Baili Tianheng issued an announcement stating that the company's independently developed iza-bren (EGFR×HER3 dual-antibody ADC), the world's first, new concept and the only one to enter the Phase III clinical stage, is used for patients with unresectable locally advanced or metastatic urothelial carcinoma who have failed previous treatment with platinum-containing chemotherapy and PD-1/PD-L1 inhibitors. It has been included in the list of breakthrough therapies by the Drug Review Center of the National Medical Products Administration.

To date, seven indications of Iza-bren have been included in the list of breakthrough therapies by the Center for Drug Evaluation, and one indication has been granted breakthrough therapy designation by the U.S. Food and Drug Administration.

The National Medical Products Administration's Center for Drug Evaluation prioritizes resources for drugs included in the Breakthrough Therapy designation, strengthening guidance and promoting drug development. Baili Tianheng's Iza-bren has been designated a Breakthrough Therapy, which is expected to accelerate its market launch and potentially benefit the company's stock price in the short term.

Source：https://www.nbd.com.cn/articles/2025-09-25/4075690.html