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本文发表于2026 年 5 月 14 日 | Published on Pulse 2.0, May 14, 2026
作者：Amit Chowdhry | Author: Amit Chowdhry
亚盛医药是一家处于商业化阶段的全球性综合型生物制药企业，致力于研发并商业化具备差异化优势的创新疗法，以解决肿瘤领域尚未满足的临床需求。公司目前已有两款新药在中国获批上市，分别为用于治疗慢性髓系白血病（CML）的奥雷巴替尼，以及用于治疗慢性淋巴细胞白血病（CLL）的利沙托克拉。同时公司在全球快速推进多项临床试验，其中多项注册性研究已获得美国食品药品监督管理局（FDA）与欧洲药品管理局(EMA)批准。亚盛医药产品布局已覆盖CML、CLL、急性淋巴细胞白血病（ALL）、中高危骨髓增生异常综合征（MDS）等多种血液肿瘤，并不断拓展实体瘤领域研发管线。Pulse 2.0 本次专访公司共同创始人、董事长兼首席执行官杨大俊博士，深入了解企业发展整体情况。
Ascentage Pharma is a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development, and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. With two approved products in China, Olverembatinib for chronic myeloid leukemia (CML) and Lisaftoclax for chronic lymphocytic leukemia (CLL), and a growing portfolio of global clinical trials, including registrational studies cleared by the FDA and the European Medicines Agency, Ascentage Pharma is advancing treatments across hematologic malignancies including CML, CLL, acute lymphoblastic leukemia (ALL), high- and intermediate-risk myelodysplastic syndrome (MDS), and is also expanding its pipeline in solid tumors. Pulse 2.0 interviewed Dr. Dajun Yang, Co-Founder, Chairman and Chief Executive Officer of Ascentage Pharma, to learn more about the development strategy of this global innovative pharmaceutical company.
杨大俊博士个人经历 | Dr. Dajun Yang’s Backround
问：能否介绍您的职业经历，以及是什么契机促使您联合创立亚盛医药？
杨大俊博士：我三十多年来一直深耕肿瘤研究，专注于细胞凋亡机制的探索 —— 也就是能够诱导肿瘤细胞发生程序性死亡的生物学过程。我在中山大学获得医学学位、密歇根州立大学获得遗传学博士后，曾在美国乔治城大学隆巴尔癌症中心从事研究工作，并在美国联合创立了 Ascenta Therapeutics。在此基础上于 2009 年创立亚盛医药。
我们创立企业想要解决的核心难题是，众多肿瘤患者，尤其是CML、CLL等血液肿瘤患者，受各类因素影响陷入无药可用的困境。现有治疗手段仅能在短期内起效，后续极易出现耐药性，即便数十年来行业不断研发新型疗法，患者一旦出现耐药，依旧缺少有效治疗方案。在联合创立亚盛医药之初，我便坚定认为，细胞凋亡通路是癌症治疗领域极具潜力、尚且有待深度挖掘的研发方向。
Q: Can you tell us about your background and what led you to co-found Ascentage Pharma?
Dr. Dajun Yang: I have spent more than 30 years focused on oncology research and the science of apoptosis, the biological process by which cells can be triggered to die. After earning my medical degree from Sun Yat-sen University and my PhD in Genetics from Michigan State, I held research positions at Georgetown University’s Lombardi Cancer Center and co-founded Ascenta Therapeutics in the U.S. before starting Ascentage Pharma in 2009.
The core problem we set out to solve was that too many cancer patients, particularly those with blood cancers like CML and CLL, were running out of options, due to a variety of factors. Existing treatments worked for a while, but resistance would develop, and once that happened, there was often nothing left to offer, despite now decades of attempts to introduce novel therapies. When co-founding Ascentage Pharma, I had clear conviction that the apoptotic pathways were one of the most promising and underdeveloped opportunities in cancer treatment.
