BeOne Medicines AG (ONC) 2025 Q3 法說會逐字稿

Good day everyone. Welcome to BeOne Medicines Q3 2025 earnings call webcast. (Operator Instructions)

大家好。歡迎參加BeOne Medicines 2025年第三季財報電話會議網路直播。（操作說明）

At this time, I would like to turn the call over to the company.

此時，我想把電話轉交給貴公司。

Hello and welcome. Thanks for joining us today. I'm Dan Maller, Head of Investor Relations at BeOne Medicines. Before we begin, please note that you can find additional materials, including a replay of today's webcast and presentation on the Investor Relations section of our website, ir.beonemedicines.com.

您好，歡迎光臨。感謝您今天收看我們的節目。我是 BeOne Medicines 的投資人關係主管 Dan Maller。在開始之前，請注意，您可以在我們網站 ir.beonemedicines.com 的投資者關係部分找到其他資料，包括今天網路直播和簡報的重播。

I would like to remind all participants that during this call, we may make forward-looking statements regarding, among other things, the company's future prospects and business strategy. Actual results may differ materially from those indicated in the forward-looking statements as a result of various factors, including those risks discussed in our most recent periodic report filed with the SEC. Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation.

我想提醒各位參與者，在本次電話會議中，我們可能會就公司的未來前景和業務策略等事項發表前瞻性聲明。由於各種因素，包括我們在最近向美國證券交易委員會提交的定期報告中討論的風險，實際結果可能與前瞻性聲明中指出的結果有重大差異。請仔細閱讀本簡報附帶的幻燈片中的前瞻性聲明免責聲明。

Reconciliations between GAAP and non-GAAP financial measures discussed on this call are provided in the appendix to our presentation, which is posted to our Investor Relations website along with the earnings release. All information in this presentation is as of the date of this presentation, and we undertake no duty to update such information unless required by law.

本次電話會議中討論的 GAAP 和非 GAAP 財務指標之間的調整表已在我們的簡報附錄中提供，該附錄已與收益報告一起發佈在我們的投資者關係網站上。本簡報中的所有資訊均截至本簡報發布之日，除非法律要求，否則我們不承擔更新此類資訊的義務。

Now turning to today's call as outlined on Slide 3. John Oyler, our Co-Founder, Chairman and CEO, will provide a business update; Aaron Rosenberg, CFO, will provide an update on our third quarter financial results and financial guidance; and Lai Wang, our Global Head of R&D, will discuss our R&D and pipeline progress. We will then open the call to questions. And joining the team for the Q&A portion of the call will be Xiaobin Wu, President and Chief Operating Officer; Matt Shaulis, our General Manager of North America; and Mark Lanasa, our Chief Medical Officer for solid tumors.

現在就來看看投影片 3 中概述的今天電話會議內容。我們的聯合創始人、董事長兼首席執行官 John Oyler 將介紹業務最新進展；首席財務官 Aaron Rosenberg 將介紹我們第三季度的財務業績和財務指導；我們的全球研發主管賴旺將討論我們的研發和產品線進展。接下來我們將開放提問環節。參與電話會議問答環節的還有：總裁兼營運長吳曉斌；北美總經理馬特·紹利斯；以及實體腫瘤首席醫療官馬克·拉納薩。

I'll now pass the call over to John. John?

現在我將把電話轉給約翰。約翰？

Thanks, Dan, and thank you, everyone, for joining us today. The third quarter marked another strong quarter of execution. From a financial perspective, revenue reached $1.4 billion, which represents 41% year-on-year growth. GAAP earnings per ADS were $1.09, which represents growth of more than $2 over Q3 of last year. And we generated over $350 million of free cash flow during the quarter.

謝謝丹，也謝謝各位今天蒞臨。第三季執行力依然強勁。從財務角度來看，營收達到 14 億美元，年增 41%。以美國存託憑證 (ADS) 計算，每股收益為 1.09 美元，比去年第三季增長超過 2 美元。本季我們產生了超過 3.5 億美元的自由現金流。

As Aaron will touch on, we strengthened our balance sheet and ended the quarter with over $4 billion in cash. BRUKINSA has continued its momentum with sustained US leadership, and it's now the number one BTK inhibitor globally. Sonro, our next-generation BCL2 inhibitor recently received FDA breakthrough designation in relapsed/refractory mantle cell lymphoma. And we're really excited about the totality of data emerging from that molecule, some of which we're going to highlight today.

正如 Aaron 將要提到的，我們加強了資產負債表，並在季度末擁有超過 40 億美元的現金。BRUKINSA 在美國市場持續保持領先地位，並繼續保持成長勢頭，目前已成為全球排名第一的 BTK 抑制劑。Sonro 是我們的下一代 BCL2 抑制劑，最近獲得了 FDA 授予的複發/難治性套細胞淋巴瘤突破性療法認定。我們對從該分子中獲得的全部數據感到非常興奮，今天我們將重點介紹其中的一些數據。

BRUKINSA, Sonro and our BTK CDAC are the core elements of our leadership in B-cell malignancies, and they'll be on display next month at ASH where we'll present 47 abstracts from across our heme portfolio. The quarter also yielded multiple developments across our growing solid tumor pipeline, including clinical proof-of-concept for multiple early-stage assets, which Lai's going to discuss in more detail later.

BRUKINSA、Sonro 和我們的 BTK CDAC 是我們 B 細胞惡性腫瘤領域領先地位的核心要素，它們將在下個月的 ASH 會議上展出，屆時我們將展示來自我們整個血液腫瘤產品組合的 47 篇摘要。本季度，我們在不斷增長的實體瘤產品線方面也取得了多項進展，包括多個早期資產的臨床概念驗證，賴先生稍後將對此進行更詳細的討論。

So let me start with BRUKINSA, the backbone of our heme franchise. BRUKINSA continued to perform exceptionally well in the third quarter, growing 51% and exceeding $1 billion in quarterly global revenue for the first time. As a result and also for the first time, BRUKINSA is now the global value share leader amongst the growing BTK market. This, of course, is a major milestone for BRUKINSA and for our company.

那麼，就讓我從 BRUKINSA 開始吧，它是我們血紅素特許經營的支柱。BRUKINSA 第三季持續表現出色，成長 51%，季度全球營收首次突破 10 億美元。因此，BRUKINSA 首次成為不斷成長的 BTK 市場中全球價值份額的領導者。這當然是 BRUKINSA 和我們公司的一個重要里程碑。

As I discussed in detail on our Q2 earnings call, the commercial success of BRUKINSA is not by chance. It's the direct result of an overwhelming body of evidence that has accumulated over more than a decade. It's evidence that spans preclinical human pharmacokinetics, head-to-head clinical trials real-world data sets and patient physician preference in the market.

正如我在第二季財報電話會議上詳細討論的那樣，BRUKINSA 的商業成功並非偶然。這是十多年來累積的大量證據的直接結果。證據涵蓋臨床前人體藥物動力學、頭對頭臨床試驗真實世界資料集以及患者和醫生在市場上的偏好。

The evidence is remarkable for both its strength as well as its consistency, and this evidence continues to build with each new piece of data, both reconfirming and further strengthening our initial therapeutic hypothesis that BRUKINSA is the best BTK inhibitor.

證據的強度和一致性都非常顯著，而且隨著每一個新數據的出現，證據還在不斷積累，這既再次證實了我們最初的治療假設，也進一步加強了我們最初的治療假設，即 BRUKINSA 是最好的 BTK 抑製劑。

At BeOne, we're relentlessly focused on our goal of discovering and developing innovative medicines that deliver long-term outcomes for patients. At ASH, we're presenting a 74% landmark PFS at 6 years for BRUKINSA in first-line CLL. This is from our Phase III SEQUOIA trial. We believe that these data have set the bar for what monotherapy BTK can and should be, what they should achieve in CLL.

在 BeOne，我們始終專注於發現和開發能夠為患者帶來長期療效的創新藥物。在 ASH 大會上，我們展示了 BRUKINSA 在一線 CLL 治療中 6 年無進展生存期 (PFS) 達到 74% 的里程碑式結果。這是來自我們的 SEQUOIA III 期試驗的數據。我們認為這些數據為 BTK 單藥療法能夠和應該達到的水平，以及它們在 CLL 中應該取得的成就設定了標準。

With all the caveats of cross-trial comparisons, this is double digit better than what has been reported for other single-agent BTKis at 72 months. Interestingly, this level of sustained PFS at 6 years is in the same ballpark as other recent data from BTK van fixturation regimens at only 3 years.

儘管存在跨試驗比較的所有局限性，但這比 72 個月時其他單藥 BTK 的報告結果高出兩位數。有趣的是，6 年的持續 PFS 水準與 BTK 範固定方案 3 年的其他近期數據處於同一水準。

Long-term follow-up from years 3 through 6 when patients are not on active therapy will be critically important to inform the future relevance of these regimens within the CLL treatment paradigm. And I think along those lines, what's also relevant about this year's ASH is what you're not seeing.

在患者未接受積極治療的第 3 年至第 6 年期間進行長期隨訪，對於了解這些方案在 CLL 治療模式中的未來相關性至關重要。我認為，從這個角度來看，今年 ASH 的另一個重要之處在於你沒有看到的東西。

Given what I've just said about the importance of our long-term BRUKINSA data in CLL the absence of other long-term follow-up data from many other relevant CLL trials, such as AMPLIFY with the last data cut off April 30, 2024, CAPTIVATE and ELEVATE where data hasn't been reported for a couple of years.

鑑於我剛才所說的關於 BRUKINSA 在 CLL 中的長期數據的重要性，以及許多其他相關的 CLL 試驗缺乏其他長期隨訪數據，例如 AMPLIFY（其最新數據截止日期為 2024 年 4 月 30 日）、CAPTIVATE 和 ELEVATE（這些試驗的數據已經幾年沒有報告了）。

Long-term data are the gold standard in CLL for a reason because CLL is an indolent disease, and it takes time to fully and truly understand how these regimens perform. BRUKINSA delivers the level of progression-free survival that patients and physicians should expect and should demand.

長期數據是 CLL 的黃金標準，這是有原因的，因為 CLL 是一種惰性疾病，需要時間才能充分且真正地了解這些治療方案的效果。BRUKINSA 能夠提供病人和醫生應該期望和要求的無惡化存活期水準。

We believe in the promise of fixed duration, but we also feel that the current van-based options fall far short of that promise. In our view, the current options fail to satisfy the 4 key criteria that you see on this slide, depth of response, sustained PFS, safety and convenience. Specifically, we have concerns related to the low MRD negativity rates and sustained PFS for AV combinations, the cardiac safety, uveitis and general tolerability for IV combinations.

