20% 到 30% 之間來自既定的投資組合,因此太平洋和里海的跡象表明,我們看到太平洋在整個地區的實力隨著我們距離某些新冠肺炎 (COVID-19) 挑戰越來越遠,全球將迎來新的挑戰。

  • We're continuing to progress against CASPIAN in parts of the globe where we have opportunities. But really, it's the new launches of TOPAZ, HIMALAYA and POSEIDON that are making up the balance of that. TOPAZ has rapidly gotten to a place in the markets where we've launched where we have market share that's well north of 50%. And I'd say HIMALAYA has had a nice uptake, but still quite a bit of opportunity to continue to move with HIMALAYA. It is a competitive context. And it's one where we are certainly coming up against therapeutic alternatives, but we like the uptake that we've had. Maybe the last proof point just to offer on this. While with TOPAZ and HIMALAYA, we have regulatory approvals in over 50-plus markets across the globe. We only now today have reimbursement in just around 10. Now they're 10 of the largest. So it's the U.S. and Japan, and we have early access that exists within France. But we still have a number of countries within Europe and a lot of countries within international, which yet to come on board. So we think the outlook for Imfinzi forward is strong.

    我們正在全球有機會的地方繼續與里海對抗。但實際上,新推出的 TOPAZ、HIMALAYA 和 POSEIDON 彌補了這一點。 TOPAZ 已迅速在我們推出的市場中佔有一席之地,我們的市場份額遠超 50%。我想說 HIMALAYA 已經得到了很好的採用,但仍然有相當多的機會繼續與 HIMALAYA 一起發展。這是一個競爭環境。我們肯定會遇到治療替代方案,但我們喜歡我們已經接受的治療方案。也許是為此提供的最後一個證據。憑藉 TOPAZ 和 HIMALAYA,我們在全球 50 多個市場獲得了監管部門的批准。現在我們只有大約 10 個報銷。現在他們是最大的 10 個。所以是美國和日本,我們在法國也有搶先體驗。但我們仍有許多歐洲國家和許多國際國家尚未加入。因此,我們認為 Imfinzi 的前景廣闊。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Emily Field, Barclays.

    艾米麗·菲爾德,巴克萊銀行。

  • Emily Field - Head of European Pharmaceuticals Equity Research

    Emily Field - Head of European Pharmaceuticals Equity Research

  • I've got 2. The first one, just on Lynparza and maybe digging in a little bit more to the dynamics going on in ovarian, how much of sales is second-line ovarian. And just kind of were aware of the registration being pulled for the competitor asset, but sort of why is this impact leading over into Lynparza do you expect to return to growth in the U.S. for this asset? And then just a question on the raised guidance for China. I was just wondering, is this truly based on sort of improving demand in the region. Is this impacted in any way by some of the price adjustments that are happening with the product from the NRDL, just any incremental color you can give there.

    我有 2。第一個,就 Lynparza 而言,也許更深入地了解卵巢的動態,有多少銷售是二線卵巢的。我們只是知道競爭對手資產的註冊被取消,但為什麼這種影響會波及 Lynparza?您預計該資產在美國會恢復增長嗎?然後是關於針對中國提出的指導的問題。我只是想知道,這真的是基於該地區需求的改善嗎?這是否會受到 NRDL 產品價格調整的影響,只是您可以在那裡提供的任何增量顏色。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Dave, do you want to cover the first one and Leon could cover the second one?

    戴夫,你想報導第一個,萊昂可以報導第二個嗎?

  • David Fredrickson - Executive Vice-President of Oncology Business Unit

    David Fredrickson - Executive Vice-President of Oncology Business Unit

  • Yes. Emily, thanks for the question. So first part of this is that if we take a look at PARP class starts across lines in ovarian cancer. Over the course of the year, the starts are declining, and that is predominantly a phenomena of lower desire on the part of medical oncologists to treat in the second line setting in ovarian cancer as there's been, as you know, I think, quite a lot of changes that have been happening there with respect to competitor labels and discussion and dialogue with the FDA. Within the context of that, we've been doing a good job to continue to drive our PAOLA and SOLO indications. SOLO, we really have probably fully penetrated though there is opportunity to continue to drive HRD testing rates in the front line. Unfortunately, a bit of what's happening is that those gains are being offset by some of the second line declines.

    是的。艾米麗,謝謝你的提問。因此,第一部分是,如果我們看一下 PARP 類在卵巢癌中的跨界起點。在這一年中,開工率正在下降,這主要是腫瘤內科醫師對卵巢癌二線治療的意願較低的現象,因為正如你所知,我認為,相當多的人對卵巢癌進行二線治療。在競爭對手標籤以及與 FDA 的討論和對話方面發生了很多變化。在此背景下,我們一直做得很好,繼續推動我們的 PAOLA 和 SOLO 適應症。 SOLO,我們確實可能已經完全滲透,儘管有機會繼續提高前線的 HRD 測試率。不幸的是,正在發生的一些情況是,這些收益被二線的一些下跌所抵消。

  • Now today, in terms of where we stand, the second line represents a significant minority of our ovarian cancer business. And so I'm hopeful that even with a narrower PROpel label, that we have an opportunity to continue to drive growth in Lynparza with PROpel and in some of the other populations that I've mentioned, but it is going to be slower progress that we're making there. I will say, outside of the United States and Europe, we're making nice progress with PROpel within Germany. We're continuing to drive growth opportunities that we have in breast cancer and also within ovarian cancer ex-U.S. but I think that the growth rates that we'll see on Lynparza, while still in front of us, will be a bit slower. I do, though, look forward with optimism to hopefully having a regulatory path forward with DUO-E. We'll see how things net with DUO-O and those would certainly be enthusiastic areas for us to launch into.

