First Pharmaceutical's new ADC cancer drug has been approved for clinical trials in China.

On March 6, the National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) officially announced that DSNKY.US's (First) 1st-class new drug DS-3939a was approved for clinical trials, and is intended to develop for the treatment of solid tumors. Public information shows that DS-3939a is an antibody-drug conjugate (ADC) targeting tumor-related MUC1, which is in the 1/2 phase clinical research stage worldwide. According to the CDE's website, this is the first time the product has been approved for clinical trials in China. The structure of the product consists of a humanized anti-TA-MUC1 antibody, an enzyme-cleavable tetrapeptide linker, and a DNA topoisomerase I inhibitor (DXd) with a high drug-antibody ratio (DAR). This innovative ADC has been approved for clinical trials in China, indicating that it will enter the clinical research stage in China.