我們相信固定期限的承諾，但我們也認為目前基於貨車的方案遠未達到這項承諾。我們認為，目前的方案未能滿足您在這張投影片上看到的 4 個關鍵標準：反應深度、持續的 PFS、安全性和便利性。具體來說，我們對 AV 聯合療法的 MRD 陰性率低和持續 PFS、IV 聯合療法的心臟安全性、葡萄膜炎和整體耐受性表示擔憂。

The long-term effects on the immune system and the related additional hospitalizations due to infections of obinutuzumab use and the overall treatment burden and feasibility of use with all of the van-based regimens. Our goal in fixed duration is simple. We aim to develop a more efficacious time-limited regimen that does not come with caveats or accommodations.

奧妥珠單抗對免疫系統的長期影響以及因感染而導致的相關額外住院治療，以及整體治療負擔和與所有萬古黴素方案聯合使用的可行性。我們在固定期限內的目標很簡單。我們的目標是開發一種更有效、有時限的治療方案，該方案不附帶任何限製或附加條件。

And based on the data we've generated to date, we believe that the combination of zanu and sonro is well on its way to achieving just that. Our confidence in ZS is based on the totality of clinical data to date, but there are a couple of key aspects in the data that we find exceptionally compelling.

根據我們迄今為止產生的數據，我們相信津巴布韋非洲民族聯盟（ZANU）和索恩羅（Sonro）的結合正在朝著實現這一目標穩步前進。我們對 ZS 的信心是基於迄今為止的全部臨床數據，但我們發現數據中有幾個關鍵方面特別令人信服。

Here, you can see the uMRD rates and the time to blood MRD from our Phase I trial. This was presented at our R&D Day in June, and we'll provide a further update on these curves at ASH. Of all the data our heme franchise is generating, these might be the most compelling to the KOLs that we meet.

在這裡，您可以查看我們 I 期試驗中的 uMRD 率和血液 MRD 檢測時間。我們在六月的研發日上展示了這些曲線，我們將在 ASH 會議上提供關於這些曲線的進一步更新。在我們血紅素產品線產生的所有數據中，這些數據可能是我們所遇到的關鍵意見領袖最感興趣的。

So let me explain. First, the combination of zanu and sonro can drive very high rates of deep response. Secondly, and perhaps more impressingly, it does so exceptionally quickly with kinetics previously unseen in other trials of drugs targeting similar mechanisms.

讓我來解釋一下。首先，zanu 和 sonro 的組合可以帶來非常高的深度反應率。其次，或許更令人印象深刻的是，它的作用速度異常快，其動力學特性在其他類似機制的藥物試驗中從未見過。

This slide is so important that we're going to show it to you twice today, once now and once in live section. This is the type of deep response that we're looking for in a fixed duration regimen to give physicians and patients the confidence to stop therapy and to achieve positive long-term outcomes.

這張投影片非常重要，所以我們今天要向你們展示兩次，一次是現在，一次是在現場簡報環節。這正是我們在固定療程中尋求的深度療效，以便讓醫生和患者有信心停止治療並取得積極的長期療效。

BeOne stands out as the only company with fully owned potentially best-in-class assets across the three foundational MOAs and CLL, BRUKINSA, sonro and our BTK CDAC. All three are anchored in differentiated design hypotheses and bolstered by an ever-growing body of evidence. All three of the potential for the broadest utility in the class. And all 3, whether as monotherapy or in combination, represent significant opportunities for patients, physicians and for our shareholders.

BeOne 是唯一一家在三個基礎 MOA 和 CLL、BRUKINSA、sonro 以及我們的 BTK CDAC 中擁有完全所有權的潛在一流資產的公司。這三者都基於不同的設計假設，並得到不斷增長的證據的支持。這三者都具備同類產品中最廣泛的應用潛力。這三種藥物，無論是作為單一療法還是聯合療法，都為患者、醫生和我們的股東帶來了巨大的機會。

Together, BRUKINSA, sonro and our BTK CDA are driving the future treatment paradigm and the $12 billion and growing global CLL market. Before I close, I'd like to introduce what we're calling our development global super highway. For those of you that are newer to our story, BeOne was built different. Early on, we recognized the vast majority of the time and cost to develop and deliver a medicine was in clinical trials. We felt that such a critical component of the biopharma supply chain should be a core competency rather than something that is outsourced to a CRO.

BRUKINSA、sonro 和我們的 BTK CDA 共同推動未來的治療模式和價值 120 億美元且不斷成長的全球 CLL 市場。在結束之前，我想介紹一下我們稱之為全球發展高速公路的計畫。對於那些不太了解我們故事的人來說，BeOne 的建立方式與眾不同。我們很早就意識到，研發和交付藥物的大部分時間和成本都耗費在臨床試驗上。我們認為，生物製藥供應鏈中如此關鍵的環節應該是核心競爭力，而不是外包給合約研究組織（CRO）的工作。

We saw the synergies that were possible by vertically integrating manufacturing with an industry-leading clinical organization. And we know from experience how hard this can be for a small company. So fast forward 15 years, and we're proud to have built a global organization of nearly 6,000 colleagues across these 2 areas: clinical development and manufacturing. And in today's hypercompetitive costly and complicated era of drug development we really believe that this global super highway is unique to BeOne, and it's critical to generating superior returns on R&D investment.

我們看到了將製造業與業界領先的臨床機構進行垂直整合所能產生的綜效。我們從經驗中知道，這對一家小公司來說有多困難。時光飛逝，15 年過去了，我們自豪地宣布，我們在臨床開發和生產這兩個領域建立了一個擁有近 6000 名同事的全球性組織。在當今競爭激烈、成本高昂且複雜的藥物研發時代，我們堅信這條全球超級高速公路是 BeOne 獨有的，對於研發投資獲得卓越回報至關重要。

To close, we're in the midst of an exciting milestone-rich period for both our heme franchise and our solid tumor pipeline. By the end of '26 we expect the initial global approval and launch of sonro and potentially pivotal data for our BTK CDAC.

最後，我們正處於血液腫瘤產品線和實體腫瘤產品線激動人心、里程碑不斷的時期。到 2026 年底，我們預計 sonro 將獲得初步的全球批准和推出，並可能獲得我們 BTK CDAC 的關鍵數據。

Our internal clinical team will be running more than 20 Phase III trials we anticipate more than 10 proof-of-concept data readouts and our research organization will advance around 10 new molecular entities into the clinic, three of which will be a heme and not just in CLL, but broadening our portfolio to help patients in other areas.

我們的內部臨床團隊將進行 20 多項 III 期試驗，預計將有 10 多項概念驗證數據公佈，我們的研究機構將推進約 10 種新的分子實體進入臨床，其中三種將是血液學藥物，不僅用於治療慢性淋巴細胞白血病 (CLL)，還將擴大我們的產品組合，以幫助其他領域的患者。

Now I'll pass it over to Aaron to provide the financial update.

現在我將把發言權交給亞倫，讓他報告財務狀況。

Thanks, John. In the third quarter, we sustained business momentum across our product portfolio with another quarter of solid execution by our global commercial teams. Product revenue reached $1.4 billion in the second quarter, representing 40% year-over-year growth. BRUKINSA global revenues eclipsed $1 billion for the first time in a quarter growing 51% driven by strong performance across all geographies.

謝謝你，約翰。第三季度，我們憑藉全球商業團隊的另一個季度穩健執行，維持了產品組合的業務成長動能。第二季產品營收達到 14 億美元，年增 40%。BRUKINSA 全球營收首次突破 10 億美元，季度成長 51%，這得益於所有地區的強勁表現。

As John mentioned, BRUKINSA is now the leading BTK globally. In the US, we grew BRUKINSA volume by approximately 40% versus Q3 2024, driven by the quality and differentiation of our long-term clinical data across all patient types. The pricing dynamics in the United States were consistent with commentary provided last quarter with a mid-single-digit pricing benefit on a year-over-year basis.

正如約翰所提到的，BRUKINSA 現在是全球領先的 BTK。在美國，由於我們針對所有患者類型的長期臨床數據的品質和差異化，BRUKINSA 的銷量比 2024 年第三季度增長了約 40%。美國的價格動態與上季提供的評論一致，年比價格上漲了中等個位數。

Meanwhile, TEVIMBRA reported a 17% increase reflecting continued market leadership in China, albeit in an increasingly competitive market environment. This growth was supplemented by early contributions from launch markets.

同時，TEVIMBRA 報告稱其銷售額增長了 17%，反映出該公司在中國市場繼續保持領先地位，儘管市場競爭日益激烈。這一增長得益於早期上市市場的貢獻。

Our in-licensed products also showed continued strength, growing 17% year-over-year, driven by growth of 31% from the Amgen in-licensed asset portfolio. We continue to see solid execution as we look at revenue from a geographic dimension. The US remains our largest market, generating $743 million with year-over-year growth of 47%.

我們的引進產品也持續保持強勁勢頭，較去年同期成長 17%，其中安進引進資產組合成長 31%。從地域角度來看，收入方面我們持續看到穩健的執行力。美國仍然是我們最大的市場，創造了 7.43 億美元的收入，年增 47%。

China revenue totaled $435 million, a 17% increase supported by TEVIMBRA and BRUKINSA market leadership and growth from our in-license assets.

中國市場收入總計 4.35 億美元，成長 17%，這得益於 TEVIMBRA 和 BRUKINSA 的市場領導地位以及我們引進資產的成長。

Europe contributed $167 million, with 71% year-over growth as we continue our launch trajectory of BRUKINSA with increased share across all major markets. And rest of world markets grew 133% and driven by market expansions and new launches.

歐洲貢獻了 1.67 億美元，年成長 71%，我們繼續推進 BRUKINSA 的上市進程，並在所有主要市場中擴大了市場份額。世界其他市場成長了 133%，這主要得益於市場擴張和新產品上市。

Now turning to the other components of our GAAP P&L. Gross margin improved to 86% from approximately 83% in the prior year. This improvement reflects the benefit from favorable product mix, price and product cost efficiencies, offset by period costs related to repositioning of our manufacturing capacity. Operating expenses grew by 11% and totaling $1.1 billion as we are investing with discipline to support our commercial growth and rapidly advance our innovative pipeline.

現在來看我們GAAP損益表的其他組成部分。毛利率從上年的約 83% 提高到 86%。這項改善反映了有利的產品組合、價格和產品成本效率的好處，但被與重新定位生產能力相關的期間成本所抵消。由於我們以嚴謹的態度進行投資，以支持我們的商業成長並快速推進我們的創新產品線，營運支出成長了 11%，總計達到 11 億美元。

I thought it's worth noting that the Q3 2024 base for R&D has higher expenses for both business development milestones plus approximately $25 million in accelerated depreciation charges. Together, this has the effect of depressing the year-over-year growth rates in our Q3 2025 R&D expense, which you can observe to a degree on the non-GAAP P&L slide, which excludes depreciation.

