Ascentage Pharma Announces a New Drug Application for Its Novel Bcl-2 Inhibitor Lisaftoclax Accepted and Recommended Priority Review Designation by CDE of China NMPA

Core Viewpoint - Ascentage Pharma has announced the acceptance of a New Drug Application (NDA) for its investigational Bcl-2 selective inhibitor, lisaftoclax, aimed at treating relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China, marking a significant milestone as it could become the first domestically developed Bcl-2 inhibitor approved in the country [1][8]. Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on discovering, developing, and commercializing therapies for unmet medical needs, particularly in malignancies [9]. - The company was listed on the Main Board of the Stock Exchange of Hong Kong Limited on October 28, 2019, under the stock code 6855.HK [9]. Product Development - The NDA for lisaftoclax is based on a pivotal Phase II study in China that assessed its efficacy and safety in patients with r/r CLL/SLL, with the overall response rate (ORR) as the primary endpoint [2]. - Lisaftoclax is the first Bcl-2 inhibitor developed in China and the second globally to enter pivotal registrational studies, demonstrating significant clinical benefits [6][8]. Market Need - CLL/SLL is a common hematologic malignancy, particularly in older populations, with over 100,000 new diagnoses globally each year [3]. In China, the incidence is rising, necessitating new treatment options due to the limitations of existing therapies [3][5]. - The introduction of Bcl-2 inhibitors has transformed CLL/SLL treatment, addressing the urgent need for effective and safe therapies for patients with r/r CLL/SLL [4][5]. Clinical Trials - Lisaftoclax is currently being evaluated in multiple registrational Phase III studies, including combinations with Bruton's tyrosine kinase inhibitors (BTKis) and azacitidine for various patient populations [7]. Research and Development - Ascentage Pharma has a robust pipeline of innovative drug candidates, including Bcl-2 inhibitors and other apoptosis-targeted therapies, and has conducted over 40 clinical trials globally [10][12]. - The company has established partnerships with leading biotechnology and pharmaceutical firms, enhancing its research capabilities [12][13].