Shanghai Henlius Biotech (HKG: 2696) is advancing its checkpoint inhibitor serplulimab toward the U.S. market, with plans to launch a bridging study in H2 2022 for extensive-stage small-cell lung cancer (ES-SCLC). The decision follows a meeting with the U.S. FDA, as the firm seeks to replicate its Phase III success in global trials.
Bridging Study and Regulatory Strategy
Henlius aims to initiate the U.S.-focused bridging study after discussions with the FDA, which previously granted orphan drug designation (ODD) for serplulimab in SCLC. The company also plans to file for market approval in Europe in 2023, following a meeting with the EMA’s Scientific Advice Working Party.
Phase III Trial Results
In December 2021, Henlius reported that serplulimab plus chemotherapy achieved a median overall survival (OS) of 15.4 months in ES-SCLC patients, compared to 10.9 months with chemotherapy alone (HR 0.63, p<0.001). The 24-month OS rate was 43.1% vs. 7.9%, with significant improvements in progression-free survival (PFS) and objective response rate (ORR).
Global Development
Serplulimab’s international trials included sites in Turkey, Georgia, and other regions, with 30% Caucasian enrollment. This diversity may address FDA concerns over prior Chinese checkpoint inhibitors, which faced Complete Response Letters (CRLs) for lacking multi-regional data.
China Approvals and Future Plans
In China, serplulimab won approval in March 2023 for microsatellite instability-high (MSI-H) solid tumors and is under review for non-small cell lung cancer (NSCLC). The drug’s U.S. bridging study aims to secure FDA approval, positioning Henlius as a global contender in immuno-oncology.-Fineline Info & Tech
