Bio-Thera Solutions (688177.SH): BAT3306 combined with BAT8008 received approval notification for drug clinical trials in the treatment of advanced solid tumors.

Bio-Thera Solutions (688177.SH) announced that the company has recently received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration. The company's clinical trial application for the combination of the investigational drug BAT3306 injection with BAT8008 for the treatment of advanced solid tumor patients has been approved. BAT3306 is a biosimilar of pembrolizumab injection developed by Bio-Thera Solutions according to the biosimilar guidelines of the National Medical Products Administration (NMPA), the Food and Drug Administration (FDA) of the United States, and the European Medicines Agency (EMA). Pembrolizumab is a humanized monoclonal antibody drug that belongs to immune checkpoint inhibitors. It can specifically bind to the PD-1 receptor located on lymphocytes, blocking the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby relieving the immune suppression of tumors on T cells, reactivating the immune response of T cells to tumor cells, and achieving therapeutic effects on various types of cancer. BAT8008 is an antibody-drug conjugate (ADC) targeting Trop2 developed by Bio-Thera Solutions for the treatment of solid tumors.