Ascentage Pharma Group International (AAPG) 2025 Q4 法說會逐字稿

Good day, everyone, and welcome to Ascentage Pharma's 2025 annual results earnings call. (Operator Instructions) As a reminder, today's call is being recorded.

各位好，歡迎參加亞盛醫藥 2025 年度業績發佈電話會議。（接線員指示）提醒各位，今天的電話會議將被錄音。

Thank you for joining us. I will now turn the call over to Yuly Chen, Senior Director of Investor Relations for the Safe Harbor statement. Yuly, please go ahead.

感謝各位加入。我現在把電話交給投資者關係資深總監陳玉麗（Yuly Chen），由她宣讀安全港聲明。Yuly，請開始。

Thank you, operator. Please note that today's discussion will include forward-looking statements based on our current expectations and assumptions. These statements involve risks and uncertainties and actual results may differ materially. For a full discussion of these risks, please refer to our filings and disclosures.

謝謝接線員。請注意，今天的討論將包含基於我們目前預期與假設的前瞻性陳述。此等陳述涉及風險與不確定性，實際結果可能存在重大差異。關於這些風險的完整討論，請參閱我們的申報文件與披露資料。

On today's call, I am joined by Dr. Dajun Yang, Chairman and CEO, who will provide an overview of recent developments and 2025 annual performance; as well as Dr. Veet Misra, CFO, who will go through the financial highlights. The presentation will then be followed by a Q&A session.

今天的電話會議上，與我一同出席的有董事長兼首席執行官楊大俊博士，他將概述近期進展及 2025 年度業績；以及首席財務官 Veet Misra 博士，他將介紹財務重點。隨後將進入問答環節。

During the Q&A session, the team will be joined by Dr. Yifan Zhai, Chief Medical Officer; Dr. Shaomeng Wang, Co-Founder, Chief Scientific Adviser; Dr. Zhichao Si, Head of Commercial.

在問答環節，團隊還將由首席醫學官翟一帆博士、聯合創始人兼首席科學顧問王少萌博士，以及商業化負責人司志超博士共同參與。

I will now turn the call over to Dr. Yang.

我現在把電話交給楊博士。

Thank you. Good morning. I'm Dajun Yang, Chairman and CEO of the company. Today, I'm very happy to present our 2025 full-year financial results and a corporate update. I will have the following agenda, business update, R&D highlights, financial results and the Q&A session.

謝謝。各位早上好。我是公司董事長兼首席執行官楊大俊。今天我很高興向各位匯報我們 2025 年全年財務業績以及公司最新進展。今天的議程包括：業務更新、研發亮點、財務結果以及問答環節。

First, on the business update. 2025 was a breakout year for Ascentage. First, we have achieved excellent total revenue over 90% of growth and totaled $82.1 million. Our year-end cash balance is about $353.2 million, cash runway through 2027.

首先是業務更新。2025 年對亞盛而言是突破性的一年。首先，我們實現了優異的總收入，增長超過 90%，達到 8,210 萬美元。年末現金餘額約為 3.532 億美元，現金可支撐至 2027 年。

I think 2025, we are the first dual listed biopharmaceutical company on Nasdaq following our Hong Kong Stock Exchange listing 2019. We successfully raised approximately $322.6 million through IPO and a follow-on offering. It's the first time we have a dual commercial product, based on that, we established a fully functional large scale and fast-growing commercial team, currently close to 300 staff. We are on the path to be a premium global commercial hematology oncology company.

我認為在 2025 年，我們在 2019 年香港聯交所上市之後，成為首家在納斯達克雙重上市的生物製藥公司。我們通過 IPO 及後續增發成功募集約 3.226 億美元。這也是我們首次擁有兩款商業化產品；基於此，我們建立了一支功能完善、規模化且快速成長的商業團隊，目前員工接近 300 人。我們正走在成為全球高端血液腫瘤商業化公司的道路上。

We also achieved many major R&D milestones, these are the following examples.

我們也取得了多項重大研發里程碑，以下是一些例子。

First, Lisaftoclax approval as a global first single-agent Bcl-2 inhibitor after BTK treatment in CLL and SLL. GLORA-4 Phase 3 registrational trial received clearance globally, including FDA, EMA and CDE. This is a truly unique opportunity as we are the global Phase 3 registrational trial in high-risk MDS, the only one in the Phase 3 registrational stage.

首先，Lisaftoclax 獲批，成為全球首個在 CLL 和 SLL 中、BTK 治療後可作為單藥使用的 Bcl-2 抑制劑。GLORA-4 Ⅲ期註冊性試驗已在全球獲得批准開展，包括 FDA、EMA 和 CDE。這是一個真正獨特的機會，因為我們是在高風險 MDS 領域推進全球 Ⅲ期註冊性試驗的公司，且是唯一處於 Ⅲ期註冊性階段的項目。

POLARIS-1 for the Ph+ALL, the Phase 3 registrational trial also received clearance globally, including FDA, EMA and CDE. Part 1 data also reported at ASH demonstrated strong 64% MRD-negative CR rate in the first-line Ph+ALL.

針對 Ph+ALL 的 POLARIS-1 Ⅲ期註冊性試驗也已在全球獲得批准開展，包括 FDA、EMA 和 CDE。第一部分數據亦在 ASH 上報告，顯示在一線 Ph+ALL 中取得了強勁的 64% MRD 陰性 CR 率。

Olverembatinib granted Breakthrough Destination for the first-line treatment of Ph+ALL by CDE. We are also very proud to have FDA and CDE IND clearance for our novel BDK degrader APG-3288. Both Lisaftoclax and Olverembatinib entered 2025 CSCO Guidelines, multiple oral presentations at ASCO and ASH 2025.

Olverembatinib 獲 CDE 授予用於一線治療 Ph+ALL 的突破性療法認定。我們也非常自豪地宣布，我們的新型 BDK 降解劑 APG-3288 已獲 FDA 與 CDE 的 IND 批准。Lisaftoclax 與 Olverembatinib 均納入 2025 年 CSCO 指南，並在 ASCO 與 ASH 2025 上有多場口頭報告。

We continue to lead in the global innovation for many of our products including multiple presentations at ASH, AACR, ASCO, EHA and other conferences. And also, we published many peer-reviewed top journals.

我們在多個產品上持續引領全球創新，包括在 ASH、AACR、ASCO、EHA 等會議上的多項報告；同時，我們也在多本同行評審的頂級期刊發表了多篇論文。

I think here is our summary of world-class innovative, highly derisked and super late-stage pipeline. We have the list of seven novel compounds. The first two, Olverembatinib, as a novel third-generation BCR-ABL inhibitor and Lisaftoclax as the novel Bcl-2 Selective inhibitor. Both have been marketed in China and also entered for global registration trial cleared by FDA, EMA, and total, we actually have nine registrational trial for multiple indications.

我認為這裡是我們世界級創新、風險高度降低且處於超後期階段的管線總覽。我們共有七個新型化合物。前兩個是 Olverembatinib（新型第三代 BCR-ABL 抑制劑）以及 Lisaftoclax（新型選擇性 Bcl-2 抑制劑）。兩者均已在中國上市，並已進入獲 FDA、EMA 批准開展的全球註冊性試驗；總體而言，我們實際上針對多個適應症共有九項註冊性試驗。

We also have several novel potentially first-in-class compound targeting such as the FAK, ALK, ROS1, triple kinase and MDM2-p53 and the dual Bcl-2/Bcl-xL and the PRC2 third generation like the EED inhibitor. And more importantly, we have newly cleared Phase 1 novel BTK Degrader, APG-3288. All of these are running the trials in US and China and in multiple countries, mainly focused on hematology/oncology, but also have a potential and also in the clinical stage testing in indications such as anemia.

我們還擁有多個具有潛在同類首創（first-in-class）特徵的新型化合物，靶向包括 FAK、ALK、ROS1、三靶點激酶、MDM2-p53、雙靶點 Bcl-2/Bcl-xL，以及 PRC2 第三代（如 EED 抑制劑）。更重要的是，我們新近獲批開展 Ⅰ期的新型 BTK 降解劑 APG-3288。上述項目均在美國、中國及多個國家開展試驗，主要聚焦血液腫瘤領域，同時也具備潛力，並在如貧血等適應症上處於臨床階段測試。

So we have built a very large commercial scale in China with a dual product approved especially for our Bcl-2 Selective inhibitor subclass was ahead of our schedule last year. And with the two commercial products, we have built over 270 by the year-end commercial team, covered 1,500 hospitals and more than 800 DTP pharmacies.

因此，我們在中國建立了非常大規模的商業化體系，並且已有兩款產品獲批上市，尤其是我們的選擇性 Bcl-2 抑制劑子類產品在去年進度超出預期。憑藉兩款商業化產品，我們在年末已建立超過 270 人的商業團隊，覆蓋 1,500 家醫院及 800 多家 DTP 藥房。

I think our Dual-Engine strategy working well. As you can see, our last year commercial revenue, I think that's a transition for Ascentage from being rely on the investment -- investors and also BD income to the last year, 100% sales of the commercial stage product. I think that, that's a really important transition for the company to be able to self-sustain with our own revenue to support our own R&D program.

我認為我們的「雙引擎」策略運行良好。正如各位所見，我們去年的商業化收入，標誌著亞盛從以往依賴投資者資金以及 BD 收入，轉變為去年商業化階段產品銷售收入佔比達到 100%。我認為這是公司非常重要的轉型，使我們能夠以自身收入實現自我造血，支持我們自身的研發項目。

If you look at just Olverembatinib alone, we have a strong sale following full NRDL listing covering CML with and without mutation. So if you look at the total sales, reaching $62.2 million, that represents 81% year-over-year growth and we will continue to cover more hospitals, DTP pharmacy and also a broader reach to the Tier-1 hospitals. And with the full NRDL coverage and also translating into very long DoT that will support sustained growth as the patients continue to use our drug over a long time.

如果僅看 Olverembatinib，我們在全面納入國家醫保目錄（NRDL）後實現了強勁銷售，覆蓋有突變與無突變的 CML。總銷售額達到 6,220 萬美元，同比增長 81%。我們將繼續覆蓋更多醫院與 DTP 藥房，並進一步拓展至更多一級醫院。隨著 NRDL 的全面覆蓋，也將轉化為更長的治療持續時間（DoT），支持持續增長，因為患者將在較長時間內持續使用我們的藥物。

If you look at Lisaftoclax, first, this July approval was ahead of schedule. And we built a very fast and full functional commercial team dedicated to Lisaftoclax. So the seamless go-to-market strategy using the national commercial infrastructure really helped us to rapidly expand the sales force and hospital coverage.

再看 Lisaftoclax，首先，7 月獲批進度超出預期。我們建立了一支專門服務於 Lisaftoclax 的快速且功能完善的商業團隊。因此，依託全國商業化基礎設施的無縫上市策略，確實幫助我們迅速擴大銷售隊伍與醫院覆蓋。

So just the first five months, we have reached more than USD10 million sales. This is, I think, is among top, at least in the hematology oncology product sales in the first couple of months in China.

