Sichuan Biokin Pharmaceutical announces acceptance of the New Drug Application for Iza-Bren (an EGFR×HER3 Bispecific ADC) for the treatment of locally advanced or metastatic nasopharyngeal carcinoma

CAR-T Digest - August 2020

Weekly Digest - November 2025

24 November 2025: Sichuan Biokin Pharmaceutical announces acceptance of the New Drug Application for Iza-Bren (an EGFR×HER3 Bispecific ADC) for the treatment of locally advanced or metastatic nasopharyngeal carcinoma

China’s National Medical Products Administration has formally accepted the NDA for iza-bren (BL-B01D1), a world-first EGFR×HER3 bispecific antibody ADC and the only drug of its kind to reach Phase 3 development
The acceptance is based on interim results from the BL-B01D1-303 study, targeting locally advanced or metastatic nasopharyngeal carcinoma in patients who failed at least two prior chemotherapy lines
Iza-bren has been included in the CDE priority review list and has received Breakthrough Therapy designations across seven indications, with more than 40 clinical trials ongoing in China and the U.S.
The company previously completed a successful Pre-NDA meeting with regulators, reinforcing the drug’s status as a first-in-class innovation with global development momentum