By Fineline Cube 
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced the successful completion of first patient dosing in a Japanese bridging trial evaluating its anti-PD-1 inhibitor, HanSiZhuang (serplulimab, HLX10), in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).
Trial Details
The trial is a single-arm, open Phase II study designed to support the marketing filing for serplulimab in Japan. It received tacit approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Patients in the study receive serplulimab in combination with carboplatin and etoposide every three weeks. The primary endpoint is response rate at week 24, with secondary endpoints including overall survival, progression-free survival, objective response rate, duration of response, safety, pharmacokinetics, and immunogenicity.
Global Approvals and Trials
Serplulimab is already approved in China for the treatment of squamous non-small cell lung cancer (sq-NSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC (nsq-NSCLC). It also holds approvals in the EU, UK, Singapore, and India. Additionally, serplulimab is undergoing global trials across multiple cancers, including lung, esophageal, head and neck, colorectal, and gastric cancers.-Fineline Info & Tech