Ascentage Pharma receives China breakthrough designation for lisaftoclax combination

• Ascentage Pharma (NASDAQ:AAPG) received Breakthrough Therapy Designation in China for lisaftoclax combined with acalabrutinib to treat previously untreated adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
• The combination is being evaluated in GLORA-2, one of four ongoing global registrational Phase III trials involving lisaftoclax.
• The designation provides prioritized regulatory guidance but does not constitute marketing approval. Lisaftoclax was separately approved in China in July 2025 for certain previously treated CLL/SLL patients.

Ascentage Pharma (NASDAQ:AAPG) received Breakthrough Therapy Designation in China for lisaftoclax combined with acalabrutinib as a potential first-line treatment for adults with CLL/SLL.

China's National Medical Products Administration granted the designation through its Center for Drug Evaluation, providing prioritized regulatory communications and development guidance.

“This BTD recognizes the clinical potential of Lisaftoclax in combination with acalabrutinib,” said Chief Medical Officer Yifan Zhai, citing the need for additional treatment options.

The combination is being evaluated in GLORA-2, a global registrational Phase III trial comparing the investigational regimen against immunochemotherapy in previously untreated patients.

Ascentage Pharma said the designation could support applications for Priority Review and conditional approval if relevant regulatory requirements are met following evaluation.

Lisaftoclax, an oral Bcl-2 inhibitor, received Chinese marketing approval in July 2025 for adults with CLL/SLL previously treated with systemic therapy including a BTK inhibitor.

The company is conducting four global registrational Phase III lisaftoclax trials, although the newly designated combination remains investigational and is not approved in any market.