BIOKIN (SH: 688506) has announced that the first patient has been enrolled in a Phase III randomized controlled clinical trial for its innovative biologic drug, T-Bren (HER2 ADC), developed in-house. This trial is comparing T-Bren to physician's choice of chemotherapy in patients with locally advanced or metastatic biliary tract cancer that expresses HER2 and has progressed following platinum-based chemotherapy.

T-Bren (BL-M07D1) is a novel ADC targeting HER2, with potential to be a best-in-class therapy. It has already demonstrated significant anti-tumor activity in clinical trials. To date, T-Bren is being evaluated across 19 clinical trials both domestically and internationally, including eight Phase III, one Phase II/III, four Phase II, three Phase I/II, and three Phase I studies.

These trials cover a broad range of indications, including first-line and later-line HER2-positive breast cancer, post-operative adjuvant treatment for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2-low breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, HER2-mutant non-squamous non-small cell lung cancer, and HER2-positive biliary tract cancer that has failed platinum-based chemotherapy. The program also extends to lung cancer, gastrointestinal tumors, urological cancers, and gynecological tumors.