BeOne Medicines AG (ONC) 2026 Q1 法說會逐字稿

Good day, everyone. Welcome to BeOne Medicines Q1 2026 earnings call webcast. (Operator Instructions) At this time, I would like to turn the call over to the company.

各位好。歡迎收看百濟神州（BeOne Medicines）2026 年第一季財報電話會議網路直播。(接線員指示) 現在，我想把電話交給公司方。

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.

大家好，歡迎各位。感謝今天加入我們。我是 Dan Maller，百濟神州投資人關係主管。在開始之前，提醒各位可在我們網站 ir.beonemedicines.com 的投資人關係專區找到更多資料，包括今日網路直播的重播與簡報。

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.

我想提醒所有與會者，在本次電話會議中，我們可能會作出前瞻性陳述，內容可能包括公司未來展望與商業策略等。

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 periodic -- recent periodic report filed with the SEC. Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation.

由於各種因素，實際結果可能與前瞻性陳述所示有重大差異，包括我們向美國證券交易委員會（SEC）提交的最近一期定期報告中所討論的風險。也請仔細閱讀本簡報投影片中所附的前瞻性陳述免責聲明。

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 IR website, along with our 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.

本次電話會議所討論之 GAAP 與非 GAAP 財務衡量指標之調節表，已載於簡報附錄；該簡報與我們的財報新聞稿一併發布於投資人關係網站。本簡報中的所有資訊均以簡報當日為準，除非法律要求，否則我們不承擔更新該等資訊之義務。

Now turning to today's call.

現在進入今天的會議內容。

As outlined on Slide 3, John Oyler, our Co-Founder, Chairman and CEO, will provide a business update. Aaron Rosenberg, our CFO, will provide an update on our first quarter financial results and 2026 guidance. And Lai Wang, President and Global Head of R&D; will discuss our R&D and pipeline progress.

如投影片第 3 頁所示，我們的共同創辦人、董事長兼執行長 John Oyler 將提供業務最新進展。我們的財務長 Aaron Rosenberg 將更新第一季財務結果與 2026 年展望。研發總裁暨全球研發負責人王來（Lai Wang）將討論研發與產品線進展。

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, General Manager of North America; Mark Lanasa, Chief Medical Officer for solid tumors; and Amit Agarwal, Chief Medical Officer for hematology.

接著我們將開放提問。在問答環節加入團隊的還包括：營運總裁兼營運長吳曉濱（Xiaobin Wu）、北美總經理 Matt Shaulis、實體腫瘤首席醫學官 Mark Lanasa，以及血液腫瘤首席醫學官 Amit Agarwal。

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

現在我把電話交給 John。John？

Thank you, Dan, and welcome, everyone, and thank you for your time today. We entered 2026 with tremendous momentum and our Q1 performance reflects strong execution across the business and a very solid start to the year.

謝謝你，Dan，也歡迎各位，感謝大家今天撥冗參與。我們以強勁動能進入 2026 年，而第一季表現反映出我們在各項業務上的有力執行，為今年打下非常穩健的開局。

From a financial perspective, we achieved significant product revenue growth and GAAP earnings per ADS. These results underpin our confidence to raise our 2026 revenue guidance range by $100 million as Aaron will discuss later.

從財務角度來看，我們實現了顯著的產品營收成長以及按 GAAP 計算的每 ADS 盈餘。這些成果支撐我們有信心將 2026 年營收指引區間上調 1 億美元，Aaron 稍後會進一步說明。

Our foundational haematology franchise consisting of BRUKINSA, sonro and our BTK CDAC is rapidly progressing with approvals, launches and key pivotal trial milestones expected in the near term.

我們以血液腫瘤為基礎的核心產品組合，包括 BRUKINSA、sonro 以及我們的 BTK CDAC，正隨著核准、上市與關鍵樞紐性試驗里程碑的推進而快速前進，近期可望迎來多項重要進展。

Both our heme franchise and our solid tumour pipeline will be on display at ASCO and EHA, where we have over 60 acceptances.

我們的血液腫瘤產品組合與實體腫瘤產品線將在 ASCO 與 EHA 會議上亮相，我們共有超過 60 項摘要獲得接受。

At ASCO, we will present proof-of-concept data from three exciting solid tumour programs moving into late-stage clinical trials, which Lai will tell you more about shortly.

在 ASCO 上，我們將發表三項令人振奮、正邁入後期臨床試驗的實體腫瘤計畫之概念驗證（proof-of-concept）數據，Lai 稍後會為各位做更詳細的介紹。

I'll begin today by highlighting the exceptional commercial and clinical progress of BRUKINSA, which has firmly established itself as the foundational BTK inhibitor. BRUKINSA continued its global leadership in the growing BTK market with first quarter sales of $1.1 billion, representing growth of 38%. We are seeing strong performance in all markets and all indications.

我今天先從 BRUKINSA 卓越的商業與臨床進展談起；它已穩固確立為基礎性的 BTK 抑制劑。BRUKINSA 在成長中的 BTK 市場持續保持全球領先，第一季銷售額達 11 億美元，年增 38%。我們在所有市場與所有適應症上都看到強勁表現。

BRUKINSA's large, consistent and expanding body of clinical and real-world evidence has elevated the benchmark for what is possible in CLL. We believe that the data shows that only BRUKINSA provides the long-term outcomes that patients and physicians should expect and should demand.

BRUKINSA 大量、一致且持續擴增的臨床與真實世界證據，已將 CLL 可達成的標準提升到新的高度。我們相信，數據顯示只有 BRUKINSA 能提供病患與醫師應該期待、也應該要求的長期療效結果。

From its inception, BRUKINSA was designed to provide the best-in-class 24/7 BTK inhibition. Our hypothesis was that achieving complete and sustained BTK inhibition would result in a superior therapeutic profile and that has been borne out in the almost seven years since, which I'll cover in the next few slides.

自一開始，BRUKINSA 的設計目標就是提供同級最佳、全天候（24/7）的 BTK 抑制。我們的假設是，達成完全且持續的 BTK 抑制將帶來更優異的治療特性；而在過去將近七年的時間裡，結果也證實了這一點，我將在接下來幾張投影片中說明。

At ASH 2025 BRUKINSA set a new standard in frontline CLL with six year progression-free survival reported at 74% and overall survival of 84%.

在 ASH 2025，BRUKINSA 於初治 CLL 樹立新標準：報告顯示六年無惡化存活率（PFS）為 74%，總存活率（OS）為 84%。

Adjusting for COVID, those are 77% for PFS and 87% for OS at seven years. CLL is an indolent disease and admittedly, much of the data across the various medicines for the first three years looks similar, but outcomes beyond this are what truly matter to patients.

若將 COVID 影響調整後，七年 PFS 為 77%，OS 為 87%。CLL 是一種進展緩慢的疾病，坦白說，各種藥物在前三年的許多數據看起來相近，但三年之後的結果才是真正對病患重要的。

So this slide builds on the scatter plot, but focuses on the landmark reported PFS at years three through six across Phase III trials in frontline CLL. On the left, we see the data for BRUKINSA and the two continuous BTK inhibitors.

因此，這張投影片延續散點圖的概念，但聚焦於初治 CLL 的第三期試驗中，第 3 年到第 6 年所報告的里程碑（landmark）PFS。左側呈現 BRUKINSA 與兩款持續給藥的 BTK 抑制劑的數據。

Recognizing the limitations of cross-trial comparisons, the early landmark PFS rates for BRUKINSA are higher and continue to diverge over time.

我們理解跨試驗比較的限制，但 BRUKINSA 在早期里程碑 PFS 的比率更高，且隨時間推移差距持續擴大。

In year six, that reaches a delta of 12%, the equivalent of one in eight patients not progressing. On the right, we see an even more pronounced delta between BRUKINSA's landmark PFS and that of fixed duration regimens such as VO.

到第 6 年，差距達到 12%，相當於每 8 位病患中就有 1 位未出現疾病進展。右側則可看到 BRUKINSA 的里程碑 PFS 與固定療程方案（例如 VO）之間更為明顯的差距。

In year six, that's a delta of 21% or roughly one in five patients. In the unmutated population, which is the majority of CLL patients, the difference between continuous BRUKINSA and VO is 27%, which is more than one in four patients who started the study.

在第 6 年，差距為 21%，約等於每 5 位病患中就有 1 位。在未突變族群（占多數 CLL 病患）中，持續使用 BRUKINSA 與 VO 的差距為 27%，也就是超過每 4 位起始入組的病患中就有 1 位。

Now AbbVie has not reported the long-term landmark PFS data to be fully represented on this chart. But I will note that despite AMPLIFY being studied in a young fit population, which has a median age of 61 versus SEQUOIA's median age of 70. It has the lowest PFS of any regimen at three years.

目前 AbbVie 尚未公布長期里程碑 PFS 數據，因此無法在此圖表中完整呈現。但我要指出的是，儘管 AMPLIFY 研究是在年輕且體能較佳的族群中進行，其中位年齡為 61 歲，而 SEQUOIA 的中位年齡為 70 歲。AMPLIFY 在三年時的 PFS 卻是所有方案中最低的。

The last AMPLIFY data cut was April 30, 2024, over two years ago. An additional follow-up data has not been provided though. Of course, it exists. BRUKINSA is the only BTK inhibitor that has demonstrated superiority on efficacy versus ibrutinib in a head-to-head trial.

AMPLIFY 上一次數據截點為 2024 年 4 月 30 日，距今已超過兩年。但之後的追蹤數據尚未提供。當然，這些數據是存在的。BRUKINSA 是唯一在頭對頭試驗中，於療效上證明優於伊布替尼（ibrutinib）的 BTK 抑制劑。

Here, we can see the Kaplan-Meier curves from BRUKINSA and the other BTK inhibitors in their respective head-to-head trials versus ibrutinib in relapsed/refractory BTK naive CLL patients. BRUKINSA demonstrated superiority with a hazard ratio of 0.69 and a p-value of 0.001.

在這裡，我們可以看到 BRUKINSA 與其他 BTK 抑制劑在各自針對復發／難治、且未曾接受 BTK 治療之 CLL 病患，與伊布替尼進行頭對頭試驗的 Kaplan-Meier 曲線。BRUKINSA 以風險比（hazard ratio）0.69、p 值 0.001 證明具優越性。

When we presented the initial early cut of these data to the CLL community, the universal feedback was, this is great. But in an indolent disease, we need to see longer follow-up.