    現在,就我們的立場而言,第二條線代表了我們卵巢癌業務的一小部分。因此,我希望即使 PROpel 標籤範圍更窄,我們也有機會繼續通過 PROpel 推動 Lynparza 以及我提到的其他一些人群的增長,但進展將會較慢我們正在那裡做。我想說,在美國和歐洲之外,我們在德國境內的 PROpel 方面取得了良好進展。我們將繼續推動乳腺癌和卵巢癌(美國以外地區)的增長機會。但我認為,我們在 Lynparza 上看到的增長率雖然仍然在我們面前,但會慢一些。不過,我確實樂觀地期待著 DUO-E 的監管之路能夠向前發展。我們將看到 DUO-O 的網絡如何運作,這些肯定是我們熱衷於進入的領域。

  • Leon Wang - Executive VP of International & China President

    Leon Wang - Executive VP of International & China President

  • Yes. Regarding China guidance, I think China is -- this year is we have some headwinds on oncology price cuts because of NRDL renewed last year, so major oncology products get a cut. And also Silicon getting to VBP which is a large product. But actually, we should also focus on a lot of opportunities because we're launching rare disease and also Enhertu in China, Calquence in China. So a lot of new products are being launching a little bit lagging behind the global pace, but I think we are looking forward to a lot of new launches. We haven't yet launched Imfinzi, TOPAZ and also HIMALAYA. And we also have launching strongly into other indication and the FLAURA2. And for inhalation business, Symbicort is a very strong growth and Breztri after getting to NRDL second year now. So is it also embracing very strong growth.

    是的。關於中國的指導,我認為中國今年在腫瘤產品降價方面遇到了一些阻力,因為去年更新了國家醫保目錄,所以主要腫瘤產品都會降價。矽也進入了 VBP,這是一個大型產品。但實際上,我們還應該關注很多機會,因為我們正在中國推出罕見疾病、Enhertu、Calquence。因此,許多新產品的推出有點落後於全球步伐,但我認為我們期待著許多新產品的推出。我們還沒有推出 Imfinzi、TOPAZ 和 HIMALAYA。我們還大力推出其他適應症和 FLAURA2。對於吸入劑業務來說,Symbicort 和 Breztri 是進入國家醫保目錄後的第二年,增長非常強勁。它也迎來了非常強勁的增長。

  • And Pulmicort, after last year's VBP, we digested and this year, we are back to growth now. So Farxiga is also one of our very major important growth driver and together with roxadustat and also all the other [CDM] portfolio doing extremely well. So I think in the next or 2 years, 3 years, we are launching a lot of new indications and new products. So a little bit behind global, but also we also need to digest the VBP impact and some price cut off NRDL. Government in China is treating innovation better than before. So I think this is also a very good sign for NRDL policy, some of the transparency and also bring quite a good policy.

    而普米克,在去年的 VBP 之後,我們消化了,今年我們又恢復了增長。因此,Farxiga 也是我們非常重要的增長動力之一,與 roxadustat 以及所有其他 [CDM] 產品組合一起表現得非常好。所以我認為在未來或者兩年、三年內,我們會推出很多新的適應症和新產品。所以有點落後於全球,但我們還需要消化 VBP 的影響和 NRDL 的一些價格下調。中國政府比以前更好地對待創新。所以我覺得這對於醫保政策來說也是一個非常好的跡象,一些透明度也帶來了相當好的政策。

  • Operator

    Operator

  • Viktor Sundberg, Nordea. Viktor over to you.

    維克多·桑德伯格,北歐聯合銀行。維克托交給你了。

  • Viktor Sundberg - Senior Analyst

    Viktor Sundberg - Senior Analyst

  • I have 2 questions, if I may. So on the outlook for 2023, I just wanted to get a bit more details on the headwinds that keeps you from raising or refining the guidance. So in China, you seem to be more optimistic that the parameter is going against you that you mentioned here seems to be quite well anticipated perhaps in the beginning of the year. So Symbicort generic situation in the U.S. and an LDL impact from China in the second half. So are there other things here as well that keep you on the sideline here for guidance upgrade or refinement that have surprised you a bit during the year. You mentioned inflation. So maybe a quick comment on that would be helpful. And the second question I have is on Imfinzi. Very strong growth across all geographies, as you said, but especially in your Rest of the World category. Can you just elaborate a bit more what is driving that and how we should extrapolate in that geography and why the uptake has been so quick here?

    如果可以的話,我有兩個問題。因此,關於 2023 年的展望,我只是想了解更多有關阻礙您提高或完善指導意見的阻力的詳細信息。因此,在中國,您似乎更樂觀地認為,您在這裡提到的參數對您不利,也許在今年年初就已經得到了很好的預期。 Symbicort 在美國的通用情況以及下半年來自中國的 LDL 影響。那麼,是否還有其他事情讓您在這一年中對指導升級或改進保持觀望,這些事情讓您有點驚訝。你提到了通貨膨脹。所以也許對此進行快速評論會有所幫助。我的第二個問題是關於 Imfinzi 的。正如您所說,所有地區的增長都非常強勁,尤其是在世界其他地區。您能否詳細說明一下是什麼推動了這一趨勢,以及我們應該如何在該地區進行推斷,以及為什麼這裡的採用速度如此之快?

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Thanks, Viktor. Aradhana, do you want to take the first one and David, the second one?

    謝謝,維克托。 Aradhana,你想要第一個,大衛,第二個嗎?

  • Aradhana Sarin - Executive Director

    Aradhana Sarin - Executive Director

  • Yes, sure. Thank you, Pascal. Thank you, Viktor, for the question. So we are reiterating guidance for the year. And I think it's a bit of phasing and dynamics between first half and second half. In the second half, we are going to experience, as you just mentioned and I mentioned before, the Symbicort generic in the U.S. Nexium, which went generic end of last year, we started to see the impact. And again, it's a progressive impact, again, more in the latter part of the year and decline in various other legacy brands (inaudible). So if you look at some of the other -- the brands that are in the other of the legacy category. The trend that was mentioned by Dave around second line in part and then the pricing impact that Leon mentioned on NRDL for Tagrisso, a lot of that went into effect sort of in the second quarter.

