1. Olverembatinib shows 21.2 months EFS vs. 2.9 months in best available therapy. 2. Safe profile with 7% vascular occlusion in patients; effective for all mutations. 3. Phase III trials for multiple indications of Olverembatinib in progress. 4. Key data presented at ASH 2025 reinforces product's efficacy and safety. 5. Exclusive licensing agreement with Takeda could expand global reach.
FAQ
Why Bullish?
The significant efficacy and safety profile of Olverembatinib could enhance investor confidence, similar to past successful drug announcements that positively impacted biotech stocks.
How important is it?
The improvements in treatment efficacy and safety, along with upcoming trials, will likely enhance market perception and drive stock performance.
Why Long Term?
The ongoing Phase III trials and potential global licensing will likely yield results impacting the stock positively over the longer duration, as seen with past biotech developments.
Ascentage Pharma Presents Promising Olverembatinib Data at ASH 2025
Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) announced significant findings from its four-year follow-up study of Olverembatinib, a promising treatment for patients with tyrosine kinase inhibitor (TKI)-resistant and intolerant chronic-phase chronic myeloid leukemia (CML-CP). The results were presented in a poster session at the 67th American Society of Hematology (ASH) Annual Meeting held in Orlando, Florida, on December 8, 2025.
Long-Term Efficacy and Safety of Olverembatinib
The presentation highlighted a substantial increase in median event-free survival (EFS) for patients treated with Olverembatinib. The data showed:
- 21.2 months vs. 2.9 months EFS for the Olverembatinib arm compared to the best available therapy (BAT).
- For patients without the T315I mutation, the EFS was 11.9 months, significantly longer than the 3.1 months for BAT.
- The drug displayed a favorable safety profile, notably with a 7% rate of vascular occlusion.
These results reaffirm Olverembatinib’s potential for long-term efficacy and safety in the treatment of CML-CP.
Olverembatinib’s Role in CML Treatment
Olverembatinib is the first third-generation BCR-ABL1 inhibitor approved in China, representing a significant advancement in therapy options for CML. The drug is particularly crucial for:
- Adult patients with TKI-resistant CML-CP and accelerated-phase CML harboring the T315I mutation.
- Adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs.
All approved indications for Olverembatinib are included in the China National Reimbursement Drug List (NRDL), enhancing patient access to this treatment.
Ongoing Clinical Studies and Future Plans
Ascentage Pharma is advancing its research with three global registrational Phase III studies evaluating Olverembatinib in multiple hematological indications. These include newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST).
The company is also pursuing an exclusive licensing agreement with Takeda for Olverembatinib, potentially expanding the drug’s availability outside of certain Asian markets.
Expert Commentary on the Findings
Professor Qian Jiang from Peking University Institute of Hematology remarked, “The latest data reinforce the excellent efficacy and long-term safety of Olverembatinib in TKI-resistant/intolerant CML-CP patients, including those without the T315I mutation. This vital information provides both physicians and patients with greater confidence for long-term treatment.”
Similarly, Dr. Yifan Zhai, Chief Medical Officer at Ascentage Pharma, emphasized: “The pivotal study has evolved, offering additional encouraging data that support Olverembatinib’s durable efficacy and favorable safety profile, enhancing quality of life for patients.”
Conclusion
Ascentage Pharma's presentation of the four-year follow-up data on Olverembatinib at ASH 2025 underscores its significant potential as a treatment for CML-CP. With promising results indicating longer event-free survival rates and a manageable safety profile, Olverembatinib may play a critical role in addressing unmet clinical needs in hematology.