僅在前五個月，我們的銷售額就超過 1,000 萬美元。我認為這至少在中國血液腫瘤產品上市最初幾個月的銷售表現中屬於領先水平。

And then let's go to the R&D highlights. First, let's look at our Lisaftoclax is actively advancing its global Phase 3 registrational trials. First, our approval as a single agent for CLL, SLL, after BTK inhibitor, is already represented the first label for the Bcl-2 Selective inhibitor. As you know, Venetoclax was approved 2016. And continually, the only single agent was limited to the 17p deletion, CLL and SLL. The other CLL, SLL is all combination with CD20 antibodies.

接下來進入研發亮點。首先，我們的 Lisaftoclax 正在積極推進全球 Ⅲ期註冊性試驗。首先，我們作為單藥在 BTK 抑制劑治療後的 CLL、SLL 獲批，已經代表了選擇性 Bcl-2 抑制劑的首個標籤。各位知道，Venetoclax 於 2016 年獲批；而且長期以來，單藥適應症僅限於 17p 缺失的 CLL 和 SLL。其他 CLL、SLL 治療均為與 CD20 抗體聯合用藥。

Our GLORA, GLORA-2 and GLORA-3 also received FDA, EMA and CDE clearance. And more importantly, I think that the GLORA-4 is the first-line high-risk-MDS in combination with AZA or without azacitidine control arm, both received -- I mean, received the FDA, EMA and the CDE clearance, will continue pushing forward all these important global Phase 3 registrational trial.

我們的 GLORA、GLORA-2 和 GLORA-3 也已獲 FDA、EMA 和 CDE 批准開展。更重要的是，GLORA-4 作為一線高風險 MDS 的研究，採用與 AZA 聯合或不聯合的方案，對照組為阿扎胞苷或不含阿扎胞苷的對照臂，均已獲得——我的意思是，已獲得 FDA、EMA 以及 CDE 的批准；我們將持續推進這些重要的全球 Ⅲ期註冊性試驗。

I want to share a few important clinical data with you. First, with the single agent approval, based on the CC201 registrational study, those patients actually have a much poor baseline characteristics. First, the CDE actually give us a very high bar about four, five years ago, required all these CLL/SLL patients have to fail both BTK and CD20 antibody-based therapy.

我想與各位分享一些重要的臨床數據。首先，關於單藥獲批，是基於 CC201 註冊性研究；這些患者的基線特徵其實更差。首先，CDE 在四、五年前就對我們提出了非常高的門檻，要求所有這些 CLL/SLL 患者必須同時在 BTK 以及基於 CD20 抗體的治療上失敗。

Many of them have a high-risk complex karyotypes and also many have multiple mutations. So we achieved a very good efficacy as a single agent and demonstrate a favorable safety profile.

其中許多患者具有高風險的複雜核型，且也有許多患者帶有多重突變。因此，我們以單藥治療達成了非常好的療效，並展現出良好的安全性概況。

If you look at another key data in the AML and MDS. Actually, this is primarily US and Australia data with the leading PI from the US. And this actually has presented both at the ASCO and ASH. If you look at our ORR as a combination with ASA, in the naive, the newly diagnosed AML patients, we achieved ORR 83%.

如果你看 AML 與 MDS 的另一項關鍵數據。其實這主要是美國與澳洲的數據，由美國的主要 PI 領導。而且這些結果已在 ASCO 與 ASH 上發表。如果你看我們與 ASA 聯合用藥的 ORR，在初治、也就是新診斷的 AML 患者中，我們達到 83% 的 ORR。

And more importantly, in some cases, about 22 patients who have failed Venetoclax. We also achieved 32% ORR in the MDS, we have in the newly diagnosed 80%. And in the second line, our MDS, we have 50% ORR. I think based on those excellent data and many other clinical data, FDA gives us clearance to conduct global Phase 3 registrational trial as the first line for the high-risk MDS. And this has been cleared by FDA, EMA and CDE and among close to 20 countries, regulatory agencies.

更重要的是，在部分病例中，約有 22 位 Venetoclax 治療失敗的患者，我們在 MDS 也達到 32% 的 ORR；在新診斷的 MDS 中，我們達到 80%；而在二線治療的 MDS 中，我們達到 50% 的 ORR。我認為基於這些優異數據以及許多其他臨床數據，FDA 已核准我們進行全球第 3 期註冊性試驗，作為高風險 MDS 的一線治療。且該試驗已獲 FDA、EMA 與 CDE，以及近 20 個國家監管機構的核准。

So we are actively enrolling patients in US, Europe, China and throughout the world. So if successfully carried out, Lisaftoclax can become the first Bcl-2 inhibitor for the treatment of first-line high-risk MDS. This is really a global unmet medical need as there is no targeted therapy approved in the last 20 years. And current therapy have much poor efficacy and five-year survival rate for high-risk patients is only about 16% to 24%.

因此，我們正在美國、歐洲、中國以及全球各地積極招募患者。若能順利完成，Lisaftoclax 有望成為首個用於一線高風險 MDS 治療的 Bcl-2 抑制劑。這確實是全球未被滿足的醫療需求，因為過去 20 年沒有任何標靶治療獲批。而現有治療療效較差，高風險患者的五年存活率僅約 16% 至 24%。

We are also very proud these global efforts leading by Dr. Garcia-Manero from MD Anderson and Dr. Xiaojun Huang from Peking University People's Hospital and many, many excellent expert PIs for MDS around the world.

我們也非常自豪，這些全球性工作由 MD Anderson 的 Dr. Garcia-Manero、北京大學人民醫院的黃曉軍教授，以及全球許多優秀的 MDS 專家 PI 共同領導。

Based on the public information, we want to highlight a few key differences of our drug versus Venetoclax or Sonrotoclax. If we look at -- based on the same similar registration trial study, again, this is not a head-to-head comparison, but a really similar patient population, including those in China.

基於公開資訊，我們想強調我們的藥物相較於 Venetoclax 或 Sonrotoclax 的幾個關鍵差異。如果我們看——基於相同或相近的註冊性試驗研究，再次強調，這不是頭對頭比較，而是非常相似的患者族群，包括中國的患者。

So if you look at the SAE incidence is much higher for Venetoclax or Sonrotoclax and the infection rate also significantly higher. So that's consistent with the clinical observation that Lisaftoclax have a better safety profile, better tolerance. And more importantly, we have a better drug combinability.

因此，如果你看 SAE 的發生率，Venetoclax 或 Sonrotoclax 明顯更高，感染率也顯著更高。這與臨床觀察一致：Lisaftoclax 具有更好的安全性概況、更佳的耐受性。更重要的是，我們具有更好的藥物聯合用藥相容性。

CLL/SLL patients often are elderly and immunocompromised with frequent infections. Commonly used antifungal drugs are strong 3A4 inhibitors but does not affect our Lisaftoclax PK. So if you look at the PK variability in combination with some strong 3A4 inhibitors, I think that the impact for Lisaftoclax is minimal for other two drugs either need to -- about 8 times or 11 times need to be adjusted dose if they are combining those. That will strongly affect clinical combination studies.

CLL/SLL 患者通常年長且免疫功能低下，常有反覆感染。常用的抗黴菌藥物是強效 3A4 抑制劑，但不會影響 Lisaftoclax 的藥物動力學（PK）。因此，如果你看在與某些強效 3A4 抑制劑合併用藥時的 PK 變異性，我認為 Lisaftoclax 的影響極小；而另外兩個藥物若合併使用，則需要——大約 8 倍或 11 倍的劑量調整。這將嚴重影響臨床聯合用藥研究。

And also look at the P-gp or BCRP substrates or inhibitors, Lisaftoclax is probably the one of a minimal risk in those combination studies. No need to adjust dose with like many BTK inhibitors. I think that those are very unique advantage for Lisaftoclax as the Bcl-2 Selective inhibitor.

另外再看 P-gp 或 BCRP 的底物或抑制劑，Lisaftoclax 在這些聯合用藥研究中的風險可能是最低之一。與許多 BTK 抑制劑合併時無需調整劑量。我認為這些都是 Lisaftoclax 作為 Bcl-2 選擇性抑制劑非常獨特的優勢。

I also want to highlight a few important progress made and the summary here for Olverembatinib. Olverembatinib is approved with full coverage by NRDL. We see excellent commercial coverage and the revenue growth last year.

我也想重點說明 Olverembatinib 取得的幾項重要進展與此處的總結。Olverembatinib 已納入 NRDL 並獲得全面給付。我們看到非常好的商業覆蓋，以及去年營收的成長。

Globally, we are conducting POLARIS-2 for the CML and this single-agent study RCT with the bosutinib control arm also received FDA, EMA, CDE and the PMDA clearance. So we are actively pursuing advancing the global enrollment.

在全球方面，我們正在針對 CML 進行 POLARIS-2。這項單藥隨機對照試驗（RCT）以 bosutinib 作為對照組，也已獲 FDA、EMA、CDE 與 PMDA 核准。因此，我們正積極推進全球招募。

POLARIS-1 is very important. This is the first time we got a clearance last year. For the first line Ph+ALL and this is also cleared by FDA, EMA and CDE in China with a breakthrough destination. Part one of this trial, the same trial design data was presented at ASH. And you can see the data from next couple of slides.

POLARIS-1 非常重要。這是我們去年首次獲得核准，用於一線 Ph+ALL，且也已獲 FDA、EMA 與中國 CDE 核准，並取得突破性療法認定。該試驗第一部分的同一試驗設計數據已在 ASH 發表。你可以在接下來幾張投影片看到相關數據。

First, in the Part A of the Phase 3 registrational trial in combination with low-intensity chemo as the first line, we have achieved 64% MRD-negative CR rate. This is almost double the same patient population for the Ponatinib, which only have 34.4% MRD-negative CR rate but this actually is among all the BCR-ABL inhibitors, the best one. So we actually almost double the currently the best BCR-ABL inhibitor for the same patient population and also demonstrate very well safety profile.

首先，在第 3 期註冊性試驗的 A 部分，作為一線與低強度化療聯合用藥，我們達到 64% 的 MRD 陰性 CR 率。這幾乎是同一患者族群使用 Ponatinib 的兩倍；Ponatinib 的 MRD 陰性 CR 率僅 34.4%，但其實在所有 BCR-ABL 抑制劑中已是最佳。因此，對於相同患者族群，我們幾乎將目前最佳的 BCR-ABL 抑制劑的效果提升近一倍，同時也展現非常良好的安全性概況。

Another data is looking at a potential second line treatment for the CML-CP patients. This also, again, presented at the ASH last year. We can achieve more than 50% -- I mean, 70% CCyR rate, more than 40% MMR rate and also have a really durable sustained response.

另一項數據是針對 CML-CP 患者的潛在二線治療。同樣地，這也在去年 ASH 發表。我們可達到超過 50%——我的意思是，70% 的 CCyR 率、超過 40% 的 MMR 率，並且具有非常持久的持續反應。

Another important is in the blast crisis of the CML. I think we demonstrated in more than 64 patients with blast phase and also some serious cytogenetic abnormalities and complex karyotypes. And those patients did very well and also into the sustained remission with improved survival and a much reduced non-relapse mortalities.

另一個重要點是在 CML 的急變期（blast crisis）。我認為我們在超過 64 位急變期患者中展示了療效，且其中也包含一些嚴重的細胞遺傳異常與複雜核型。這些患者表現非常好，並達到持續緩解，存活改善，且非復發死亡率大幅降低。

Another potential treatment is really for the combination with our Olverembatinib. And in this case, it's actually in the pediatric patient population that is a first-line regimen in the Ph+ALL demonstrated really excellent efficacy and safety profile. I think that this would be really important for some of the patients to receive the chemo-free and the two orally active agent with a long-term benefit.

