1. Olverembatinib shows 76.7% cytogenetic response in TKI-resistant patients. 2. Efficacy data suggests advancement in treatment lines potentially benefiting more patients. 3. No new safety signals reported, maintaining the drug’s previous safety profile. 4. Ascentage is conducting vital Phase III studies for multiple indications of Olverembatinib. 5. Takeda may license Olverembatinib for territories outside China if option is exercised.
FAQ
Why Bullish?
The strong efficacy data for Olverembatinib could enhance investor confidence and support AAPG's valuation. Historical instances, like the successful regulatory approvals following positive trial data, have generally resulted in stock price rebounds in biotech firms.
How important is it?
Given the substantial new data on Olverembatinib, the article strongly impacts AAPG's stock potential and market perception, reflecting heightened investor interest and clinical progression.
Why Long Term?
The continued advancement of clinical trials will establish greater market positioning and revenue potential over time. Historically, companies with successful drug pipelines experience capital growth as they contribute further to revenue.
Ascentage Pharma Presents Promising Data on Olverembatinib for Second-Line Treatment of Chronic Myeloid Leukemia
ROCKVILLE, Md., and SUZHOU, China, December 8, 2025 – Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a leading biopharmaceutical company, has unveiled new data on its innovative drug, Olverembatinib, during a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. This research reinforces Olverembatinib’s potential as a second-line treatment for patients with chronic myeloid leukemia in chronic phase (CML-CP) who have previously failed first-line therapies.
Key Efficacy and Safety Findings
The updated results showcase a notable 76.7% complete cytogenetic response (CCyR) rate in patients who did not respond to second-generation tyrosine kinase inhibitors (TKIs). Additionally, data reveal a major molecular response (MMR) rate of 60% at 21 treatment cycles, indicating that patient responses deepen over time.
Data from the study highlighted:
- CCyR rate of 71.8% and MMR rate of 43.6% in patients resistant or intolerant to prior TKI therapy without the T315I mutation.
- CCyR rate of 76.7% and MMR rate of 43.3% in patients failing first-line second-generation TKI treatment.
- No new safety signals were identified, with safety data aligning with previously reported outcomes.
Significance of Olverembatinib in CML Treatment
Olverembatinib is the first third-generation BCR-ABL inhibitor approved in China, targeting adult patients with TKI-resistant CML-CP and accelerated-phase CML (CML-AP). The drug recently received inclusion on the China National Reimbursement Drug List (NRDL), enhancing access for patients.
Ascentage Pharma is advancing three global Phase III studies evaluating Olverembatinib's efficacy in multiple oncology indications, including its application in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and gastrointestinal stromal tumors (GIST) deficient in succinate dehydrogenase.
Expert Commentary on Study Findings
Professor Weiming Li from the Union Hospital, Tongji Medical College, emphasized, “This updated dataset confirms the promising efficacy and safety profile associated with Olverembatinib for second-line treatment of CML-CP patients. It has attracted notable interest from the international hematology community.”
Yifan Zhai, M.D., Ph.D., Chief Medical Officer of Ascentage Pharma, added, “With these encouraging findings, we aim to expand the clinical availability of Olverembatinib to address the significant unmet needs of CML patients in China and globally.”
Conference Presentation Details
The data on Olverembatinib was showcased at the ASH Annual Meeting under the following details:
- Presentation Type: Poster Presentation
- Abstract Number: 3782
- Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II
- Presentation Date: December 7, 2025, from 6:00 PM - 8:00 PM EST
- Presenter: Professor Weiming Li