值得注意的是，2024 年第三季的研發基數包含了更高的業務發展里程碑支出，以及約 2,500 萬美元的加速折舊費用。綜合來看，這將導致我們 2025 年第三季研發費用年增率下降，這一點在不包括折舊的非 GAAP 損益表中可以一定程度上看出。

We continue to invest assertively to advance our most promising development candidates. Income tax expense totaled $22 million for the quarter. And altogether, net income reached $125 million, representing diluted earnings per ADS of $1.09. Our non-GAAP P&L includes adjustments for typical items with a full reconciliation provided in the appendix. Non-GAAP net income reached $304 million, reflecting an increase of $252 million compared to the previous year. This performance translates to diluted non-GAAP earnings per ADS of $2.65 for the third quarter.

我們將繼續大力投資，推動最有前景的研發項目。本季所得稅支出總計2,200萬美元。總計淨利達1.25億美元，相當於每股ADS攤薄收益1.09美元。我們的非GAAP損益表包含典型項目的調整，完整的調節表請見附錄。非GAAP淨利達3.04億美元，比前一年增加了2.52億美元。此業績轉化為第三季稀釋後的非GAAP每股ADS收益為2.65美元。

The third quarter saw a notable progress in our priority of balance sheet strength as a competitive advantage. In August, we entered into a transaction to monetize our global IMDELLTRA royalty rights, generating $885 million in cash in the quarter while allowing us to participate in the potential upside with the asset. The Royalty Pharma agreement is accounted for as a liability, and therefore, we will continue to recognize the full IMDELLTRA royalty in other revenue as it is earned while simultaneously amortizing the financing liability and interest expense, please see our 10-Q for a full description of the accounting for this transaction.

第三季度，我們在將資產負債表實力作為競爭優勢這一優先事項方面取得了顯著進展。8 月，我們達成了一項交易，將我們的全球 IMDELLTRA 特許權變現，在本季度產生了 8.85 億美元的現金，同時讓我們能夠參與該資產的潛在增值。Royalty Pharma 協議已作為負債入賬，因此，我們將繼續在其他收入中確認 IMDELLTRA 的全部特許權使用費，同時攤還融資負債和利息支出。有關此交易會計處理的完整說明，請參閱我們的 10-Q 表格。

And with our meaningful top line growth with margin expansion, we've seen a notable increase in free cash flow generation to $354 million in this quarter. Cash generation is the key metric of business sustainability, and we are very pleased with our progress on this dimension.

隨著營收顯著成長和利潤率擴張，本季自由現金流顯著增加至 3.54 億美元。現金流是衡量企業永續發展的關鍵指標，我們對這方面的進展非常滿意。

All in, Q3 ending cash and cash equivalents totaled $4.1 billion, an increase of $1.3 billion versus Q2. Moving to our 2025 financial guidance. Given our continued execution, we are updating our full year revenue guidance to be between $5.1 billion and $5.3 billion. Our gross margin guidance is unchanged, remaining in the mid- to high 80% range. And we are updating our operating expense guidance to be between $4.1 billion to $4.3 billion.

總計，第三季末現金及現金等價物總額為 41 億美元，比第二季增加了 13 億美元。接下來是我們的2025年財務指引。鑑於我們持續的執行情況，我們將全年營收預期更新為 51 億美元至 53 億美元。我們的毛利率預期保持不變，仍維持在 80% 中高段位。我們將營運支出預期更新為 41 億美元至 43 億美元之間。

We remain committed to achieving positive GAAP operating income, and we expect to generate positive free cash flow for the year. Overall, we are pleased with our execution through the first three quarters of 2025, and we remain focused on full year delivery across all financial performance measures.

我們仍致力於實現正的GAAP營業收入，並預計今年將產生正的自由現金流。總體而言，我們對 2025 年前三個季度的執行感到滿意，我們將繼續專注於全年所有財務業績指標的實現。

Now while early and staying away from providing detailed guidance, I'd like to provide some perspectives on 2026. As you consider your models for the fourth quarter of 2025 and into the first quarter of 2026, I thought it would be useful to remind you of the seasonality patterns in the US of the BTK class. This includes factors such as typical inventory increases at the end of the year, followed by normal drawdowns in January.

雖然現在談論 2026 年還為時過早，而且我也不想提供詳細的指導，但我還是想就 2026 年談談我的看法。當您考慮 2025 年第四季和 2026 年第一季的模型時，我認為有必要提醒您美國 BTK 類的季節性模式。這包括年底典型的庫存增加，以及隨後一月份的正常庫存下降等因素。

Also, just like this year, Q1 2026 will have fewer shipment gains versus a typical 13-week quarter. This is simply the nature of the calendar, but it's something that should be considered in quarterly phasing. And while we remain committed to margin expansion across our planning horizon, the pace of improvement will be measured in the near term to ensure we are investing to maximize the value of our late-stage pipeline opportunities. We look forward to providing our detailed 2026 guidance on our Q4 earnings call in February.

此外，與今年一樣，2026 年第一季的出貨量增幅將低於典型的 13 週季。這只是日曆的固有特性，但在按季度分階段進行規劃時應該考慮到這一點。雖然我們仍致力於在整個規劃期內擴大利潤率，但短期內我們將衡量改進的速度，以確保我們進行投資，從而最大限度地發揮後期研發管線機會的價值。我們期待在2月的第四季財報電話會議上提供詳細的2026年業績指引。

And with that, it seems like an excellent time to pass it over to Lai who will share more progress about our pipeline.

因此，現在似乎是把麥克風交給賴先生的好時機，他將分享更多關於我們管道建設進展的資訊。

Thank you, Aaron. Hi, everyone. Thanks for joining us today. Let me start with hematology. We have 50 abstracts, including six orals from our hematology portfolio have been accepted for presentation at ASH this year. This is a tremendous validation of the strength and the depth of our signs. I will highlight some of those key data later in my presentation.

謝謝你，亞倫。大家好。感謝您今天收看我們的節目。讓我先從血液學說起。今年，我們血液學領域的 50 篇摘要（包括 6 篇口頭報告）已被 ASH 接受展示。這極大地驗證了我們標誌的力量和深度。我將在稍後的演講中重點介紹其中一些關鍵數據。

Importantly, sonro has now received FDA breakthrough therapy designation for mental cell lymphoma. We're actively working on its first filing around the globe and our BTK integrated program has just started the Phase III head-to-head trial versus pirtobrutinib in the last refractory cell patients, a major step towards transforming the space.

重要的是，Sonro 目前已獲得 FDA 授予的治療精神細胞淋巴瘤的突破性療法認定。我們正在積極準備在全球範圍內提交首個申請，我們的 BTK 整合計畫剛剛啟動了針對最後幾例難治性細胞患者的 III 期頭對頭試驗，與 pirtobrutinib 進行對比，這是朝著改變該領域邁出的重要一步。

On the solid tumor side, our momentum continues to build. We have achieved proof-of-concept for several innovative programs, including our CDK4 inhibitor, B7-H4 ADC, PRMT5 inhibitor under GPC3x41BB bispecifics. To be noted, most of these assets have been in the clinic for less than 18 months and some less than one year, this is the level of efficiency and the focus we aim to deliver across the portfolio.

在實體瘤方面，我們的勢頭持續增強。我們已經實現了幾個創新項目的概念驗證，包括我們的 CDK4 抑制劑、B7-H4 ADC、GPC3x41BB 雙特異性抗體下的 PRMT5 抑制劑。值得注意的是，這些資產中的大多數進入臨床的時間不到 18 個月，有些甚至不到一年，這就是我們力求在整個投資組合中實現的效率和專注度。

For CDK4 we aim to initiate a Phase III trial in first-line BC in the first half of 2026. On the non- oncology side, our IRAK4 CDAC program achieved over 95%, IRAK4 protein degradation in healthy volunteers skin tissue, a clear PD proof-of-concept. We have already initiated a Phase II trial in rheumatoid arthritis.

對於 CDK4，我們的目標是在 2026 年上半年啟動第一線乳癌治療的 III 期試驗。在非腫瘤學方面，我們的 IRAK4 CDAC 計畫在健康志願者的皮膚組織中實現了超過 95% 的 IRAK4 蛋白降解，這是一個明確的 PD 概念驗證。我們已經啟動了類風濕性關節炎的 II 期臨床試驗。

Over the past few years, especially in the last 24 months, we have dramatically increased our output from the discovery engine. In that time, we have advanced 16 new molecule entities into the clinic, including 13 from our internal research team. Among them, all molecules have already achieved clinical proof-of-concept, supporting pivotal study plan. This does not count our 4 degrade program, achieving tissue PD, POC. Across the portfolio, our programs have complete R&D-enabling studies in the medium of just 10 months, well ahead of industry benchmarks.

過去幾年，尤其是最近 24 個月，我們的發現引擎的產出大幅增加。在此期間，我們已將 16 個新的分子實體推進到臨床階段，其中 13 個來自我們內部的研究團隊。其中，所有分子均已實現臨床概念驗證，並支持關鍵性研究計畫。這還不包括我們的 4 降解計劃，實現組織 PD、POC。在整個產品組合中，我們的專案在短短 10 個月內就完成了研發支援研究，遠遠領先產業基準。

Even more impressively, in 2024 and 2025, we have completed over 170 dose escalation cohorts with a median time of only 7 weeks. This level of speed and the precision is what defines BeOne. Our ability to move fast, execute flawlessly under turn innovation into impact.

更令人印象深刻的是，在 2024 年和 2025 年，我們完成了 170 多個劑量遞增隊列，中位數時間僅為 7 週。這種速度和精準度正是 BeOne 的特點。我們能夠快速行動，完美執行，將創新轉化為影響力。

Moving on to our solid tumor portfolio. An area we are very excited about and where we feel increasingly confident in several programs advance towards registration. This confidence is built on strong evolving clinical data.

接下來介紹我們的實體腫瘤產品組合。我們對此領域感到非常興奮，並且越來越有信心，多個專案正在推進註冊工作。這種信心建立在不斷更新的強有力的臨床數據之上。

First, our CDK4 inhibitor program is moving forward quickly. We plan to initiate a Phase III trial in first-line hormone receptor positive breast cancer in the first half of 2026 driven by emerging strong efficacy and the safety data from our expansion cohorts. In addition, we depriotized the Phase III development in the second-line post-CDK4/6 setting due to the evolving competitive landscape.

首先，我們的 CDK4 抑制劑計畫正在快速推進。我們計劃在 2026 年上半年啟動一線荷爾蒙受體陽性乳癌的 III 期試驗，這得益於我們擴展隊列中湧現的強大療效和安全性數據。此外，由於競爭格局不斷變化，我們降低了二線 CDK4/6 後治療領域 III 期研發的優先順序。

In that context, we decided for competitive reasons to delay the disclosure of our late-line data since it is also relevant to our dose selection in frontline. Second, our B7-H4 ADC program has completed dose escalation, and we are now conducting dose optimization studies with particularly encouraging responses seen Gynecological and endometrial breast cancers.

