Ascentage's Lisaftoclax Combo Wins China Breakthrough Designation for First-Line CLL/SLL

Ascentage Pharma (AAPG) said Tuesday that China's Center for Drug Evaluation granted breakthrough therapy designation to lisaftoclax combined with acalabrutinib for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. The designation gives drug candidates priority for regulatory communications and development guidance, the company said. Candidates meeting requirements may also apply for priority review and conditional approval when filing a new drug application in China. Lisaftoclax, an oral Bcl-2 inhibitor, was approved in China in July 2025 for adults with CLL/SLL who had received at least one prior systemic therapy, including a BTK inhibitor. Ascentage is running four global registrational Phase 3 trials, including GLORA-2, which evaluates the combination as a first-line treatment. AAPG closed Tuesday at $15.92, up 3.04%, and rose 3.69% to $16.51 after hours.