Akeso's cadonilimab approved in China for cervical cancer

Akeso, Inc. (HKEX:9926) announced that the National Medical Products Administration (NMPA) in China has approved its supplemental New Drug Application (sNDA) for cadonilimab (開坦尼®), a PD-1/CTLA-4 bi-specific antibody, as a first-line treatment for persistent, recurrent, or metastatic cervical cancer when combined with platinum-based chemotherapy. This approval addresses a critical unmet need for immune-based therapies. The approval is based on the results of the COMPASSION-16/AK104-303 clinical trial, which met primary endpoints of progression-free survival (PFS) and overall survival (OS). Cervical cancer in China saw 150,700 new cases in 2022, making it a major global health challenge. Cadonilimab has already received approval for gastric and gastroesophageal junction adenocarcinoma, highlighting its potential across multiple cancer types.