另一個潛在治療方向是與我們的 Olverembatinib 聯合用藥。在此案例中，實際上是在兒科患者族群中，作為 Ph+ALL 的一線方案，展現出非常優異的療效與安全性概況。我認為這對部分患者非常重要，因為他們可以接受無化療方案，並使用兩種口服活性藥物，帶來長期獲益。

Olverembatinib as multiple kinase inhibitors also demonstrate clinical benefit for some rare hematological malignancies such as very hard to treat myeloid/lymphoid neoplasm with the FGFR1 rearrangement. And this actually takes a while to recruit those patients, but most of them achieve excellent response clinically.

Olverembatinib 作為多重激酶抑制劑，也在一些罕見血液惡性腫瘤中展現臨床獲益，例如非常難治的、具有 FGFR1 重排的髓系/淋巴系腫瘤。這類患者招募需要一些時間，但大多數患者在臨床上都達到非常好的反應。

And we continue to push our pipeline. In the interest of time, we only show you one example as our novel BTK Degrader APG-3288. This actually we receive almost the same time clearance by FDA and CDE. And based on the preclinical data, I think we also did a comparison with B1 or Nurix BTK Degrader demonstrate good selectivity and potency. And we're pushing forward this compound in US and China for multiple indications.

我們也持續推進研發管線。為節省時間，我們只展示一個例子：我們的新型 BTK 降解劑 APG-3288。該項目幾乎同時獲得 FDA 與 CDE 的核准。基於臨床前數據，我認為我們也與 B1 或 Nurix 的 BTK 降解劑做了比較，顯示出良好的選擇性與效力。我們正在美國與中國推進該化合物，用於多個適應症。

I think in summary, Lisaftoclax has a very safe and potent Bcl-2 Selective inhibitor, some refer Bcl-2 inhibitor as a small molecule of PD-1, that really means it has multiple indications and also opportunity for multiple combinations. But I think more importantly, we're probably, globally, the only company has not just the Bcl-2 Selective inhibitor, but also Olverembatinib representing the best third generation BCR-ABL inhibitor and MDM2-p53 inhibitor and also the novel new BTK protein degrader. As you can see, each one of these is a single agent or in combination, have potential to treat a multiple B-cell malignancies among many hematological malignancies.

總結來說，Lisaftoclax 是一款非常安全且高效的 Bcl-2 選擇性抑制劑；有人把 Bcl-2 抑制劑稱為「小分子 PD-1」，意思是它具有多個適應症，且也有多種聯合用藥機會。但我認為更重要的是，我們可能是全球唯一一家不僅擁有 Bcl-2 選擇性抑制劑，還擁有 Olverembatinib（代表最佳的第三代 BCR-ABL 抑制劑）、MDM2-p53 抑制劑，以及新型 BTK 蛋白降解劑的公司。如你所見，這些藥物無論單藥或聯合用藥，都有潛力治療多種 B 細胞惡性腫瘤以及多種血液惡性腫瘤。

Lastly, I think I will turn the financial results to our CFO, Veet. We also go to the slide number 28.

最後，我想把財務結果交給我們的 CFO Veet。我們也請看第 28 張投影片。

Thank you so much. Yeah. So 2025 was a successful year for us as we established our commercial strength with now two approved novel oncology products.

非常感謝。是的。2025 年對我們而言是成功的一年，因為我們已建立起商業化實力，目前已有兩款獲批的創新腫瘤產品。

In 2025, our total revenue was USD82.1 million, excluding payments from Takeda as a comparison to last year, which represents a year-over-year increase of 90% on a constant exchange rate basis. This high revenue growth rate was driven by our aforementioned dual-engine commercialization strategy as articulated by Dr. Yang and centered on Olverembatinib and Lisaftoclax.

2025 年，我們的總營收為 8,210 萬美元；若排除來自武田（Takeda）的付款，以便與去年比較，則在固定匯率基礎上同比成長 90%。這一高營收成長率，主要由前述的雙引擎商業化策略所驅動，正如楊博士所闡述，並以 Olverembatinib 與 Lisaftoclax 為核心。

Turning to Olverembatinib and Lisaftoclax individually. Olverembatinib sales of USD62.2 million represents year-over-year growth of 81%. Sales of this product reflected first full years -- first full year of NRDL inclusion, hospital and DTP market penetration, which drove increased volume uptake. Turning to Lisaftoclax, which was approved in July 2025. First five-month sales of $10.1 million was attributed to our established commercial infrastructure that was built to scale ahead of approval and is anticipated to drive strong market penetration going forward.

接下來分別談談 Olverembatinib 與 Lisaftoclax。Olverembatinib 銷售額為 6,220 萬美元，年增 81%。該產品銷售反映了首個完整年度——首次完整年度納入 NRDL、以及在醫院與 DTP 市場的滲透，帶動用量提升。再談 Lisaftoclax，其於 2025 年 7 月獲批。上市後前五個月銷售額為 1,010 萬美元，主要歸因於我們在獲批前即已建置並可擴張的商業化基礎設施，預期將在未來推動強勁的市場滲透。

At the same time, we continue to adhere to a disciplined approach to efficiently manage and prioritize our operating expenses to support accelerated commercial activity, as well as our ongoing clinical studies, including global registrational trials. As you can see, our year-over-year increase in R&D expense from USD130 million to USD163 million year over year, which is tied to advancing ongoing global pivotal studies, represents a 20.1% growth rate to support trials ongoing to -- that are expanding and moving forward.

同時，我們持續秉持嚴謹的方式，高效率管理並優先排序營運費用，以支持加速的商業活動，以及我們正在進行的臨床研究（包括全球註冊性試驗）。如各位所見，我們研發費用年增由 1.30 億美元提升至 1.63 億美元，主要與推進正在進行的全球關鍵性研究相關，年增率為 20.1%，以支持正在擴大並持續推進的試驗。

In addition, the increase in S&D expenses, sales and distribution, in 2025 from USD27 million to USD51 million was primarily driven for sales force expansion ahead of commercial launch of Lisaftoclax, which is an efficient use of capital. So as you can see, the increase in these two major line expense items compared to our revenue growth demonstrates our disciplined approach.

此外，2025 年銷售與配送（S&D）費用由 2,700 萬美元增加至 5,100 萬美元，主要是因 Lisaftoclax 商業上市前擴充銷售團隊所致，這是資本的有效運用。因此，如各位所見，這兩項主要費用科目相較於我們的營收成長，其增幅展現了我們一貫的紀律性作法。

Finally, in terms of our cash balance, our 2025 year-end cash balance of USD353.2 million compared to USD172.8 million reported year-end 2024 is a result of product sales and two completed successful financings in 2025, our January 2025 Nasdaq IPO as well as our follow-on offering in July 2025 on the heels of Lisaftoclax approval, raising combined proceeds of $322.6 million.

最後，就現金餘額而言，我們 2025 年底現金餘額為 3.532 億美元，相較於 2024 年底報告的 1.728 億美元，主要來自產品銷售以及 2025 年完成的兩次成功融資：2025 年 1 月在納斯達克 IPO，以及在 Lisaftoclax 獲批後於 2025 年 7 月進行的後續發行，合計募得 3.226 億美元。

So as a result, this allows us to maintain our estimate of cash runway through 2027, as we've stated before, which importantly funds us through multiple key registrational studies that are being conducted globally and execution of our overall commercialization strategy.

因此，這使我們得以維持先前所述對現金可支撐期（cash runway）可延續至 2027 年的估計；更重要的是，這筆資金可支持我們在全球進行的多項關鍵註冊性研究，以及整體商業化策略的執行。

Thank you. I'll now turn it back to you, Dr. Yang.

謝謝。接下來我把時間交還給楊博士。

Thank you, Veet. I also want to present our clinical catalysts and milestones for 2026.

謝謝你，Veet。我也想介紹我們 2026 年的臨床催化劑與里程碑。

On the clinical development side, our major focus will be an advanced enrollment for the GLORA and GLORA-4 registrational trial and also advanced enrollment for Olverembatinib in terms of POLARIS-2 trial and also POLARIS-1 trial. I think as we mentioned earlier with our team, I think the keyword for 2026 is really the enrollment and enrollment. I think we'll do our best to achieve a complete enrollment and then be able to file NDAs in 2027.

在臨床開發方面，我們的主要重點將是加速 GLORA 與 GLORA-4 註冊性試驗的入組，同時也將加速 Olverembatinib 的入組，包括 POLARIS-2 試驗以及 POLARIS-1 試驗。正如我們先前與團隊提到的，我認為 2026 年的關鍵字就是「入組、入組、再入組」。我們會盡最大努力完成入組，並在 2027 年提交 NDA。

We'll continue to push Degrader APG-3288 global Phase 1 study in terms of safety, tolerability, PK and potential efficacy data and then also advance our EED inhibitor APG-5918 in both oncology and anemia. Of course, we'll continue to push other active compounds in clinical study in US and in China as well. But I think the major in terms of milestone for the clinical development are those highlighted here.

我們將持續推進 Degrader APG-3288 的全球一期研究，聚焦於安全性、耐受性、PK 以及潛在療效數據；同時也將推進 EED 抑制劑 APG-5918，涵蓋腫瘤與貧血領域。當然，我們也會持續推進其他在美國與中國進行臨床研究的活躍化合物。不過，就臨床開發的主要里程碑而言，重點就是此處所強調的項目。

On the commercial front, we will continue to drive the sales growth for our Olverembatinib and also the Lisaftoclax to the Tier 1 hospitals and more pharmacies. And for Lisaftoclax, we will do our best for the benefit of patients, especially CLL/SLL, together to the NRDL coverage in China in 2026.

在商業化方面，我們將持續推動 Olverembatinib 與 Lisaftoclax 在一級醫院（Tier 1 hospitals）以及更多藥局的銷售成長。對於 Lisaftoclax，我們也將為了病患福祉，特別是 CLL/SLL 病患，盡最大努力在 2026 年推動其在中國納入 NRDL 覆蓋。

I think that the key driver for Ascentage to be a global player in hematology/oncology is really driven by the two novel and potentially best-in-class compound, Olverembatinib and Lisaftoclax. We also have a dedicated hematology oncology sales force not just based on the really rapid scale in China, but more importantly, our global strategy positioning and branding.

我認為，推動 Ascentage 成為血液腫瘤/腫瘤領域全球玩家的關鍵動能，主要來自兩個創新且具潛在同類最佳（best-in-class）的化合物：Olverembatinib 與 Lisaftoclax。我們也擁有一支專注於血液腫瘤的銷售團隊，不僅建立在中國快速擴張的基礎上，更重要的是支撐我們的全球策略定位與品牌打造。

I think with our world-class clinical execution and a proven track record of translating the clinical development into the novel commercial product and advance our best-in-class potential therapeutics in global registrational studies, I think with the dedication and the effort from all our team and also our collaborators and the PIs around the world, we're really moving our pipeline to addressing the global unmet medical need, making Ascentage to become the global leader in these therapeutic areas.

