Ascentage Pharma drug Lisenatograt receives breakthrough therapy designation

Ascentage Pharma has announced that its novel Bcl-2 inhibitor, Lisenatograt (APG-2575), has been granted breakthrough therapy designation by China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). The designation is for the use of Lisenatograt in combination with acalabrutinib to treat adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Breakthrough therapy designation is awarded to innovative drugs that demonstrate significant clinical advantages over existing treatments for serious or life-threatening conditions. This status allows for prioritized communication and guidance from regulatory authorities to accelerate the drug development and review process.

CLL/SLL is a mature B-cell neoplasm that primarily affects elderly patients, with over 100,000 new cases globally each year. While immunotherapy and BTK inhibitors are standard first-line treatments, certain high-risk patients face limitations in response depth and long-term safety. Ascentage Pharma is currently conducting several global Phase III clinical trials, including the GLORA-2 study, to further explore the clinical potential of this combination therapy.