Ascentage Pharma’s Lisaftoclax Granted Breakthrough Therapy Designation in China for Treatment-Naïve CLL/SLL
Key Highlights
- ➤Lisaftoclax plus acalabrutinib receives China Breakthrough Therapy Designation for treatment-naïve CLL/SLL
- ➤BTD may enable priority communications, development guidance, review, and conditional approval eligibility
- ➤Lisaftoclax was approved in China in July 2025 after prior systemic therapy including a BTK inhibitor
- ➤Ascentage conducts four global registrational Phase III trials for lisaftoclax
- ➤GLORA-2 evaluates lisaftoclax plus acalabrutinib as first-line CLL/SLL treatment
Expert Statements
Yifan Zhai, Chief Medical Officer of Ascentage Pharma
“This BTD recognizes the clinical potential of Lisaftoclax in combination with acalabrutinib for patients with treatment-naïve CLL/SLL and the urgent unmet need in this setting. Moving forward, we are continuing to accelerate the global clinical development of lisaftoclax across relevant indications and are striving to bring this treatment to more patients as quickly as possible.”
ROCKVILLE, Md., Oct. 20, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced today that lisaftoclax (APG-2575), the Company’s novel Bcl-2 inhibitor, has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), in combination with acalabrutinib, for the treatment of treatment-naïve adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
BTDs are granted to innovative drugs or modified new drugs intended for the prevention or treatment of serious, life-threatening diseases or conditions that severely impair quality of life, for which there is no effective treatment, or where sufficient existing evidence demonstrates significant clinical advantages over currently available treatment options. Drug candidates that are granted BTDs receive priority from the CDE for communications and development guidance to accelerate drug development. Furthermore, if the applicant meets the relevant conditions after evaluation, it may apply for Priority Review status and conditional approval when submitting a New Drug Application (NDA) in China. Overall, the BTD pathway is designed to accelerate the development and review of innovative drugs and modified new drugs that offer significant clinical value or address urgent unmet clinical needs.
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