憑藉世界級的臨床執行力，以及將臨床開發轉化為創新商業產品的成熟實績，並在全球註冊性研究中推進具同類最佳潛力的治療方案；我相信在全體團隊的投入與努力，以及全球合作夥伴與主要研究者（PIs）的支持下，我們正推動產品管線去滿足全球未被滿足的醫療需求，讓 Ascentage 成為這些治療領域的全球領導者。

Lastly, I think with the patient-centric innovation and global breakthrough therapies and with currently seven, we'll call the seven magnificent, seven active compound, small molecule drugs in active clinical trials, addressing multiple hematology malignancies from the CML/ALL to CLL, AML/MDS, multiple myeloma and potentially some of the lymphomas and anemias. Hopefully, with all your support, we can make 2026 another successful year for Ascentage.

最後，我認為以病患為中心的創新與全球突破性療法，加上目前我們有七個——我們稱之為「七大王牌」——七個活躍化合物、小分子藥物正在進行臨床試驗，涵蓋多種血液惡性腫瘤，從 CML/ALL 到 CLL、AML/MDS、多發性骨髓瘤，以及可能的部分淋巴瘤與貧血。希望在各位的支持下，我們能讓 2026 年成為 Ascentage 另一個成功的一年。

Thank you all for your attention. And now we will be happy to answer any questions you may have. Thank you.

感謝各位的關注。接下來我們很樂意回答各位可能有的任何問題。謝謝。

(Operator Instructions) Brian Cheng, JPMorgan.

（接線員指示）Brian Cheng，摩根大通。

Maybe just first, Dr. Yang, you talked about how this year is really about on enrollment, enrollment, enrollment. Can you give us a bit more color on where you are in terms of enrollment for your registrational studies, especially the GLORA-4 study in MDS with Lisaftoclax and also the POLARIS-1 study in Ph+ALL? And related to those indication, how should we think about the next data milestone at the upcoming medical conferences later this year?

首先，楊博士，您提到今年的重點就是入組、入組、入組。能否請您更具體說明一下註冊性研究的入組進度，特別是 Lisaftoclax 用於 MDS 的 GLORA-4 研究，以及用於 Ph+ALL 的 POLARIS-1 研究？另外，針對這些適應症，我們應該如何看待今年稍晚在即將召開的醫學會議上的下一個數據里程碑？

Thank you, Brian. Very excellent question. I think let me maybe address this in two parts.

謝謝你，Brian。非常好的問題。我想我可以分兩個部分來回答。

First, for the GLORA-4 MDS, -- high-risk MDS, we are very happy to see this Phase 3 registrational trial protocol receive clearance by not just the FDA, EMA, CDE and also among close to 20 countries regulatory agency. And this is the first-line treatment for the naive -- treatment naive newly diagnosed high-risk MDS.

第一，關於 GLORA-4 的 MDS——高風險 MDS，我們非常高興看到這項三期註冊性試驗的方案不僅獲得 FDA、EMA、CDE 的核准/放行，也獲得近 20 個國家監管機構的核准/放行。這是一線治療，針對初治——治療未經治療（treatment naive）的新診斷高風險 MDS 病患。

And more importantly, this is now really the only Phase 3 registrational trial in the high-risk MDS globally. And we are very happy to receive the support from the PIs around the world, and they're really enthusiastic for this clinical trial to help patients globally with MDS.

更重要的是，這目前確實是全球高風險 MDS 領域唯一的三期註冊性試驗。我們也非常高興獲得全球主要研究者（PIs）的支持，他們對這項臨床試驗非常熱忱，希望能幫助全球的 MDS 病患。

And with the POLARIS-1, this is the first-line Ph+ALL. As you know, we also presented Part 1 of the same protocol data at ASH. The three months MRD-negative rate CR is 64%, almost double the Ponatinib and the same patient population, about only 34%. So I think that those two registration trials are both for the first-line treatment, which will actually much easier enroll than some of the late-line protocols.

至於 POLARIS-1，這是一線 Ph+ALL。如各位所知，我們也在 ASH 發表了同一方案的第一部分數據。三個月 MRD 陰性率的 CR 為 64%，幾乎是 Ponatinib 在相同病患族群中的兩倍，後者大約只有 34%。因此我認為，這兩項註冊性試驗都是一線治療，實際上會比一些後線方案更容易入組。

And of course, also have a huge potential market return. And with those two first-line treatment, and you can see MDS, we are the only one front runner in the Phase 3 registrational trial globally. There's almost no competition there.

當然，這也意味著具備巨大的潛在市場回報。就這兩個一線治療而言，你可以看到在 MDS 上，我們是全球唯一進入三期註冊性試驗的領跑者，幾乎沒有競爭。

The POLARIS-1 is first line for the Ph+ALL, also with excellent data, potentially the best-in-class for the Ph+ALL patient population. So I think the enrollment are doing well. And even though those only initiated late last year, but we see so far very excellent enrollment and very strong support from the health care providers around the world.

而 POLARIS-1 是 Ph+ALL 的一線治療，數據也非常出色，對於 Ph+ALL 病患族群可能是同類最佳。因此我認為入組進展良好。儘管這些研究是在去年底才啟動，但截至目前我們看到非常優異的入組表現，以及全球醫療照護提供者非常強力的支持。

And POLARIS-1 only require three months MRD-negative CR rate as a primary endpoint. And also, we have a strong support from FDA and all the regulatory agencies to support the protocol of the GLORA-4.

此外，POLARIS-1 只需要三個月 MRD 陰性 CR 率作為主要終點。同時，我們也獲得 FDA 與所有監管機構對 GLORA-4 方案的強力支持。

I think the -- overall, we will do our best to achieve complete enrollment. And with the current timeline and the primary endpoint, we anticipate to the best we can and then to be able release the top-line data or complete enrollment and then be able to file NDA in 2027.

整體而言，我們會盡最大努力完成入組。依照目前的時程與主要終點，我們預期將在能力所及範圍內，發布頂線（top-line）數據或完成入組，並在 2027 年提交 NDA。

Got it. And maybe just one more. Just how do you think about the commercial growth opportunities for both Olverembatinib and Lisaftoclax franchise this year in China? Are there any specific drivers that you see today that your sales team is fully leaning on? And then perhaps we actually have a follow-up after this.

了解。再問最後一個問題：您如何看待今年在中國 Olverembatinib 與 Lisaftoclax 兩個產品線的商業成長機會？目前是否有任何特定驅動因素，是你們的銷售團隊正在全力倚重的？另外我們之後可能還有一個追問。

Yeah. Maybe for the commercial part, we can have our Head of Commercial, Zhichao to address the part of your question first.

是的。也許就商業面的部分，我們可以請我們的商業負責人 Zhichao 先來回應您問題中的這一部分。

Yeah. Okay. Thank you for the question. And if you look at the actual driver of growth in 2025 in China, I believe there are several key drivers. And first of all, if you look at Olverembatinib and which really benefit from the broader reimbursement support, the affordability after NRDL inclusion, right, which Dr. Yang also mentioned, and also very strong patient affordability improvement.

是的。好的。謝謝您的提問。如果您看 2025 年在中國的實際成長驅動因素，我認為有幾個關鍵驅動。首先，如果看 Olverembatinib，它確實受益於更廣泛的醫保報銷支持，也就是納入 NRDL 之後的可負擔性，對吧，楊博士也提到過，同時患者的可負擔性也有非常顯著的改善。

And second, if we look at our annual report, we continue to expand the hospital and D2C pharmacy access with more than 800 hospitals and DTP pharmacy, which significantly improved the accessibility by the year-end, which also includes more than 355 hospitals with formulary access. Hospital listing is very important in China market.

第二，如果我們看年報，我們持續擴大醫院與 D2C 藥房的可及性，覆蓋超過 800 家醫院與 DTP 藥房，這在年底前顯著提升了可及性，其中也包括超過 355 家已取得院內目錄准入的醫院。在中國市場，進院上架非常重要。

And third, I believe if you look at Lisaftoclax which was approved in China and since July, and we got sales for five months. And Lisaftoclax, I mean, really give us a second growth engine after launch and generating more than RMB70 million in the first five years on the market.

第三，我認為如果看 Lisaftoclax，它自 7 月在中國獲批以來，我們有 5 個月的銷售貢獻。Lisaftoclax 的推出——我是說——在上市後確實為我們帶來第二個成長引擎，並在上市後前五個月創造了超過人民幣 7,000 萬的收入。

And fourth, I think we scaled our commercial organization and Dr. Yang and Dr. Veet both mentioned, we scaled up our commercial organization meaningfully. Our team actually almost tripled compared to 2025 -- compared to 2025 compared to 2024. And this commercialization team growing to more than 270 people and converting more than 1,500 hospitals nationwide. I believe that's the key drivers for the last year's commercial growth. Thank you.

第四，我認為我們擴大了商業化組織規模，楊博士和 Veet 博士都提到過，我們在商業化組織上做了有意義的擴編。我們的團隊相較於 2024 年幾乎成長到三倍——我是說，相較於 2024 年。商業化團隊增至超過 270 人，並在全國覆蓋轉化了超過 1,500 家醫院。我認為這些就是去年商業成長的關鍵驅動因素。謝謝。

Great. And then maybe just lastly, I just want to touch on your BTK Degrader here. Dr. Yang, can you first give us a better sense of how you see differentiation compared to other BTK Degrader that's out there? And then as you think about your Phase 1 study, what would be good to see from this initial Phase 1?

很好。最後我想再談一下你們的 BTK 降解劑。楊博士，您能否先讓我們更清楚了解，您認為相較於市面上其他 BTK 降解劑，你們的差異化在哪裡？另外，當您思考一期研究時，從這個初始一期中看到哪些結果會是好的？

Brian, very good question. For the first maybe clinical part, I will have our Chief Medical Officer, Dr. Zhai to address. Yifan, can you hear?

Brian，這是個很好的問題。第一部分可能偏臨床，我會請我們的首席醫學官翟博士來回答。Yifan，你聽得到嗎？

So if not, maybe let me try to answer your question. So first, we have conducted very thorough, of course, currently preclinical data to compare our BTK Degrader with B1 or Nurix. I think based on this comparison, we selected our candidate compound moving into the Phase 1. And based on the preclinical data, at least, we show better selectivity and also more potency. That's number one.

如果不行，那我先嘗試回答您的問題。首先，我們已經做了非常全面的比較——當然目前是臨床前數據——把我們的 BTK 降解劑與 B1 或 Nurix 的產品進行對比。基於這些比較，我們選定了進入一期的候選化合物。從臨床前數據來看，至少我們顯示出更好的選擇性以及更高的效力。這是第一點。

Number two, I think as the BTK is a validated target, the BTK Degrader can take care many of the BTK inhibitors covalent, non-covalent mutation or not basically have broad efficacy in the oncology space. I think the most unique for Ascentage, once we go through the Phase 1 typical safety, tolerability, PK and some signal of efficacy with the potential RP2D, we probably move very quickly into the potential single-agent indications for the fast-to-market approach.

