AKESO, INC. Akeso, Inc. announced that the National Medical Products Administration of China has accepted the supplemental New Drug Application for (cadonilimab, PD-1/CTLA-4), a novel global first-in-class PD-1/CTLA-4 bi-specific immuno-therapy drug independently developed by the Company, in combination with platinum-based chemotherapy with or without bevacizumab as first line treatment for persistent, recurrent, or metastatic cervical cancer. In June 2022, CADONOLIMAB, PD-1/CTLA-4 has been granted marketing approval by NMPA of China as the second/third-line treatment of recurrent or metastatic cervical cancer patients who have progressed on or after platinum-based chemotherapy. This sNDA is based on AK104303, which demonstrated cadonilimab's superior improvement to all comers (regardless of PD-L1 expression).
This sNDA of will advance into first-line treatment of cervical cancer and benefit all comers of advanced cervical cancer patients. This is the third indication of CADONOLIMAB, PD-1/CTLA-4 submitting new drug application. Earlier in January 2024, NMPA accepted the sNDA of CADONOLIMAB, PD-1/CTLA-4 in combination with chemotherapy as first-line treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, which will bring a more efficacious and safe therapy to all comers (regardless of PD-L1 expression) of gastric cancer patients.
AK104303 is a phase III clinical trial of cadonilimab, the global first approved PD-1/CTLA-4 bi-specific antibody, in combination with platinum-based chemotherapy with or without bevacizumab as first line treatment for persistent, recurrent, or metastatic cervical cancer. AK104303 is a randomized, double-blind, multi-centered Phase III clinical trial with primary endpoint of progression-free-survival (PFS) and overall survival (OS). ABOUT (CADONOLIMAB, PD-1/CTLA-4): CADONOLIMAB, PD-1/CTLA-4 is a novel global first-in-class PD-1/CTLA-4 bi-specific immuno-therapy drugindependently developed by the Company.
In June 2022, CADONOLIMAB, PD-1/CTLA-4 has been granted marketing approval by the NMPA of China and became the global first approved PD-1/CTLA-4 bi-specific antibody. In January 2024, NMPA accepted the sNDA of CADONOLIMAB, PD-1/CTLA-4 in combination with chemotherapy as first-line treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. Currently, the Company is conducting 20 clinical trials of cadonilimab combination therapies, covering 16 indications including cervical cancer, gastric cancer, liver cancer, lung cancer, renal cancer, esophageal squamous cell cancer.
