Henlius doses first patient in Japan bridging study

Shanghai Henlius Biotech, Inc. (HKEX:2696) announced the dosing of the first patient in a bridging study in Japan for HANSIZHUANG (serplulimab injection) in combination with chemotherapy (carboplatin-etoposide) for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). This bridging study follows the implied approval for a phase 2 clinical trial from the Japan Pharmaceuticals and Medical Devices Agency (PMDA) to support the future marketing application of HANSIZHUANG in Japan. A previous international multicentre phase 3 clinical trial comparing HANSIZHUANG versus placebo in combination with chemotherapy met its primary endpoint of overall survival in December 2021. HANSIZHUANG is an innovative anti-PD-1 monoclonal antibody approved for marketing in mainland China and the EU and other countries. The drug holds orphan-drug designations for SCLC in the United States, Europe, and Switzerland.