第二點，我認為 BTK 是一個已被驗證的靶點，BTK 降解劑可以覆蓋許多 BTK 抑制劑面臨的問題——無論是共價、非共價，或是否存在突變——基本上在腫瘤領域具有廣泛療效。我認為對 Ascentage 最獨特之處在於，一旦我們在一期完成典型的安全性、耐受性、PK，以及一些療效信號並確定潛在 RP2D，我們可能會非常快速地推進到潛在的單藥適應症，以採取更快上市的策略。

The second part, I think, unique to Ascentage that we have a very excellent Bcl-2 Selective inhibitor. So the combination of BTK inhibitor or degrader and the Bcl-2 inhibitor could really offer some of the hard-to-treat patients benefit.

第二部分，我認為 Ascentage 的獨特之處在於我們擁有一款非常優秀的 Bcl-2 選擇性抑制劑。因此，BTK 抑制劑或降解劑與 Bcl-2 抑制劑的聯合，確實能為一些難治患者帶來獲益。

And in the case of the CLL/SLL, at least with the fixed duration is really potential even in some case clinical cure that means there's no progression after five years treatment -- I mean, stop treatment. I think that will also offer additional benefit, especially for the young patients with the CLL/SLL. And in combination with the Bcl-2 maybe also can treat some hard to treat like DLBCL.

以 CLL/SLL 為例，至少固定療程（fixed duration）具有很大潛力，甚至在某些情況下可達到臨床治癒，也就是停藥後五年沒有疾病進展——我是說，停止治療後。我認為這也會帶來額外益處，特別是對年輕的 CLL/SLL 患者。而且與 Bcl-2 聯合也可能治療一些難治類型，例如 DLBCL。

I think thirdly, I think also this part of our moving forward strategy, potential, the maximum return is that there are also many non-oncology indications for the BTK Degrader, like autoimmune diseases. I think with all those three reasons, we are really looking forward to full speed to push this novel BTK Degrader into the clinic development and many other potential combinations and indications.

第三點，我認為這也是我們未來推進策略的一部分，潛在的最大回報在於 BTK 降解劑在非腫瘤領域也有許多適應症，例如自體免疫疾病。基於這三個原因，我們非常期待以全速推進這款新型 BTK 降解劑進入臨床開發，以及探索更多潛在的聯合方案與適應症。

Biren Amin, Piper Sandler.

Biren Amin，Piper Sandler。

Maybe to start, for Olverembatinib, what is your market share in China versus the Asciminib and Ponatinib. And which CML patients are you seeing the most adoption?

先從 Olverembatinib 開始，你們在中國相對於 Asciminib 和 Ponatinib 的市占率是多少？你們看到採用最多的是哪些 CML 患者？

And then I guess for second-half 2025, sales grew by about 7% versus first-half '25. What can we expect for the growth rate for Olverembatinib in 2026?

另外我想問，2025 年下半年銷售額相較於 2025 年上半年成長約 7%。那麼 2026 年 Olverembatinib 的成長率我們可以期待多少？

Really good question. The 2025 was the first year for the NRDL coverage and especially for with/without mutation. And so the patient population compare our first approved indication with T315 mutation only, we -- the patient population will more than triple. That's number one.

這是個非常好的問題。2025 年是 NRDL 覆蓋的第一年，特別是針對有／無突變的適用人群。因此，相較於我們最初僅針對 T315 突變的獲批適應症，患者人群將超過三倍。這是第一點。

The NRDL coverage for this chronic patient is really significant as they can average nationwide can reduce at least 70% the payment. And in certain better economy, the countries, I mean the province, the reduction payment can be reduced by 90%. So that's really significant as this patient is taking the drug in a long time, right, very good long DOT. So the NRDL coverage in China for the CML patients, we see really benefit -- important benefit.

NRDL 對這類慢性患者的覆蓋非常重要，因為平均在全國範圍內可至少降低 70% 的自付費用。在經濟條件較好的地區——我是說省份——自付降幅可達 90%。這非常顯著，因為這些患者需要長期用藥，對吧，用藥持續時間（DOT）很長。因此在中國，NRDL 對 CML 患者的覆蓋，我們看到確實帶來很重要的益處。

The patient population in China as other late-line treatment, like you mentioned Asciminib or Ponatinib, both were only approved last year, okay? But they don't have any establishment or the data from China. We also have last three, four years market use, even though for small dedicated mutation patient population. But overall, the physicians and the patients are really well educated position once they get into the full NRDL coverage.

至於中國的患者人群以及其他後線治療，如您提到的 Asciminib 或 Ponatinib，這兩款藥都是去年才獲批，對吧？但它們在中國沒有既有的基礎或本土數據。我們則有過去三、四年的市場使用經驗，儘管當時僅針對較小的特定突變患者人群。但總體而言，一旦進入全面 NRDL 覆蓋，醫師與患者其實已經被充分教育並建立了認知。

For both Asciminib and Ponatinib, they were not under NRDL coverage, okay? So that also limits the use of those two drugs only got approved a year ago. So there are not really much sales affordability for those non-NRDL coverage, the Asciminib or Ponatinib in China.

對於 Asciminib 和 Ponatinib 來說，它們並未納入 NRDL 覆蓋，對吧？這也限制了這兩款藥在中國的使用；而且它們也只是獲批一年。因此，對於未納入 NRDL 的 Asciminib 或 Ponatinib，在中國並沒有太多具可負擔性的銷售放量。

Then moving forward for 2026, we see the benefit of NRDL will continue as the price is good for two years. And if we just looking a little bit next year ahead of NRDL renewal, we're also very confident as the new policy from the NRDL is to maximize the support for the novel agent and also those unmet medical need. I think Olverembatinib is one of the examples falling into the category with a strong support by the NRDL.

展望 2026 年，我們認為 NRDL 的利好會持續，因為目前的價格可維持兩年。如果我們稍微往明年、也就是 NRDL 續約前看，我們也非常有信心，因為 NRDL 的新政策是最大化支持創新藥以及未被滿足的醫療需求。我認為 Olverembatinib 就是其中一個例子，屬於 NRDL 強力支持的類別。

And also, we currently, another important indication, also very high prevalence disease is the Ph+ALL. In the real world, we do have many Ph+ALL patients benefit by the Olverembatinib. But at the same time, because they are not officially into the NRDL coverage, so currently, in those patient population, we still want to finish our registrational trial, be able to get into the NRDL. So moving forward, I think there's a continued expansion and the growth of the revenue for Olverembatinib in China, both CML and the Ph+ALL.

此外，我們目前還有另一個重要適應症，也是高盛行疾病，即 Ph+ALL。在真實世界中，確實有許多 Ph+ALL 患者從 Olverembatinib 中獲益。但同時，由於該適應症尚未正式納入 NRDL 覆蓋，因此在這部分患者人群中，我們仍希望完成註冊性試驗，以便能夠納入 NRDL。往前看，我認為 Olverembatinib 在中國的收入仍將持續擴張並成長，涵蓋 CML 與 Ph+ALL 兩個領域。

And maybe just a follow-up. Clearly, there's a lot of focus on the CML treatment landscape, especially yesterday, Merck announced acquisition of Terns for $6.7 billion. How do you think Olverembatinib would fit into the emerging treatment landscape in the US for CML?

再追問一下。顯然市場非常關注 CML 的治療格局，尤其是昨天 Merck 宣布以 67 億美元收購 Terns。您認為在美國新興的 CML 治療格局中，Olverembatinib 會如何定位與融入？

And then second question, which of your global pivotal trials across both Olverembatinib and Lisaftoclax can we expect to see data in 2027?

第二個問題，你們在 Olverembatinib 與 Lisaftoclax 兩條產品線上的全球關鍵性試驗中，哪些我們可以期待在 2027 年看到數據？

Great. Really excellent question. And actually, we're all very excited to see the acquisition of the Terns by Merck with obviously, really good price, $6.7 billion in all cash. I think the positive side is really that means the CML market globally is actually quite big, right?

很好。這是非常出色的問題。其實我們也都非常興奮看到 Merck 收購 Terns 的消息，顯然價格非常不錯，67 億美元全現金。我認為正面的意義在於，這確實表明全球的 CML 市場其實相當大，對吧？

So to be honest, a couple of years ago, when we were developing Olverembatinib, there are some concerns from the investors that maybe this indication is small compared like lung cancer, breast cancer. But if you look at the history, the first generation, the Imatinib or Gleevec, actually, just in the CML alone, the peak sales before patent expiration is almost $5 billion peak sales annually, right?

所以坦白說，幾年前我們在開發 Olverembatinib 的時候，投資人確實有一些疑慮，覺得這個適應症相較於肺癌、乳癌等可能市場較小。但如果你回顧歷史，第一代的 Imatinib（或 Gleevec）其實光是在 CML 這個適應症上，在專利到期前的銷售峰值就接近每年 50 億美元，對吧？

So I think overall, the current CML market globally, the peak sale is about -- I think the total annual sales is about $7 billion. And Asciminib last year already reached more than $1 billion sales. So I think there's an estimate the potential just CML global market, the peak sale can reach over $14 billion.

所以我認為整體而言，目前全球 CML 市場的峰值銷售大約是——我想年總銷售額約 70 億美元。而 Asciminib 去年就已經達到超過 10 億美元的銷售額。所以我認為有估算指出，僅 CML 的全球市場潛力，其峰值銷售可達 140 億美元以上。

So I think this is also supported by the Merck acquisition of Terns primarily for the CML drug, TERN-701. So that's really great news, great stimulation for the market, for the investors' confidence in this indication and novel drugs.

所以我認為這也受到默克（Merck）收購 Terns 的支持，主要就是為了其 CML 藥物 TERN-701。因此這真的是很好的消息，對市場而言是很大的刺激，也提升了投資人對這個適應症以及創新藥物的信心。

To answer your question, I think we are very also happy we entered the option agreement with Takeda about two years ago, June 2024. I think globally, Takeda will be our partner. I think as you know, in the CML and AL space globally, Takeda is really one of the leading company aside from the Novartis. I think Takeda will be our strong -- the best commercial partner for Olverembatinib moving forward.

回答你的問題，我想我們也非常高興在大約兩年前、也就是 2024 年 6 月，與武田（Takeda）簽訂了選擇權協議。我認為在全球範圍內，武田將會是我們的合作夥伴。正如你所知，在 CML 與 AL 領域的全球市場上，除了諾華（Novartis）之外，武田確實是領先公司之一。我認為武田將會是我們未來推進 Olverembatinib 最強、也是最好的商業化合作夥伴。

The third part of your question is about the registration trial of the two drugs, right?

你問題的第三部分是關於兩個藥物的註冊性試驗，對吧？

Yeah, that's correct. Which of your trials should we expect to see data in 2027 that are global pivotal?

對，沒錯。你們哪些試驗是我們可以預期在 2027 年看到數據、而且屬於全球關鍵性（pivotal）試驗的？

Yeah. I think we currently push forward really full speed, the best effort for the GLORA-4, the high-risk MDS registration trial and also both POLARIS-2 and POLARS-1 for the Olverembatinib. I think the POLARIS-2 or POLARIS-1 -- POLARIS-2 is six months rate MMR rate after the last patient for the potential accelerated approval. And POLARIS-1 is three months MRD-negative CR rate. So I think once we complete enrollment, those two probably most likely would have an opportunity to file the NDA in 2027.

