Sichuan Biokin Pharmaceutical Co.,Ltd. (688506.SH) announced that the company recently received the official Drug Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA), granting approval for a clinical trial of its independently developed globally first-in-class, new-concept, and the world's first and only approved EGFR×HER3 bispecific antibody-drug conjugate Yizekang (luncheng yilongtuodan monoclonal antibody, BL-B01D1/iza-bren) in combination therapy.

Yizekang (luncheng yilongtuodan monoclonal antibody, BL-B01D1/iza-bren) is a globally first-in-class, new-concept bispecific ADC and the world's first and only approved bispecific ADC. To date, Yizekang has been studied in over 45 clinical trials targeting multiple tumor types in both China and the United States, including 20 Phase III clinical studies (including Phase II/III).

Yizekang has had 9 indications included in the Breakthrough Therapy Designation list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, 2 indications included in the Priority Review list by the CDE, and 1 indication included in the Breakthrough Therapy Designation list by the U.S. Food and Drug Administration (FDA).

Yizekang has received marketing approval from the National Medical Products Administration (NMPA) for a total of 2 indications, including recurrent or metastatic nasopharyngeal carcinoma and recurrent or metastatic esophageal squamous cell carcinoma. Its New Drug Application (NDA) for the treatment of locally advanced or metastatic triple-negative breast cancer has also been accepted by the CDE. Interim analyses for 2 indications, including locally advanced or metastatic EGFR-mutant non-small cell lung cancer and HR+HER2- breast cancer, have met their primary endpoints.