On October 16, 2022 Akeso’s 开坦尼 (Cadonilimab injection), a first-in-class PD-1/CTLA-4 bi-specific antibody independently developed by the Company, was included in the guidelines as the top recommended second-line immunotherapy for recurrent or metastatic cervical cancer (R/M CC) (Press release, Akeso Biopharma, OCT 16, 2022, View Source [SID1234622045]).
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As the globally first approved dual immune checkpoint bi-specific antibody, Cadonilimab is the first approved immuno-oncology drug for advanced cervical cancer treatment in China. It was granted marketing approval by the National Medical Products Administration (NMPA) at the end of June 2022, addressing the unmet market demand for immunotherapy for cervical cancer. Cadonilimab has been included in the Guidelines for Cervical Cancer Treatment as the top recommendation by CSCO only after 4 months since its approval, which would enable the clinical doctors in China to obtain a more extensive and in-depth understanding of the clinical efficacy of Cadonilimab, that will further help Cadonilimab to satisfy the patients’ needs more promptly and extensively by improving their survival benefit.
China has the world’s second-largest population of cervical cancer patients, with 110,000 new cases in 2020. Akeso is now conducting a phase III trial of Cadonilimab plus platinum-based chemotherapy +/- bevacizumab in first-line treatment for R/M CC and has completed patient enrollment. In addition, a registrational/phase III trial of Cadonilimab plus concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC) is also ongoing.