Sichuan Biokin Pharmaceutical (688506.SH): Approval of the application for listing of Lungan Erlotuzumab/ Yizekang (BL-B01D1/iza-bren) for esophageal cancer indications.

Sichuan Biokin Pharmaceutical (688506.SH) announced that recently, the company received the Drug Registration Certificate from the National Medical Products Administration, approving the company's independently developed global first-in-class and new concept EGFRHER3 bispecific ADC Luncangyilongtuo monoclonal antibody/Izecang (BL-B01D1/iza-bren) for the second-line treatment of advanced esophageal cancer. Luncangyilongtuo monoclonal antibody has conducted over 40 clinical trials targeting various types of tumors in China and the United States, including 20 Phase III clinical studies (including Phase II/III). Currently, Luncangyilongtuo monoclonal antibody has been included in the breakthrough therapy list for 7 indications by the Center for Drug Evaluation of the National Medical Products Administration (CDE), and 2 indications have been included in the priority review list by the CDE, as well as 1 indication being included in the breakthrough therapy list by the Food and Drug Administration (FDA) in the United States. In addition to the drug registration approval obtained this time, Luncangyilongtuo monoclonal antibody has already received market approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic nasopharyngeal carcinoma, and the New Drug Application (NDA) for the treatment of locally advanced or metastatic triple-negative breast cancer has also been accepted by the CDE.