當我們向 CLL 社群首次呈現這些數據的早期截點時，普遍回饋是：這很棒。但對於一種進展緩慢的疾病，我們需要看到更長期的追蹤。

And there was an important scientific reason for that. Ibrutinib has known tolerability issues that could potentially influence the patient's ability to stay on the therapy during early treatment. In the ELEVATE-RR study, acalabrutinib had previously showed early PFS separation from ibrutinib, but that early separation was not sustained.

而這背後有一個重要的科學原因。Ibrutinib 已知存在耐受性問題，可能會影響患者在治療早期持續用藥的能力。在 ELEVATE-RR 研究中，acalabrutinib 先前顯示相較於 ibrutinib 的 PFS 在早期出現分離，但這種早期分離並未持續。

As you can see in the middle panel, acalabrutinib actually crossed over and became numerically worse than ibrutinib at roughly 33 months and reported a hazard ratio of one and again, while early separation was an encouraging signal, CLL prescribers wanted to see with BRUKINSA sustained separation with longer follow-up to be convinced.

如同你在中間圖所見，acalabrutinib 實際上在約 33 個月時出現交叉，數值上變得比 ibrutinib 更差，且報告的風險比為 1；同樣地，儘管早期分離是一個令人鼓舞的訊號，CLL 處方醫師仍希望看到 BRUKINSA 在更長期追蹤下能維持分離，才會信服。

You can see that in ALPINE, BRUKINSA showed exactly that. After these data were presented, the adoption of BRUKINSA began in earnest. Pirto with a very short follow-up period of only 18 months shows the weakest early separation versus ibrutinib with a hazard ratio of 0.845 and a p value of 0.4102.

你可以看到在 ALPINE 研究中，BRUKINSA 正是展現了這一點。在這些數據發表後，BRUKINSA 的採用開始真正加速。Pirto 在僅 18 個月的非常短追蹤期下，顯示相較於 ibrutinib 最弱的早期分離，風險比為 0.845，p 值為 0.4102。

The CLL community needs to see much longer follow-up data from pirto. But given this curve, pirto may face challenges demonstrating statistical superiority on PFS.

CLL 社群需要看到 pirto 更長期的追蹤數據。但就這條曲線而言，pirto 可能會在證明 PFS 具統計學優越性方面面臨挑戰。

So what about tolerability? Pirto is self-described as a third-generation BTK inhibitor, with the hope that it would be more tolerable than the second-generation covalent BTK inhibitors. In reality, the BRUIN-314 study, Pirto demonstrated numerically more adverse events leading to discontinuation than ibrutinib.

那耐受性呢？Pirto 自稱為第三代 BTK 抑制劑，期望其耐受性優於第二代共價 BTK 抑制劑。但實際上，在 BRUIN-314 研究中，Pirto 顯示導致停藥的不良事件在數值上多於 ibrutinib。

This is important because it has potential ramifications for use in specific subgroups such as older patients. Notably, in the BRUIN-313 trial in first-line CLL, the average age of patients randomized to pirto was 65 years old, roughly five years younger than the respective first-line trials for both of the second-generation covalent BTKis.

這點很重要，因為它可能對特定亞族群（例如高齡患者）的使用帶來影響。值得注意的是，在一線 CLL 的 BRUIN-313 試驗中，隨機分派至 pirto 的患者平均年齡為 65 歲，約比兩項第二代共價 BTKi 的各自一線試驗年輕 5 歲。

But taken together, pirto's limited follow-up, lack of differentiation on efficacy and tolerability over ibrutinib and its mechanistic rationale designed for covalent BTKi resistance do not support moving it from the relapsed setting, where it currently plays a much-needed role.

但綜合而言，pirto 的追蹤期有限、在療效與耐受性上相較 ibrutinib 缺乏差異化，以及其機轉設計主要針對共價 BTKi 抗藥性，並不支持將其從目前在復發情境中扮演迫切所需角色的定位，移往更早期的治療線別。

BRUKINSA's comprehensive body of evidence continues to expand. It consistently is supporting it as the foundational best-in-class BTK inhibitor.

BRUKINSA 的完整證據體系仍在持續擴充。這些證據一貫支持其作為同類最佳、奠基性的 BTK 抑制劑。

Last quarter, we highlighted three published studies that illustrate BRUKINSA's efficacy and safety benefits over the existing fixed duration regimens, VO, IV and AV and at ASCO will present new evidence from over 58,000 real-world patient data sets, each of which demonstrate the significant real-world benefits of BRUKINSA.

上季我們重點介紹了三項已發表研究，說明 BRUKINSA 相較於現有固定療程方案（VO、IV 與 AV）的療效與安全性優勢；並且在 ASCO 將發表來自超過 58,000 份真實世界患者資料集的新證據，每一份都顯示 BRUKINSA 顯著的真實世界效益。

While BRUKINSA's momentum as the foundational BTK continues, we're aggressively moving to redefine the fixed duration treatment landscape with our next-generation foundational BCL-2 inhibitor, sonro.

在 BRUKINSA 作為奠基性 BTK 的動能持續之際，我們也正積極推進，透過下一代奠基性 BCL-2 抑制劑 sonro，重新定義固定療程的治療版圖。

We intentionally designed sonro to be 14times more potent and 6x more selective than venetoclax and with a much shorter half-life to minimize drug accumulation. This differentiated profile may enable a simpler ramp-up compared to the burdensome monitoring that is required by the first-generation agent.

我們刻意將 sonro 設計為較 venetoclax 強效 14 倍、選擇性高 6 倍，且半衰期更短，以降低藥物累積。這種差異化特性，可能使其相較第一代藥物所需的繁重監測，能採用更簡化的劑量遞增（ramp-up）方式。

The trial studying this optimized ramp-up schedule is progressing well. Sonro's first approvals are as monotherapy but its true transformative potential lies in combination with BRUKINSA.

研究此一最佳化劑量遞增時程的試驗進展順利。Sonro 的首批核准適應症將以單藥治療為主，但其真正具變革性的潛力在於與 BRUKINSA 聯合使用。

The clinical data that we're generating with the combination of BRUKINSA and sonro is truly exciting. In the 101 trial shown here, ZS demonstrated a uMRD rate of above 90%, a remarkably flat PFS curve and a favourable safety profile.

我們正在產生的 BRUKINSA 與 sonro 聯合治療臨床數據確實令人振奮。在此處所示的 101 試驗中，ZS 顯示 uMRD 比率超過 90%、PFS 曲線非常平坦，且安全性概況良好。

This compares very favourably with AV on the right, where in a much healthier, younger population, they saw uMRD of only 34%. We look forward to sharing updated data from this trial at ASCO.

這與右側的 AV 相比非常有利；在一個更健康、年齡更輕的族群中，他們的 uMRD 僅為 34%。我們期待在 ASCO 分享此試驗的更新數據。

With three Phase studies underway, the ZS combination has the potential to change the first-line CLL treatment paradigm and enable BeOne to participate in half of the market where today we have no presence.

目前已有三項第三期研究進行中，ZS 聯合方案有潛力改變一線 CLL 的治療典範，並使 BeOne 能參與目前我們尚未涉足、約占一半的市場。

Finally, I want to highlight the progress of our BTK CDAC, a novel potential therapy for patients who have progressed on other treatments. Our BTK CDAC is first-in-class. It shows complete BTK degradation and it holds a clear mechanistic advantage in terms of BTK mutation coverage.

最後，我想強調我們的 BTK CDAC 的進展，這是一種新穎的潛在療法，適用於在其他治療後仍出現疾病進展的患者。我們的 BTK CDAC 為同類首創（first-in-class）。它可實現完全的 BTK 降解，並在 BTK 突變覆蓋方面具備明確的機轉優勢。

Data presented at ASH 2025 showcased its profound efficacy in heavily pretreated patients, including those with mutations conferring resistance to both covalent and non-covalent BTK inhibitors. In our Phase I/II study, the patients receiving the recommended 200-milligram dose achieved an outstanding 94.4% overall response rate with responses deepening consistently over time.

在 ASH 2025 發表的數據展示了其在重度既往治療患者中的顯著療效，包括帶有同時對共價與非共價 BTK 抑制劑產生抗藥性之突變的患者。在我們的第一/二期研究中，接受建議劑量 200 毫克的患者達到卓越的 94.4% 總反應率，且反應隨時間推移持續加深。

Based on the strong efficacy and favourable safety profile of the molecule, we're advancing a highly ambitious clinical development plan, including several Phase III trials that are well underway.

基於該分子強勁的療效與良好的安全性概況，我們正推進一項高度積極的臨床開發計畫，其中包含多項已在順利進行中的第三期試驗。

We've guided to a potentially accelerated approval submission in the US relapsed/refractory CLL in the second half of this year. In summary, our foundational haematology franchise has never been stronger. BRUKINSA is driving continued global revenue growth.

我們已指引，預計於今年下半年在美國就復發/難治性 CLL 提交可能的加速核准申請。總結而言，我們的核心血液腫瘤產品組合從未如此強勁。BRUKINSA 正推動全球營收持續成長。

Sonro is poised to disrupt the fixed duration market, and our BTK CDAC is leading the next wave of innovation in CLL. Only BeOne is uniquely equipped to provide the best-in-class therapies for every CLL patient regardless of their stage of disease.

Sonro 蓄勢待發，將顛覆固定療程市場，而我們的 BTK CDAC 正引領 CLL 下一波創新浪潮。只有 BeOne 具備獨特能力，能在不論疾病分期的情況下，為每一位 CLL 患者提供同類最佳的治療。

We're looking forward to ASCO and EHA this year, where we will have a large leadership presence highlighting our foundational medicines in heme and our three rising stars from the solid tumour portfolio, which Lai will tell us more about shortly.

我們期待今年的 ASCO 與 EHA；屆時我們將有強大的領導團隊出席，重點展示我們在血液腫瘤領域的奠基性藥物，以及實體腫瘤產品組合中的三顆新星，Lai 稍後會進一步說明。

With that, I'll pass it over to Aaron to provide our financial update.

接下來，我把時間交給 Aaron，為大家提供我們的財務更新。

Thanks, John. In Q1, we sustained strong business momentum across our product portfolio. Product revenue reached $1.5 billion in the quarter, representing 34% year-over-year growth. BRUKINSA global revenues totalled $1.1 billion, with strong growth and performance across all approved markets and indications. In the US, BRUKINSA Q1 sales were $761 million, principally driven by volume growth of approximately 28% versus Q1 2025.

