Sichuan Baili Tianheng Pharmaceutical’s BL-B01D1 marketing application (NDA) has been formally accepted by China’s National Medical Products Administration (NMPA)

CAR-T Digest - August 2020

Weekly Digest - January 2026

21 January 2026: Sichuan Baili Tianheng Pharmaceutical’s BL-B01D1 marketing application (NDA) has been formally accepted by China’s National Medical Products Administration (NMPA)

Sichuan Baili Tianheng Pharmaceutical announced that China’s National Medical Products Administration has formally accepted the marketing application for BL-B01D1 (Iza-bren), an EGFR×HER3 bispecific antibody-drug conjugate, for the treatment of recurrent or metastatic esophageal squamous cell carcinoma
The acceptance is based on results from a Phase 3 clinical trial (BL-B01D1-305) in patients who had previously received PD-1/PD-L1 inhibitors in combination with platinum-based chemotherapy, where an interim analysis confirmed that the study met its progression-free survival endpoint, with overall survival also designated as a primary endpoint
This milestone positions Iza-bren as a first-in-class, next-generation bispecific ADC and the only therapy of its kind to advance to Phase 3 and reach NDA acceptance, underscoring its potential to address a significant unmet need in heavily pretreated esophageal cancer
Beyond this indication, Iza-bren is being evaluated across more than 40 clinical trials in China and the United States covering multiple tumor types, and has already received multiple regulatory recognitions, including several Breakthrough Therapy designations and priority review status for select indications
While the NDA acceptance marks a major regulatory step, the company noted that final marketing approval will depend on the completion of the NMPA’s full review process, with additional NDA submissions for other cancers, including nasopharyngeal carcinoma, also progressing in parallel