The board of directors of Akeso, Inc. announced that the National Medical Products Administration of China just accepted the supplemental New Drug Application for Kai Tan Ni (cadonilimab, PD-1/CTLA-4), a novel global first-in-class PD-1/CT LA-4 bi-specific immuno-therapy drug independently developed by the Company, in combination with XELOX chemotherapy (oxaliplatin and capecitabine) as first-line treatment for unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The supplemental new drug application is based on the results of AK104-302, a randomized, double-blind, multi-center Phase III clinical trial with primary endpoint of overall survival (OS). Based on the interim analysis of independent data monitoring committee (IDMC), cadonilimab in combination with chemotherapy demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of OS for all comers (reg regardless of PD-L1 status), compared to placebo in combination with chemotherapy, and significantly reduced risk of death for all comers.

The safety profile of cadonilimab in this clinical trial was consistent with that observed in previously reported results of cadonilimab, no additional safety signals were identified. The results of AK104-302 will be presented at an upcoming medical conference.astric cancer is one of the most common malignant tumor globally. According to the latest data published by the International Agency for Research on Cancer (IARC) of World Health Organization (WHO), the incidences of gastric cancer around the world and in China have exceeded 1.09 million and 500 thousand respectively in 2020, and mainly of the gastric cancer patients are diagnosed at advanced stage.

The Company believes this sNDA of cadonilimab will benefit more gastric cancer patients (regardless of PD-L1 status) by providing a more efficacious and safe therapy, and will further expand its market potential.