Biopharmaceutical company Ascentage Pharma (6855.HK) announced on Sunday that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted and recommended the Priority Review designation for a New Drug Application (NDA) for its inhouse developed investigational novel Bcl-2 selective inhibitor, lisaftoclax (APG-2575), intended for the treatment of patients with relapsed or refractory (r/r) chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).

This NDA is the first for a domestically developed Bcl-2 inhibitor in China and could potentially lead to lisaftoclax becoming the second Bcl-2 inhibitor approved anywhere in the world.

The lisaftoclax NDA has been submitted based on results from a pivotal registrational Phase II study in China (APG2575CC201) that assessed the efficacy and safety of the product in patients with r/r CLL/SLL. The study's primary endpoint was the overall response rate (ORR).

Lisaftoclax is a novel, investigational orally administered small-molecule Bcl-2 selective inhibitor being developed by Ascentage Pharma to treat patients with malignancies by selectively blocking the antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells. The company says that Lisaftoclax is the first Bcl-2 inhibitor in China and the second anywhere globally that has demonstrated compelling clinical benefit and entered a pivotal registrational study. Lisaftoclax is claimed to have broad therapeutic potential for a variety of hematologic malignancies and solid tumours, particularly as a single agent and in combinations in CLL/SLL. Lisaftoclax is a potential drug that may offer patients a safe, effective, and easy to use treatment option.