Ascentage Pharma’s APG-115 NDA Gains CDE Acceptance, Eyes 2027 Launch
Ascentage Pharma’s New Drug Application for APG-115, a first-in-class MDM2–p53 inhibitor, secured China CDE clearance on Feb. 6, 2026, formally entering regulatory review. The company expects CDE feedback by mid-2027 and is preparing commercial-scale manufacturing for a planned China launch thereafter.
1. CDE Acceptance of APG-115 NDA
On Feb. 6, 2026, Ascentage Pharma’s New Drug Application for APG-115, a first-in-class MDM2–p53 inhibitor for acute myeloid leukemia, received acceptance from China’s Center for Drug Evaluation, marking formal entry into regulatory review.
2. Next Steps and Commercial Planning
The company aims to complete the CDE review by mid-2027, initiate registration batch production immediately, and is gearing up commercial-scale manufacturing to support a planned launch in China shortly after approval.