Sichuan Biokin Pharmaceutical (688506.SH): T-Bren included in the breakthrough therapy designation list

Sichuan Biokin Pharmaceutical (688506.SH) announced that its independently developed innovative biologic drug T-Bren (HER2 ADC) is an innovative ADC targeting HER2 with best-in-class potential, and has demonstrated significant anti-tumor efficacy in clinical trials. Its regimen for patients with HER2-expressing locally advanced or metastatic biliary tract cancer who have failed platinum-containing chemotherapy has been included in the breakthrough therapy designation list by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, and the public notice period has recently been completed. To date, T-Bren is being evaluated in 20 clinical trials in China and internationally, including 9 Phase III, 1 Phase II/III, 4 Phase II, 3 Phase I/II, and 3 Phase I clinical trials, covering multiple indications including first-line and second-line and beyond HER2-positive breast cancer, postoperative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2-low breast cancer, HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma, HER2-mutant non-squamous non-small cell lung cancer, as well as lung cancer, gastrointestinal tumors, genitourinary tumors, and gynecological tumors. In addition to this new inclusion, in November 2025, T-Bren's regimen for patients with HER2-positive locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma who have failed prior first-line anti-HER2 therapy and first-line standard chemotherapy was included in the breakthrough therapy designation list by the CDE and completed the public notice period.