Baili Tianheng’s HER2 ADC drug T-Bren receives Breakthrough Designation for HER2-positive gastric cancer
November 5, 2025
Source: drugdu
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On November 4th, Baili Tianheng(688506) announced that its independently developed innovative biological drug T-Bren (HER2ADC) has been included in the Breakthrough Therapy List by the Center for Drug Evaluation of the National Medical Products Administration. It is indicated for patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed first-line anti-HER2 therapy and first-line standard chemotherapy. The application date for this drug is September 17, 2025, registration category 1, and acceptance number CXSL2200209.
T-Bren is an innovative ADC targeting HER2 with best-in-class potential. Currently, 14 clinical trials are underway both domestically and internationally, including 5 Phase III trials, 1 Phase II/III trial, 2 Phase II trials, 3 Phase I/II trials, and 3 Phase I trials, covering multiple indications.
In the first three quarters of 2025, Baili Tianheng achieved revenue of 2.066 billion yuan and net profit attributable to the parent company of -495 million yuan.
https://finance.eastmoney.com/a/202511043554798583.html
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