    是的,當然。謝謝你,帕斯卡。謝謝維克托提出的問題。因此,我們重申今年的指導。我認為上半場和下半場之間有一些階段性和動態性。下半年,我們將體驗到,正如您剛才提到的和我之前提到的,美國 Nexium 的 Symbicort 仿製藥,去年年底開始仿製藥,我們開始看到影響。再說一次,這是一個漸進的影響,更多的是在今年下半年,以及其他各種傳統品牌的衰落(聽不清)。因此,如果你看看其他一些品牌——屬於其他傳統類別的品牌。 Dave 部分提到了二線的趨勢,然後 Leon 提到了 Tagrisso 的 NRDL 定價影響,其中很多都在第二季度生效。

  • So again, we'll see the full impact of that in the second half. I made some comments around gross margins. FluMist is, again, a product that does impact our gross margin, and that's, again, more weighted towards the second half. But really, when you look at both from a revenue and cost standpoint, in both SG&A as well as R&D, primarily driven by all the study starts as well as the material that we will need to produce from a clinical supply standpoint, a lot of that is weighted towards the second half in R&D costs. So again, it's more phasing than anything else, and we are reiterating our guidance for the full year. And then Dave, on Imfinzi Rest of World.

    同樣,我們將在下半年看到其全面影響。我圍繞毛利率發表了一些評論。 FluMist 是一款確實影響我們毛利率的產品,而且它對下半年的影響更大。但實際上,當你從收入和成本的角度來看時,無論是SG&A還是研發,主要是由所有研究開始以及我們從臨床供應的角度需要生產的材料驅動的,很多這是下半年研發成本的加權。再說一遍,這比其他任何事情都更分階段,我們重申我們對全年的指導。然後是戴夫,在 Imfinzi 世界其他地區。

  • David Fredrickson - Executive Vice-President of Oncology Business Unit

    David Fredrickson - Executive Vice-President of Oncology Business Unit

  • So Viktor, it stems back to the answer to the question that I gave previously to James. Established Rest of World is made up predominantly of sales from Japan. I think that if you take a look at a lot of the other international markets, they sit within emerging markets. So the success that you see in the quarter for Imfinzi, Imjudo is really driven by very rapid uptake that's been happening over the course of the half with TOPAZ 1. And then also within the last quarter, we've had reimbursement from Imjudo that's allowed us to be able to move forward with HIMALAYA.

    維克托,這又回到了我之前向詹姆斯提出的問題的答案。世界其他地區的成熟產品主要由日本的銷售組成。我認為,如果你看一下許多其他國際市場,就會發現它們屬於新興市場。因此,您在本季度看到的 Imfinzi、Imjudo 的成功實際上是由 TOPAZ 1 上半個月的快速採用所推動的。然後也在上個季度,我們從 Imjudo 獲得了允許的報銷我們能夠與喜馬拉雅一起前進。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Steve Scala. Do you want to go ahead, Steve?

    史蒂夫·斯卡拉。你想繼續嗎,史蒂夫?

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • Two questions. First for Dave. In the third quarter of 2022, you said that Enhertu could be one of the largest medicines in oncology. Are you willing to say the same for Dato-DXd based on what you now know. And second, for Susan, does AstraZeneca plan to alter the study design of TROPION-Lung07 and TROPION-Lung08 based on the results of TL01?

    兩個問題。首先是戴夫。在 2022 年第三季度,您說 Enhertu 可能是腫瘤學領域最大的藥物之一。根據您現在所了解的情況,您是否願意對 Dato-DXd 說同樣的話?其次,對於Susan來說,阿斯利康是否計劃根據TL01的結果改變TROPION-Lung07和TROPION-Lung08的研究設計?

  • David Fredrickson - Executive Vice-President of Oncology Business Unit

    David Fredrickson - Executive Vice-President of Oncology Business Unit

  • Thanks, Steve. I continue to believe that Enhertu has the opportunity to be one of the largest medicines and certainly one of the most transformative medicines in the treatment of cancer. I will just come back to -- we've talked a lot on Enhertu about three important pillars. And the Pantumor02 data, and Susan talked about that in greater depth earlier, really does begin to open up the opportunity to take Enhertu into areas outside of breast, gastric and lung cancer, and I think it's really promising for that. And with Dato, I would say, similarly, that I confirm my enthusiasm for Dato's opportunity to be potentially as big as Enhertu. And I think that it's going to be an important medicine.

    謝謝,史蒂夫。我仍然相信 Enhertu 有機會成為最大的藥物之一,當然也是癌症治療領域最具變革性的藥物之一。我會回到——我們在 Enhertu 上就三個重要支柱討論了很多。 Pantumor02 的數據,Susan 之前更深入地談到過,確實開始為 Enhertu 進入乳腺癌、胃癌和肺癌以外的領域提供機會,我認為這確實很有希望。對於拿督,我想說,同樣,我確認我對拿督有機會成為與恩赫圖一樣大的機會的熱情。我認為它將成為一種重要的藥物。

  • Certainly, also relative to last quarter having a positive Phase III readout reinforces confidence in the ability to be able to take a program forward, and I think that that's a big driver of it. And I think the last thing, when we did the deal on Dato, we knew that there was a big opportunity to replace systemic chemotherapy in lung cancer and also in breast cancer. The real opportunity for Dato to be bigger than Enhertu would be if we can take it into tumor types outside of those two areas. And so that's really what we look forward to seeing if we're able to effectively do.