是的。我認為我們目前正全速推進、盡最大努力推動 GLORA-4（高風險 MDS 的註冊性試驗），以及 Olverembatinib 的 POLARIS-2 和 POLARIS-1。我認為 POLARIS-2 或 POLARIS-1——其中 POLARIS-2 是在最後一位受試者後 6 個月的 MMR 比率，用於潛在的加速核准；而 POLARIS-1 是 3 個月的 MRD 陰性 CR 比率。所以我認為一旦完成收案，這兩項試驗很可能都有機會在 2027 年提交 NDA。

The GLORA-4 actually also have a good chance because we enter -- I mean, we enroll patients very fast as in this indication with the Bcl-2 inhibitor, we are the only registrational trial globally for high-risk MDS because many drugs failed, including VERONA trial was inactive. So we do see a really strong interest and really good enrollment in that space.

GLORA-4 其實也有很好的機會，因為我們——我是說，我們在這個適應症的收案速度非常快；搭配 Bcl-2 抑制劑的高風險 MDS 領域，我們是全球唯一的註冊性試驗，因為很多藥物都失敗了，包括 VERONA 試驗也沒有進展。因此我們確實看到這個領域有非常強的興趣，收案情況也非常好。

And with the current protocol achieved, I think this is -- in my 20 years of drug development record, it is really the first time for the registration trial of the same protocol approved, cleared by multiple regulatory agency in the same indication. As you know, in our CLL, we actually did three different registrational trial because of different landscape and different regulatory requirement. So I think we are very happy to see the GLORA-4 registrational trial enrollment is actually really promising and we potentially also looking forward to have the NDA filing in 2027.

而且以目前的方案（protocol）獲批情況來看，我認為這是——在我 20 年的新藥開發經歷中，第一次看到同一個適應症、同一份註冊性試驗方案同時獲得多個監管機構核准與放行。你也知道，在我們的 CLL 項目中，因為不同的競爭格局與不同的監管要求，我們其實做了三個不同的註冊性試驗。所以我認為我們非常高興看到 GLORA-4 註冊性試驗的收案確實非常有希望，我們也可能期待在 2027 年提交 NDA。

Gregory Renza, Truist Securities.

Gregory Renza，Truist Securities。

Congrats on the progress. This is Supawat on for Greg. Just continuing on the theme of the last question. Just I was wondering if you could characterize Olverembatinib's profile relative to TERN-701, particularly around the 24 weeks or 6 months MMR rate with your existing data?

恭喜你們的進展。我是代 Greg 提問的 Supawat。延續上一個問題的主題，我想請問你能否描述一下，基於你們現有數據，Olverembatinib 相對於 TERN-701 的特徵，特別是在 24 週或 6 個月的 MMR 比率方面？

And then just as a follow-up, so on -- I know you have a POLARIS-2 study going, but just curious about potentially expanding into second line or earlier lines in CML. What's the progress on that one?

另外再追問一下——我知道你們正在進行 POLARIS-2 研究，但也想了解你們是否可能擴展到 CML 的二線或更早線別治療？這方面的進展如何？

Thank you. Very good question. Obviously, we are very happy to see Tern's acquisition and also 11 data presented at ASH last year. But I think Olverembatinib will really have a unique advantage based on the clinical data, right? So we're probably the same ATP binding inhibitor as 11 and the Tern is more like Asciminib as allosteric inhibitor.

謝謝。這是非常好的問題。顯然，我們很高興看到 Tern 被收購，以及去年在 ASH 上發表的 11（資料）。但我認為 Olverembatinib 基於臨床數據確實會有獨特優勢，對吧？所以我們可能與 11 一樣屬於 ATP 結合位點抑制劑，而 Tern 的則更像 Asciminib，屬於變構（allosteric）抑制劑。

But do remember, both drugs are in Phase 1 or Phase 1/2 and but they have much less patient number compared to Olverembatinib. And this is based on the current data, they are less than 100. And also the dose in terms of the RP3D or registrational trial has not established for both drugs.

但請記得，這兩個藥物都還在一期或一期/二期，而且相較於 Olverembatinib，他們的受試者人數少得多。根據目前數據，他們的受試者數都不到 100 人。此外，就 RP3D 或註冊性試驗用劑量而言，兩個藥物都尚未建立。

And at least based on the current published data, it's not clear they're working on any the gatekeeper mutation, T315I or those with compound mutations, is not reported or based on the Asciminib data require 5x dose for those with T3151 mutation. So clearly, there's no long-term safety data or efficacy data, and there's no also report on any efficacy in the Ph+ALL.

而且至少從目前已發表的數據來看，尚不清楚他們是否對任何 gatekeeper 突變（如 T315I）或複合突變患者有效；這部分沒有報告。或者從 Asciminib 的數據來看，對於帶有 T315I 突變者需要 5 倍劑量。因此很明顯，目前沒有長期安全性或療效數據，也沒有任何關於在 Ph+ALL 中療效的報告。

And specifically, if you look at the -- you mentioned like MMR rate, I think one is much less patient number. But more importantly, if you look at the line of prior treatment, we published the data on JAMA Oncology a year ago and also have the presentation at ASCO and ASH that the patient population we treated in US primarily with PIs from MD Anderson and others were heavily pretreated. They are representing the CML patients of fourth or fifth line and one-third of them has T315I mutation.

具體來說，如果你看——你提到像 MMR 比率，我認為一方面是受試者人數少；但更重要的是，如果你看既往治療線別，我們一年前在《JAMA Oncology》發表了數據，也在 ASCO 與 ASH 做了報告：我們在美國主要由 MD Anderson 等 PI 治療的患者族群是高度既往治療的。他們代表的是四線或五線的 CML 患者，其中三分之一帶有 T315I 突變。

So I think all the B-cell inhibitor, either kinase inhibitor, allosteric inhibitor, the response is really depend on the patient baseline characteristics and how many prior lines treatment and mutation profile. So I think that the -- of course, this is not head-to-head comparison. But just with the current data, I think we really demonstrate very broad, very potent activities and also long-term safety profile and efficacy as well.

所以我認為所有 B 細胞抑制劑——無論是激酶抑制劑或變構抑制劑——其反應都非常取決於患者的基線特徵、既往治療線數以及突變譜。因此我認為——當然，這不是頭對頭比較。但就目前數據而言，我認為我們確實展示了非常廣泛、非常強效的活性，以及長期安全性與療效表現。

So I think that the -- another thing, I think for both drugs, especially under the Project Optimus, FDA would require Tern's compound and others have to do the RCT, right? They have to do the RCT trial to get approval. And in that case, they also must have a control arm. So it's hard to see what will be the control arm, but these are definitely required based on the Project Optimus, the optimal dose in terms of safety, efficacy and the RCT design and the control arm.

所以我認為——另外一點是，我認為對這兩個藥物而言，特別是在 Project Optimus 之下，FDA 會要求 Tern 的化合物以及其他同類必須做 RCT，對吧？他們必須進行隨機對照試驗（RCT）才能獲批。而在那種情況下，他們也必須有對照組。所以很難看出對照組會是什麼，但根據 Project Optimus，這些要求是明確的：需要在安全性、療效的最佳劑量上做優化，並且採用 RCT 設計與對照組。

So -- but I think overall, we are really confident, especially with our partner, Takeda, we're going to position well for the late line CML for those with mutation and also very active data in the Ph+ALL. And we are -- we already conducted and published the ASH data for the second line, the CML patients. I think actually, in China, the approval label is what we call the near second-line approval because its two TKI resistant and all intolerant.

所以——但我認為整體而言，我們非常有信心，特別是有武田作為合作夥伴，我們將能在晚線 CML（針對帶突變者）以及在 Ph+ALL 的非常積極數據方面取得良好定位。而且我們——我們已經完成並發表了二線 CML 患者的 ASH 數據。我認為其實在中國，核准標籤是我們所謂的「接近二線」核准，因為它適用於兩種 TKI 抗藥以及所有不耐受者。

So I think we are really confident we will benefit the patients for those early line as well. But of course, we will conduct the more studies, especially after we complete the registration trial for Olverembatinib.

所以我認為我們非常有信心，也能讓早線治療的患者受益。但當然，我們會進行更多研究，特別是在完成 Olverembatinib 的註冊性試驗之後。

Got it. If I may squeeze in one more. Lisa has really strong start following five months of launch. But we know that BeOne has the Bcl-2 inhibitors just approved recently as well. Just curious how that would play into dynamics for Lisa's uptake in 2026?

了解。如果我可以再塞一個問題。Lisa 在上市後五個月的起步非常強勁。但我們也知道 BeOne 的 Bcl-2 抑制劑最近也剛獲批。想請教這會如何影響 Lisa 在 2026 年的放量動態？

Yeah. I think that the -- first, in China, we were the first domestic Bcl-2 inhibitor commercialized last year. So we were at least six months ahead of BeOne Sonrotoclax approval in China. That's number one.

是的。我認為——首先，在中國，我們是去年第一個商業化的國產 Bcl-2 抑制劑。所以我們至少比 BeOne 的 Sonrotoclax 在中國獲批早了六個月。這是第一點。

Number two, I think based on the data -- current data safety and also another thing is the Sonrotoclax dose ramp up is similar to the Venetoclax, weekly dose ramp up and the starting dose for Sonrotoclax is actually 1 milligram. And the approval dose is 320 milligram. So from 1 milligram to 320 milligram, and with five different dose strengths and taken nine steps, okay, to do the dose ramp up. I think that's really not convenient for patients with CLL and SLL.

第二點，我認為基於數據——目前的安全性，還有另一點是 Sonrotoclax 的劑量遞增（ramp up）方式與 Venetoclax 類似，是每週遞增；而 Sonrotoclax 的起始劑量其實是 1 毫克，核准劑量是 320 毫克。也就是從 1 毫克到 320 毫克，並且有五種不同的劑量規格、需要走九個步驟來完成劑量遞增。對於 CLL 與 SLL 患者來說，我認為這確實不太方便。

And also, if you look at the overall safety profile, the SAE even some of the deaths in that registrational trial and the infection rate and so on, Lisaftoclax is probably the best among the currently three marketed Bcl-2 inhibitor. And actually, this on the published drug label, Sonrotoclax actually have even worse DDI risk among the three drugs.

此外，如果你看整體安全性概況，包括該註冊性試驗中的SAE，甚至其中一些死亡案例，以及感染率等等，Lisaftoclax 可能是目前已上市的三款 Bcl-2 抑制劑中表現最好的一個。而且實際上，從已公布的藥品標籤來看，Sonrotoclax 在這三款藥物中反而具有更高的 DDI 風險。

So I think we are confident that we will continue to do well and expand commercial sales coverage and also especially the registration trial among the -- globally for the MDS and also our GLORA-2 and GLORA-3 also approved by CDE and other countries. The GLORA-2 will offer the patients with CLL, the first-line treatment in combination with acalabrutinib in fixed duration.

所以我認為我們有信心能持續表現良好，並擴大商業銷售覆蓋，尤其是在全球範圍內針對 MDS 的註冊性試驗，以及我們的 GLORA-2 和 GLORA-3 也已獲 CDE 及其他國家批准。GLORA-2 將為 CLL 患者提供與 acalabrutinib 聯合、固定療程的一線治療方案。

The 18 months fixed duration with the CIT as a control arm. I think that actually is doing well in terms of enrollment. And the GLORA-3 is the AML. And we are also the first -- the only the AML registrational trial approved by the CDE a year -- more than a year ago and currently active enroll. And this is the same validated indication, validated protocol.

