By Fineline Cube 
China-based Ascentage Pharma (NASDAQ: AAPG, HKG: 6855) announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for its self-developed novel Bcl-2 selective inhibitor, lisaftoclax. The drug is now approved for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. This milestone marks China’s first homegrown Bcl-2 inhibitor and positions it as the second globally approved drug in its class.
Mechanism of Action and Therapeutic Potential
Lisaftoclax functions by selectively inhibiting the Bcl-2 protein, a mechanism that restores normal apoptosis in tumor cells. This action has demonstrated therapeutic potential across various hematologic and solid tumors, highlighting its broad applicability in oncology.
Approval Based on Strong Clinical Data
The approval was supported by results from the pivotal Phase II registration trial (APG2575CC201), which achieved its primary endpoint with a significant overall response rate (ORR). Notably, the trial also showed no tumor lysis syndrome (TLS) events, underscoring the drug’s favorable safety profile.
Breaking New Ground in CLL/SLL Treatment
Prior to this approval, no Bcl-2 inhibitors were available for CLL/SLL treatment in China, making lisaftoclax a groundbreaking therapeutic option for patients. The drug is currently the subject of four global regulatory Phase III clinical trials, being tested in CLL/SLL, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), further solidifying its position as a promising treatment in the field of hematology.-Fineline Info & Tech