有鑑於此，出於競爭原因，我們決定推遲披露我們的後期治療數據，因為這些數據也與我們一線治療的劑量選擇有關。其次，我們的 B7-H4 ADC 計畫已完成劑量遞增，目前正在進行劑量優化研究，在婦科和子宮內膜乳癌方面取得了特別令人鼓舞的療效。

Third, our PRMT5i Inhibitor stands out with potentially best-in-class features, including potency, selectivity and most importantly, brain penetration. Based on the emerging Phase I data, we are now accelerating this program into frontline lung and frontline pancreatic cancer.

第三，我們的 PRMT5i 抑制劑具有同類最佳的特性，包括效力、選擇性，以及最重要的腦滲透性。根據初步的 I 期數據，我們現在正在加速推進該項目，將其應用於一線肺癌和一線胰腺癌的治療。

And finally, our GPC3 x 4-1BB bispecific has delivered a pleasant spikes, while seeing very exciting signals as monotherapy in its first in-human study in heavily pretreated HCC tumors. Altogether, this is a portfolio that is maturing quickly and backed by early clinical momentum, and we are incredibly energized by what's ahead.

最後，我們的 GPC3 x 4-1BB 雙特異性抗體在首次人體單藥治療重度預處理的 HCC 腫瘤的研究中取得了令人欣喜的療效，並顯示出非常令人興奮的信號。總而言之，這是一個發展迅速且擁有早期臨床進展勢頭的投資組合，我們對未來的發展充滿信心。

For our other solid tumor assets, we'll continue to execute and prioritize programs with the strongest potential. Our CEA ADC, EGFR x MET x MET Trispecific and the FGFR2b ADC programs are all showing encouraging early signals while continuing advancing the CDK2 Inhibitor, EGFR CDAC and the Pan-KRAS Inhibitor programs through Phase I dose aspiration studies.

對於我們其他的實體瘤資產，我們將繼續執行並優先考慮最具潛力的項目。我們的 CEA ADC、EGFR x MET x MET 三特異性抗體和 FGFR2b ADC 計畫均顯示出令人鼓舞的早期訊號，同時 CDK2 抑制劑、EGFR CDAC 和泛 KRAS 抑制劑計畫正在透過 I 期劑量探索研究繼續推進。

At the same time, based on the current data and the broad competitive landscape, we have made the strategic decision to realign the B7-H3 ADC, and Pro-IL15 programs within the portfolio. This really reflects BeOne's disciplined development strategy, focusing our resources on programs with clear differentiation and advancing them quickly to the most important value inflection point clinical POC, where we can make database decisions.

同時，根據當前數據和廣泛的競爭格局，我們已做出策略決定，重新調整產品組合中的 B7-H3 ADC 和 Pro-IL15 專案。這真正體現了 BeOne 嚴謹的發展策略，我們將資源集中在具有明顯差異化的項目，並迅速推進到最重要的價值轉折點臨床 POC，以便我們能夠做出資料庫決策。

This is how we continue to build a high-quality, high-velocity portfolio in solid tumors. Moving on to our hematology portfolio. Our sonro program is shaping up to be a potential best-in-class BCL2 inhibitor, offering greater efficacy improved safety and better convenience compared with the first-generation agents venetoclax.

這就是我們持續建立高品質、高成長的實體瘤產品組合的方式。接下來介紹我們的血液學產品組合。我們的 Sonro 計畫有望成為同類最佳的 BCL2 抑制劑，與第一代藥物維奈托克相比，它具有更高的療效、更好的安全性和更便利性。

We're now in the process of filing for approval in relapsed/refractory mantle cell lymphoma globally. And then we look forward to sharing good news very soon in this space. The most critical indication for sonro is CLL. We have completed enrollment in our Phase III trial comparing the ZS fixed duration regimen versus VO earlier this year.

我們目前正在向全球提交復發/難治性套細胞淋巴瘤的上市申請。我們期待很快能在這裡與大家分享好消息。sonro 最關鍵的適應症是 CLL。今年早些時候，我們完成了比較 ZS 固定療程方案與 VO 方案的 III 期試驗的受試者招募工作。

In addition, we plan to launch another global Phase III study in the first half of 2026. Comparing ZS versus AV and mean to establish ZS as the best oral fixed duration regimen in treatment-naive CLL.

此外，我們計劃在 2026 年上半年啟動另一項全球 III 期研究。比較 ZS 與 AV 和平均值，以確定 ZS 是否為初治 CLL 患者的最佳口服固定療程。

And finally, in 2026, we also plan to initiate a Phase III in second-line plus multiple myeloma exploring sonro-based triplet combination. Next, a quick update on the ASH presentation for sonro. What you see on this slide are 2 selected abstracts published early this week on sonro monotherpy, starting with mantle cell lymphoma in 103 relapsed/refractory patients who had power BTK inhibitor an anti-CD20 therapy.

最後，在 2026 年，我們還計劃啟動一項 III 期臨床試驗，研究基於 sonro 的三聯療法在二線及以上多發性骨髓瘤中的應用。接下來，快速更新一下關於sonro的ASH報告。您在這張投影片上看到的是本週稍早發表的 2 篇關於單一藥物治療的精選摘要，首先是關於 103 名復發/難治性套細胞淋巴瘤患者的研究，這些患者接受了強效 BTK 抑制劑和抗 CD20 療法。

So achieved an overall response rate of 53% with a medium progression-free survival of 6.5 months and a median duration of response of 15.8 months. These results look favorable compared to advanced historical data in a similar population even when van was used at 3 times of its clinical proven dose.

因此，整體緩解率為 53%，中位無惡化存活期為 6.5 個月，中位緩解持續時間為 15.8 個月。即使使用 3 倍於臨床驗證劑量的萬古黴素，與類似族群的先進歷史數據相比，這些結果看起來也很有希望。

On the CRL side, the table on the right shows the data from a single arm study of 100 patients or post BTK in factor and post-chemoimmunotherapy. Here, sonro achieved a 76% over response rate with 19% compete responses. Both the efficacy and the safety profile look quite favorable relative to advanced previous published data in a similar population. Altogether, this results reinforced sonros strong potential to be the best-in-class BCL2 inhibitor in hematological malignancies.

在 CRL 方面，右側的表格顯示了來自一項單臂研究的數據，該研究納入了 100 名患者，這些患者在接受 BTK 因子治療後或接受化療免疫治療後接受了治療。在此，sonro 的超額回應率達到了 76%，完全回應率為 19%。與先前在類似族群中發表的先進數據相比，其療效和安全性都相當令人滿意。總而言之，這些結果進一步證實了sonros具有成為血液惡性腫瘤領域最佳BCL2抑制劑的強大潛力。

In addition to the sonro monotherapy update, we are also presenting new data on the sonro combinations with Zanu under or with obinutuzumab in CLL at this year's ASH. For the ZS combination, we have more mature data as additional patients have gone through treatment. The 12 months uMRD rate has reached 92% and the most impressively with a median follow-up of 27 months to date, no patients have progressed in the 320-milligram cohort, which is truly remarkable.

除了 sonro 單藥治療的最新進展外，我們還將在今年的 ASH 大會上公佈 sonro 與 Zanu 聯合治療 CLL 的新數據，這些聯合治療可在 obinutuzumab 下進行。對於 ZS 聯合療法，由於更多患者接受了治療，我們擁有更成熟的數據。12 個月 uMRD 率已達到 92%，最令人印象深刻的是，截至目前，中位追蹤時間為 27 個月，320 毫克劑量組中沒有患者病情進展，這真是令人矚目。

For the ASH presentation, we have another data cut with additional months of follow-up showing consistent results. In terms of the safety, the profile continues to show a clear advantage compared to other fixed duration regimens. And in terms of convenience, we're very optimistic that for the vast majority of patients, only one clinical visit during the ramp up will be required for -- after (inaudible).

對於 ASH 會議報告，我們還有另一組數據，其中包含了額外的幾個月的隨訪，結果一致。就安全性而言，與其他固定療程方案相比，該方案仍顯示出明顯的優勢。就便利性而言，我們非常樂觀地認為，對於絕大多數患者來說，在過渡期只需一次臨床就診即可——之後（聽不清楚）

This is a meaningful improvement for both patients and the physicians. What's most exciting about this combination is the kinetics of the uMRD achievements, which John showed you earlier. As shown on the left, the medium time to uMRD with the ZS combination was only around 4 months after starting the combo and importantly, this is independent of IGHV mutation status by about 1 year of combination therapy. That's the dashed line on the graph, the vast majority of patients achieved uMRD in contrast with the IV combination on the right, the medium time to uMRD is 16 months for IGHV mutated and 10 months for unmutated patients.

這對患者和醫生來說都是一項意義重大的改進。這個組合最令人興奮的地方在於 uMRD 所取得的成就的動態變化，約翰之前已經向你們展示了這一點。如左圖所示，ZS 聯合療法達到 uMRD 的中位數時間僅在開始聯合療法後約 4 個月，而且重要的是，在聯合療法治療約 1 年後，這與 IGHV 突變狀態無關。圖中的虛線表示，絕大多數患者達到了 uMRD，與右側的 IV 組合相比，IGHV 突變患者達到 uMRD 的中位數時間為 16 個月，未突變患者為 10 個月。

And at the one-year mark of combo treatments, many still remain MRD positive. So overall, we believe that combining two potentially best-in-class agents, anu and sonro may provide the only true fixed duration options that delivers optimal efficacy safety and the convenience for patients with CLL in a reasonable time frame.

聯合治療一年後，許多患者仍呈現 MRD 陽性。因此，總的來說，我們認為將兩種可能一流的藥物 anu 和 sonro 結合起來，可能是唯一真正的固定療程選擇，可以在合理的時間範圍內為 CLL 患者提供最佳療效、安全性和便利性。

Now the update on our BTK CDAC, BGB-16673,16673 is the most advanced program of its kind in the clinic with clear best-In-class potential. We have initiated a head-to-head Phase III trial against the pirtobrutinib in the potentially pivotal Phase II study in (inaudible) is expected to have a data readout in the first half of 2026.

現在，我們最新的 BTK CDAC，BGB-16673，16673 是目前​​臨床上最先進的同類項目，具有明顯的同類最佳潛力。我們已啟動一項針對 pirtobrutinib 的頭對頭 III 期試驗，該試驗在可能具有關鍵意義的 II 期研究中進行（聽不清楚），預計將於 2026 年上半年公佈數據。

We're also planning a fixed duration combination Phase III study with sonro in relapsed/refractory CLL and potentially pivotal II in Waldenström's Macroglobulinemia has been initiated. We will also show new BTK CDAC data at this year's ASH meeting. The table on that showed the CLL results published in the abstract. 16673 demonstrated an over response rate of 86.4% and with medium 18 months follow-up, the 12-month progression-free survival is now mature at 79%, a very favorable profile compared with pirtobrutinib in the similar patient population.

