Ascentage Pharma's Lisaftoclax Granted China Breakthrough Designation

MT Newswires Live10-21 17:49

Ascentage Pharma Group International (AAPG) said Tuesday that China's Center for Drug Evaluation has granted breakthrough therapy designation to lisaftoclax in combination with acalabrutinib for treatment-naive adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Candidates granted the designation in China receive priority for official communications and development guidance to speed up drug development, the company said.

Eligible candidates may also apply for priority review and conditional approval when submitting a new drug application in China, it added.

Ascentage Pharma is currently conducting four global registrational phase 3 trials of lisaftoclax, the company said.

The drug remains investigational in the US, and the lisaftoclax-acalabrutinib combination has not been approved in any market, Ascentage Pharma said.

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