18 個月的固定療程，以 CIT 作為對照組。我認為在入組方面實際上進展良好。GLORA-3 則是針對 AML。我們也是第一個——也是唯一一個在一年多前就獲 CDE 批准的 AML 註冊性試驗，目前正在積極入組。而且這是同一個已驗證的適應症、已驗證的方案。

We expect we will do well for both GLORA-2 and GLORA-3 in China and a few other countries. And of course, they both are not -- yet not for the US or Europe because of the control arm or because of the trial design. But I think to answer your question, I think we'll do well, not just because we are six months ahead of approval for Sonrotoclax, but based on the very excellent drug properties and the clinical data and as well as the multiple indications, we are more in advanced position than Sonrotoclax in China or globally.

我們預期 GLORA-2 和 GLORA-3 在中國以及其他幾個國家都會進展順利。當然，由於對照組或試驗設計的原因，它們目前尚不適用於美國或歐洲。但回到你的問題，我認為我們會做得很好，不僅因為我們比 Sonrotoclax 早約六個月獲批，更是基於非常優異的藥物特性與臨床數據，以及多個適應症布局，無論在中國或全球，我們都比 Sonrotoclax 處於更領先的位置。

Jeet Mukherjee, BTIG.

Jeet Mukherjee，BTIG。

Two questions from us. In terms of the China opportunity and your ongoing launch there, is there a target number of hospitals that you aim to have under formulary for both products that are there? Just trying to get some visibility into the long-term opportunity and peak sales potential for both drugs.

我們有兩個問題。就中國市場機會以及你們目前在當地的上市推進而言，對於已在那裡的兩款產品，你們是否有一個目標醫院數量，希望能納入院內處方目錄（formulary）？只是想更清楚了解兩款藥物的長期機會與峰值銷售潛力。

And the second question, coming back to your BTK Degrader, certainly focus on the oncology side of things. But do you have any plans or intentions to go into non-oncology opportunities such as I&I or CNS diseases?

第二個問題回到你們的 BTK 降解劑（Degrader），目前當然聚焦在腫瘤領域。但你們是否有任何計畫或意向，拓展到非腫瘤機會，例如 I&I 或 CNS 疾病？

Yeah. For your first question, I think the hematology/oncology commercialization in China is really unique because in China, those disease and treatment are highly concentrated to some of the top hospitals or cancer centers. So to cover -- our aim is to cover at least 80% of the sales potential. That represents probably around 2,000 hospitals, okay? And so we already covered about 1,500 hospitals, okay?

好的。關於第一個問題，我認為在中國，血液腫瘤/腫瘤的商業化非常獨特，因為在中國，這些疾病與治療高度集中在一些頂尖醫院或癌症中心。因此，我們的目標是覆蓋至少 80% 的銷售潛力，這大概相當於約 2,000 家醫院，好嗎？而我們目前已覆蓋約 1,500 家醫院，好嗎？

So the commercial team for the hematology/oncology is really different than like a solid tumor, lung cancer, breast cancer. As those indications probably need easily probably 2,000 to 3,000 sales force to cover the 80% potential sales. So that's the benefit to develop the hematology/oncology product in terms of commercialization in China.

因此，血液腫瘤/腫瘤的商業團隊與實體瘤（例如肺癌、乳癌）非常不同。那些適應症要覆蓋 80% 的潛在銷售，可能很容易需要 2,000 到 3,000 人的銷售隊伍。所以，從在中國商業化的角度來看，開發血液腫瘤/腫瘤產品是有優勢的。

So I think we currently have 300 staff in the commercial team. We will continue to make that -- to expand that to about probably 400 to 500. And then with a much deeper coverage, probably close to about 2,000 hospitals.

所以我認為我們目前商業團隊有 300 名員工。我們會持續擴編到大約 400 到 500 人。並且以更深度的覆蓋，目標接近約 2,000 家醫院。

The second question, I think, is very interesting. As I mentioned, one of the reasons we felt that BTK Degrader, even though we are not the first one, but it's not really too late. The first is there's a lot of -- I mean, this is validated target and also the BTK Degrader to take care of many of the inhibitors, but it doesn't matter covalent or non-covalent mutation or not. That's one.

第二個問題我覺得非常有意思。如我提到的，我們之所以認為 BTK 降解劑即使不是第一個進入者，也不算太晚，第一個原因是——有很多……我的意思是，這是一個已被驗證的靶點，而且 BTK 降解劑可以解決許多抑制劑的問題，不論是共價或非共價、是否有突變都無所謂。這是其一。

Second is, as your question pointed out, the BTK Degrader, like some of the other BTK inhibitors that actually have more probably potential in non-oncology, some of the autoimmune diseases and also with just probably a little bit CNS penetration, which we have based on the preclinical data, those may actually to treat some of the CNS indications as well. So we do have a strong confidence and see much huge potential for the BTK Degrader in oncology and non-oncology and also with our Bcl-2 inhibitor in terms of combination.

第二，如你所指出，BTK 降解劑就像一些其他 BTK 抑制劑一樣，在非腫瘤領域可能也有更大的潛力，例如一些自體免疫疾病；另外，如果具備一點 CNS 穿透性——根據我們的臨床前數據我們確實具備——也可能用於治療某些 CNS 適應症。因此，我們對 BTK 降解劑在腫瘤與非腫瘤領域都很有信心，也看到非常巨大的潛力；同時，從聯合用藥角度來看，與我們的 Bcl-2 抑制劑也具有組合價值。

Matthew Biegler, Oppenheimer.

Matthew Biegler，Oppenheimer。

Just wanted to piggyback on some earlier comments on the BTK Degrader, particularly the ability to combine with Lisa in earlier-line settings. I guess like the 30,000-foot view questionnaire, like do you think the CLL market is heading in the direction of an all-oral time-limited therapy ala CLL-117 trial that we saw at ASH? And do you think that, that set up -- or how do you think that setup plays to Ascentage favor here with BTK Degrader and Lisaftoclax?

我想延續先前關於 BTK 降解劑的一些評論，特別是它在更早線治療中與 Lisa 聯合的能力。我想從更宏觀的角度問一下：你是否認為 CLL 市場正朝向「全口服、限時療程」的方向發展，例如我們在 ASH 看到的 CLL-117 試驗？你認為那樣的格局——或者你認為那樣的格局會如何讓 Ascentage 在 BTK 降解劑與 Lisaftoclax 方面受益？

Excellent question. I think obviously, the BTK inhibitor is well established for the CLL/SLL globally. And the current inhibitor already generate annual sales more than $14 billion. So that's a huge benefit.

這是個很好的問題。我認為很明顯，BTK 抑制劑在全球 CLL/SLL 治療中已經非常成熟。而現有抑制劑的年銷售額已超過 140 億美元。所以這是一個巨大的利基。

But at the same time, as you pointed out, the CLL, especially some of the young patients with the CLL, they don't like to take either BTK or Bcl-2 inhibitor for the lifetime, right? So the fixed duration, especially the combination of the BTK currently mostly inhibitor with the Bcl-2 inhibitor really offer the patient another option. They don't have to take the drug lifetime, right?

但同時，如你所說，CLL，尤其是一些較年輕的 CLL 患者，他們不喜歡終身服用 BTK 或 Bcl-2 抑制劑，對吧？因此，固定療程，特別是目前以 BTK 抑制劑為主與 Bcl-2 抑制劑的聯合，確實為患者提供了另一個選擇。他們不必終身用藥，對吧？

So the current data pointed out actually at least the combination BTK inhibitor primarily with the inhibitor offer a good benefit in terms of really durable PFS over five years, right? And the Bcl-2, our drug Lisaftoclax having very unique benefit in terms of other inhibitors is that we don't have a DDI issue. We don't have a DDI issue with the BTK inhibitor and much less DDI risk with other potential antifungal drugs. That's very important.

所以目前的數據顯示，BTK 抑制劑與（主要是）Bcl-2 抑制劑的聯合，在超過五年的持久 PFS 方面至少帶來了良好獲益，對吧？而 Bcl-2 方面，我們的 Lisaftoclax 相較其他抑制劑有一個非常獨特的優勢：我們沒有 DDI 問題。我們與 BTK 抑制劑之間沒有 DDI 問題，且與其他潛在抗黴菌藥物相比，DDI 風險也低得多。這非常重要。

And then on top of that, with the Degrader, it's not too late because they take care any of the inhibitors issues, mutation or not. So -- and I think our plan and hopefully, we can demonstrate that with the clinical data is that the BTK Degrader combined with Lisaftoclax, first is to offer the fixed duration and be able to have a long-term benefit in terms of PFS. And then in certain cases, because you offer the best treatment regimen early on, then you may actually offer the clinical cure for some of the CLL patients. That's in the CLL/SLL space.

此外，有了降解劑也不算太晚，因為它能處理任何抑制劑相關的問題，不論是否有突變。因此——我認為我們的計畫是，並希望能用臨床數據證明：BTK 降解劑與 Lisaftoclax 聯合，第一是提供固定療程，並在 PFS 方面帶來長期獲益。然後在某些情況下，因為你在早期就提供最佳治療方案，可能實際上能為部分 CLL 患者帶來臨床治癒。這是在 CLL/SLL 領域。

Number two is from the BTK Degrader, I think another potential, especially in combination with the Bcl-2 inhibitor, maybe offer some hard-to-treat disease like DLBCL or in the case, the BTK single agent failed the patients, right? So one of our strategy globally is our GLORA trial is add-on strategy because the single agent alone of BTK inhibitor or degrader probably at least half of them cannot achieve the optimal response in terms of CR.

第二，從 BTK 降解劑來看，我認為另一個潛在方向，特別是與 Bcl-2 抑制劑聯合，可能能應對一些難治疾病，例如 DLBCL，或是在 BTK 單藥治療失敗的患者情境，對吧？因此我們在全球的一個策略是 GLORA 試驗採取 add-on（加用）策略，因為 BTK 抑制劑或降解劑單藥治療，可能至少有一半患者無法在 CR 方面達到最佳反應。

So in that case, you combine with the Bcl-2 inhibitor will then offer the patient better response, deeper response and potentially in terms of fixed duration to stop the treatment with long PFS. So I think the Ascentage is really in a unique position to having both the BTK Degrader and the Bcl-2 inhibitor for those multiple indications.

所以在那種情況下，與 Bcl-2 抑制劑聯合就能為患者帶來更好的反應、更深的反應，並且在固定療程的框架下，有機會停止治療且維持較長的 PFS。因此我認為 Ascentage 的確處於一個非常獨特的位置，能同時擁有 BTK 降解劑與 Bcl-2 抑制劑，覆蓋多個適應症。

Christopher Liu, Lucid Capital Markets.

Christopher Liu，Lucid Capital Markets。

Congrats on the quarter. Just wondering if you have any insight into what the go/no-go decision would be from Takeda in order to opt in from their agreement?

恭喜本季表現。想請問你是否能分享一些看法：Takeda 需要基於哪些因素做出 go/no-go 的決策，來決定是否依協議選擇行使其選擇權（opt in）？

First, our current partner agreement is for the option agreement, right? Because they have competitive product, Ponatinib, that's based on the antitrust rules. And there are cases before that in the antitrust issue that they may have to return the drug if there's that competition, the antitrust issue. So the current agreement -- but still is exclusive global partnership. So basically, both Takeda and Ascentage are bound to have that partnership to work together. That's number one.