我們也計劃進行一項針對復發/難治性 CLL 的固定療程合併治療 III 期研究，以及一項針對華氏巨球蛋白血症的潛在關鍵性 II 期研究。我們也將在今年的 ASH 會議上展示新的 BTK CDAC 數據。表格顯示了摘要中發表的 CLL 結果。 16673 例患者的超額緩解率達到 86.4%，經過 18 個月的中期隨訪，12 個月無進展生存率已達到 79%，與類似患者人群中的吡托布替尼相比，這是一個非常理想的結果。

We also reported new data in Richter's transformation on the Waldenström's Macroglobulinemia in Richter's The OR was 52% with nearly 10% complete responses. In Waldenström's, we saw 83% ORR with a 26% VGPR risk. Altogether, this data further strengthens CDAC's position as a potentially best-in-class BTK degrader across multiple B-cell malignancies.

我們也報告了 Richter 轉化治療 Waldenström 巨球蛋白血症的新數據，Richter 的 OR 為 52%，完全緩解率接近 10%。在 Waldenström 的研究中，我們看到 ORR 為 83%，VGPR 風險為 26%。總而言之，這些數據進一步鞏固了 CDAC 作為多種 B 細胞惡性腫瘤中潛在的最佳 BTK 降解劑的地位。

The robust clinical activity we observed is consistent with the preclinical data package with regard to the potency as shown on the left, we observed similar DC50 and DC90 values for 16673 and the [Nurex] molecule in head-to-head BTK-degraded assays in both human whole block cells and B-cells. And we believe 16673 holds a clear mechanistic advantage in terms of BTK mutation coverage as shown on the right, except for the A42AD mutation, 16673 can cover all other BTK mutants, whereas we observe the Nurex molecule to two resistant hotspot at Methionine 477 and Glycerine 480 resumes. The broad mutation coverage of 1673 further reinforces its best-in-class potential.

我們觀察到的強效臨床活性與臨床前資料包的效力一致，如左圖所示，我們在人類全細胞塊和 B 細胞中進行的 BTK 降解試驗中觀察到 16673 和 [Nurex] 分子具有相似的 DC50 和 DC90 值。我們相信，16673 在 BTK 突變覆蓋方面具有明顯的機制優勢，如右圖所示，除了 A42AD 突變外，16673 可以覆蓋所有其他 BTK 突變體，而我們觀察到 Nurex 分子對甲硫氨酸 477 和甘油 480 處的兩個抗性熱點恢復了作用。1673 的廣泛突變覆蓋範圍進一步鞏固了其一流的潛力。

And its ability to deliver potentially more durable responses for patients. Together, sonro and 16673 highlighted the depths, quality and the momentum of our hematology portfolio advancing rapidly towards multiple late-stage milestones and the transformation opportunities in the years ahead.

以及它為患者帶來更持久療效的能力。sonro 和 16673 共同突顯了我們血液學產品組合的深度、品質和發展勢頭，這些產品組合正迅速朝著多個後期里程碑邁進，並在未來幾年迎來轉型機會。

Finally, I'd like to share a few key milestones we are tracking for the remainder of this year and into 2026, focusing on the ones I have not mentioned earlier.

最後，我想分享我們在今年剩餘時間和 2026 年將追蹤的一些關鍵里程碑，重點是我之前沒有提到的那些。

First, for BRUKINSA, the Phase III in term analysis readout for the MAMRO study in treatment-naive mantle cell lymphoma has been delayed from the second half of this year to the first half of next year due to the slower-than-anticipated event rate.

首先，對於 BRUKINSA 公司而言，由於事件發生率低於預期，針對未經治療的套細胞淋巴瘤的 MAMRO 研究的 III 期中期分析結果已從今年下半年推遲到明年上半年。

In addition, we are anticipating accelerated approval for sonrotoclax in relapse/refractory mantle cell lymphoma and the CRO in China early next year. Important milestones as we continue to broaden access for patients globally.

此外，我們預計 sonrotoclax 在復發/難治性套細胞淋巴瘤治療中將獲得加速批准，並且明年年初將在中國獲得 CRO 批准。在我們不斷擴大全球病患就醫途徑的過程中，取得了重要的里程碑。

Turning to our early stage pipeline. We're anticipating POCs for CDAC before the year-end and the other assets in 2026. We look forward to sharing more data in future updates.

接下來，我們來看看早期研發管線。我們預計在年底前完成 CDAC 的概念驗證，並在 2026 年完成其他資產的概念驗證。我們期待在未來的更新中分享更多數據。

And with that, I will turn the call back to John.

接下來，我將把電話轉回給約翰。

Thanks, lii. We'll now open the call to Q&A. Please limit the number of questions to ensure we have time to hear from as many attendees as possible. Operator, please go ahead.

謝謝，lii。現在進入問答環節。請盡量減少提問數量，以便我們有時間聽取盡可能多的與會者的意見。操作員，請開始。

(Operator Instructions)

（操作說明）

Yaron Werber, Cowen and Company

亞倫韋伯 (Yaron Weber)、考恩公司

All right, well, terrific. Hopefully you can hear me. Congrats, really nice quarter. I'm going to violate the rule right away. Just two quick questions. Number one, BRUKINSA's the global leader. You're obviously a little bit behind in Europe in terms of when you launched any sense and when new territories are coming in to accelerate that?

好的，太棒了。希望你能聽到我說話。恭喜，季度業績非常出色。我馬上就要違反這條規則了。問兩個問題。第一，BRUKINSA是全球領導者。顯然，你們在歐洲的業務拓展方面有點落後，無論是在推出任何產品的時間上，還是在開拓新市場加速發展方面？

And then secondly, Life for the CDAC data in the first half next year in CLL for the potentially support accelerated approval, can you give us a sense of what to expect there? And sort of how mature is the PFS is going to be? Thank you.

其次，關於明年上半年 CDAC 數據在 CLL 治療中可能支持加速審批的情況，您能否讓我們了解一下預期結果？PFS（無惡化存活期）的成熟度究竟如何？謝謝。

Right. So Xiaobin, do you want to start?

正確的。小斌，你想開始嗎？

Yes. In Europe, we grow for BRUKINSA are tremendously, so close to 70%. And we notified in Europe in some country like Germany, Austria, AMPLIFY launched. And we don't see much excitement among the (inaudible) and the company may actively switch the mono acala to AMPLIFY. But so far, we have not -- we see some prescription, but not extremely a lot prescription. Therefore, the total acala in Europe, if you see the number, is flattening.

是的。在歐洲，我們為 BRUKINSA 的成長非常顯著，接近 70%。我們已通知歐洲一些國家，例如德國、奧地利，AMPLIFY 已正式上線。我們沒有看到（聽不清楚）方面有太大的興奮，而且該公司可能會積極地將單聲道acala切換到AMPLIFY。但到目前為止，我們還沒有看到——我們看到了一些處方，但處方並不多。因此，如果你看一下這個數字，你會發現歐洲的阿卡拉總數正在趨於穩定。

So regarding to the CDAC data, and this is a single-arm study, so likely to be based on the ORR as well as the DOL. So depending on the first discussion with the agency, as usually, it will be probably about 12 months after the last patient.

因此，關於 CDAC 數據，這是一項單臂研究，所以很可能是基於 ORR 和 DOL。因此，根據與機構的第一次討論，通常情況下，可能在最後一位患者之後大約 12 個月。

Great. Next question.

偉大的。下一個問題。

Reni Benjamin, Citizens Bank.

雷尼‧班傑明，公民銀行。

Hey, good morning, guys. Thanks for taking the questions and Congratulations on another amazing quarter. Would love to just focus on the earlier stage pipeline a little bit. You had mentioned proof-of-concept data. Can you maybe provide a little bit more color as to what you're seeing with some of these other assets? And should we be thinking that all these would likely progress to Phase III trials moving forward?

嘿，各位早安。感謝您回答問題，並祝賀您又一個季度取得了令人矚目的成績。我想稍微專注於早期階段的流程。您之前提到過概念驗證資料。您能否更詳細地描述一下您在使用其他素材時所看到的情況？我們是否應該認為所有這些研究都有可能進入 III 期臨床試驗？

And if I can sneak one in, is there a teaser you could provide regarding the 10 new molecular entities that you're filing next year? Is there a novel target that you're most excited about? Thanks.

如果可以的話，能否透露一下您明年將要提交的 10 個新分子實體的相關資訊？有沒有哪個新目標讓你特別興奮？謝謝。

God, we wish that science worked in a way where everything worked. But Lai, why don't you answer that question?

上帝啊，我們多麼希望科學能讓一切朝著好的方向發展。但是賴，為什麼不回答這個問題呢？

I'll probably refer to Mark because he is in the frontline for all this data, Mark?

我可能會請馬克幫忙，因為他負責所有這些數據的第一線工作，對吧，馬克？

Thank you, Lai. Thank you, Reni what I would say is that for all of our early programs, we established very clear criteria of what success looks like based upon the preclinical data what are we looking for in terms of PK, PD, safety and ultimately, efficacy? If you think back to the slide that Lai showed where he talked about where the different programs stand.

謝謝你，賴。謝謝Reni，我想說的是，對於我們所有的早期項目，我們都根據臨床前數據制定了非常明確的成功標準，即我們在藥物動力學、藥效學、安全性和最終療效方面尋找什麼？回想一下賴先生展示的那張幻燈片，他在幻燈片中談到了各個項目的現狀。

I think you can think about that as some of those programs are meeting all of those criteria, the four of CDK4, PRMT5, B7-H4, GPC3, and therefore, we're actively planning acceleration to Phase III studies and program growth. Others, we continue to wait for data. And we believe that we'll have the data to make the final determination for both of the programs in the first half of '26.

我認為你可以這樣理解，因為其中一些項目符合所有這些標準，即 CDK4、PRMT5、B7-H4 和 GPC3 這四個項目，因此，我們正在積極計劃加速推進 III 期研究和項目發展。其他方面，我們仍在等待數據。我們相信，在 2026 年上半年，我們將獲得足夠的數據，對這兩個項目做出最終決定。

Yeah. Then in terms of the new molecular entities we are going to bring to clinic next year. I'm going to use the GPC3 4-1BB as an example. To be honest, among the program we took into the clinic last year, that certainly was not the most exciting one for us based on the preclinical data. But certainly, we are very pleased with what we have seen in the clinic today.

是的。接下來，我們來看看明年要引進臨床的新分子實體。我將以 GPC3 4-1BB 為例。坦白說，在我們去年帶入臨床的計畫中，根據臨床前數據來看，這絕對不是我們最感興趣的項目。但可以肯定的是，我們對今天在診所看到的情況非常滿意。

So I'm not going to say which one is the most exciting one for us in the next year, but we're certainly looking forward to bring more. Just want to emphasize one more thing. What you have seen from BeOne is really just the beginning, what you can see from our really prolific discovery engine.