    當然,相對於上個季度,第三階段的積極數據增強了人們對能夠推進項目的能力的信心,我認為這是一個很大的推動力。我認為最後一件事,當我們與 Dato 達成交易時,我們知道有很大的機會取代肺癌和乳腺癌的全身化療。如果我們能夠將 Dato 應用於這兩個領域之外的腫瘤類型,那麼 Dato 比 Enhertu 更大的真正機會是。因此,如果我們能夠有效地做到這一點,這確實是我們期待看到的。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Thank you, Dave. Just also we'll state the obvious, which is -- we have a lot more data points for Enhertu than we have for Dato. We need to keep this in mind, of course, but the potential is indeed very large. Simon Baker...

    謝謝你,戴夫。我們還要指出一個顯而易見的事實,那就是——我們為 Enhertu 提供的數據點比為 Dato 提供的數據點多得多。當然,我們需要牢記這一點,但潛力確實非常大。西蒙·貝克...

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • The second question.

    第二個問題。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Sorry, there was a second question.

    抱歉,還有第二個問題。

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • Thanks for the question again. So I think I said before, TROPION-Lung01, I expected that we were going to learn some things from that trial. And indeed, there are learnings in TLO1, as you expect from any clinical trial, particularly the first pivotal trial. So it's normal practice for drug development that as you go along and you learn, there may be adaptations to trials. So I think that's just a normal part of drug development. And I just say that we remain confident Dato is extremely important medicine in lung cancer, including in the first-line settings of the trials that are already ongoing

    再次感謝您的提問。所以我想我之前說過,TROPION-Lung01,我預計我們將從該試驗中學到一些東西。事實上,正如您從任何臨床試驗(尤其是第一個關鍵試驗)中所期望的那樣,TLO1 中可以學到一些東西。因此,藥物開發的正常做法是,隨著您的進展和學習,可能會對試驗進行調整。所以我認為這只是藥物開發的正常部分。我只是說,我們仍然相信 Dato 是治療肺癌的極其重要的藥物,包括在已經正在進行的試驗的一線環境中

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Thanks, Susan. Simon, do you want to go ahead?

    謝謝,蘇珊。西蒙,你想繼續嗎?

  • Simon P. Baker - Head of Pharmaceutical Research

    Simon P. Baker - Head of Pharmaceutical Research

  • Two questions, if I may, please. Firstly, on the Pfizer deal. You did allude to it on the slide a little bit, but I want you to give us a bit more color on what you're buying. Is this more technology rather than specific products? You highlighted some of the capsids on there. And specific to those, are there any characteristics that Pfizer brings that are differentiated in terms of selectivity and payload capacity. And then secondly, a question on brazikumab and inflammatory bowel disease. Now that you've written, often terminated that project, I just wondered what your level of interest in that space still was. I see you've done some work with NLRP3 inflammasome inhibitors. But is this still an area that is under active development.

    如果可以的話,請提兩個問題。首先,關于輝瑞交易。您確實在幻燈片上提到了一點,但我希望您能就您所購買的產品向我們提供更多信息。這是更多的技術而不是具體的產品嗎?您突出顯示了那裡的一些衣殼。具體來說,輝瑞在選擇性和有效負載能力方面是否具有差異化特徵。其次,關於 brazikumab 和炎症性腸病的問題。現在你已經寫了,經常終止那個項目,我只是想知道你對那個領域的興趣程度仍然是多少。我看到您已經對 NLRP3 炎性體抑製劑進行了一些研究。但這仍然是一個正在積極開發的領域嗎?

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Thank you, Simon. So we are a little bit from Dato. But Marc, you can go ahead and then Mene.

    謝謝你,西蒙。所以我們離拿督有點遠。但是馬克,你可以繼續,然後是梅內。

  • Marc Dunoyer - CEO of Alexion & Chief Strategy Officer

    Marc Dunoyer - CEO of Alexion & Chief Strategy Officer

  • Simon, thank you for the question. I'm happy to talk a little bit about gene therapy. So basically, the agreement with Pfizer concerns about a dozen preclinical construct and assets and also a large number of capsids that have been developed over the years, and that can be probably further refined to get the best possible capsid for both CNS or cardiotropic asset. So it's a combination of a dozen projects. We could start clinical probably from next year over the next 1, 2 or 3 years, plus other technologies, including capsids, which could be further refined, but we need to work on those to get the ultimate topic for the right tissue.

    西蒙,謝謝你的提問。我很高興能談談基因治療。因此,基本上,與輝瑞的協議涉及十幾個臨床前構建體和資產,以及多年來開發的大量衣殼,這些衣殼可能可以進一步完善,以獲得中樞神經系統或心臟資產的最佳衣殼。所以它是十幾個項目的組合。我們可能會從明年開始在接下來的 1、2 或 3 年內開始臨床,再加上其他技術,包括衣殼,這些技術可以進一步完善,但我們需要在這些方面開展工作,以獲得正確組織的最終主題。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • I think I look forward to the day when we can actually show you the progress we are making in the election portfolio in the pipeline. It's very exciting, but it's also true for the cardiovascular respiratory immunology portfolio. And at some point, hopefully, in the future, we can spend more time on those products because many of those are exciting, also making progress in VNI, even though it's much more at an early stage. But with that Mene, you want to cover the question that Simon asked.

    我想我期待著有一天我們能夠真正向你們展示我們在籌備中的選舉組合中所取得的進展。這非常令人興奮,但對於心血管呼吸免疫學組合來說也是如此。希望在未來的某個時候,我們可以在這些產品上投入更多時間,因為其中許多產品令人興奮,並且在 VNI 方面也取得了進展,儘管還處於早期階段。但通過梅內,你想涵蓋西蒙提出的問題。

  • Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board

    Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board

  • It's a great question. And the answer is we have an interest, both in terms of building our immunology capability and autoimmune disease and specifically in diseases like IBD. And I'll give you two examples. And again, this -- I'm sure it's something that Sharon will be talking about over the coming year. The first program is an anti-CCR9 antibody that's in Phase I, which has demonstrated really dramatic lowering of T-regulatory cells in the gut. And it looks like a very interesting mechanism and antibody, and we're looking to see how we can accelerate that. And you may also -- about a deal, we did with a small company called Quell in the Treg space, and I talked about it today in my presentation. They have a really interesting way of locking Treg cells to maintain their anti-inflammatory state. And one of the indications that we were pursuing with them is IBD.

