Policy & Regulation
Akeso's cadonilimab gains Chinese approval for first-line treatment of cervical cancer
5 June 2025 -

Chinese pharmaceutical company Akeso Inc (HK:9926) announced on Wednesday that China's National Medical Products Administration (NMPA) has approved the company's first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab.

The NMPA approval marks the third approved indication for cadonilimab.

With the approval for first-line cervical cancer, cadonilimab has achieved comprehensive coverage for the treatment of advanced cervical cancer, offering an innovative treatment option for patients across all stages of advanced cervical cancer. In addition to the treatment for first-line cervical cancer, cadonilimab is also approved for first-line treatment of advanced gastric cancer, and for the treatment of relapsed or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.

The approval for cadonilimab's use in combination with chemotherapy (with or without bevacizumab) in first-line cervical cancer is based on clinical data from a Phase III study in which this combination regimen showed a notable efficacy benefit in patients with tumours that have a negative PD-L1 expression (CPS

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