Ascentage Pharma and Takeda have reported favorable milestones in their joint development program for a novel Bcl-2 inhibitor, advancing the drug into Phase 2b clinical trials. The collaboration is progressing on schedule with key data expected by mid-2026.
- ASP2215 achieved 68% overall response rate in CLL and 72% in SLL in Phase 2a trial
- Phase 2b trial now underway with 300-patient target across North America, Europe, and East Asia
- Takeda committed $180 million in milestone payments, with up to $450 million in additional potential
- Ascentage retains commercial rights in Greater China, Takeda in all other regions
- Market valuation of Ascentage Pharma rose 23% following positive trial data
- Regulatory submissions expected in Japan by Q3 2026, U.S. and EU by early 2027
Ascentage Pharma and Takeda have confirmed that their co-development partnership for the investigational Bcl-2 inhibitor ASP2215 has met all pre-specified Phase 2a endpoints. The compound demonstrated a 68% overall response rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and a 72% response rate in those with small lymphocytic lymphoma (SLL), according to interim results from a 120-patient trial. These outcomes exceed initial efficacy targets set at the start of the collaboration in early 2023. The companies have now initiated Phase 2b trials across three regions: North America, Europe, and East Asia, with a target enrollment of 300 patients. Takeda has committed $180 million in milestone payments tied to regulatory approvals and market launch, with potential additional payments of up to $450 million based on global sales performance. Ascentage retains commercial rights in Greater China, while Takeda holds rights in all other territories. Market analysts note that the positive trial data have boosted Ascentage's market valuation by 23% over the past quarter, with its shares rising from $14.80 to $18.25. Takeda’s shares also saw a 1.7% uptick following the announcement, reflecting investor confidence in the pipeline’s strategic value. The partnership is now seen as a cornerstone of Takeda’s oncology portfolio expansion beyond traditional small molecule inhibitors. The collaboration underscores a growing trend of international biotech partnerships, particularly in hematologic malignancies. Regulatory filings for accelerated approval in Japan are expected by Q3 2026, with submissions in the U.S. and EU planned for early 2027.