謝謝，John。在第一季，我們在整體產品組合上維持強勁的業務動能。本季產品營收達 15 億美元，年增 34%。BRUKINSA 全球營收合計 11 億美元，在所有已核准市場與適應症均展現強勁成長與表現。在美國，BRUKINSA 第一季銷售額為 7.61 億美元，主要由銷量成長所驅動，較 2025 年第一季約成長 28%。

The US saw a mid-single-digit pricing benefit on a year-over-year basis with nonrecurring gross to net favourability of approximately $20 million in the period.

美國市場在年對年基礎上獲得中個位數的價格效益，且本期因一次性毛利到淨額（gross-to-net）有利因素，帶來約 2,000 萬美元的貢獻。

Excluding these items, we continue to expect relatively stable pricing in 2026, consistent with prior commentary. Q1 results reflect the typical seasonality patterns seen across the BTKi class, including inventory dynamics and one fewer shipping week in the first quarter.

排除上述項目後，我們仍預期 2026 年定價將相對穩定，與先前評論一致。第一季結果反映 BTKi 類別常見的季節性型態，包括庫存動態，以及第一季少了一週出貨週的影響。

The business performed nicely relative to our range of expectations for the quarter with increasingly positive demand signals in March, which have carried through to April.

本季業務表現優於我們對該季度的預期區間，且 3 月出現愈發正面的需求訊號，並延續至 4 月。

We are confident around performance in the US for the year, and this is reflected in our guidance update. Meanwhile, TEVIMBRA reported a 20% increase with sustained market leadership in China despite the competitive environment.

我們對今年美國市場的表現充滿信心，這也反映在我們更新後的財測指引中。同時，儘管競爭環境激烈，TEVIMBRA 在中國仍維持市場領導地位，並錄得 20% 的成長。

We are pleased with contributions from launch markets with approximately half of the growth for TEVIMBRA coming from markets outside of China. In-licensed and other products also showed continued strength, growing 27% year-over-year including robust performance from our Amgen in-licensed portfolio.

我們對上市市場的貢獻感到滿意，TEVIMBRA 的成長約有一半來自中國以外的市場。引進授權（in-licensed）及其他產品亦持續展現強勁動能，年增 27%，其中包括我們自 Amgen 引進授權產品組合的亮眼表現。

XGEVA continued to perform very well in the quarter with $90 million of revenue. Of note, we did see several biosimilar entrants filed for approval in April, which could lead to enhanced competition for XGEVA. We are pleased with the early market reception for sonrotoclax, our foundational next-generation BCL-2 inhibitor approved in China for post-BTKi CLL/SLL and relapsed/refractory MCL. We continue our solid execution across all geographies.

XGEVA 本季持續表現非常出色，營收達 9,000 萬美元。值得注意的是，我們確實看到數個生物相似藥申請於 4 月送件審批，這可能導致 XGEVA 面臨更激烈的競爭。我們對 sonrotoclax 的早期市場反應感到滿意；這是我們具基礎性、次世代的 BCL-2 抑制劑，已在中國獲批用於 BTKi 治療後的 CLL/SLL 以及復發/難治性 MCL。我們在所有地區持續穩健執行。

The US remains our largest market, generating $766 million with year-over-year growth of 36%. China revenue totalled $465 million, a 17% increase compared to the first quarter of 2025, of which 5% was driven by foreign exchange.

美國仍是我們最大的市場，營收 7.66 億美元，年增 36%。中國營收合計 4.65 億美元，較 2025 年第一季成長 17%，其中 5% 由外匯因素帶動。

We continue to see good performance and sustained leadership from TEVIMBRA and BRUKINSA. Europe contributed $191 million, representing growth of 64%. Foreign exchange contributed approximately 11% of this growth given euro strengthening on a year-over-year basis.

我們持續看到 TEVIMBRA 與 BRUKINSA 的良好表現與穩固領先地位。歐洲貢獻 1.91 億美元，成長 64%。由於歐元相較去年同期走強，外匯因素約貢獻了其中 11% 的成長。

We continue to drive demand growth for BRUKINSA in Europe in all major markets, and there remains plenty of opportunity to increase brand share, given BRUKINSA's differentiated long-term data across all patient types.

我們持續在歐洲所有主要市場推動 BRUKINSA 的需求成長；鑑於 BRUKINSA 在各類患者族群上具差異化的長期數據，仍有很大機會提升品牌市占。

While the AV combination has yet to achieve broad market reimbursement, we have observed BCL-2 BTKi fixed-dose treatments gaining traction in some early markets.

雖然 AV 聯合療法尚未在市場上取得廣泛給付，但我們已觀察到 BCL-2 與 BTKi 的固定劑量治療在部分早期市場逐漸獲得採用。

As we've discussed, Europe is a more mature market for these fixed dose treatments given the legacy availability of venetoclax plus ibrutinib.

如同我們先前討論，歐洲在這類固定劑量治療方面屬於較成熟的市場，因為過去已可使用 venetoclax 加 ibrutinib 的組合。

The long-term data is clear on the efficacy and durability of BRUKINSA across all patient risk factors particularly for the large unmutated population, which we expect will continue to support growth moving forward.

長期數據清楚顯示 BRUKINSA 在所有患者風險因子上的療效與持久性，尤其對於龐大的未突變族群；我們預期這將持續支持未來成長。

Rest of World markets grew 104% driven by market expansions and new launches in key markets such as Japan and Brazil.

世界其他地區市場成長 104%，主要由市場擴張與在日本、巴西等關鍵市場的新上市所帶動。

Now turning to the other components of our GAAP P&L. Gross margin improved to 89% from approximately 85% in the prior year.

接下來談我們 GAAP 損益表的其他組成項目。毛利率由去年約 85% 提升至 89%。

This improvement primarily reflects the benefits from favourable product mix, price and cost efficiencies. Operating expenses grew by 16%, totalling $1.1 billion as we are investing to support our commercial growth and rapidly advance our innovative pipeline.

此改善主要反映有利的產品組合、價格以及成本效率提升所帶來的效益。營業費用成長 16%，合計 11 億美元，因我們正投入資源以支持商業成長並加速推進創新研發管線。

The weighting of growth between SG&A and R&D is expected to normalize over the course of the year, with both converging toward rates consistent with the overall OpEx growth implied by our full year guidance.

預期今年 SG&A 與 R&D 之間的成長權重將逐步回歸常態，兩者將趨近於我們全年指引所隱含的整體營業費用（OpEx）成長率。

Income from operations totaled $250 million, an increase from $11 million in the prior period. Income tax expense totalled $32 million for the first quarter, primarily reflecting cash tax expenses in certain geographies.

營業利益合計 2.5 億美元，較前期的 1,100 萬美元增加。第一季所得稅費用合計 3,200 萬美元，主要反映部分地區的現金稅負支出。

Altogether, net income totalled $227 million with GAAP diluted earnings per ADS of $1.96. Our non-GAAP P&L includes adjustments for typical items with a full reconciliation provided in the appendix. Non-GAAP income from operations totalled $414 million in the first quarter up from $139 million in the prior period.

綜合而言，淨利合計 2.27 億美元，GAAP 稀釋後每 ADS 盈餘為 1.96 美元。我們的 non-GAAP 損益表包含對常見項目的調整，並於附錄提供完整調節表。第一季 non-GAAP 營業利益合計 4.14 億美元，高於前期的 1.39 億美元。

And non-GAAP net income came in at $375 million for the first quarter, which translates to diluted non-GAAP earnings per ADS of $3.24.

第一季 non-GAAP 淨利為 3.75 億美元，折合稀釋後 non-GAAP 每 ADS 盈餘為 3.24 美元。

We generated free cash flow of $161 million in the first quarter, an increase of $173 million over the prior period. Note that operating and free cash flow is typically lower in the first quarter due to working capital seasonality. Now turning to our 2026 financial guidance update.

第一季我們產生自由現金流 1.61 億美元，較前期增加 1.73 億美元。請注意，由於營運資金的季節性因素，第一季的營運現金流與自由現金流通常較低。接下來更新我們 2026 年財務指引。

We like what we see so far in the US with strong demand growth and with relatively stable net pricing. Growth is anticipated in all markets and will benefit from continued global expansion and we anticipate modest full year initial contributions from our launches of zanidatamab and sonro.

截至目前，我們對美國市場的表現感到樂觀，需求成長強勁且淨價格相對穩定。預期所有市場皆將成長，並將受惠於持續的全球擴張；同時，我們預期 zanidatamab 與 sonro 的上市將在全年帶來溫和的初期貢獻。

And our guide incorporates all current and anticipated competitive market dynamics. Given our Q1 performance and assessment of recent trends, we now project 2026 revenue to be between $6.3 billion to $6.5 billion, an increase of $100 million across the range.

我們的指引已納入所有目前及預期的競爭市場動態。基於第一季表現及對近期趨勢的評估，我們現將 2026 年營收預估上調至 63 億至 65 億美元，區間整體上調 1 億美元。

Our estimate of GAAP gross margin remains in the high 80% range with continued benefit from mix and a full year of productivity from improvements implemented last year.

我們對 GAAP 毛利率的估計仍維持在 80% 高段區間，並將持續受惠於產品組合，以及去年所實施改善措施帶來的全年生產力提升。

GAAP operating expense expectations are unchanged between $4.7 billion and $4.9 billion. Given our top line improvement, GAAP operating income estimates are updated to be between $750 million and $850 million with a corresponding change in non-GAAP operating income. In summary, we are pleased with our start to the year and are confident with how 2026 is shaping up.

GAAP 營業費用預期維持不變，介於 47 億至 49 億美元。鑑於營收端改善，我們將 GAAP 營業利益預估更新為 7.5 億至 8.5 億美元，non-GAAP 營業利益亦相應調整。總結而言，我們對今年的開局感到滿意，並對 2026 年的發展態勢充滿信心。

And with that, I'd like to pass the call over to Lai.

接下來，我想把電話會議交給 Lai。

Thank you, Aaron. Hello, everyone. Thank you for joining us today. This slide highlights recent progress across BeOne's pipeline. In haematology, BRUKINSA's MANGROVE Phase III study in treatment-naive mantle cell lymphoma remains on track with interim PFS readout expected next month, supporting a potential first chemo-free regimen in this setting.

謝謝你，Aaron。各位好。感謝大家今天加入我們。這張投影片重點呈現 BeOne 研發管線近期的進展。在血液腫瘤領域，BRUKINSA 用於初治披蓋細胞淋巴瘤的 MANGROVE 第三期研究進展如期，預計下個月公布期中 PFS 讀出，支持在此治療情境下成為首個無化療療程的潛力。

Sonro is approaching a key inflection with US PDUFA decision expected soon alongside EU submission and ESMO guideline inclusion. Our BTK CDAC continued to advance with potentially pivotal Phase II programs in relapsed/refractory CLL and Waldenström, and the Phase III head-to-head study versus pirto is on track to complete enrolment in early 2027. In solid tumors, TEVIMBRA received US priority review in HER2-positive gastric cancer.

