China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the milestone of the first patient dosing in the global multi-center Phase III clinical study for its anti-PD-1 monoclonal antibody (mAb) HanSiZhuang (serplulimab). The study is evaluating the drug in combination with chemotherapy and concurrent radiotherapy for patients with limited-stage small cell lung cancer (LS-SCLC) and is currently underway in Latvia, following initiations in China, the US, Australia, and other countries.
HanSiZhuang: Development and Approvals
HanSiZhuang, developed by Henlius, is the first innovative mAb from the company. It has received approval from the National Medical Products Administration (NMPA) for the treatment of MSI-H solid tumors, non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). The drug has been administered to over 40,000 patients in China.
Orphan Drug Designations and European Validation
HanSiZhuang has been granted orphan-drug designations for the treatment of SCLC by both the US FDA and the European Commission (EC). Additionally, the European Medicines Agency (EMA) has validated the application for HanSiZhuang in combination with chemotherapy for the first-line treatment of ES-SCLC.
US Market Approval Anticipation
Notably, the first patient has been dosed in a bridging head-to-head trial in the US, comparing HanSiZhuang to the standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC. This trial is expected to be a significant step towards securing US market approval for HanSiZhuang.-Fineline Info & Tech