    這是一個很好的問題。答案是我們對建立免疫學能力和自身免疫性疾病,特別是炎症性腸病等疾病感興趣。我給你舉兩個例子。再說一次,我確信這是沙龍在來年會談論的事情。第一個項目是處於 I 期的抗 CCR9 抗體,該抗體已證明能夠顯著降低腸道中的 T 調節細胞。它看起來是一個非常有趣的機制和抗體,我們正在尋找如何加速這一過程。您也可能 - 關於一筆交易,我們與 Treg 領域一家名為 Quell 的小公司達成了交易,我今天在演講中談到了這一點。他們有一種非常有趣的方法來鎖定 Treg 細胞以維持其抗炎狀態。我們與他們一起尋找的跡象之一是 IBD。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • We have a few more questions, so we maybe extend by 5 minutes. But if you don't mind, if you could ask one question. Seamus Fernandez, go ahead.

    我們還有幾個問題,所以我們可能會延長 5 分鐘。但如果你不介意的話,可以問一個問題嗎?謝默斯·費爾南德斯,繼續吧。

  • Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

    Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals

  • Yes. Just a quick question on the change in leadership and Mene's retirement. It's interesting to see that Sharon is coming in from Alexion. Is this a directional move away from sort of more primary care type opportunities. I know this is something Pascal, you have talked about before but there's a lot of interest in opportunities to treat metabolic disease. Just interested if there's -- this is a strategic shift away from diabetes and metabolic disease, perhaps obesity opportunities or if we're going to see AstraZeneca continue its efforts along those lines or perhaps even accelerate those efforts through business development going forward.

    是的。我想問一個關於領導層變動和梅內退休的簡單問題。有趣的是,莎倫來自亞力兄。這是遠離更多初級保健類型機會的定向轉變嗎?我知道這是帕斯卡的事情,您之前已經談到過,但人們對治療代謝疾病的機會很感興趣。只是感興趣,如果有的話——這是遠離糖尿病和代謝疾病的戰略轉變,也許是肥胖機會,或者我們是否會看到阿斯利康繼續沿著這些路線努力,甚至可能通過未來的業務發展加速這些努力。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • That's a good question. Actually, what it is, is very simply the appointment of a very talented scientist and a very -- an exceptional leader. It's not reflecting a change in strategy, certainly not reflecting that we want to consolidate rare disease and the bio-pharma business because Sharon is being replaced in her role as Head of Research and Product Development at Alexion and it's also not reflecting move away from -- or this engagement from primary care. I mean I'm sure you've noticed that looking at ourselves, but also our portfolio, you've noticed that certainly over the last few years, naturally, our portfolios move to more specialty care, but primary care remains important. And that's why a few minute ago, we're saying we look forward to the day when we can talk about what we have in R&I, but also in cardiovascular medicines, we have quite a few projects. And Mene, maybe you want also to comment there on the portfolio we have, in fact.

    這是個好問題。事實上,這只是任命一位非常有才華的科學家和一位非常傑出的領導者。這並不反映戰略的變化,當然也不反映我們想要鞏固罕見疾病和生物製藥業務,因為莎倫作為亞力兄研究和產品開發主管的職位被替換,而且也不反映離開 - - 或初級保健的參與。我的意思是,我確信您已經註意到,看看我們自己以及我們的投資組合,您肯定已經註意到,在過去幾年中,我們的投資組合自然而然地轉向了更多的專業護理,但初級護理仍然很重要。這就是為什麼幾分鐘前,我們說我們期待有一天我們可以談論我們在研發和心血管藥物方面的情況,我們有很多項目。事實上,梅內,也許您還想對我們擁有的投資組合發表評論。

  • Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board

    Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board

  • Yes. I mean I think when we have a chance, hopefully, in the next 6 to 12 months to talk about all of the assets, both early, mid- and late-stage assets across CVRM, across respiratory immunology, V&I, I mean it's a very rich and deep portfolio with many, many opportunities, many of them significant. We are moving more to specialty, but there's still a place for the primary care. And Sharon, let me say, she's going to be a fantastic leader for us. It doesn't reflect any change in strategy, more continuity with hopefully going from strength to strength and building on what we have already built.

    是的。我的意思是,我認為當我們有機會在未來 6 到 12 個月內討論所有資產時,包括 CVRM、呼吸免疫學、V&I 的早期、中期和後期資產,我的意思是,這是一個非常豐富和深入的投資組合,有很多很多的機會,其中很多都很重要。我們正在更多地轉向專科,但初級保健仍然有一席之地。莎倫,讓我說,她將成為我們出色的領導者。它並不反映戰略上的任何變化,而是更多的連續性,希望不斷增強並在我們已經建立的基礎上繼續發展。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • One thing that certainly Sharon can help us do is continue building this focus in immunology, sorry, that Mene started and that will be an important chapter of our future. Matt Weston at Credit Suisse.

    莎倫當然可以幫助我們做的一件事是繼續建立免疫學的重點,抱歉,梅內開始了這將是我們未來的重要篇章。瑞士信貸銀行的馬特·韋斯頓。

  • Matthew Weston - MD and Co-Head of European Pharmaceutical Equity Research

    Matthew Weston - MD and Co-Head of European Pharmaceutical Equity Research

  • Can I ask a question about IRA Part D reform. So at face value, Astra's oral oncology business is going to face significant headwinds over the coming years as former's contribution to catastrophic cover in Part D steps up significantly. But offsetting that was also the potential for volume uplift on lower co-pays and reduced foundation support. I wonder if they could walk us through the pushes and pulls for the oncology business and whether he sees it as a meaningful net negative, something that washes its face or maybe even a net positive. And if I am allowed, Pascal. I know you said one, can I cheat Susan on TLO1, when do you expect the OS data to be mature? And will you present the PFS data before the OS data is available?