Sonro 正接近關鍵轉折點，預期不久將迎來美國 PDUFA 審查決定，同時也將進行歐盟送件並納入 ESMO 指引。我們的 BTK CDAC 持續推進，於復發/難治性 CLL 與 Waldenström 方面具潛在關鍵性（pivotal）的第二期計畫；而與 pirto 的第三期頭對頭研究亦按計畫進行，預計於 2027 年初完成收案。在實體腫瘤方面，TEVIMBRA 在 HER2 陽性胃癌取得美國優先審查資格。

In parallel, the CDK4 inhibitor has activated its first Phase III site under the GPC3 x 4-1BB bispecific is enrolling a potentially pivotal HCC study. In addition, we acquired an exclusive option to license a novel PD-1 VEGF CTLA-4 trispecific, which is expected to enter the clinic in June.

同時，CDK4 抑制劑已在 GPC3 x 4-1BB 雙特異性抗體項目下啟動首個第三期試驗中心，並正在收案一項可能具關鍵性（pivotal）的 HCC 研究。此外，我們取得一項新型 PD-1 VEGF CTLA-4 三特異性抗體的獨家選擇權授權（option to license），預計於 6 月進入臨床。

In immunology, we made a data-driven decision not to pursue IRAK4 in rheumatoid arthritis, while the BTK CDAC CSU Phase II study is on track to initiate by year-end.

在免疫學方面，我們基於數據做出決策，不再推進 IRAK4 用於類風濕性關節炎；同時，BTK CDAC 用於 CSU 的第二期研究仍按計畫於年底前啟動。

The progress you just saw reflects the very deliberate way we are building our pipeline. Our strategy starts with focus, selecting a small number of disease areas where we believe we can lead and then building depth not just the single asset.

你們剛看到的進展，反映我們以非常審慎的方式打造研發管線。我們的策略從聚焦開始：選擇少數我們相信能取得領先的疾病領域，並建立深度——不僅僅是單一資產。

What enables this approach is our in-house technology stack, expanding CDAC's novel payload ADCs, cell therapy and emerging platforms like T cell engagers.

支撐這一方法的是我們自建的技術堆疊，並擴展 CDAC 的創新載荷 ADC、細胞治療以及如 T 細胞接合器等新興平台。

We're not bound to a specific target or platform alone. We systematically match the right biology with the right modality to build a pipeline that is deep and sustainable.

我們不受限於單一特定靶點或平台。我們系統性地將正確的生物學與正確的治療模態相匹配，以打造一條深厚且可持續的研發管線。

The engine has clearly accelerated from 2011 to 2020. We delivered 11 new molecular entities building the foundation with assets like zanu and the tisle.

這個引擎在 2011 年到 2020 年間明顯加速。我們交付了 11 個新分子實體（NME），並以 zanu 與 tisle 等資產奠定基礎。

Between 2021 and 2023, we added another 10 NMEs, demonstrating consistent productivity and execution. The momentum stepped up again in the last two years with 18 NMEs across small molecules, CDAC, ADC and trispecific antibodies, reflecting the maturation of our in-house platforms.

在 2021 年至 2023 年間，我們又新增了 10 個 NME，展現出一致的生產力與執行力。過去兩年動能再度提升，在小分子、CDAC、ADC 與三特異性抗體等領域共取得 18 個 NME，反映我們自建平台的成熟。

Looking ahead, we expect to sustain a cadence of roughly 8 to 10 NMEs per year from 2026 and beyond, innovation that BeOne is accelerating systematic and built to scale.

展望未來，我們預期自 2026 年起及其後，每年可維持約 8 到 10 個 NME 的節奏；BeOne 正在加速這種系統化、可規模化的創新。

As our innovation engine accelerates, it is producing a broad but intentionally focused pipeline across our key disease areas. We have built depth with multiple mechanisms and modalities coexisting within the same indications.

隨著我們的創新引擎加速，它正在我們的關鍵疾病領域產出一條廣泛但刻意聚焦的研發管線。我們在同一適應症內建立了多種機制與多種模態並存的深度。

This is important because it creates unique opportunities for proprietary combinations developed entirely within our own portfolio, which drives higher return on investment rather than relying on external assets. 2026 marks a true inflection year for our solid tumor portfolio.

這很重要，因為它為完全在我們自有產品組合內開發的專有聯合療法創造了獨特機會，從而帶來更高的投資回報，而非依賴外部資產。2026 年將是我們實體腫瘤產品組合真正的拐點之年。

After several years of disciplined build-out, we now have a new wave of programs advancing toward registration. In breast cancer, our CDK4 inhibitor is moving to late-stage development in a large, well-established setting, while the B7-H4 ADC continues to advance with encouraging signals in gynecological and breast cancers.

經過數年的紀律性建設，我們如今有新一波項目正朝向註冊申請推進。在乳癌方面，我們的 CDK4 抑制劑正於一個規模大且已充分建立的治療場景中邁向後期開發；同時，B7-H4 ADC 也持續推進，並在婦科腫瘤與乳癌中呈現令人鼓舞的訊號。

In liver cancer, the GPC3 x 4-1BB bispecific represents a focused, first-in-class approach designed specifically for HCC with a potentially pivotal study actively enrolling.

在肝癌方面，GPC3 x 4-1BB 雙特異性抗體代表一種聚焦、同類首創（first-in-class）的策略，專為肝細胞癌（HCC）設計，且一項可能具關鍵性的研究正在積極收案。

We're also advancing our PRMT5i inhibitor, which has already been evaluated in first-line settings, underscoring its potential relevance in earlier lines of therapy.

我們也在推進 PRMT5i 抑制劑；該藥物已在一線治療情境中接受評估，凸顯其在更早治療線別中的潛在相關性。

Finally, based on the exciting early data, we are planning pivotal trials for our CEA ADC, further strengthening the solid tumor portfolio. Taken together, our solid tumor pipeline is clearly shifting from early promise to late-stage execution with multiple programs advancing towards meaningful latestage milestones.

最後，基於令人振奮的早期數據，我們正規劃 CEA ADC 的關鍵性試驗，進一步強化實體腫瘤產品組合。綜合而言，我們的實體腫瘤研發管線正明顯從早期潛力轉向後期執行，多個項目正朝向具意義的後期里程碑推進。

While several of these programs we highlighted are in large well-understood cancers, such as CDK4 in breast cancer, there remains less appreciation for the opportunity in hepatocellular carcinoma, HCC. As we said at JP, there is much work left to do in cancer and HCC is a clear example.

儘管我們強調的若干項目位於大型且已充分理解的癌種中，例如乳癌的 CDK4，但市場對肝細胞癌（HCC）的機會仍認識不足。正如我們在 JP 所說，癌症領域仍有大量工作要做，而 HCC 就是一個明確例子。

As the sixth most common cancer worldwide, it is the third leading cause of cancer death, reflecting dismal five-year survival rates that are well below many other major cancers.

作為全球第六常見的癌症，它是癌症死亡原因中的第三位，反映出其五年存活率極低，遠低於許多其他主要癌種。

A truly differentiated, potentially game-changing approach in this setting can meaningfully improve patient outcomes and expand what is already a multibillion-dollar market.

在此治療場景中，真正具差異化、可能改變遊戲規則的方法，能夠實質改善患者結局，並擴大一個本已達數十億美元規模的市場。

The unmet medical need, you just saw in HCC demands not only innovation, but the ability to execute with a sense of urgency.

你剛才在 HCC 看到的未被滿足醫療需求，不僅需要創新，也需要以緊迫感來執行。

Our first-in-class program, GPC3 x 4-1BB is a clear demonstration of our unprecedented clinical execution capability. We moved from first-in-human dosing to enrolling the first patient in a potentially registrational study in just 19 months.

我們的同類首創項目 GPC3 x 4-1BB，清楚展現了我們前所未有的臨床執行能力。我們僅用 19 個月，就從首次人體給藥推進到在一項可能用於註冊的研究中納入首位患者。

This is exceptionally fast for a novel bispecific in solid tumor. Dose escalation was completed under six weeks per cohort.

對於實體腫瘤中的新型雙特異性抗體而言，這個速度異常之快。劑量遞增在每個隊列不到六週內完成。

We have enrolled over 200 patients in 20 months, including over 45 first-line HCC patients treated in combination with tisle and bev, giving us early experience across clinical meaningful settings.

我們在 20 個月內已納入超過 200 名患者，其中包括超過 45 名一線 HCC 患者以 tisle 與 bev 聯合治療，讓我們在具臨床意義的治療情境中累積了早期經驗。

Along the way, the program has received a fast track and orphan drug designation by FDA. At the bottom of this slide is the simple view of the potential pivotal study design with ORR per IRC as the primary endpoint.

在推進過程中，該項目已獲 FDA 授予快速通道與孤兒藥資格認定。本頁底部以簡要方式呈現了潛在關鍵性研究設計，主要終點為由 IRC 評估的 ORR。

ASCO 2026 will be an important moment for BeOne. We have 24 abstracts accepted, including three oral presentations, underscoring both the breadth and the momentum of our pipeline.

ASCO 2026 將是 BeOne 的重要時刻。我們有 24 篇摘要獲接收，其中包含 3 場口頭報告，凸顯我們研發管線的廣度與動能。

You will see the clinical updates across key programs, including our CDK4 inhibitor, B7-H4 ADC and the GPC3 x 4-1BB. Please join us at our ASCO Investor Relations event on June 1 to learn more about our clinical data and why we are so excited about these assets.

你將看到關鍵項目的臨床更新，包括我們的 CDK4 抑制劑、B7-H4 ADC 以及 GPC3 x 4-1BB。請於 6 月 1 日參加我們的 ASCO 投資人關係活動，深入了解我們的臨床數據，以及我們為何對這些資產如此振奮。

At BeOne, we move quickly to clinical proof of concept and advance only programs with the strongest data into late stage development.

在 BeOne，我們快速推進至臨床概念驗證（proof of concept），並僅將數據最強的項目推進到後期開發。

You can see how that discipline is being applied across the portfolio and the actions we are taking this year. We will have additional data disclosure this year for programs such as PRMT5i and the CEA ADC, while new assets like ADAM9 ADC and the KLRG1 have recently entered the clinic.