核心产品 | Core Products
问：请简要介绍亚盛医药的核心产品，以及产品独有的差异化优势？
杨大俊博士：目前我们已有两款原创新药在中国获批上市，两款产品均在推进由美国FDA 与欧洲EMA批准的全球注册临床试验。
我们的第一个上市产品奥雷巴替尼，是中国首个上市的第三代 BCR-ABL 抑制剂，用于治疗CML。我们相信这款药物具有全球best-in-class潜力。它的独特优势在于，针对经多线治疗失败的最难治性患者仍然疗效突出，其中包括对前代药物产生耐药并携带 T315I 突变以及复合突变的患者。在中国有些患者从2021年奥雷巴替尼获批以来就一直在长期服用该药，并且至今仍在获益。这种长期稳定的疗效极具价值，也使我们在竞争中脱颖而出。
我们的第二个上市产品利沙托克拉，是中国首个上市的国产原创 Bcl-2 抑制剂，用于治疗CLL。它也是全球首个获批上市用于单药治疗 BTK 抑制剂经治CLL患者的Bcl-2抑制剂。
除两款已上市产品外，我们的研发管线同步向实体瘤领域延伸：
血液肿瘤依旧是我们的发展根基，与此同时，我们正构建能深入实体瘤领域的研发管线。
公司自主研发的原创BTK 蛋白降解剂 APG-3288，已同步获得美国FDA与中国CDE的临床试验许可。该药物是我们自主构建的PROTAC技术平台产出的首个候选药物，旨在攻克共价与非共价BTK 抑制剂引发的耐药难题。目前我们已在全球范围内启动该药物针对复发难治性血液肿瘤的Ⅰ期临床试验。
Q: Can you give us an overview of Ascentage Pharma’s core products and what makes them different?
Dr. Dajun Yang: We now have two novel products approved in China, and both are advancing in global registration trials cleared by the FDA and the European Medicines Agency
Our first approved product, Olverembatinib, is the first third-generation BCR-ABL inhibitor approved in China for CML. Overall, we believe it has best-in-class potential globally. What makes it special is its performance in the hardest-to-treat patients, those who have failed multiple prior therapies, including patients with T315I mutations and compound mutations that defeat earlier generation drugs. We have patients in China who have been on Olverembatinib since its first approval in 2021 and are still benefiting. That kind of long-term durability is very meaningful and distinguishes us from our competition.
Our second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor approved in China for CLL, and it is the first single-agent Bcl-2 inhibitor ever approved and is directed towards patients who have failed BTK inhibitor therapy.
Beyond our two approved products, our broader pipeline extends into solid tumors as well. Our triple kinase inhibitor targeting FAK, ALK, and ROS1 is currently in clinical development for non-small cell lung cancer and ovarian cancer. Our EED inhibitor, APG-5918, is advancing in both oncology and anemia indications. We also have clinical activity data from our MDM2-p53 inhibitor across both blood cancers and certain solid tumors. So, while hematologic malignancies remain our foundation, we are building a pipeline that reaches meaningfully into solid tumor oncology as well.
We also recently received IND clearance from both the FDA and China’s CDE for our novel BTK protein degrader, APG-3288, which is the first therapeutic candidate from our proprietary PROTAC technology platform. It is designed to overcome resistance to both covalent and noncovalent BTK inhibitors, and we are now initiating a global Phase 1 study for APG-3288 in relapsed or refractory hematological malignancies.
公司发展重要里程碑 | Significant Milestones
问：回顾公司发展，有哪些里程碑最具标志性意义？
杨大俊博士：企业发展历程中里程碑众多，其中几项意义尤为重大。奥雷巴替尼在中国成功获批，是极具标志性的时刻，不仅印证了我们多年的研发成果，也让亚盛成为国内首家上市第三代 BCR-ABL抑制剂的药企。该产品获批适应症全部纳入国家医保目录同样至关重要，这一突破大大提升患者可及性。利沙托克拉作为单药治疗BTK抑制剂经治CLL的Bcl-2 抑制剂在中国获批上市，更是又一重大突破，并实现全球首创。
临床开发方面，去年 12 月我们在美国血液学会（ASH）年会上公布了 POLARIS-1 三期注册临床试验数据。数据显示，初治费城染色体阳性急性淋巴细胞白血病患者，经过三个周期治疗后，MRD阴性完全缓解率可达 64.2%。
公司先后在港交所与纳斯达克上市，完成两地双重主要上市，也是一大重要成就，彰显了我们长久以来布局全球化发展的愿景。商业化方面，2025 年公司业绩表现亮眼。得益于医保全面落地以及医院覆盖范围扩大，奥雷巴替尼2025年全年销售额达 6220 万美元，同比增长 81%。利沙托克拉于 2025 年 7 月正式获批上市，在尚未纳入医保的前提下，上市仅五个月销售额便突破 1010 万美元，成为近年来中国血液肿瘤领域表现极为亮眼的新药上市案例之一。两款产品形成双引擎驱动，合力推动公司2025 年收入达到 8210 万美元，同比增长 90%。
Q: What have been some of the company’s most significant milestones?
