Baili Tianheng (688506.SH): Renkang's application for marketing of ilontuzumab/iza-Bren (BL-B01D1/iza-Bren) esophageal cancer indications approved

Zhitong Finance App News, Baili Tianheng (688506.SH) issued an announcement. Recently, the company received the “Drug Registration Certificate” from the State Drug Administration, and approved the marketing application for EGFR×HER3 dual anti-ADC Renkang Elontuzumab/BL-B01D1/iza-Bren (BL-B01D1/iza-Bren) advanced second-line indications of esophageal cancer developed independently by the company and approved for marketing.

Renconilizumab has conducted more than 40 clinical trials on various tumor types in China and the US, including 20 phase III clinical studies (including phase II/III). Up to now, 7 indications of lencamilonitumab have been included in the list of breakthrough treatment varieties by the Drug Evaluation Center (CDE) of the China Drug Administration, 2 indications have been included in the CDE list of priority review varieties, and 1 indication has been included in the US Food and Drug Administration (FDA) list of breakthrough therapeutic varieties.

In addition to receiving drug registration approval this time, lencamilontuzumab for the treatment of recurrent or metastatic nasopharyngeal cancer has obtained marketing approval from the National Drug Administration (NMPA), and a drug marketing application (NDA) to treat locally advanced or metastatic triple-negative breast cancer has also been accepted by the CDE.