    我可以詢問有關 IRA D 部分改革的問題嗎?因此,從表面上看,Astra 的口腔腫瘤業務在未來幾年將面臨重大阻力,因為前者對 D 部分災難性保險的貢獻顯著增加。但共同支付費用降低和基金會支持減少也有可能增加銷量,從而抵消了這一影響。我想知道他們是否可以引導我們了解腫瘤學業務的推動和拉動,以及他是否將其視為有意義的淨負面影響、洗臉的東西,甚至可能是淨正面影響。如果允許的話,帕斯卡。我知道你說過,我可以在TLO1上騙Susan嗎,你預計OS數據什麼時候成熟?您會在 OS 數據可用之前提供 PFS 數據嗎?

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • So thanks, Matt. So on the IRA, it is in terms of co-pays, et cetera. I think it's probably a small positive for primary care products and a big positive or a bigger positive for oncology, not only oncology but more expensive oral medicines. And with this, I will hand over to Dave, who can comment more specifically on oncology.

    所以謝謝,馬特。所以在 IRA 上,它是在共同支付等方面。我認為這對初級保健產品可能是一個小積極因素,對腫瘤學來說可能是一個大積極或更大的積極因素,不僅是腫瘤學,而且是更昂貴的口服藥物。接下來,我將把時間交給戴夫,他可以對腫瘤學進行更具體的評論。

  • David Fredrickson - Executive Vice-President of Oncology Business Unit

    David Fredrickson - Executive Vice-President of Oncology Business Unit

  • Yes. So if we take a look at the first part, Matt, of the question, we haven't shared now for quite some time specific product level breakdown of percent of business that's within Medicare Part D, what we have shared that across the AstraZeneca complete portfolio, the 25% to 30% of it is Part D. And you're right that the oral oncolytics are above that average relative to kind of understanding the magnitude of the exposure here. So certainly, you can model out what the impact of having to pick up catastrophic looks like. I will say though that it is an important offset that comes with the ability to be able to have co-pay capped and also smoothed over the course of the year with these expensive oncologics, really the co-pay exposure that patients in Medicare plans face on the affordability is quite significant. There's no mechanism for industry to be able to help in the way that we do with programs in the commercial side of things.

    是的。因此,如果我們看一下問題的第一部分,馬特,我們已經有一段時間沒有分享 Medicare D 部分中業務百分比的具體產品級別細分了,我們在阿斯利康完整分享了這一點在投資組合中,其中 25% 到 30% 是 D 部分。您是對的,相對於理解這裡暴露的程度,口服溶瘤藥物高於平均水平。因此,當然,您可以模擬必須承受災難性後果的影響。我要說的是,雖然這是一個重要的抵消,但能夠對這些昂貴的腫瘤藥物的共同支付上限進行限制,並且在一年中也能平滑這些昂貴的腫瘤藥物,這確實是醫療保險計劃中的患者面臨的共同支付風險對承受能力的影響相當大。工業界沒有任何機制能夠像我們在商業方面的項目那樣提供幫助。

  • So while $2,000 of co-pay may be a barrier for a number of patients still within the United States, particularly within some of the elderly populations, we do think that there's an important reduction that's going to happen here. Overall, we'll have to see how much we're able to actually get patients off of free goods programs as a result of this, and we'll keep that -- we'll keep you updated on that as it unfolds, and we'll start to find out next year, actually as co-pay moves down to a $3,500 cap on January of 2024.

    因此,雖然 2,000 美元的自付額對於仍在美國境內的許多患者來說可能是一個障礙,特別是對於一些老年人口,但我們確實認為這裡將會發生重大的減少。總的來說,我們必須看看我們能夠在多大程度上真正讓患者擺脫免費商品計劃,我們將保留這一點——我們將隨時向您通報最新情況,並且我們明年就會開始知道答案,實際上,自付額上限將於 2024 年 1 月降至 3,500 美元。

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • So thanks for the question, Matt. So as you're aware, we've not indicated when the final OS analysis are going to be conducted for TLO1. When we've got -- it's an event rate driven as expected and when we've got the projected event rate we can update that. But just for you -- in the meantime, when considering the outlook and the maturity, just bear in mind that this is the second, third-line non-small cell lung cancer patient population. And unfortunately, for those patients, median OS is still not long. So with docetaxel, it's in a 10- to 12-month range is typically what you would expect. It's not hugely prolonged versus progression-free sure.

    謝謝你的提問,馬特。如您所知,我們沒有表明何時對 TLO1 進行最終操作系統分析。當我們得到——這是一個按預期驅動的事件率,當我們得到預計的事件率時,我們可以更新它。但僅對您來說 - 同時,在考慮前景和成熟度時,請記住這是第二、三線非小細胞肺癌患者群體。不幸的是,對於這些患者來說,中位 OS 仍然不長。因此,對於多西紫杉醇,其效果通常在 10 至 12 個月的範圍內,這是您所期望的。與無進展相比,它的延長時間並不算長。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • So Eric Le Berrigaud. Can I ask everybody to stick to one and not cheat. Please Eric.

    埃里克·勒貝里戈就是這樣。我可以要求大家堅持一個,不要作弊嗎?請埃里克。

  • Eric Le Berrigaud - Research Analyst

    Eric Le Berrigaud - Research Analyst

  • First was on HER3, actually as a target in ADC still continuing to see good data coming from your partners product and some physicians would like you to embark into this partnership as well. Is there any option? And are you still discussing to get access to it? And if not, are you nonetheless interested by these targets? And are you then considering doing one proprietary product with any kind of construct. And maybe if I can try a very, very short 1 in rare disease, putting together Soliris and Ultomiris until the R&D deliveries will represent probably 80% of sales for the next 2 or 3 years with some biosimilars coming in Europe first and competition growing. Can you maybe give a little bit of confidence into the ability to maintain or slightly grow self for the two together for the next 2 or 3 years?

