On December 19th, the official website of the Drug Evaluation Center (CDE) of the National Medical Products Administration announced that BeiGene's Class 1 new drug BG-C137 for injection has been approved for clinical use and is intended to be developed for advanced solid tumor patients.
Public data shows that BG-C137 is an antibody coupled drug (ADC) targeting FGFR2b, and Baekje Shenzhou plans to develop this product for use in upper digestive tract tumors and breast cancer. According to the CDE official website, this is the first time that the product has been approved for clinical use in China.
BeiGene publicly disclosed that its ADC targeting FGFR2b has a differentiated antibody backbone, with an effective payload of topoisomerase I inhibitor and a DAR of 8. This product has a bystander effect and can solve the problem of tumor heterogeneity; In addition, its ligand blocking effect is weak and does not produce targeted corneal toxicity. Preclinical data also shows that it does not produce corneal toxicity in mice.