所以我不會說明年對我們來說最令人興奮的是哪一項，但我們當然期待著推出更多。我還要強調一點。您從 BeOne 看到的只是個開始，您還可以從我們高效的發現引擎中看到更多。

All right, next question, please.

好的，請問下一個問題。

Andrew Berens, Leerink Partners. Please unmute your line and ask your question.

安德魯貝倫斯，Leerink Partners。請解除靜音並提出您的問題。

Hi, thanks, and let me give my congratulations on the progress and execution for the quarter. I think with Aaron's question, you answered one of the ones I had because Astra in their earnings release today did highlight the fixed duration AMPLIFY regimen getting traction in Europe, but it sounds like you guys have not seen a lot of that yet.

您好，謝謝，也請容許我祝賀您本季的進展和執行成果。我認為你回答了 Aaron 的問題，也解答了我的一個疑問，因為 Astra 在今天發布的財報中確實強調了固定期限的 AMPLIFY 療法在歐洲獲得了認可，但聽起來你們還沒有看到很多相關案例。

So I just wanted to confirm that that's what you said. And then a question on the PRMT5 program. It's still expected by year-end. Just wondering, I know you mentioned the first-line PDAC and non-small cell lung cancer opportunity. Just wondering how you think of combination partners for those settings? Thanks.

我只是想確認一下，你是不是就是這麼說的。然後是一個關於 PRMT5 程序的問題。預計仍將在年底前完成。我只是好奇，我知道您提到第一線治療胰腺導管腺癌和非小細胞肺癌的機會。想問您對這些情況下的組合夥伴有什麼看法？謝謝。

Yeah. I confirm and the -- so Ocala market share and also the revenue in the last 3 months are pretty stable in Germany and not increasing -- of course, with AMPLIFY approval and the fixed duration of AMPLIFY will be added to the respective guideline. This may give some plus for [Acala]. But overall, in Europe and also in Germany, the Acala total data flattening.

是的。我確認，Ocala 在德國的市佔率以及過去 3 個月的收入都相當穩定，沒有成長——當然，隨著 AMPLIFY 的批准，AMPLIFY 的固定期限將被添加到相應的指導方針中。這或許會帶來一些好處。[阿卡拉]。但總體而言，在歐洲，包括德國，Acala 總數據趨於平緩。

Mark, do you want to take the second part?

馬克，你想參加第二部分嗎？

So we, as you heard, are very excited about our PRMT5 molecule. That's only been in the clinic since January of this year. But given its high potency and CNS penetration, we're now seeing objective responses across multiple tumor types, including both lung and pancreatic cancer as well as additional tumor types. And critically, given its high selectivity, we're also seeing a very favorable safety profile that we think will enable combinations, which will be key to unlocking the potential of this mechanism.

正如你所聽到的，我們對我們的 PRMT5 分子感到非常興奮。那台設備從今年一月才開始在診所使用。但鑑於其高效性和對中樞神經系統的滲透性，我們現在看到多種腫瘤類型都出現了客觀反應，包括肺癌和胰腺癌以及其他類型的腫瘤。至關重要的是，鑑於其高選擇性，我們也看到了非常有利的安全性，我們認為這將能夠實現組合，這將是釋放該機制潛力的關鍵。

And therefore, we're advancing into frontline to combine with current standards of care. We do not yet have the data, but it is our expectation that we'll be able to combine with chemotherapy and PD-1 in non-small cell lung cancer and standard of care chemotherapy in frontline pancreatic cancer, and we'll look for similar development opportunities in early lines of other tumor types with frequent MTAP deletion.

因此，我們正在向一線推進，以結合當前的護理標準。我們目前還沒有相關數據，但我們預計能夠將這種療法與化療和 PD-1 聯合用於非小細胞肺癌，與一線胰腺癌的標準治療化療聯合使用，並且我們將在其他 MTAP 缺失頻繁發生的腫瘤類型的早期治療中尋找類似的開發機會。

Okay, thanks. Any belief that maybe combining with some of the selective agents might work in certain mutations like RAS mutations.

好的，謝謝。有人認為，與某些選擇性藥物合併使用可能對某些突變（如 RAS 突變）有效。

So we are very interested in RAS biology. Our pan-KRAS molecule is advancing through Phase I. We discussed at R&D Day a commitment to bring multiple additional RAS targeting molecules into the clinic. So certainly, in pancreatic cancer, for example, we will ultimately look to combine PRMT5 with KRAS. So again, the aspiration given potency and selectivity is that we should be able to combine with whatever is the appropriate additional therapies for that patient given the disease state and any other concurrent mutations.

所以我們對RAS生物學非常感興趣。我們的泛KRAS分子正在推進I期臨床試驗。在研發日上，我們討論了將多種其他RAS靶向分子推進臨床試驗的計畫。因此，例如在胰臟癌中，我們最終肯定會考慮將 PRMT5 與 KRAS 結合。因此，鑑於其效力和選擇性，我們的期望是能夠根據患者的疾病狀態和任何其他伴隨突變，將其與任何適當的附加療法相結合。

Okay, thank you. Congrats again.

好的，謝謝。再次恭喜。

Yigel Nochomovitz, Citigroup.

Yigel Nochomovitz，花旗集團。

Hi. Can you hear me? Okay. Great. This one is for Lai or Mark. Maybe. Could you give a little more detail on the design of the CDK4, Phase III in terms of what you can say at this point about the control arm, the size of the study, anything on the powering? And also what are the doses that are the final contenders for that study?

你好。你聽得到我嗎？好的。偉大的。這則訊息是給賴或馬克的。或許。您能否更詳細地介紹一下 CDK4 第三階段的設計，例如目前您能透露的關於對照組、研究規模、電源等方面的資訊？此外，該研究最終入圍的劑量方案為何？

Please go ahead, Mark.

請繼續，馬克。

Thank you, Yigel. So at R&D Day, we talked about the 3 dose levels that are being explored in our expansion phase, 240, 400 and 600. We've completed enrollment of our frontline cohorts. And we're very excited with the data as they're coming in.

謝謝你，伊格爾。所以在研發日上，我們討論了在擴展階段正在探索的 3 個劑量水平，即 240、400 和 600。我們已經完成了一線人員的招募工作。我們對目前得到的數據感到非常興奮。

We are seeing a high response rate that we think will justify as initiation of a Phase III study the core hypothesis with the molecule is that having a more selective CDK4 inhibitor will be superior to currently available CDK4/6 inhibitors.

我們看到了很高的回應率，我們認為這足以證明啟動 III 期研究的合理性。該分子的核心假設是，具有更具選擇性的 CDK4 抑制劑將優於目前可用的 CDK4/6 抑制劑。

And therefore, we're intending a head-to-head study we're still waiting for data to make final decisions around study size and powering, but we certainly should be able to share those details in the near future as we move towards a Phase III study start by the end of the first half of next year.

因此，我們計劃進行一項頭對頭研究，目前仍在等待數據以最終決定研究規模和統計效力，但隨著我們朝著明年上半年末開始的 III 期研究邁進，我們肯定能夠在不久的將來分享這些細節。

Okay. And then I think Lai mentioned the new Phase III ZS versus AV. I was just wondering regarding the rationale around that. I was under the impression you kind of already knew the conclusion there that ZS was better? So I'm just curious as to the rationale for that additional investment to further prove that point.

好的。然後我想賴先生提到了新的第三階段 ZS 與 AV 的對比。我只是好奇背後的原因。我以為你已經大致知道結論了，那就是ZS比較好？所以我很好奇，追加投資的理由是什麼，以進一步證明這一點。

Please go ahead, Wang.

請繼續，王先生。

Yeah. Thank you for the question, and we agree with your comments. But we felt this is important to establish ZS as really the best oral fixed duration regimen. So we picked the one which likely will be approved soon by FDA, the AV regimen. We do have a lot of confidence in term for this particular study.

是的。感謝您的提問，我們同意您的觀點。但我們認為這對於確立 ZS 作為真正最佳的口服固定療程方案至關重要。所以我們選擇了很可能很快就會獲得 FDA 批准的 AV 療法。我們對這項研究的預期結果非常有信心。

Yeah. I think if I just elaborate a little bit on that, we encourage everyone to look frequently at the CLL data, especially the long-term data that we've presented but still people will say, well, there's no head-to-head study against Acala versus [Xanab]. And still, people will discount the body and wealth of information that's there. And I think when you look at the data and you talk to the top KOLs, I think at this point, with this long-term data, it's very clear.

是的。我想再詳細解釋一下，我們鼓勵大家經常查看CLL數據，特別是我們已經公佈的長期數據，但仍有人會說，目前還沒有Acala與CLL的直接比較研究。[阿那布]。然而，人們仍然會忽視那裡存在的資訊量和資訊量。我認為，當你查看數據並與頂級 KOL 交談時，我認為，就目前這些長期數據而言，這一點非常清楚。

But nonetheless, there's always someone who says there's not direct head-to-head. And I think this commercially is helpful, and it's helpful to bridge that information gap help educate people more quickly. I mean just when we're looking at that space, the long-term data, it's meaningfully different with all the cross trial comparison.

但即便如此，總有人會說這之間沒有直接的正面較量。我認為這在商業上是有幫助的，而且有助於彌合資訊差距，幫助人們更快地接受教育。我的意思是，當我們檢視這個領域，檢視長期數據時，就會發現所有交叉試驗的比較都有顯著差異。

As we said, it's double-digit different. look at the PFS, look at the OS data. It's impressive, but we still get that comment in a small portion of the population around the globe. So we just think, it's important to do this so we can ensure that everyone is getting the best medicine and the best regimen. So we're committed to doing it.

正如我們所說，兩者相差兩位數。看看 PFS，看看 OS 資料。這令人印象深刻，但我們仍然會在全球一小部分人群中聽到這樣的評論。所以我們認為，這樣做很重要，這樣才能確保每個人都能得到最好的藥物和最好的治療方案。所以我們決心要做這件事。

Great. Thank you.

偉大的。謝謝。

Leonid Timashev, RBC.

列昂尼德·蒂馬舍夫，RBC。

Hey guys, thanks for taking my question. I just want to ask maybe on some of the commercial dynamics you're seeing outside of the early line setting in CLL and maybe more in the relapsed/refractory setting is how is BRUKINSA share holding up or growing there? And then ultimately, how do you expect the mix of a degrader BRUKINSA and covalent inhibitors to play in the future there? Thanks.

各位好，感謝你們回答我的問題。我想問一下，在 CLL 早期治療之外，尤其是在復發/難治性治療領域，您觀察到的一些商業動態是怎麼樣的？ BRUKINSA 在這些領域的市佔率如何？是保持穩定還是成長？最後，您認為降解劑 BRUKINSA 和共價抑制劑的組合在未來會如何發揮作用？謝謝。

Sure. Matt, please.