首先，我們目前與合作夥伴的協議是選擇權協議（option agreement），對吧？因為他們有具競爭性的產品 Ponatinib，這涉及反壟斷規則。過去也有一些涉及反壟斷問題的案例，如果存在競爭與反壟斷疑慮，他們可能必須返還該藥物。因此目前的協議——但仍然是全球獨家合作夥伴關係。所以基本上，Takeda 與 Ascentage 都受該合作關係約束，需要共同推進合作。這是第一點。

Number two, of course, they have to get either clear antitrust or to wait the patent expiration of Ponatinib, which I believe is later this year or early next year. I think that with that patent expiration, then there's no issue in terms of antitrust issue.

第二點，當然，他們必須要麼取得明確的反壟斷核准，要麼等待 Ponatinib 的專利到期；我相信是在今年稍晚或明年初。我認為隨著該專利到期，在反壟斷方面就不會有問題。

Thirdly, I think for your question, of course, first of all, we are already a partner. We are strongly bind exclusive. But at the same time, in terms of when to access the option, which I honestly cannot speak for my partner. But with the Merck acquisition of Terns for over $6 billion, I think there's no reason that we do not work together and maybe work together early in terms of exercising the option as your question. So I do think it is a benefit to both parties that we move forward, pushing forward full speed on the Olverembatinib commercialization for the global market.

第三點，針對你的問題，當然，首先我們已經是合作夥伴，我們以獨家方式緊密綁定。但同時，至於何時行使該選擇權，坦白說我無法替我的合作夥伴發言。不過，隨著默克（Merck）以超過 60 億美元收購 Terns，我認為我們沒有理由不一起合作，並且也可能更早地合作、就像你問的那樣更早行使選擇權。因此我確實認為，雙方共同向前推進、全速推動 Olverembatinib 面向全球市場的商業化，對兩方都有利。

And for Lisaftoclax, would you be looking to partner that asset as well? Or are you pretty adamant about going alone with that asset?

那麼對於 Lisaftoclax，你們也會考慮為這個資產尋找合作夥伴嗎？還是你們相當堅持要自行推進這個資產？

I think that we are really open and flexible. We -- as I mentioned at the JPMorgan conference, we are open, flexible, ready to enter any partnership that will benefit, bring the synergy with our product and also the complementary resources to commercialization on the large scale and the more global market.

我認為我們非常開放且具彈性。我們——正如我在摩根大通（JPMorgan）會議上提到的——我們保持開放、彈性，並且隨時準備進入任何能帶來效益的合作關係，能與我們的產品形成協同效應，並提供大規模商業化以及更全球化市場所需的互補資源。

But of course, at the same time, we are within the time frame of be ready commercialization in two years and many of the experts in the commercialization is that you need to be minimal ready two years ahead of anticipated commercialization. So I think we are in a position and actively looking for the Chief Commercial Officer.

但當然，同時我們也處於預計兩年內可準備商業化的時間框架內，而許多商業化專家認為，你至少需要在預期商業化前兩年就做好最低限度的準備。因此我認為我們目前具備條件，並且正在積極尋找首席商務官（Chief Commercial Officer）。

That's more, I would say, our dual strategy that combines business development partnership and also to build at least in US our commercialization capabilities. They are not exclusive. They are really working hand-hand in parallel. I think either case we'll benefit strongly our Lisaftoclax commercialization at least in US and also through the potential partners either US or global.

我會說這更像是我們的雙軌策略：結合商務拓展（business development）的合作夥伴關係，同時也至少在美國建立我們的商業化能力。兩者並不互斥，而是並行、手牽手地推進。我認為無論哪種情況，都將強力有利於我們 Lisaftoclax 至少在美國的商業化，以及透過潛在合作夥伴（無論是美國或全球）來推進。

So I think that we are in a really good position in terms of clinical development, be ready for commercialization and also looking for the partners that can bring the best value to this product and also patients globally.

因此我認為，我們在臨床開發、商業化準備，以及尋找能為此產品帶來最佳價值並惠及全球患者的合作夥伴方面，都處於非常有利的位置。

Michael King, Rodman & Renshaw.

Michael King，Rodman & Renshaw。

I had a question about the allosteric inhibitors and that was entered earlier in the call.

我有一個關於變構（allosteric）抑制劑的問題，這在剛才的電話會議中較早時已被提到。

So what's the question?

所以問題是什麼？

I was just looking for your commentary on the market dynamics of the introduction of some of the Asciminib in the allosteric inhibitors in the CML space.

我只是想請你評論一下，在 CML 領域引入一些變構抑制劑（例如 Asciminib）後的市場動態。

Okay. No, I think the current data, first, Asciminib as allosteric is doing well, right? Last year, sales more than $1 billion. And in certain countries, like US also received the conditional approval -- I mean, accelerated approval for the first-line CML.

好的。不，我認為目前的數據顯示，首先，作為變構抑制劑的 Asciminib 表現不錯，對吧？去年銷售額超過 10 億美元。而且在某些國家，例如美國，也獲得了有條件核准——我是說，針對一線 CML 的加速核准。

So -- but the current compound, 11, do not have data, at least clinical data to show the activity in terms of T315I mutation, the gatekeeper mutation and those with T315I mutation plus other mutations, the compound mutations. So I think the -- I mean, Ponatinib, of course, there's a patent and safety issues.

所以——但目前的化合物 11，至少沒有臨床數據顯示其對 T315I 突變（守門員突變）以及 T315I 突變合併其他突變、也就是複合突變的活性。因此我認為——我是說，Ponatinib 當然存在專利與安全性問題。

So currently, our strong competitor, to be honest, is considered Asciminib. And -- but they are not active in about 40% of late line CML, which require five times dose or five times the cost. And all the drugs based on the current data does not show activity or strong activity as Olverembatinib in Ph+ALL. So I think those two are based on the current clinical data, which Olverembatinib has advantage over those Asciminib.

所以目前，我們強勁的競爭對手，坦白說，被認為是 Asciminib。而且——但它對約 40% 的晚線 CML 並不活躍，這些患者需要五倍劑量或五倍成本。並且根據目前數據，所有藥物在 Ph+ALL 上都未顯示出與 Olverembatinib 相同的活性或強勁活性。因此我認為，基於目前的臨床數據，Olverembatinib 相較於 Asciminib 在這兩點上具有優勢。

And 11 Terns first still early, require RCT trial and approval by the FDA. And more importantly, I think the late line, we are definitely the best and the most potent one and the broad activity against all mutations. The early line, I think we are doing the second-line trial. We do have data -- early data to support that.

而 Terns 的 11 仍處於早期，仍需要隨機對照試驗（RCT）以及 FDA 的核准。更重要的是，我認為在晚線治療上，我們絕對是最佳、也是效力最強的一個，並且對所有突變具有廣泛活性。至於早線，我認為我們正在進行二線試驗；我們確實有數據——早期數據——支持這一點。

I think the focus -- if you look at the current market share, two of the second line actually is taking the most market shares. Among the $7 billion annual sales, two of the second line has been consistently taken each about $2 billion annual sales, okay?

我認為重點——如果你看目前的市占率，二線治療中的兩個產品其實拿走了最多的市占。在每年 70 億美元的銷售額中，二線的兩個產品一直各自穩定取得約 20 億美元的年銷售額，對吧？

Moving forward, I think currently, there's -- including the Asciminib, there are five drugs with first-line label. So for Terns or any other compound try to moving into the first line is going to be heavy up hill battle and they also take a long time and very costly.

往前看，我認為目前——包括 Asciminib 在內——已有五個藥物具有一線適應症標籤。因此，Terns 或任何其他化合物若想進入一線，將會是一場非常艱難的上坡戰，而且也需要很長時間並且成本非常高。

So I think our focus really moving forward and also based on the data is probably Olverembatinib will be the first choice of the TKI for the second-line patients. So in that regard, we don't worry about the competition of the first line. Actually, more first-line treatment, the patient will favor through to Olverembatinib in terms of the best second-line treatment.

所以我認為我們接下來的重點，並且也基於數據，可能是讓 Olverembatinib 成為二線患者的首選 TKI。就這點而言，我們不擔心一線的競爭。事實上，一線治療越多，患者在需要最佳二線治療時，就越可能轉向 Olverembatinib。

Thank you. There are no further questions at this time. I would like to turn the call back to management for any closing remarks.

謝謝。目前沒有進一步問題。我想把電話交回管理層做結語。

First, thank you all for attending and also really excellent insightful questions. This is a very timing in terms of our annual report for 2025, representing the first year we are -- have a dual-engine for commercialization, build a full-scale functional sales force and also the first time as a dual listed -- dual primary listed company on Nasdaq. So moving forward, we also see really strong confidence and broad potential in CML, ALL and also really the probably cornerstone product for hematology, oncology with our selective Bcl-2 inhibitor.

首先，感謝各位參與，也謝謝大家提出非常出色且具洞見的問題。就我們 2025 年年報而言，這是一個非常關鍵的時點，代表我們第一年——擁有商業化的雙引擎：建立全規模、具完整職能的銷售團隊；同時也是我們首次作為在納斯達克雙重上市——雙主要上市的公司。展望未來，我們也對 CML、ALL 以及我們選擇性 Bcl-2 抑制劑作為血液腫瘤領域可能的基石產品，抱持非常強的信心與廣泛潛力。

We are probably in a really best position in the global novel product development that not just being the first approval commercialized in China in those products and indications, but globally, we are potentially best-in-class with the clinical data in terms of safety, efficacy and also in the registration trial. I think that's a really unique position.

我們可能處於全球新型產品開發的非常有利位置：不僅在中國率先取得核准並完成這些產品與適應症的商業化，而且在全球範圍內，基於安全性、有效性以及註冊性試驗的臨床數據，我們有潛力成為同類最佳（best-in-class）。我認為這是一個非常獨特的位置。

At the same time, of course, there's a huge potential in terms of commercialization readiness in US and also looking forward to our partners for the global market expansion. So we are very excited with our strong achievement, the milestones transformation year for 2025. And looking forward, we are more excited to see all the registrational trial advance well, looking forward to have -- be ready to have the commercialized in US being the global leader in those therapeutic areas with best-in-class potential drugs for multiple hematology malignancies.

同時，當然，在美國的商業化準備方面也有巨大的潛力，並且我們也期待與合作夥伴一起推動全球市場擴張。我們對 2025 年這個里程碑式的轉型之年所取得的重大成果感到非常振奮。展望未來，我們更期待看到所有註冊性試驗順利推進，並期待——做好在美國商業化的準備，成為這些治療領域的全球領導者，並以具同類最佳潛力的藥物治療多種血液惡性腫瘤。

And looking forward to working with you all and all the investigators and investors around the world to bring the best drug to benefit patients globally. And thank you all. Have a good day. Thank you.

也期待與各位，以及全球的所有研究者與投資人合作，把最好的藥帶給全球患者並使其受益。謝謝大家。祝各位有美好的一天。謝謝。

This concludes today's conference call. Thank you for participating and you may now disconnect.

今天的電話會議到此結束。感謝各位參與，現在可以掛線。

Thank you. Thank you all.

謝謝。謝謝大家。