你可以看到這種紀律如何在整個產品組合中落實，以及我們今年正在採取的行動。今年我們將進一步披露如 PRMT5i 與 CEA ADC 等項目的更多數據；同時，ADAM9 ADC 與 KLRG1 等新資產近期也已進入臨床。

At the same time, we have made a data-driven deprioritization decisions in programs such as CDK2 inhibitor, EGFR CDAC, MAT2A inhibitor and the PanKRAS inhibitor, allowing us to reallocate resources towards the potentially highest impact opportunities.

同時，我們也基於數據對 CDK2 抑制劑、EGFR CDAC、MAT2A 抑制劑與 PanKRAS 抑制劑等項目做出降優先順序的決策，使我們能將資源重新配置至可能影響力最高的機會。

This is exactly how our strategy is intended to work, move faster to proof of concept, identify the most promising candidates and invest aggressively to maximize patient impact. In addition to our focus on our internal breakthroughs, we are further strengthening our pipeline through selective external innovation.

這正是我們策略設計的運作方式：更快推進至概念驗證、辨識最有前景的候選項目，並積極投資以最大化對患者的影響。除了聚焦內部突破外，我們也透過選擇性的外部創新進一步強化研發管線。

BON-110 is a good example of the approach and it represents a potential backbone for our solid tumor portfolio. What differentiates the trispecific from PD-1 VEGF bispecific is the addition of a CTLA-4, which gives the potential for deeper and more durable immune activation.

BON-110 是這種方法的一個良好例子，並可能成為我們實體腫瘤產品組合的骨幹。三特異性抗體相較於 PD-1/VEGF 雙特異性抗體的差異在於加入了 CTLA-4，從而有望帶來更深且更持久的免疫活化。

Importantly, this creates a broad opportunity for proprietary combinations across our pipeline, including ADCs and 4-1BB-based programs. This program -- this is on track to enter clinic next month. We have covered most of the milestones already, so I will just call out three remaining 2026 catalysts.

重要的是，這為我們整體研發管線中的專有聯合療法創造了廣泛機會，包括 ADC 與以 4-1BB 為基礎的項目。該項目——預計將於下個月按計畫進入臨床。我們已涵蓋大部分里程碑，因此我只點出 2026 年剩餘的三個催化劑。

First, we expect to initiate the sonro Phase III study in second-line plus multiple myeloma later this year, extending our BCL-2 strategy into a new important patient population.

第一，我們預期將於今年稍晚啟動 sonro 在二線及以上多發性骨髓瘤的第三期研究，將我們的 BCL-2 策略延伸至一個新的重要患者族群。

Second, in the half -- in the second half of this year, assuming the data is supportive, we expect an accelerated approval submission for our BTK CDAC in relapsed/refractory CLL.

第二，在今年下半年——假設數據支持——我們預期將就復發／難治性 CLL 的 BTK CDAC 提交加速核准申請。

And finally, we anticipate a US approval for TEVIMBRA in first-line HER2-positive gastric cancer, marking a meaningful regulatory milestone in solid tumors.

最後，我們預期 TEVIMBRA 將在美國獲批用於一線 HER2 陽性胃癌，這將是實體腫瘤領域一項具意義的法規里程碑。

I will now turn it back to John.

我現在把時間交回給 John。

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

謝謝，Lai。我們現在開放問答。請限制提問數量，以確保我們有時間聽到盡可能多與會者的問題。接線員，請開始。

(Operator Instructions) Yigal Nochomovitz, Citigroup.

（接線員指示）Yigal Nochomovitz，花旗集團。

Hi, great. Thank you very much for taking the questions. John, you've consistently highlighted BRUKINSA as the only BTK to demonstrate superiority versus ibrutinib in ALPINE, as you just noted on Slide 10.

嗨，很好。非常感謝讓我提問。John，你一直強調 BRUKINSA 是唯一在 ALPINE 試驗中相較於 ibrutinib 證明具優越性的 BTK，如你剛才在投影片 10 所提到的。

I'm just curious because one of your competitors, Lilly, has also been highlighting pirto's performance versus as recently as some of their materials in the recent earnings call stating 76% risk reduction versus ibrutinib in treatment naive and 27% PFS risk reduction in relapsed/refractory BTK naive.

我只是好奇，因為你們的一位競爭對手禮來（Lilly）也一直在強調 pirto 的表現；甚至就在最近一次財報電話會議的一些資料中提到，在初治（treatment naive）族群相較於 ibrutinib 風險降低 76%，以及在復發／難治且 BTK 未治療（BTK naive）族群 PFS 風險降低 27%。

So I'm just wondering if you could help contextualize that and sort of sort out the apparent disconnect there Thank you.

所以我想請問你能否協助把這些放在脈絡中解讀，並釐清其中看似不一致之處？謝謝。

Hey, you go. Thanks for the question. I appreciate it. And I think that's probably best handled by Amit.

嘿，你好。謝謝你的問題。我很感謝。我想這部分可能由 Amit 來回答最合適。

Yeah. Happy to take that, John. Thank you for that question. So unequivocally, what we're saying is correct. BRUKINSA is the only BTKi to demonstrate superiority to ibrutinib in a head-to-head study.

好的。我很樂意回答這個問題，John。謝謝你提出這個問題。我們所說的毫無疑問是正確的。BRUKINSA 是唯一一個在頭對頭研究中證明優於 ibrutinib 的 BTKi。

So before I talk about some of the specific problems with the pirto claims, let me just talk about a couple of important study conduct principles.

在我談 pirto 相關主張的一些具體問題之前，我先談幾個重要的試驗執行原則。

So in an open-label study, when you have two arms being compared, the standard industry practice based on regulatory guidance is to actually look at the data assessed by an independent review committee or an IRC rather than relying on investigator assessments.

在開放標籤試驗中，當比較兩個治療組別時，依據監管指引的產業標準作法，是看由獨立審查委員會（IRC）評估的數據，而不是依賴研究者評估。

This is for the obvious reason that investigator assessments can favor the experimental arm over the control arm. Also, it is important to ensure that there is no discordance in the investigator and IRC results, and I'll come back to that in a minute. A second important aspect is that there should be predefined alpha allocation for the subgroups being tested and the order of testing itself.

原因很明顯：研究者評估可能會偏向實驗組而非對照組。此外，也必須確保研究者與 IRC 的結果之間沒有不一致；我稍後會再回到這點。第二個重要面向是：對於要檢驗的亞組以及檢驗順序本身，應事先定義 alpha 分配。

So all of the claims have to be based on alpha-allocated predefined subgroups rather than exploratory subgroups.

因此，所有主張都必須基於已分配 alpha、事先定義的亞組，而不是探索性亞組。

So with that, to talk a little bit more specifically about the BRUIN-314 based claims. Now what you may have seen in some of the presentations is a claim on risk reduction compared to ibrutinib in the relapse setting of about 26%.

在此基礎上，更具體談談以 BRUIN-314 為依據的主張。你可能在一些簡報中看到，在復發情境下相較於 ibrutinib 風險降低約 26% 的說法。

But if you actually look at the IRC data and John had this in his previous -- in his presentation, what you see is that there are only two events that separate the two arms. So the pirto has reported 48 events and the ibrutinib arm has noted 50 events.

但如果你實際看 IRC 的數據——John 在他先前的簡報中也提到——你會看到兩組之間只差了兩個事件。也就是說，pirto 組報告 48 個事件，而 ibrutinib 組記錄 50 個事件。

So if you compare this to the investigator curves, you can see that there is a significant discordance,and this really highlights the importance of the IRC curves.

所以如果你把這與研究者評估的曲線相比，你會看到存在顯著不一致；這也凸顯了 IRC 曲線的重要性。

Now with the two event difference here, the likelihood of this comparison showing statistical significance even with longer follow-up seems to be very low and John made the important point that with ibrutinib in particular, as patients are able to tolerate it, we've seen what happened with the ELEVATE-RR study as well.

在這裡僅有兩個事件差異的情況下，即使延長追蹤，這項比較要顯示統計顯著性的可能性似乎也非常低；John 也提出一個重要觀點：特別是對 ibrutinib 而言，只要病人能耐受，我們也在 ELEVATE-RR 研究中看到其結果表現。

Now moving on to the treatment-naive group, the claims are even more questionable. Because this is a very small subgroup of the overall trial population. And according to the JCO paper is not even listed in the hierarchy of testing.

接著談初治（treatment-naive）族群，相關主張就更值得質疑。因為這只是整體試驗族群中的一個非常小的亞組。而且根據 JCO 論文，這個亞組甚至沒有列在檢驗階層（hierarchy of testing）中。

So this is not a predefined group. And moreover, even in this group, when you look at the IRC assessed difference, that is not statistically significant.

所以這不是一個事先定義的族群。此外，即便在這個族群中，當你看 IRC 評估的差異，也沒有達到統計顯著。

And finally, for the treatment-naive group, given the extremely short follow-up of the BRUIN study, questions around long-term safety, treatment sequencing as well as overall benefits over other BTK inhibitors remains quite questionable.

最後，就初治族群而言，鑑於 BRUIN 研究的追蹤時間極短，關於長期安全性、治療序列安排，以及相較於其他 BTK 抑制劑的整體效益，仍然相當令人存疑。

So I think really to conclude what I can say is based on all of this data, BRUKINSA remains the only BTK inhibitor to have shown clear superiority. Thank you.

所以我想總結來說，基於所有這些數據，BRUKINSA 仍然是唯一顯示明確優越性的 BTK 抑制劑。謝謝。

Thanks Amit. And I don't think that's a like technical statistical answer. I think this is the governing chart, IRC, that the industry recognizes and as Amit shared, the data is what the data is. So anyway, we're very comfortable with that statement. Okay, thank you.

謝謝你，Amit。而且我不認為這只是技術性的統計回答。我認為這是產業所認可的主導圖表——IRC——正如 Amit 分享的，數據就是數據。所以無論如何，我們對這個說法非常有信心。好的，謝謝。

Operator, can we have next question please?

接線員，請問可以進行下一個問題嗎？

Kalpit Patel, Wolfe Research.

Kalpit Patel，Wolfe Research。

Good morning and thanks for taking the questions. One on BRUKINSA's CELESTIAL-TNCLL trial. We were expecting uMRD results, but we didn't see that on the slide deck. So curious on the update there. And then second, for the degrader, the CDAC, what hurdle are you targeting? What efficacy hurdle for filing for accelerated approval? Thank you.