當然。馬特，拜託了。

Sure, happy to address that. Yes, we continue to see strong new patient start share across the lines of therapy, including in that relapse setting. And then as we've discussed in the past, we're really confident in our overall CLL franchise leadership strategy.

當然，我很樂意解答這個問題。是的，我們看到各種治療方案的新患者起始率持續強勁成長，包括復發治療方案。正如我們過去討論過的，我們對 CLL 特許經營的整體領導策略非常有信心。

You made reference to the multiple mechanisms that are in our portfolio. And as you've heard from John, we continue to have confidence in our BTK mono due to our head-to-head superiority with another BTK and our best-in-class profile. Including PFS, safety and tolerability in the long-term setting that John mentioned.

您提到了我們產品組合中的多種機制。正如約翰所說，我們仍然對我們的 BTK 單聲道耳機充滿信心，因為我們在與另一款 BTK 耳機的直接對比中表現出了優勢，並且我們擁有同類最佳的性能。包括約翰提到的長期療效、安全性和耐受性。

We also see an opportunity for therapy that will include zanu plus sonro. We've spoken before about the requirements for therapy there. And we're confident in a really strong MRD PFS safety and tolerability profile, but also in the convenience that sonro can bring to that regimen.

我們也看到了一種將包含zanu加sonro的療法的機會。我們之前已經討論過那裡的治療要求。我們對 MRD PFS 的安全性和耐受性非常有信心，同時也對 sonro 能為這個治療方案帶來的便利性充滿信心。

So of course, we see the future opportunity for fixed duration with zanu plus sonro. But right now, we're confident in monotherapy. Of course, when it comes to the degrader we see a clear opportunity there in later lines of therapy. I'm sure you're familiar with resistance mutations that can happen in those earlier lines, and we have the confidence to do a head-to-head superiority study for the degrader versus pure dose. So we see a strong opportunity across patient types in the cross lines of therapy in CLL.

所以，我們當然看到了Zanu Plus Sonro未來固定期限投資的機會。但就目前而言，我們對單一療法充滿信心。當然，就降解劑而言，我們看到了在後續治療中存在著明顯的機會。我相信您一定了解早期品系中可能出現的抗性突變，我們有信心對降解劑與純劑量進行直接比較的優效性研究。因此，我們看到在 CLL 的交叉治療中，不同類型的患者都有很大的機會。

Next question, please.

下一個問題。

Sean Laaman, Morgan Stanley.

肖恩拉曼，摩根士丹利。

Good morning, everyone. And hope you're all well. Just to go back on the CDK4 inhibitor, just to maybe throw some meat on the bones around the decision not to pursue later lines and to go for first line. And then also just to confirm, are we still going to see some data at San Antonio and what do you hope to present at that forum? Thank you, Mark.

各位早安。希望你們一切都好。只是想重新啟用 CDK4 抑制劑，或許是為了進一步論證不進行後續治療而選擇第一線治療的決定。另外，我想確認一下，我們是否還能在聖安東尼奧看到一些數據？您希望在那個論壇上展示哪些內容？謝謝你，馬克。

Thank you very much, Sean. Yes. So again, what we're seeing in our expansion cohorts is a very strong emerging response rate. We are waiting for data maturity. Now in the context of the strength of that data and also importantly, the context of emerging data externally, so there are a number of new agents that are leading to both fragmentation in the second-line as well as an increasing bar for success in second-line.

非常感謝你，肖恩。是的。所以，我們在擴展隊列中再次看到的是非常強勁的新興回應率。我們正在等待數據成熟。現在，考慮到這些數據的強大之處，以及更重要的，外部不斷湧現的數據，出現了許多新的參與者，這既導致了二線市場的碎片化，也提高了二線市場成功的門檻。

We always view the second-line opportunity as a transitional opportunity for this molecule and the key study as the frontline study. So given this external dynamic and our strong internal data, we made the decision to deprioritize second-line and to accelerate frontline.

我們始終將二線治療機會視為該分子的過渡機會，而將關鍵研究視為第一線治療研究。鑑於這種外部動態和我們強大的內部數據，我們決定降低二線建設的優先級，加速第一線建設。

And again, we're very much looking forward to that study. Currently, we then subsequently made the decision that we would not share the second-line data this year San Antonio. We think those data are relevant to our dose level selection for Phase III in frontline and we, therefore, will not have data for this molecule at the San Antonio, but look forward to sharing data at a future venue that will -- should we say substantiate our plans for the Phase III study in frontline.

我們非常期待這項研究。目前，我們隨後決定今年不會分享聖安東尼奧的二線數據。我們認為這些數據與我們一線治療 III 期臨床試驗的劑量水平選擇相關，因此，我們不會在聖安東尼奧會議上公佈該分子的相關數據，但期待在未來的會議上分享這些數據，這些數據將——或者說，將證實我們一線治療 III 期臨床試驗的計劃。

Great. Thank you. And one quick follow-up just on zani plus sonro versus [V plus O]. So Phase IIIs are recruited earlier this year. What's sort of the signpost pathway or the map going forward in terms of future announcements around that trial?

偉大的。謝謝。最後再快速跟進一下關於zani plus sonro vs[V 加 O]。因此，第三階段的受試者招募工作將在今年稍早進行。就該試驗的未來公告而言，大致的指引方向或路線圖是什麼？

Lai, do you want to answer that, please?

賴女士，請問您願意回答這個問題嗎？

Yes. So to me, in that particular study is a PFS events-driven studies, as you can imagine, with the control arm using the vial, it's really good therapy as well. So it would take a little bit of time to get into the PFS readout at the same time, we are also monitoring the uMRD rate, this will be something we can probably take an earlier look at.

是的。所以在我看來，那項特定的研究是一項以 PFS 事件為驅動的研究，正如你所想，對照組使用小瓶，那也是一種非常好的療法。因此，要獲得 PFS 讀數還需要一些時間，同時，我們也在監測 uMRD 率，這可能是我們可以更早查看的內容。

Wonderful. Thank you.

精彩的。謝謝。

Jessica Fye, JP Morgan.

潔西卡費伊，摩根大通。

Hey guys, good morning. Thanks for taking my question. I have one on the EGFR targeted assets. I guess what in particular makes you say that the EGFR cMET product goes in the promising bucket, whereas the EGFR CDAC is in the still exploring bucket. Is that based on clinical data? Or if not, can you just elaborate on kind of how you segment of those. Thank you.

嘿，各位，早安。謝謝您回答我的問題。我有一個關於EGFR靶向資產的案例。我想問的是，是什麼讓您認為 EGFR cMET 產品屬於有前景的範疇，而 EGFR CDAC 仍處於探索階段？這是基於臨床數據嗎？如果不行，您能否詳細說明一下您是如何將這些類別劃分的？謝謝。

Sure, Mark, please go ahead.

當然可以，馬克，請繼續。

Sure. Thank you, Jess. So we have a number of different EGFR targeted therapies that are moving forward. And as I mentioned earlier, for each program based upon the preclinical evidence, we have expectations of what we would like to see for the molecule initially in terms of PK and safety, but ultimately in terms of efficacy. So what we're seeing from the EGFR MET-MET Trispecific, though it's very early days in dose escalation is that we are seeing clinically meaningful responses with that agent.

當然。謝謝你，傑西。因此，我們有許多不同的 EGFR 標靶療法正在推進中。正如我之前提到的，對於每個基於臨床前證據的項目，我們最初對該分子的藥物動力學和安全性以及最終的療效都有期望。所以，儘管 EGFR MET-MET 三特異性藥物的劑量遞增還處於非常早期的階段，但我們目前看到的是，該藥物已經產生了具有臨床意義的反應。

With the EGFR degrader, we continue through dose escalation. We've had some tumor regressions. We're happy with the PK and the safety profile. We simply need more data maturity. It's important to highlight that these are 2 totally different mechanisms of action, and therefore, our expectations for what we would expect from each molecule are somewhat different.

使用 EGFR 降解劑，我們繼續進行劑量遞增試驗。我們發現有些腫瘤有消退。我們對PK值和安全性都很滿意。我們只需要提高資料成熟度。需要強調的是，這是兩種完全不同的作用機制，因此，我們對每種分子的作用預期也略有不同。

Thank you.

謝謝。

Clara Dong, Jefferies.

克拉拉‧董，傑富瑞。

Hi, good morning. Can you guys hear me?

您好，早安。你們聽得到我說話嗎？

Yes.

是的。

Yes, we can hear you.

是的，我們能聽到你們的聲音。

Now we can't hear you.

現在我們聽不到你的聲音了。

Can you still hear me? Congrats on the quarter. So you talked about the seasonality for the entire BTKi class. So just wonder how the seasonality dynamics differ across key regions in the US, Europe and the rest of the world as well. And then just looking at the time line for sonro and the BTK CDAC entering the market, sonro expected to file for MCL in the US this year and BTK CDAC could have a pivotal readout next year in CRL.

你還能聽到我說話嗎？恭喜你本季取得佳績。所以你談到了整個 BTKi 課程的季節性。所以我想知道美國、歐洲以及世界其他主要地區的季節性動態有何不同。然後，從 Sonro 和 BTK CDAC 進入市場的時間表來看，Sonro 預計將於今年在美國提交 MCL 申請，而 BTK CDAC 明年可能會在 CRL 方面取得關鍵性進展。

So is this the right understanding that potentially BTK CDAC that can be approved first in CLL in the US? And how do you anticipate this influencing physician sequencing strategy across B-cell malignancies special in CLL? Thank you.

那麼，BTK CDAC 有可能率先在美國獲準用於治療 CLL 嗎？這種理解是否正確？您認為這會對 B 細胞惡性腫瘤（尤其是 CLL）的醫生治療策略產生怎樣的影響？謝謝。

Great, so Aaron, go into Lai.

很好，那亞倫，去賴府吧。

Great, thanks for the questions, Clara. Great. Thanks for the questions, Clara. So as I said in my prepared remarks, I just wanted to reinforce as you think about your models, the seasonality patterns, this is really a focus in the US where we typically do see inventory builds across the sector in the fourth quarter and then that unwinds to a degree in the first quarter. And then we did reference back to the same calendar issues that we experienced in '25 also in '26.

太好了，謝謝你的提問，克拉拉。偉大的。謝謝你的提問，克拉拉。正如我在準備好的發言稿中所說，我只想強調，在你們思考模型時，季節性模式確實是一個重點，這在美國尤其如此，我們通常會在第四季度看到整個行業的庫存增加，然後這種情況會在第一季度有所緩解。然後，我們在 2025 年遇到的日曆問題，在 2026 年也再次出現。

Globally, you see that to a lesser effect in our business in China, Q4 is typically a relatively lighter quarter by comparison. But given the magnitude and import in terms of percentage of revenue, for BRUKINSA in the US, we thought it was really important to highlight as you think about rolling over your models from '25 to '26.