Dr. Dajun Yang: There have been many, but a few stand out. Getting Olverembatinib approved in China was a landmark moment; it validated years of research and made us the first company to bring a third-generation BCR-ABL inhibitor to market in China. Achieving full coverage on China’s National Reimbursement Drug List (NRDL) was equally important because it meant patients across the country could access the drug affordably. Getting Lisaftoclax approved in China as a single-agent Bcl-2 inhibitor after BTK inhibitor failure was another major milestone – a global first.
On the clinical side, we presented data from our POLARIS-1 Phase 3 registrational trial at the American Society of Hematology (ASH) Annual Meeting last December, showing an MRD-negative complete response rate of 64.2% in newly diagnosed Ph-positive ALL patients after three cycles of treatment.
Being dual listed on the Hong Kong Stock Exchange, and then on Nasdaq was also a significant achievement, reflecting the global expansion ambitions we have always had for Ascentage. On the commercial side, 2025 was a strong year financially. Olverembatinib generated full-year sales of $62.2 million, representing 81% year-over-year growth, driven by full NRDL inclusion and expanded hospital coverage. Lisaftoclax, approved in July 2025, achieved $10.1 million in its first five months on the market and not yet on the NRDL, which is one of the strongest hematology oncology launches in China in recent memory. Together, these two products drove total revenue of $82.1 million in 2025, a 90% increase year-over-year.
市场发展前景 | Market Opportunities
问：公司聚焦的治疗领域市场空间如何？
杨大俊博士：仅CML市场，全球年度市场规模就已接近 70 亿美元，并且预计未来几年将实现翻倍增长。我们相信奥雷巴替尼处于非常有利的位置，有望占据该市场的可观份额。特别我们与武田已达成选择权协议，未来奥雷巴替尼将交由武田负责中国以外地区商业化推广。2026 年 3 月，默克宣布斥资 67 亿美元收购Terns Pharmaceuticals，此次收购核心标的正是其旗下慢性髓系白血病候选药物 TERN-701。这一行业动作充分体现出投资者与行业对CML赛道的高度认可，也印证了该领域全球范围内依旧存在庞大未满足临床需求，进一步凸显奥雷巴替尼巨大的全球商业机遇。
在ALL和MDS领域同样蕴藏广阔发展机遇。在Ph+ ALL领域，目前尚没有专门针对初治Ph+ ALL患者获批的小分子酪氨酸激酶抑制剂（TKI）。而在中高危MDS领域，近二十年间没有全新靶向治疗药物获批上市，该领域长期缺少有价值的新型治疗方案，患者迫切需要更佳治疗选择。目前亚盛是全球唯一一家开展 Bcl-2 抑制剂用于中高危MDS全球注册Ⅲ期临床试验的药企，我们的早期数据显示在初治患者中应答率约为80%。
Q: What does the market opportunity look like for the conditions Ascentage Pharma is focused on?
Dr. Dajun Yang: The CML market alone is already valued at roughly $7 billion in annual sales globally, with expectations to double in the coming years. We believe Olverembatinib is very well positioned to capture a meaningful share of that market, particularly given our option agreement with Takeda that could lead to Takeda’s commercialization outside China. The CML market opportunity was further validated in March 2026 when Merck announced the acquisition of Terns Pharmaceuticals for $6.7 billion, primarily for its CML asset TERN-701. This reflects strong investor and industry confidence in the CML space, the current unmet need globally, and reinforces the significant global commercial opportunity for Olverembatinib.
