Sichuan Biokin Pharmaceutical (688506.SH): BL-M05D1 for Injection Included in the Breakthrough Therapy Designation List

Sichuan Biokin Pharmaceutical (688506.SH) announced that its independently developed innovative biologic drug BL-M05D1 for Injection (Claudin18.2 ADC), intended for patients with CLDN18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC) who have previously received first-line standard treatment, has been included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. It is reported that BL-M05D1 for Injection is an innovative ADC targeting Claudin18.2 independently developed by the company. It is an ADC drug that comes from the same technology platform and shares the same "linker + toxin" platform as Yizekang (lunconitug, BL-B01D1/iza-bren). This is the first time that BL-M05D1 for Injection has been included in the CDE's Breakthrough Therapy Designation list. To date, BL-M05D1 for Injection is undergoing 3 clinical trials both domestically and internationally, including 1 Phase III, 1 Phase Ib, and 1 Phase Ia clinical trial, with the indication being locally advanced solid tumors.