早安，謝謝讓我提問。第一個問題關於 BRUKINSA 的 CELESTIAL-TNCLL 試驗。我們原本預期會看到 uMRD 結果，但在投影片中沒有看到。所以想了解目前的最新進展。第二個問題，關於降解劑（degrader）、CDAC，你們鎖定的門檻是什麼？申請加速核准（accelerated approval）時，你們的療效門檻目標是什麼？謝謝。

Thanks so much. Those are great questions, but I think we're back to you, Amit.

非常感謝。這些問題很棒，但我想又要交給你了，Amit。

Yes, happy to take those as well. Thank you, John. So for the CELESTIAL uMRD question, let me start by talking a little bit about how that study is set up. So just as a quick reminder, the CELESTIAL-301 study effectively has dual primary end points. One is the uMRD at the end of the treatment in the 2 arms and the other is PFS or progression-free survival.

是的，我也很樂意回答。謝謝你，John。關於 CELESTIAL 的 uMRD 問題，我先簡單說明一下該研究的設計。快速提醒一下，CELESTIAL-301 研究實際上有兩個主要終點。一個是兩個治療組在治療結束時的 uMRD，另一個是 PFS（無惡化存活期）。

So in our case, progression-free survival is the traditional regulatory end point and is the base case for our filing. So we expect PFS to be the endpoint that will support regulatory approval for that regimen. UMRD is not currently accepted as a regulatory end point but obviously remains scientifically very interesting as well as there's efforts ongoing from a regulatory perspective as well. So in Q3 of this year, our IDMC will review the uMRD data across the arms and tell us whether statistical significance has been met or not. Irrespective of the outcomes for UMRD, we would disclose that externally at the next proximate opportunity and the study will continue to the PFS readout, essentially unchanged with no change in the study conduct.

就我們而言，無惡化存活期是傳統的監管終點，也是我們申報的基本情境（base case）。因此，我們預期 PFS 會是支持該治療方案取得監管核准的終點。uMRD 目前尚未被接受為監管終點，但顯然在科學上仍非常有趣，而且監管層面也正在推動相關工作。今年第三季，我們的 IDMC 將審查各治療組的 uMRD 數據，並告知我們是否達到統計顯著。不論 uMRD 的結果如何，我們都會在下一個最接近的適當時點對外揭露；而研究將繼續進行至 PFS 讀出，基本上維持不變，試驗執行不會有任何改變。

Now it is worth noting that demonstrating statistical significance versus VO is an extremely high bar. And if positive, the CELESTIAL-301 study would be the first study to show uMRD superiority for a BTK and BCL-2 combination over VO. In prior large studies, VO has shown the highest benchmark uMRD rates. So just as an example, if you look at the recently reported CLL17 trial, the uMRD rates for VO are 73.3% and for VI they are 47.2%. Even with the uMRD rate difference of 25% in the 2 arms, the PFS for VO and VI are essentially superimposable.

另外值得注意的是，要證明相較於 VO 具有統計顯著性是一個極高的門檻。若結果為正，CELESTIAL-301 將會是第一個研究顯示 BTK 與 BCL-2 聯合療法在 uMRD 上優於 VO。在先前的大型研究中，VO 一直展現最高的 uMRD 基準比率。舉例來說，如果你看最近報告的 CLL17 試驗，VO 的 uMRD 比率為 73.3%，VI 則為 47.2%。即使兩組 uMRD 比率差異達 25%，VO 與 VI 的 PFS 幾乎是重疊的。

So you can imagine that even if the ZS uMRD rates are on par with the VO rates, we will actually feel quite good about the likelihood of demonstrating PFS benefit.

因此你可以想像，即使 ZS 的 uMRD 比率與 VO 的比率相當，我們其實也會對於證明 PFS 獲益的可能性覺得相當樂觀。

Based on this data and the data that we've seen to date with the SONRO-101 study, we remain very confident in achieving the PFS endpoint, even if uMRD is not statistically significant.

基於這些數據以及我們迄今在 SONRO-101 研究中看到的數據，我們仍然非常有信心達成 PFS 終點，即使 uMRD 在統計上不顯著。

Also, we have a separate ongoing Phase III head-to-head versus AV, which we feel, based on the data presented so far represents a meaningfully lower bar for uMRD than VO in terms of the MRD rates. And either trial can enable global registration in that frontline setting. So we look forward to bringing ZS to patients based on these 2 trials.

另外，我們還有一項獨立、正在進行的第三期（Phase III）與 AV 的正面對決試驗；根據目前已呈現的數據，我們認為就 MRD 比率而言，該試驗對 uMRD 的門檻明顯低於 VO。而且任一試驗都可支持在一線治療（frontline）情境下的全球註冊。因此，我們期待能基於這兩項試驗把 ZS 帶給病患。

Now quickly, just on the degrader. We've been enrolling patients in -- the relapsed/refractory patients in a Phase II study. And as far as benchmarks are concerned, I think this is an evolving area depending on what are considered available and approved therapies in the US But certainly, based on that study and -- as well as the studies run with pirtobrutinib as monotherapy, we're sort of looking at the benchmark of somewhere between 50% to 70% depending on the population.

接著快速談一下 degrader。我們一直在第二期（Phase II）研究中招募復發／難治（relapsed/refractory）病患。就基準（benchmark）而言，我認為這是個持續演進的領域，取決於美國有哪些可用且已核准的治療；但可以肯定的是，根據該研究以及以 pirtobrutinib 單藥治療所進行的研究，我們大致把基準看在約 50% 到 70% 之間，視族群而定。

Thanks so much for the answer. And could we have the next question, please?

非常感謝你的回答。請問可以進行下一個問題嗎？

Jessica Fye, JPMorgan.

Jessica Fye，摩根大通（JPMorgan）。

Hey, guys. Good morning. Thanks for taking my questions. I was just hoping if you could give us a status update of what inning you think we're in of BRUKINSA's launch in Europe? And then for the BTK CDAC, which I believe you suggested could be launching next year in relapsed/refractory CLL following potential filing later this year. Can you talk about how we should think about the initial launch ramp for that one? Thank you.

嗨，各位。早安。謝謝讓我提問。我想請你們更新一下，你們認為 BRUKINSA 在歐洲上市推進大概進行到第幾局（inning）了？另外，關於 BTK CDAC，我記得你們提到可能在今年稍晚提交申請後，明年可望在復發／難治 CLL 上市。能否談談我們應該如何看待它初期的上市爬坡（launch ramp）？謝謝。

Perhaps I can kind of answer the first question. I'm not very good at innings because I'm from Pittsburgh and our baseball team is not so great. But I think as we all know, Europe takes a while to launch and to work your way on to reimbursement. And I think we've always been behind there versus the US We're very encouraged by what we see, but I think that it's still pretty early in those days, and we see the opportunity for substantial growth for BRUKINSA as a single agent.

也許我可以先回答第一個問題。我不太擅長用「第幾局」來比喻，因為我來自匹茲堡，我們的棒球隊不怎麼樣。但我想大家都知道，歐洲的上市與逐步取得給付（reimbursement）需要一些時間。而且我認為我們在那邊一直都比美國慢一些。我們對目前看到的情況很受鼓舞，但我認為仍然算是相當早期的階段，我們也看到 BRUKINSA 作為單藥仍有可觀的成長機會。

Of course, with the combination when sonro comes into play, we think this is game-changing, and the opportunity for that is just tremendous in every country across the world. That's the first question. The second question on the CDAC launch ramp, I think that's a question that we could refer to Matt.

當然，當 sonro 的聯合療法開始發揮作用時，我們認為這將改變遊戲規則，而這個機會在全球各國都非常巨大。以上是第一個問題。第二個關於 CDAC 上市爬坡的問題，我想我們可以請 Matt 來回答。

Glad to take that question around CDAC launch ramp. I think you've already heard from Amit and also from John about aspects of the CDAC clinical profile, which we anticipate will be very strong and particularly note the head-to-head trial design versus pirto on those later lines of therapy. So in terms of overall launch ramp, we think that it should be relatively robust. Would anticipate a typical S-shaped uptake curve, but again, we think it's a well-prepared market, and we're confident about its prospects.

很高興回答關於 CDAC 上市爬坡的問題。你們已經從 Amit 以及 John 那裡聽到一些關於 CDAC 臨床特徵的內容；我們預期其表現會非常強，尤其要注意的是在後線治療中與 pirto 的正面對決試驗設計。因此就整體上市爬坡而言，我們認為應該會相對強勁。我們預期會是典型的 S 型滲透曲線（uptake curve），但同樣地，我們認為市場已準備就緒，並對其前景充滿信心。

And I think one of the nice things about that program and sonro is both of these largely leverage the existing infrastructure that we have in place which is great for us and makes it much easier effort, but it's also economically highly favorable. So that's a great thing about having several programs that overlap on the clinicians that are using those medicines. Thank you so much. Can we have the next question, please?

而且我認為這個專案以及 sonro 的一個優點是，兩者在很大程度上都能利用我們既有的基礎設施，這對我們很有利、也讓執行更容易，同時在經濟性上也非常有利。因此，能有多個專案在使用這些藥物的臨床醫師族群上有所重疊，是一件很好的事。非常感謝。請問可以進行下一個問題嗎？

Leonid Timashev, RBC.

Leonid Timashev，RBC。

Hey, guys. Thanks for taking my question. Just wanted to ask on the immunology programs. Looks like CSU is moving ahead potentially to a Phase 2, I guess. Is that suggesting that you're encouraged by what you're seeing out of the Phase 1B? And related to that, could you maybe provide some color on why the IRAC 4 and RA was discontinued?

嗨，各位。謝謝讓我提問。我想問一下免疫學（immunology）專案。看起來 CSU 可能正往第二期（Phase 2）推進。這是否表示你們對第一期 B（Phase 1B）看到的結果感到鼓舞？另外相關地，你們能否補充一些背景，說明為什麼 IRAK4 在 RA（類風濕性關節炎）被停止？

Sure. I think probably Lai, you are best to answer that question, please.

好的。我想這題可能 Lai 最適合回答，麻煩你。

Yes. We are planning to initiate the Phase II for our BTK CDAC program in the CSU by the end of the year. In terms of -- based on the current data we have seen from the Phase I study.

是的。我們計畫在今年年底前，於 CSU 適應症啟動我們 BTK CDAC 專案的第二期（Phase II）。就目前我們從第一期（Phase I）研究所看到的數據而言。

In terms for the IRAK4 in the rheumatoid arthritis, we decide to not further pursue the trial based on emerging new data. We're in the process of analyzing the data and decide the next steps for this program.

