Sichuan Biokin Pharmaceutical Co., Ltd. (688506.SH) announced that its self-developed, first-in-class, novel-concept EGFR×HER3 bispecific antibody-drug conjugate (iza-bren), currently the only one in Phase III clinical trials, has achieved both primary endpoints of progression-free survival (PFS) and overall survival (OS) in a prespecified interim analysis of a Phase III clinical trial (Study No.: BL-B01D1-305) for esophageal squamous cell carcinoma. The trial was evaluated by an independent data monitoring committee (iDMC). The indication targets recurrent or metastatic esophageal squamous cell carcinoma in patients who failed prior PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy. This marks the first Phase III clinical study globally where an ADC drug demonstrated positive PFS and OS outcomes in esophageal cancer treatment.

Iza-bren is the first and only EGFR×HER3 bispecific ADC in Phase III clinical development. Currently, over 40 clinical trials are underway in China and the U.S. for various tumor types. To date, the drug has secured breakthrough therapy designation from China's Center for Drug Evaluation (CDE) for seven indications and one breakthrough therapy designation from the U.S. FDA.