Ascentage Pharma Advances Bcl-2 Inhibitor for CLL/SLL

Ascentage Pharma (6855.HK), a global biopharmaceutical leader focused on addressing unmet medical needs in malignancies, announced a significant milestone with the acceptance of its New Drug Application (NDA) for lisaftoclax (APG-2575) by China’s National Medical Products Administration (NMPA). Lisaftoclax, a novel Bcl-2 selective inhibitor developed in-house, targets relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL). This NDA submission is particularly noteworthy as it marks the first domestically developed Bcl-2 inhibitor in China and could position lisaftoclax as only the second Bcl-2 inhibitor approved globally, following intensive research and development efforts.

The NDA is supported by robust data from Ascentage Pharma’s pivotal Phase II study (APG2575CC201) conducted in China, which evaluated lisaftoclax’s efficacy and safety in patients with r/r CLL/SLL. The primary endpoint, overall response rate (ORR), demonstrated significant clinical benefits, highlighting lisaftoclax’s potential to meet the urgent needs of patients suffering from this aggressive leukemia subtype. Systemic sclerosis, characterized by severe inflammation and fibrosis, underscores the necessity for innovative treatments like lisaftoclax, especially given the high relapse rates and poor prognosis associated with existing therapies.

Lisaftoclax works by selectively inhibiting the Bcl-2 protein, which plays a crucial role in preventing apoptosis in cancer cells. By blocking Bcl-2, lisaftoclax restores the natural cell death process, offering a targeted approach to treating CLL/SLL. The drug has shown promising results in preclinical models, effectively reducing tumor growth and enhancing patient outcomes. Ascentage Pharma is now preparing to advance lisaftoclax through further clinical trials, including Phase III studies in combination with other therapies, to solidify its position as a leading treatment option for CLL/SLL and potentially other hematologic malignancies.

Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, emphasized the company’s commitment to overcoming the challenges associated with developing Bcl-2 inhibitors. “Submitting the NDA for lisaftoclax is a testament to our team’s dedication and expertise in creating effective apoptosis-targeted therapies,” he stated. “With this approval, we aim to provide a much-needed treatment option for patients in China and globally, addressing the significant unmet needs in r/r CLL/SLL. Our focus remains on accelerating the development of lisaftoclax and expanding its use to benefit more patients facing these severe conditions.”