至於 IRAK4 在類風濕性關節炎（rheumatoid arthritis）方面，我們是基於新出現的數據而決定不再進一步推進該試驗。我們正在分析數據，並決定此專案的下一步。

All right. Operator, can we have the next question, please?

好的。接線員，請問可以進行下一個問題嗎？

Ziyu Chen, Goldman Sachs.

Ziyu Chen，高盛（Goldman Sachs）。

Thank you for taking my questions and congrats. You had a very strong first quarter. Just one question regarding the recent deal on the HH160, the PDY by HF CTLA for price-specific.

謝謝讓我提問，也恭喜你們。你們第一季表現非常強勁。我只有一個問題，關於近期 HH160 的交易，也就是由 HF 的 CTLA 針對特定價格的 PDY。

Could you share a bit more about your view on SN and particularly amid the competition of emerging PD-1 by HF bispecific and also different strategy for trispecific? And also talking about the FC silence strategy, it's definitely going to be reduced toxicity of DCTLA-4, but also it's going to lose potentially T-RAC depletion. So what is your view on that?

你們能否多分享一些對 SN 的看法，特別是在新興的 PD-1×HF 雙特異性（bispecific）競爭，以及三特異性（trispecific）不同策略的背景下？另外談到 Fc 靜默（FC silence）策略，這確實會降低 DCTLA-4 的毒性，但也可能會失去 T-RAC 耗竭（depletion）。你們對此有何看法？

Sure. Thank you so much for the question. Again, I think we'll go right back to Lai.

好的。非常感謝你的問題。同樣地，我想我們直接請 Lai 回答。

Yeah, this molecule was called a BON110, previous called HH160 was engineered to simultaneously block industry well-established pathway. There certainly has been bispace spec between the PD-1 VGF and the PD-1 CTL4 demonstrating clinical activity. We believe by adding the CTLA4 arm will present potential differentiation from the currently existing bispacifics. As for the tuning out of the FC.

是的，這個分子名為 BON110，先前稱為 HH160；它經過工程化設計，可同時阻斷業界已充分建立的途徑。確實已經有 PD-1 VGF 與 PD-1 CTL4 的雙特異性藥物展現臨床活性。我們相信加入 CTLA4 這一臂（arm）將可相對於目前既有的雙特異性藥物形成潛在差異化。至於 Fc 的調整（tuning out）。

Function is to exactly to the point you raised, is to try to mitigate the tox concern. We do believe from pre-quant data, this kind of engineering will be able to still retain largely the efficacy by removing some of the safety liabilities.

其目的正如你所提到的，是為了降低毒性方面的疑慮。我們確實相信，從臨床前（pre-quant）數據來看，這類工程化設計在移除部分安全性風險的同時，仍能在很大程度上保留療效。

Thank you, Lai. All right, we have another question, please.

謝謝你，Lai。好的，請問還有下一個問題嗎？

Gregory Renza, Truist Securities.

Gregory Renza，Truist Securities。

Great. Thanks. Good morning, John and team. Congrats on the quarter. Thanks for taking my question. Maybe I'll weave in Aaron here for a bit and just ask a bit on the guidance. Aaron, you acknowledge that you like what you see with the growth in the markets, but also some assessment of recent trends. Perhaps you could just elaborate further.

很好。謝謝。早安，John 以及團隊。恭喜本季表現。謝謝讓我提問。也許我先把 Aaron 拉進來談一下，想就指引多問幾點。Aaron，你提到你喜歡看到市場成長的態勢，但也對近期趨勢做了一些評估。或許你可以再多做一些說明。

On the pieces that enabled you to feel confident about revenue performance for the rest of the year and if you could, if I may, just ask a bit about some of the factors to consider when it comes to the net pricing.

關於哪些因素讓你們對今年剩餘時間的營收表現有信心；如果可以的話，也想再請教一下在淨定價（net pricing）方面需要考量的一些因素。

I think we heard you've mentioned consistency, but just wanted to give you an opportunity to elaborate further on maybe some of those headwinds, but also pressures if they are, by and large, passed into guidance at this point. Thanks so much.

我想我們聽到你提到「一致性」，但也想給你機會再進一步談談一些可能的逆風，以及相關壓力是否大致上已經在目前的指引中反映。非常感謝。

Great. Thanks for the question, Greg. So as I said in the prepared remarks, we really do like what we see and the setup for the year. Q1 came in on expectations, but particularly, we were encouraged by performance in the United States, both in March and into April. You mentioned price.

好的。謝謝你的問題，Greg。如同我在事先準備的發言中所說，我們確實很喜歡目前看到的情況以及今年的布局。第一季符合預期，但特別是，我們對美國市場的表現感到鼓舞，無論是 3 月，或延續到 4 月。你提到了價格。

When we issued our original guidance, we talked about relatively stable net pricing. We feel very confident in that as we enter the year, given where we are with our various contracting opportunities.

當我們發布原先的指引時，我們談到淨定價相對穩定。在進入今年之際，考量到我們在各項合約洽談機會上的進展，我們對此非常有信心。

So we feel really good about that moving forward in the -- for the balance of 2026. I did touch on in Q1, we had $20 million or so of nonrecurring gross to net. So that obviously occurred in Q1, and we anticipate that will pass through for the year.

因此，展望 2026 年剩餘期間，我們對後續走勢感覺非常良好。我也提到過，在第一季我們有約 2,000 萬美元的一次性毛額到淨額（gross-to-net）項目。所以那顯然已在第一季發生，我們預期全年會把這個影響反映進去。

So overall, we really like where the business is sitting, strength in the United States, but really strong performance across all of our geographies.

整體而言，我們很喜歡目前業務所處的位置：美國市場強勁，同時我們在所有地區的表現也都非常強。

I think you see really strong growth with our European business. our China business continues to perform and demonstrate leadership and we're still in very -- using Jessica's analogy very early innings in Rest of World where the business doubled again in the first quarter.

我想你也看到我們歐洲業務的成長非常強勁。我們的中國業務持續表現並展現領先地位；而在「世界其他地區」（Rest of World），用 Jessica 的比喻來說，我們仍在非常早期的局數，該業務在第一季又再度翻倍。

So we really like to set up. That's what gives us confidence for the guidance update with the $100 million improvement across the range. Thanks for the question.

所以我們非常喜歡目前的布局。這也是我們有信心更新指引、將區間整體上調 1 億美元的原因。謝謝你的提問。

All right. Thank you, Aaron. Could we move to another question, please?

好的。謝謝你，Aaron。我們可以進行下一個問題嗎？

Michael Schmidt, Guggenheim.

Guggenheim 的 Michael Schmidt。

Oh, hey, guys. Congrats on the great first quarter here. Perhaps switching back to the pipeline, a question about the GPC-341BB bispecific where it sounds like there's things are starting to emerge that are quite interesting. And perhaps, could you just comment a bit more about the pivotal study in second-line HCC?

嗨，各位。恭喜第一季表現非常出色。我想把話題切回研發管線，想問一下 GPC-341BB 這個雙特異性抗體；聽起來有一些相當有趣的訊號開始浮現。也許你們可以再多評論一下在二線 HCC 的關鍵性研究（pivotal study）？

How should you think about the efficacy bar in the setting? It seems like there's an ORR readout planned. And then longer-term, how do you think about the overall opportunity for this asset, perhaps in frontline HCC and other opportunities? Thanks so much.

在這個治療情境下，你們認為療效門檻（efficacy bar）應該如何看待？看起來規劃會有 ORR 的讀出。再更長期來看，你們如何看待這個資產的整體機會，例如在一線 HCC 以及其他機會？非常感謝。

Thanks for the question. Good to hear your voice. And perhaps we can have Mark answer that and Mark, you may be muted and if Mark doesn't jump in, we'll have Lai answer that. Maybe he's been disconnected.

謝謝你的提問。很高興聽到你的聲音。也許我們請 Mark 來回答；Mark，你可能被靜音了。如果 Mark 沒有加入，我們就請 Lai 來回答。也許他已經斷線了。

So happy to address this question. In terms of the -- we're in the process of having the discussion with the health authorities to discuss about the bar. You will see our -- the Phase I data at this year's ASCO. The abstract should be released soon, but we will have further data updates at the ASCO oral presentation as well as at our investor relationship -- relation events.

我很樂意回答這個問題。就門檻（bar）而言，我們正在與衛生主管機關進行討論，來釐清相關標準。你們會在今年的 ASCO 看到我們的第一期數據。摘要應該很快就會公布；此外，我們也會在 ASCO 的口頭報告以及我們的投資人關係——投資人關係活動上，提供更多數據更新。

We're quite confident about the early data we have seen with this asset and certainly, we have already enrolled over 40 patients in the frontline HCC in combination with tislelizumab as well as bevacizumab. The early data is quite encouraging. We're looking forward to bring this effective medicine to patients around the globe with HCC.

我們對這個資產目前看到的早期數據相當有信心；而且我們已在一線 HCC 的組合治療中（與 tislelizumab 以及 bevacizumab 併用）納入超過 40 位病人。早期數據相當令人鼓舞。我們期待能把這個有效的藥物帶給全球的 HCC 病患。

Thanks so much, Lai. Could we jump to the next question?

非常感謝你，Lai。我們可以進行下一個問題嗎？

Rennie Benjamin, Citizens.

Citizens 的 Rennie Benjamin。

Great, thanks very much for taking the questions and congratulations on a great quarter. Congratulations on a great quarter. My question is regarding sonrotoclax and the launch in China. Can you talk a little bit about kind of how that's going, kind of is it tracking like BRUKINSA did? Or is it tracking according to internal expectations? And maybe related to that, what do you think might be the competitive dynamics once sonrotoclax is approved here in the US, even though it will be for MCL, any sort of on-label or potential off-label use that might impact BRUKINSA or the CLL market as a whole?

好的，非常感謝讓我提問，也恭喜本季表現很棒。恭喜本季表現出色。我的問題是關於 sonrotoclax 以及在中國的上市。你們能否談談目前進展如何？它的走勢是否像 BRUKINSA 當初那樣？或是符合你們內部的預期？另外相關地，一旦 sonrotoclax 在美國獲批（即使適應症會是 MCL），你們認為競爭動態會如何？是否會有任何標示內或潛在標示外使用，可能影響 BRUKINSA 或整體 CLL 市場？

Thanks for the question. Xiaobin, do you want to start? Maybe I can finish.

謝謝你的提問。Xiaobin，你要先開始嗎？我也許可以補充收尾。

Yes. So the launch is very encouraging. In China, we got approval in January and 8 days later, we launched the product.