在全球範圍內，儘管對我們在中國的業務影響較小，但第四季通常是一個相對清淡的季度。但考慮到其規模和對美國 BRUKINSA 收入百分比的重要性，我們認為在您考慮將 2025 年車型更新到 2026 年車型時，強調這一點非常重要。

So I can hand it over to Lai.

這樣我就可以把它交給賴了。

Aaron, you're correct. In terms of in the US as well as probably use out of that -- CDAC is likely to get the CLL approval probably ahead of the sonro, but that's not the case in China. In China, we already filed the (inaudible) for the CLL, which we're also anticipating approval early next year.

亞倫，你說得對。就美國的情況以及可能在其他地區使用的情況而言——CDAC 可能會比 sonro 更早獲得 CLL 批准，但在中國情況並非如此。在中國，我們已經提交了 CLL 的（聽不清楚）申請，我們也預計明年年初會獲得批准。

In terms of sequence of the therapy, we view that CDAC can provide a really broad coverage in terms of patients who had BTK inhibitor. As shown actually in one of the slide in today's presentation, this really covers pretty much everything except maybe one mutation. So we do believe this is probably at this moment based the level evidence is positioned very well in the later line therapies after the COVID and BTK inhibitor.

就治療順序而言，我們認為 CDAC 可以為接受 BTK 抑制劑治療的患者提供非常廣泛的覆蓋。正如今天簡報中的一張投影片所示，這幾乎涵蓋了所有內容，可能只漏掉了一種突變。因此，我們認為，就目前的證據水平而言，這可能是 COVID 和 BTK 抑制劑之後的後續療法中非常有利的一步。

Great. Thank you.

偉大的。謝謝。

Michael Schmidt, Guggenheim Partners.

麥可‧施密特，古根漢合夥公司。

Oh, hey, thanks for taking my question. I just had another bigger picture question around the CLL market. As you noted in the slides, I mean it sounds like the AMPLIFY regimen has moderate uptake. But fixed duration treatment will clearly be part of the CLL treatment landscape longer term, including your own combination. And so I was just wondering how you think about how that might impact the overall size of the CLL market, the BTK inhibitor market longer term?

哦，嘿，謝謝你回答我的問題。我還有一個關於慢性淋巴球白血病市場更宏觀的問題。正如你在幻燈片中提到的那樣，我的意思是，AMPLIFY 療法的接受度似乎還不錯。但從長遠來看，固定療程治療顯然將成為 CLL 治療方案的一部分，包括您自己的聯合治療方案。所以我想知道您認為這可能會對 CLL 市場的整體規模，以及 BTK 抑制劑市場的長期發展產生什麼樣的影響？

And then just a clarification on seasonality, Aaron. I know you made some comments around inventory in stocking at the end of the year. But then when I look at guidance, it seems like the top line the higher end, the top end of the range for revenue could be achieved with almost only flat Q-on-Q growth. And so was just wondering if there's anything else going on in 4Q that we should be aware of?

亞倫，關於季節性，我還需要澄清一下。我知道你對年底的庫存盤點問題發表了一些評論。但當我查看業績指引時，似乎營收目標（即營收範圍的上限）只需季度環比成長幾乎持平即可實現。所以我想知道第四季還有沒有其他我們應該注意的事情？

So maybe I'll start with a quick answer around that. As I laid out earlier in this long-term PFS really matters. You have 6 years of follow-up for data matters. These are cancer patients and you don't want progression there's no area outside of CLL I've seen where people talk about, let's take a regimen where you give up years of milestone PFS.

那我先就此簡單回答一下。正如我之前所闡述的，長期 PFS 真的非常重要。你有 6 年的數據後續追蹤期。這些都是癌症患者，你不希望病情惡化。除了慢性淋巴球白血病（CLL）之外，我還沒看過有人討論過，讓我們接受一種治療方案，放棄數年的里程碑式無惡化存活期（PFS）。

You just don't see that. Whether it's van-based fixturation treatments or other BTKs or [Porto], really all options beside chemo, they look pretty decent at 2 to 3 years. And there just isn't enough time to understand the durability and the outcome for patients. BRUKINSA consistently shows best long-term patient outcomes in CLL.

你就是看不到這一點。無論是基於貨車的固定治療，還是其他 BTK 或 [Porto]，實際上除了化療之外的所有選擇，在 2 到 3 年內看起來都相當不錯。而且根本沒有足夠的時間來了解其持久性和對患者的療效。BRUKINSA 在 CLL 患者中始終表現出最佳的長期治療效果。

It's why it's the standard of care, and it's why it's the global leader. The more follow-up we show as we're doing at ASH, the more differentiated it looks. The 6-year data in CLL in first-line and second-line and in all high-risk subgroups, the story is the same, the best long-term outcomes for patients. It's 6 years follow-up, 74% PFS rate for BRUKINSA in first-line CLL.

這就是為什麼它是護理行業的標準，也是為什麼它是全球領導者。我們像在 ASH 會議上一樣進行更多後續跟進，結果就越能體現出差異化。6 年的 CLL 一線和二線治療數據以及所有高風險亞組數據都表明，患者獲得了最佳的長期療效。6 年追蹤結果顯示，BRUKINSA 一線治療 CLL 的 PFS 率為 74%。

When you COVID-adjust this at 77%, our OS is 84%, 88% COVID-adjusted. In ELEVATE TN, Acalus PFS is 62%, and their OS is 76% at the same time period. In second-line and deletion 17p, it's the same story. Unparalleled median PFS from Alpine and our SEQUOIA Deletion 17P data shows that BRUKINSA works very well in high-risk patients. It's just not the case with the other options.

如果將 COVID 調整為 77%，我們的作業系統為 84%，COVID 調整後為 88%。在 ELEVATE TN 研究中，Acalus 的 PFS 為 62%，同期 OS 為 76%。第二行和第 17p 行的刪除也是相同的情況。來自 Alpine 的無與倫比的中位 PFS 和我們的 SEQUOIA 17P 缺失數據表明，BRUKINSA 對高風險患者非常有效。但其他選項並非如此。

And we're still reporting our follow-up data because it tells the story. Where is the other data? Where is the long-term data from ELEVATE? Where is it from CAPTIVATE. Where is it from AMPLIFY.

我們仍在報告後續數據，因為它能說明問題。其他數據在哪裡？ELEVATE的長期數據在哪裡？它是出自 CAPTIVATE 嗎？它來自 AMPLIFY 嗎？

It's very noticeable, it's not being reported. And with respect to Porto it's 18 months of follow-up in second-line CLL it's not even close to being long enough. And as we've mentioned, 2 to 3 years, you just can't differentiate yet.

這件事非常明顯，但卻沒有人報道。至於波爾圖的研究，對於二線 CLL 患者來說，18 個月的追蹤時間遠遠不夠長。正如我們之前提到的，2到3年的時間裡，你還無法分辨。

And I think from that perspective, we're extremely confident in both the short term. And when we talk about long term, the really exciting thing is this desire to have fixed duration treatments. It's a great thing if you can get there. And so far, it does look like SC is going to be unlike anything we've seen yet. It's too early to be sure. There's not enough long-term follow-up data for that either, but the early data looks noticeably different than anything we've seen before. So we're really, really excited about that.

我認為從這個角度來看，我們對短期前景非常有信心。當我們談到長期治療時，真正令人興奮的是人們對固定療程的渴望。如果你能去那裡，那真是太好了。目前看來，SC 的確會與我們之前見過的任何遊戲都截然不同。現在下結論還為時過早。目前還沒有足夠的長期後續數據，但早期數據看起來與我們以前見過的任何情況都有明顯不同。所以我們對此真的非常非常興奮。

Now maybe I'll jump to Aaron to answer some of the other parts of that question.

現在或許我可以請 Aaron 來回答這個問題的其他部分了。

Yeah, thanks. Obviously, there's tremendous opportunity across the franchise as we think about where we're participating today in a $12 billion in growing market, whether you look at it from either a BTK space or an overall CLL space. To your question on the guidance, we did reinforce the seasonality really to make sure we support dialing in your modeling in that regard, given the history. We feel really confident on our execution over the course of the year.

嗯，謝謝。顯然，在我們思考如今參與的這個價值 120 億美元的不斷增長的市場時，整個特許經營領域都蘊藏著巨大的機遇，無論你是從 BTK 領域還是從整個 CLL 領域來看。關於您提出的指導問題，我們確實強調了季節性因素，以確保我們能夠支持您在這方面調整模型，考慮到歷史經驗。我們對全年的執行情況非常有信心。

As you referenced, we've taken up the bottom of our range from where we started we started the year at 4.9% to 5.3%, and now we're at 5.1% to 5.3%, showing increased confidence and really the great execution from our global teams. As you said, if you annualize the current quarter run rate and you think about the next quarter, we feel that the range that we provided is certainly within our expectations. The import of the seasonality common is really specific to the United States, and we want to make sure that, that perspective is really incorporate. Thank you.

正如您所提到的，我們已經從年初的 4.9% 到 5.3% 的區間下限回升到 5.1% 到 5.3%，這表明我們信心增強，也體現了我們全球團隊的出色執行力。正如您所說，如果將當前季度的運行率按年計算，再考慮下一個季度，我們認為我們提供的範圍肯定在我們的預期之內。季節性普遍現象的重要性在美國確實很突出，我們希望確保這種觀點能真正融入其中。謝謝。

There are no further questions at this time. I will turn the call over to John Oyler for closing remarks.

目前沒有其他問題了。我將把電話交給約翰·奧伊勒，請他作總結發言。

All right. Thank you all. I would like to point out that a few weeks ago, BeOne celebrated our 15 anniversary as a company. It's very hard to believe that in this relatively short period of time we've been able to become one of the leading oncology companies in the world.

好的。謝謝大家。我想指出的是，幾週前，BeOne慶祝了公司成立15週年。很難相信，在相對較短的時間內，我們已經能夠成為世界領先的腫瘤公司之一。

I'd really like to think that this is because, as you heard today, were driven by scientific excellence, exceptional speed, and a relentless drive to provide the best long-term outcomes for patients. And on behalf of everyone here at BeOne, I'd really like to thank the broader oncology community including the patients, their families, the clinicians, our employees and all of you who have been with us for the journey.

我真心希望這是因為，正如你們今天所聽到的，我們秉持著科學卓越、速度超群以及為患者提供最佳長期療效的不懈追求。我謹代表 BeOne 的全體成員，衷心感謝更廣泛的腫瘤學界，包括患者、他們的家人、臨床醫生、我們的員工以及所有一路陪伴我們的人。

We truly believe that together, we are how the world stops cancer, and we're just getting started. So thank you again for your time today and your thoughtful questions. Have a great day.

我們堅信，團結一致，我們就能戰勝癌症，而這只是個開始。再次感謝您今天抽出時間並提出如此有見地的問題。祝你有美好的一天。