Sichuan Biokin Pharmaceutical (688506.SH): Yizekang combined with radiotherapy for the treatment of locally advanced unresectable head and neck squamous cell carcinoma and other solid tumors receives drug clinical trial approval.

Sichuan Biokin Pharmaceutical (688506.SH) announced that the company recently received the "Drug Clinical Trial Approval Notice" officially approved and issued by the National Medical Products Administration (NMPA). The clinical trial of the combination therapy of Yizekang (lunkanlilong duomab, BL-B01D1/iza-bren), the company's independently developed globally first-in-class, new-concept, and the world's first and only approved EGFRHER3 bispecific antibody-drug conjugate (ADC), has been approved. Yizekang (lunkanlilong duomab, BL-B01D1/iza-bren) is globally first-in-class and new-concept, and is also the world's first and only approved bispecific antibody-drug conjugate (ADC). To date, Yizekang has conducted more than 45 clinical trials targeting multiple tumor types in China and the United States, including 20 Phase III clinical studies (including Phase II/III). Nine indications of Yizekang have been included in the breakthrough therapy designation list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, two indications have been included in the priority review designation list by the CDE, and one indication has been included in the breakthrough therapy designation list by the U.S. Food and Drug Administration (FDA). Two indications of Yizekang for recurrent or metastatic nasopharyngeal carcinoma and recurrent or metastatic esophageal squamous cell carcinoma have received marketing approval from the National Medical Products Administration (NMPA); the New Drug Application (NDA) for the treatment of locally advanced or metastatic triple-negative breast cancer has also been accepted by the CDE; and the interim analysis for two indications for the treatment of locally advanced or metastatic EGFR-mutant non-small cell lung cancer and HR+HER2- breast cancer has reached the primary endpoint.