Attractive opportunities also exist in ALL and MDS. In Ph-positive ALL, there is currently no approved small molecule tyrosine kinase inhibitor (TKI) specifically for newly diagnosed patients. In intermediate and higher-risk (HR-) MDS, no targeted therapy has been approved in 20 years. It is a disease that has gone without a meaningful new treatment option for far too long and where patients desperately need better alternatives. We are currently the only company running a global registration Phase 3 trial of a Bcl-2 inhibitor in HR-MDS, and our early data shows around 80% response rates in treatment-naive patients.
企业核心竞争优势 | Differentiation From The Competition
问：相较于同行企业，亚盛医药的核心竞争力体现在哪里？
杨大俊博士：我想指出三点。首先，我们拥有大规模的成熟临床验证，两款产品已在中国获批，并积累了来自数千名患者的真实世界数据。这种包含长期疗效稳定性、安全性的完整临床数据，是众多仅处于临床研发阶段企业难以实现的，这有助于让临床医生和监管机构对我们的科学实力充满信心。
第二，我们的研发管线布局丰富，旗下自研药物可实现联合用药。目前我们共有七款处于临床阶段的候选药物，且多款自研药物联合使用已收获积极临床数据，例如奥雷巴替尼联合利沙托克拉、利沙托克拉联合我们的MDM2-p53 抑制剂等。这种利用我们自己专有化合物进行内部联合用药的策略，是一个真正的竞争优势。
“第三，企业搭建了完善的全球化运营体系，全球员工超 800 人。我们开展的多项注册临床试验，均已获得美国FDA、欧洲EMA以及全球多个国家药监机构的批准。
Q: What differentiates Ascentage Pharma from its competition?
Dr. Dajun Yang: I would point out three things. First, we have genuine clinical validation at scale, featuring two products already approved in China with real-world data from thousands of patients. That depth of evidence, including long-term durability and safety data, is something not all clinical-stage companies can point to, and it helps to give physicians and regulators confidence in our science.
Second, our pipeline is broad, and the compounds can work together. We have seven active clinical-stage compounds, and we are already seeing promising data from combining our own medicines, such as Olverembatinib with Lisaftoclax, and Lisaftoclax with our MDM2-p53 inhibitor. That kind of internal combination strategy with our own proprietary compounds is a real competitive advantage.
Third, we have a global reach as well as over 800 employees worldwide. Our registration trials are cleared by the FDA, the European Medicines Agency, and regulators in many other countries.
未来目标 | Future Goals
问：放眼未来，公司最重要的发展目标是什么？
杨大俊博士：2026 年我们的发展重心主要分为两大方向。第一，全力快速推进各项全球注册临床试验，重点推进针对MDS的GLORA-4 Ⅲ期临床试验，以及针对Ph+ ALL的 POLARIS-1 Ⅲ期临床试验。这两项临床试验所针对的疾病领域均存在未满足临床需求，且试验项目均已获得FDA、EMA批准。目前项目推进顺利，我对后续试验进展充满信心
第二，我们持续深耕拓展国内商业化市场。2025 年是奥雷巴替尼全面纳入医保后的首个完整运营年度，极大提升了药物临床可及性，惠及更广泛患者。与此同时利沙托克拉也保持强劲增长势头。
从长远发展角度来看，我们正积极寻求合适的全球合作伙伴，以加速我们的下一阶段增长。我们拥有丰富且具有差异化优势的产品管线，期待与秉持相同愿景、致力于为全球患者带来创新药物的合作伙伴携手共进。
Q: What are some of the company’s most important goals looking ahead?
Dr. Dajun Yang: Our focus in 2026 is mainly on two things. First, execution on our global registration trials. The GLORA-4 Phase 3 trial for MDS and the POLARIS-1 Phase 3 trial for Ph-positive ALL are two I would highlight; both address diseases where patients have very few options, and both are cleared by the FDA and the European Medicines Agency. We are making strong progress, and I am optimistic about where those trials are heading.
Second, we are focused on expanding our commercial business in China. Last year was the first full year of NRDL coverage for Olverembatinib, which opened up access for significantly more patients, and Lisaftoclax is also gaining strong momentum.
Longer term, we are actively looking for the right global partnerships to accelerate our next phase of growth. We have a broad, differentiated pipeline and are open to working with partners who share our commitment to bringing these medicines to patients worldwide.
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