    首先是 HER3,實際上作為 ADC 的目標,仍然繼續看到來自您的合作夥伴產品的良好數據,一些醫生也希望您也開始這種合作關係。有什麼選擇嗎?您還在討論訪問它嗎?如果沒有,您仍然對這些目標感興趣嗎?那麼您是否正在考慮製作一款具有任何類型構造的專有產品?也許如果我可以在罕見疾病中嘗試非常非常短的1,將Soliris和Ultomiris放在一起,直到研發交付量將佔未來2或3年銷售額的80%,其中一些生物仿製藥首先在歐洲上市,競爭日益激烈。您能否對兩人在未來兩三年內保持或稍微成長的能力給予一點信心?

  • Susan Mary Galbraith - EVP of Oncology Research & Development

    Susan Mary Galbraith - EVP of Oncology Research & Development

  • Thanks for the question. About the HER3, you're talking about datopotamab deruxtecan. So obviously, there's going to be some data presented at the upcoming World Congress on Lung Cancer. Obviously, we've got an ongoing clinical collaboration with Daiichi Sankyo on this as part of the ORCHARD study in patients with EGFR mutated and non-small cell lung cancer, looking in combination with osimertinib in that setting. When we're looking at ADCs in general and making some of the choices that we've made in recent business development in that space, we're looking at the overall benefit risk ratio versus what we've already got with our internal assets and already partnered assets.

    謝謝你的提問。關於 HER3,您談論的是 datopotamab deruxtecan。顯然,即將召開的世界肺癌大會上將會公佈一些數據。顯然,我們與第一三共公司就此開展了持續的臨床合作,作為針對 EGFR 突變和非小細胞肺癌患者的 ORCHARD 研究的一部分,在這種情況下尋找與奧西替尼的聯合治療。當我們總體考慮 ADC 並在該領域的近期業務發展中做出一些選擇時,我們會考慮總體收益風險比與我們已經擁有的內部資產和風險比。已經合作的資產。

  • So we'll look forward to seeing the updated clinical data both as monotherapy and in combination with osimertinib, which we get access to. And we -- I'd also just say that we're excited about our internal portfolio that's progressing. We have B7-H4 ADC. We now have the EGFR-cMET bispecific ADC and folate receptor alpha-targeted ADC or with our proprietary linker warhead with topoisomerase warhead. So these decisions are made in the context of that internal portfolio that we've got as well.

    因此,我們期待看到更新的臨床數據,無論是單一療法還是與我們可以獲得的奧希替尼聯合療法。我也想說,我們對內部投資組合的進展感到興奮。我們有 B7-H4 ADC。我們現在擁有 EGFR-cMET 雙特異性 ADC 和葉酸受體 α 靶向 ADC 或帶有拓撲異構酶彈頭的專有連接彈頭。因此,這些決策也是在我們現有的內部投資組合的背景下做出的。

  • Marc Dunoyer - CEO of Alexion & Chief Strategy Officer

    Marc Dunoyer - CEO of Alexion & Chief Strategy Officer

  • Eric, thank you for your question on the future of the C5 franchise. So if you refer only to Soliris and Ultomiris, there will be a continued growth and it will be supported by both regional expansion, but also by expansion of indications. But I want to take the opportunity to also signal or remind you of the ALXN1720, the mini-body, which is our C5 third generation, which is presently undergoing Phase III trials, which could also provide some further options to physicians and patients.

    Eric,感謝您提出有關 C5 系列未來的問題。因此,如果您僅參考 Soliris 和 Ultomiris,將會持續增長,這將受到區域擴張和適應症擴展的支持。但我想藉此機會也向您發出信號或提醒您注意 ALXN1720,迷你體,這是我們的 C5 第三代,目前正在進行 III 期試驗,這也可以為醫生和患者提供一些進一步的選擇。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • We'll take two more questions, and then we'll have to close for the day. Peter Welford, over to you, Peter.

    我們將再回答兩個問題,然後今天就結束了。彼得·韋爾福德,交給你了,彼得。

  • Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst

    Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst

  • I will just stick to one question. So we'll start with China. I wonder, given the changes that you mentioned with regards to the NRDL and some of the recent sort of reforms we've heard, just wondered AstraZeneca's attitude towards China and investment there has changed at all. I mean, recently, you've sort of cooled a little bit with the expansion of spend and investment in the country and even perhaps pulled back on some resources. Just wondering your current thoughts on investment and further investment in China from here and whether there's any change at all in how you see the longer-term market there with the changes?

    我只想回答一個問題。所以我們將從中國開始。我想知道,鑑於您提到的國家醫保目錄的變化以及我們最近聽到的一些改革,我只是想知道阿斯利康對中國及其投資的態度是否發生了變化。我的意思是,最近,隨著該國支出和投資的擴大,你有點冷靜下來,甚至可能撤回了一些資源。只是想知道您目前對中國投資和進一步投資的想法,以及您對中國長期市場的看法是否會隨著這些變化而發生任何變化?

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Let me call this one, if I may Leon, because, of course, it's going to be positive, right? Yes. I mean actually, we are very committed upturn and China is, and we remain a very important country for -- I think, for the industry, but not only for AstraZeneca. We are very committed. We are building our presence in rare diseases. We have just approved the build of a very important factory in China, in Qingdao to make inhalers for China and potentially export out of China to some emerging markets. So we are definitely committed. We have a strong R&D team. We also, as I said before, leveraging our connections to partner with local biotech companies and help them develop and commercialize their products globally. So it will remain a very important country for us, not only because we have products to sell to help patients there. And there as you know, there are lots of patients, but also because it's a source of innovation. And it is, for us, becoming -- or has become some time ago already actually a strategic center.

