Ascentage's lisaftoclax gets breakthrough therapy status in China for untreated CLL/SLL

Ascentage Pharma Group International announced on October 20, 2026 that its Bcl-2 inhibitor lisaftoclax (APG-2575) received Breakthrough Therapy Designation from the Center for Drug Evaluation of China's National Medical Products Administration. The designation covers lisaftoclax in combination with acalabrutinib for treatment-naive adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.¹

A BTD gives the drug priority access to CDE communications and development guidance, and if conditions are met, the company may later apply for Priority Review and conditional approval when it files a New Drug Application in China.¹

The company pointed to gaps in current first-line therapy. Immunochemotherapy has limited efficacy in patients with high-risk features such as del(17p)/TP53 mutations, complex karyotypes, and unmutated IGHV, while BTK inhibitor monotherapy carries concerns about depth of response and long-term safety and requires continuous dosing; once treatment fails, patients have very limited subsequent options.¹

Lisaftoclax was approved in China in July 2025 for adult CLL/SLL patients who had received at least one prior systemic therapy including a BTK inhibitor, making it the first China-developed Bcl-2 inhibitor approved in China and the second approved globally.¹ Ascentage is running four global registrational Phase III trials of lisaftoclax, including GLORA-2, which is evaluating the drug with acalabrutinib as a first-line treatment for CLL/SLL.¹

Ascentage Chief Medical Officer Dr. Yifan Zhai said the designation "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."¹

In the United States, lisaftoclax remains investigational and has not been approved by the FDA, and the lisaftoclax-acalabrutinib combination is not approved in any market.¹