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 Co-Founder, Chairman, and Chief Executive Officer Dr. Dajun Yang to learn more about the company.
Dr. Dajun Yang’s Background
Can you tell us about your background and what led you to co-found Ascentage Pharma? Dr. Yang said:
“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.”
Core Products
Can you give us an overview of Ascentage Pharma’s core products and what makes them different? Dr. Yang explained:
“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.”
Significant Milestones
What have been some of the company’s most significant milestones? Dr. Yang cited:
“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.”
Market Opportunity
What does the market opportunity look like for the conditions Ascentage Pharma is focused on? Dr. Yang assessed:
“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.”
Differentiation From The Competition
What differentiates Ascentage Pharma from its competition? Dr. Yang affirmed:
“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.”
Future Goals
What are some of the company’s most important goals looking ahead? Dr. Yang concluded:
“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.”