好的。上市表現非常令人鼓舞。在中國，我們在 1 月取得核准，8 天後就推出產品。

So far, YTD, we have over 300 hospitals across the country started to treat patients in China and also sonrotoclax is also included in China, in the CSCO guideline for first-line CLL, second-line CLL and also second-line mantle cell and also for the AML.

截至目前今年以來（YTD），全國已有超過 300 家醫院開始在中國為病患治療；此外，sonrotoclax 也已納入中國 CSCO 指南，用於一線 CLL、二線 CLL，以及二線套細胞淋巴瘤，並且也涵蓋 AML。

So second line AML is also listed in the guideline. And we are very, very happy the initial feedback from hospital is very encouraging. So this is China situation

所以二線 AML 也列在指南中。我們對醫院端的初期回饋感到非常、非常高興，因為相當正面。以上是中國的情況。

Thanks so much, Xiaobin. I think that with the launch in the US, we're very encouraged by everything we see with sonro. As we've described it's a more potent, more selective, specifically designed PK parameters to try to make this a very differentiated and more effective medicine. We believe that will be the case in the initial indication, where it's approved as a single agent. And the combination data, it's just in our minds, game-changing.

非常感謝你，Xiaobin。我想就美國上市而言，我們對 sonro 看到的一切都非常受到鼓舞。如同我們所描述的，它更具效力、更具選擇性，並且在藥物動力學（PK）參數上是特別設計的，目標是讓它成為一款差異化非常明顯、且更有效的藥物。我們相信在初始適應症（以單藥獲批）上會是如此。而其組合治療數據，在我們看來是改變遊戲規則的。

Now you have to work your way to approvals before you're an official commercial product, and we are working our way through that process.

當然，你必須先一路完成核准流程，才能成為正式的商業化產品，而我們正在推進這個流程。

At the same time, we will take the data that we have, and we'll share it with the guideline committees all across the world and see if they are willing to have those join the guidelines, and it's great data.

同時，我們也會把手上的數據分享給全球各地的指南委員會，看看他們是否願意將其納入指南；而這些數據確實非常出色。

So hopefully, there's some chance that, that can occur. But we're very, very excited about this as game-changing medicine and many indications based on the data we see today. Okay. Thank you so much. Could we take another question or 2, and then we probably have to wrap up.

所以希望這件事有機會發生。但我們對此作為具顛覆性的藥物感到非常、非常興奮，基於我們今天看到的數據，它在許多適應症上都有潛力。好的。非常感謝。我們可以再接一到兩個問題嗎？然後我們可能就得結束了。

Yaron Werber, TD Cowen.

Yaron Werber，TD Cowen。

Great. Thanks so much. Maybe a couple of questions. The first one, you mentioned a little bit that AV, Aaron, is gaining some traction in some markets wasn't sure if those were sort of ex-US, and I don't know if you can expand on that. And then secondly, on the CDK4 inhibitor at ASCO, any sense sort of what can we expect, how mature would the durability data be at that point on efficacy? Thank you.

太好了。非常感謝。我可能有兩個問題。第一個，你稍微提到 AV（Aaron）在某些市場開始有一些進展，但我不確定那是否屬於美國以外的市場，也不確定你能否再多談一些。第二個，關於在 ASCO 的 CDK4 抑制劑，你們對於我們可以期待什麼是否有一些概念？到那個時間點，療效的持久性數據成熟度會到什麼程度？謝謝。

Thanks, Yaron. Nice to hear your voice too. You stuck in two questions there, I think on the AV question. I think that what Aaron was referring to probably is the statements that they've made that they're having some international, success in some perspective. I think from our point of view, it's not something that we've seen widely in the US, and it's hard for us to track exactly.

謝謝你，Yaron。也很高興聽到你的聲音。你一次塞了兩個問題，我想先談 AV 的問題。我認為 Aaron 所指的，可能是他們曾經提到在某些國際市場有一些成功、從某種角度來看。以我們的觀點來看，這並不是我們在美國廣泛看到的情況，而且我們也很難精確追蹤。

From the CDK4 perspective at ASCO, I do believe that we have Mark back connected. So let's see if he can handle that question and we can hear him.

至於 ASCO 上 CDK4 的部分，我相信 Mark 已經重新連線回來了。所以我們看看他能否回答這個問題，讓我們也能聽到他的說法。

Thank you, John, and I hope you can hear me okay. Super. Thank you, Yaron, for the question. We're very excited to share our updated data at ASCO for our CDK4 program. We encourage everyone listening to the call to visit our poster, which will be on Monday morning of ASCO.

謝謝你，John，也希望你們聽得到我。太好了。謝謝你，Yaron，提出這個問題。我們非常期待在 ASCO 分享我們 CDK4 計畫的更新數據。也鼓勵所有正在收聽電話會議的人到我們的海報展示，時間是在 ASCO 的週一上午。

We'll be sharing data from approximately 60 patients who are frontline for Stage IV disease treated in combination with letrozole.

我們將分享約 60 位患者的數據，這些患者為第四期疾病的一線治療，並與來曲唑（letrozole）合併治療。

What we will show is a strong response rate across a range of doses tested that informed our Phase III dose selection. We'll also be showing early but encouraging data about the beneficial effect of food and improving the GI tolerability profile.

我們將展示在所測試的一系列劑量下都有強勁的反應率，而這些結果也為我們第三期試驗的劑量選擇提供了依據。我們也會展示一些早期但令人鼓舞的數據，說明食物帶來的有利影響，以及如何改善腸胃道（GI）耐受性表現。

Because the anticipated progression-free survival for frontline breast cancer is over two years, the maturity still remains quite low at this time. But again, we're very excited to share the early efficacy and safety data.

由於一線乳癌的預期無惡化存活期超過兩年，因此目前數據成熟度仍然相當低。但再次強調，我們非常期待分享這些早期的療效與安全性數據。

Okay. Next question, please. Thank you, Mark.

好的。請下一個問題。謝謝你，Mark。

Thank you. Our final question is from Sean Laaman from Morgan Stanley.

謝謝。我們最後一個問題來自 Morgan Stanley 的 Sean Laaman。

Good morning, John and team. Hope everyone is well. John, in the business, you're showing some really strong operating leverage and you've now got meaningfully positive operating income and net income.

早安，John 和團隊各位。希望大家都一切順利。John，在業務方面，你們展現了非常強的營運槓桿，而且現在營業利益與淨利都已顯著轉正。

Maybe it's a question for Aaron, but looking out, how would you characterize sort of growth in OpEx versus the top-line and just the efficiencies that you're really showing in your R&D engine?

這可能是問 Aaron 的問題，但往前看，你會如何描述營運費用（OpEx）的成長相對於營收成長的情況，以及你們在研發引擎上所展現的效率？

Great. Thanks for the question, Sean. This happens to be amongst my favorite questions because that means our pipeline has so much opportunity, is going to make such a difference for patients. And ultimately, as that's what creates value in this industry.

很好。謝謝你的問題，Sean。這剛好是我最喜歡的問題之一，因為這代表我們的產品線有非常多機會，將為病患帶來很大的改變。而最終，這正是這個產業創造價值的來源。

We don't provide long-term guidance, but I've shared a number of times, we really have two objectives as we think about managing the business financially.

我們不提供長期指引，但我已多次分享，從財務角度管理業務時，我們確實有兩個目標。

The first is that we are undoubtedly a growth company. You see that in our performance and in our guidance and the second, to do that in a sustainable way, which means driving continuous operating leverage. Now, we've talked about.

第一，我們毫無疑問是一家成長型公司。你可以從我們的表現與指引中看到；第二，必須以可持續的方式做到這一點，也就是推動持續的營運槓桿。現在，我們也談到過。

Moving toward margin expansion continuously, but in a measured way that matches the opportunity in front of us. So we really like the setup to be able to hit on both of those objectives and look forward to running the business and making a difference relative to our purpose for the long-term.

持續朝向毛利率擴張前進，但會以審慎、衡量過的方式，與我們眼前的機會相匹配。因此我們非常喜歡目前的布局，能同時達成這兩個目標，也期待長期經營這項業務，並依循我們的使命帶來改變。

Thanks a lot, Aaron. And I do want to thank everyone for participating in the call. I think, again, in summary, we delivered a very strong first quarter and a solid start to 2026. We executed against our priorities. We drove revenue growth, and we're raising our full year outlook.

非常感謝你，Aaron。我也要感謝各位參與今天的電話會議。我想再次總結一下：我們交出非常強勁的第一季成績，為 2026 年帶來穩健的開局。我們依照優先事項執行。我們推動營收成長，並上調全年展望。

At the same time, as you can see, the pipeline is entering a really critical phase of execution with foundational strength in hematology and a clear inflection point in solid tumors as our programs are advancing into later-stage development.

同時，如各位所見，我們的產品線正進入一個非常關鍵的執行階段：血液腫瘤領域具備扎實的基礎實力；而在實體腫瘤方面，隨著各項計畫推進到後期開發，也出現明確的拐點。

We have demonstrated, again, the power of the BeOne super highway and our strategic competitive advantage that we have in executing, which help make investment in R&D more attractive in our organization than other places in the industry and again, the aspiration and vision of our company, which we feel closer to than we ever have is to be the company that is creating the most impact for cancer patients globally that means lots of medicines and lots of indications that are truly game changing for patients and I feel more confident today than I ever have that we're on a path to being that company not in decades, but in years.

我們再次證明了 BeOne 超級高速公路的力量，以及我們在執行上的策略性競爭優勢；這使得在我們組織內投資研發比在產業其他地方更具吸引力。同時，我們公司的抱負與願景——我們覺得自己比以往任何時候都更接近——是成為一家在全球為癌症病患創造最大影響力的公司；這意味著有許多藥物、許多適應症，且對病患而言真正具有顛覆性。我今天比以往任何時候都更有信心，我們正走在成為那家公司的道路上，而且不是以數十年為尺度，而是以數年為尺度。

I really want to thank the patients and the families that we serve, our physicians and our partners and our more than 12,000 colleagues and their families whose focus and urgency make our progress possible. We're really encouraged by the momentum. We're confident where we're headed, and we're focused on developing medicines that are great for patients. So thank you all so much for joining us today, and have a wonderful week

我真的要感謝我們所服務的病患與家屬、我們的醫師與合作夥伴，以及超過 12,000 位同仁與他們的家人；正是他們的專注與緊迫感，讓我們的進展成為可能。我們對這股動能深受鼓舞。我們對前進方向充滿信心，並專注於開發對病患非常好的藥物。因此非常感謝各位今天加入我們，祝各位有個美好的一週。