Ascentage Pharma announced on July 10, 2025, that its proprietary novel Bcl-2 selective inhibitor, lisaftoclax (APG-2575), received approval from China’s National Medical Products Administration (NMPA). The approval is for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including BTK inhibitors.
This approval makes lisaftoclax the first Bcl-2 inhibitor to receive conditional approval and marketing authorization for CLL/SLL in China, and the second Bcl-2 inhibitor approved globally. This milestone underscores Ascentage Pharma’s capabilities in global clinical development and innovation.
The approval is based on results from a pivotal registrational Phase II study (APG2575CC201), which demonstrated compelling efficacy and a favorable safety profile, with no tumor-lysis syndrome (TLS) observed. This fills a critical treatment gap in China and provides a new option for patients with CLL/SLL.
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