ASCENTAGE(06855) Lisaftoclax Receives Breakthrough Therapy Designation for the Treatment of Treatment-Naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

ASCENTAGE (06855) announced that its original Class 1 new drug Bcl-2 inhibitor Lisaftoclax (generic name: lisaftoclax; development code: APG-2575) has been included by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in the "Breakthrough Therapy Designation" list for the treatment of adult patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in combination with acalabrutinib. Breakthrough Therapy Designation is typically granted to innovative drugs or improved new drugs that are used for the prevention and treatment of diseases that seriously endanger life or seriously affect quality of life, and for which no effective prevention or treatment exists, or for which sufficient evidence shows significant clinical advantages compared with existing treatments. For drugs included in the Breakthrough Therapy Designation list, the CDE will prioritize the allocation of resources for communication and exchange, strengthen guidance, and promote the drug development process; applicants that are assessed as meeting the relevant conditions may also submit applications for conditional approval and priority review and approval when applying for marketing authorization. The review policy for Breakthrough Therapy Designation will accelerate the development and marketing of innovative drugs or improved new drugs with major clinical value and urgent clinical need.