On July 26, Bio-Thera Solutions revealed that its independently developed innovative biologic, T-Bren Injection (HER2ADC), has successfully enrolled its first participant in a Phase III randomized controlled clinical trial. This trial is specifically designed for patients with HER2-expressing locally advanced or metastatic biliary tract cancer who have not responded to platinum-based chemotherapy. The drug shows promise as a leading contender in its class, with an impressive 19 clinical trials currently in progress both domestically and internationally. These trials encompass a broad range of treatments, including first-line and second-line or higher therapies for HER2-positive breast cancer, postoperative adjuvant therapy, neoadjuvant therapy, HER2-low expressing breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, HER2-mutated non-squamous non-small cell lung cancer, as well as HER2-positive biliary tract cancer that has proven resistant to platinum-based chemotherapy. Additionally, the trials are exploring various indications, including lung cancer, gastrointestinal tumors, urological tumors, and gynecological tumors.
