Baili Tianheng (688506.SH): Phase III clinical trial of injectable T-Bren (HER2 ADC) completed the first patient enrollment

Zhitongcaijing · 1d ago

According to Zhitong Finance App News, Baili Tianheng (688506.SH) announced that the innovative biopharmaceutical T-Bren (HER2 ADC) independently developed by the company has recently completed a phase III randomized controlled clinical trial comparing BL-M07D1 with doctor-selected chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer expressed by HER2.

T-Bren (BL-M07D1) is an innovative ADC targeting HER2. It has best-in-class (best-in-class) potential and has shown significant anti-tumor efficacy in clinical trials. Recently, T-bren recently completed a phase III randomized controlled clinical trial comparing BL-M07D1 with doctor-selected chemotherapy in patients with platinum-resistant her2-expressed platinum-resistant ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

Up to now, T-Bren is carrying out 20 clinical trials at home and abroad, including 9 stage III, 1 phase II/III, 4 phase II, 3 phase I/II, and 3 phase I clinical trials, covering first-line and second-line HER2-positive breast cancer, HER2-positive breast cancer post-operative support, new adjuvant treatment for HER2-positive breast cancer, and HER2-positive breast cancer, HER2-positive gastric cancer or gastroesophageal adenocarcinoma, HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma, HER2 mutant non-squamous non-small cell lung cancer, and HER2 positive chemotherapy with failed platinum Biliary tract cancer, lung cancer, digestive tract tumors, Multiple indications such as urinary system tumors and gynecological tumors.

T-bren's treatment of HER2-positive gastric cancer or gastroesophageal adenocarcinoma and treatment of her2-expressed biliary tract cancer with platinum-containing chemotherapy failure have been included in the list of breakthrough treatment types by the Drug Evaluation Center of the China Drug Administration and completed publicity.