Ascentage Pharma’s Lisaftoclax Granted Breakthrough Therapy Designation in China for Treatment-Naïve CLL/SLL
Ascentage Pharma's lisaftoclax received Breakthrough Therapy Designation from China's NMPA Center for Drug Evaluation, in combination with acalabrutinib, for treatment-naive adult CLL/SLL patients. BTD status provides CDE priority communications and development guidance, and positions the combination for potential Priority Review and conditional approval when an NDA is filed in China. Lisaftoclax was already approved in China in July 2025 for relapsed/refractory CLL/SLL and is being studied in four global registrational Phase III trials, including the first-line GLORA-2 study.
Key figures
- Drug Name
- lisaftoclax (APG-2575)
- Phase Of Trial
- Phase 3 (GLORA-2 registrational trial)
- Indication
- treatment-naive CLL/SLL in combination with acalabrutinib
- Prior approval
- approved in China July 2025 for relapsed/refractory CLL/SLL
- Designating agency
- China NMPA Center for Drug Evaluation (CDE)
- Global phase3 trials
- 4
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