Its drug marketing application for injectable iza-bren has been accepted
January 21, 2026
Source: drugdu
29
On January 20, Baili Tianheng (688506.SH) announced that it had received an Acceptance Notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The NDA for its independently developed, first-in-class, new-concept EGFR×HER3 bispecific antibody ADC (iza-bren), the only one to enter Phase III clinical trials, has been formally accepted. Iza-bren, used to treat recurrent or metastatic esophageal squamous cell carcinoma, has also been included in the priority review list by the CDE. This drug is the world's first EGFR×HER3 bispecific antibody ADC to have its NDA accepted. Iza-bren is currently undergoing more than 40 clinical trials in China and the United States targeting various tumor types. To date, iza-bren has 7 indications included in the CDE's Breakthrough Therapy List, 2 indications included in the CDE's Priority Review List, and 1 indication included in the U.S. Food and Drug Administration's Breakthrough Therapy List.
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