ASCENTAGE PHARMA GROUP INTERNATIONAL (AAPG) Form 6-K — Oct 21, 2026
Ascentage Pharma's lisaftoclax (APG-2575) was granted Breakthrough Therapy Designation by China's NMPA Center for Drug Evaluation, in combination with acalabrutinib, for treatment-naive adult patients with CLL/SLL. The BTD provides priority CDE communications and development guidance, and can enable Priority Review status and conditional approval at NDA submission in China. This supports the GLORA-2 global Phase III trial evaluating the combination as a first-line CLL/SLL treatment. Lisaftoclax was already approved in China in July 2025 for previously treated CLL/SLL as the first China-developed Bcl-2 inhibitor and the second Bcl-2 inhibitor approved globally.
Key figures
- Prior approval
- lisaftoclax approved in China July 2025 for previously treated CLL/SLL
- Cll sll new cases worldwide
- >100,000 per year
- Registrational phase3 trials
- 4
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