    如果可以的話,讓我稱之為萊昂,因為當然,這將是積極的,對吧?是的。我的意思是,實際上,我們非常致力於經濟復甦,中國也是,而且我們仍然是一個非常重要的國家——我認為,對於整個行業來說,但不僅僅是阿斯利康。我們非常致力於。我們正在加強在罕見疾病領域的業務。我們剛剛批准在中國青島建立一家非常重要的工廠,為中國生產吸入器,並可能從中國出口到一些新興市場。所以我們絕對承諾。我們擁有強大的研發團隊。正如我之前所說,我們還利用我們的聯繫與當地生物技術公司合作,幫助他們在全球開發和商業化產品。因此,它對我們來說仍然是一個非常重要的國家,不僅因為我們有產品可以銷售來幫助那裡的患者。如您所知,那裡有很多患者,而且還因為它是創新的源泉。對我們來說,它正在成為——或者在不久前實際上已經成為一個戰略中心。

  • Anything you want to add Leon?

    萊昂,你還有什麼要補充的嗎?

  • Leon Wang - Executive VP of International & China President

    Leon Wang - Executive VP of International & China President

  • Yes. I think Pascal mentioned quite completely. I think I really hope that you can pay also more attention to outside China because outside China, emerging market is larger than China now and are growing much faster. And I think there will be a lot of opportunity in untreated, undiagnosed patient opportunities there. And within China, we still have a lot of products, like biologics for (inaudible) and all these important new launches. We're still very excited and look forward. And it's a source of innovation and it's a manufacturing center, and it's also a big market.

    是的。我認為帕斯卡提到得相當完整。我想我真的希望你們也能更多地關注中國以外的地方,因為在中國之外,新興市場現在比中國更大,而且增長得更快。我認為,未經治療、未經診斷的患者將會有很多機會。在中國,我們仍然有很多產品,例如生物製劑(聽不清)以及所有這些重要的新產品。我們仍然非常興奮和期待。它是創新的源泉,是製造中心,也是一個大市場。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • That's a good point. I mean outside of China, the growth was 38% first half. So I'm sure you noticed that. Every region of the emerging market regions is growing very strongly. We've been accelerating the catching up on the approval of new products and launching them. So a lot of growth today and also to come. So maybe the last question with Hector, Berenberg.

    那是個很好的觀點。我的意思是在中國以外的地區,上半年增長了 38%。所以我確信你注意到了這一點。新興市場地區的每個地區都增長非常強勁。我們一直在加快新產品的審批和上市速度。所以今天和未來都會有很大的增長。也許最後一個問題是問赫克托、貝倫貝格。

  • Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team

    Luisa Caroline Hector - Co-Head of Global Pharmaceutical Team

  • And maybe a chance to say thank you to Mene for sharing his insights over the years and for discussions around the productivity. So Mene, maybe a question for you on that, so your slide on the breadth of platforms in place in biopharma, my question there would be that actually much of Astra's success has come from the simplicity of small molecules and antibodies. So with these novel platforms there, does it change anything in the R&D decision-making processes? I think you're at 6 hours maybe more now, but how does anything change in that decision-making given the complexities of these exciting platforms? And do they carry more risk?

    也許還有機會向梅內表示感謝,感謝他多年來分享他的見解以及圍繞生產力進行的討論。所以梅內,也許你有一個問題,所以你在生物製藥領域廣泛的平台上的幻燈片,我的問題是,實際上阿斯特拉的成功很大程度上來自於小分子和抗體的簡單性。那麼有了這些新穎的平台,它會改變研發決策過程嗎?我認為您現在可能需要 6 個小時,但是考慮到這些令人興奮的平台的複雜性,決策會發生什麼變化?它們是否會帶來更多風險?

  • Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board

    Menelas Pangalos - EVP of BioPharmaceuticals R&D and Member of External Sustainability Advisory Board

  • And the reason I wanted to show the platform is because we have been building them for a long time. And of course, monoclonal antibodies and small molecules remain a very important part of the pipeline. And you know many of the molecules that we have across the pipeline across both oncology and biopharm, but these next-generation platforms are important because the reason why we failed today predominantly is because certainly the hypothesis is wrong, as we go into more genetically validated targets, quite often, you can't target them with a monoclonal antibody or a small molecule. So having access to gene editing, oligonucleotides, advanced biologics gives you a chance to attack more complicated pharmacology and disease and hopefully improve our probability of success. And that's what we've been trying to do. So it's not that we're not interested in small molecules or biologics. I don't think our decision-making changes. It just opens up more opportunities in terms of the biology that we can attack.

    我想展示這個平台的原因是因為我們已經構建它們很長時間了。當然,單克隆抗體和小分子仍然是管道中非常重要的一部分。你知道我們在腫瘤學和生物製藥領域擁有許多分子,但這些下一代平台很重要,因為我們今天失敗的原因主要是因為假設肯定是錯誤的,因為我們進入了更多的基因驗證階段通常,您無法用單克隆抗體或小分子來靶向它們。因此,獲得基因編輯、寡核苷酸、先進的生物製劑讓您有機會攻擊更複雜的藥理學和疾病,並有望提高我們的成功概率。這就是我們一直在努力做的事情。所以這並不是說我們對小分子或生物製劑不感興趣。我不認為我們的決策會改變。它只是在我們可以攻擊的生物學方面開闢了更多機會。

  • Pascal Soriot - CEO & Executive Director

    Pascal Soriot - CEO & Executive Director

  • Such a beautiful question to finish with. Thank you for this. So we'll end the Q&A here. Thank you again for all your great interest in our company, and I wish you all a great weekend.

    這是一個美麗的問題。這次真是萬分感謝。那麼我們的問答就到此結束。再次感謝您對我們公司的極大興趣,祝大家週末愉快。