China's National Medical Products Administration (NMPA) approved Ascentage Pharma's lisaftoclax (APG-2575) on 10 July for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marking China's first domestically developed Bcl-2 inhibitor and the second globally. The oral selective Bcl-2 inhibitor demonstrated 98% objective response rate (ORR) in treatment-naive CLL/SLL patients when combined with acalabrutinib in Phase II trials. Approval was based on pivotal APG2575CC201 study data, though detailed results remain undisclosed.

Lisaftoclax is currently in four global Phase III trials for CLL/SLL, acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). CLL/SLL represents a significant unmet need, with conventional therapies like Bruton tyrosine kinase inhibitors (BTKi) showing limitations in relapsed settings. Bcl-2 inhibitors target apoptosis resistance mechanisms prevalent in hematologic malignancies.