HENLIUS's Serplulimab Injection Receives Positive CHMP Opinion from EMA

Stock News05-22 21:56

HENLIUS (02696) has announced that its independently developed Serplulimab Injection (marketed as Hansizhuang® in China and HETRONIFLY® in the EU) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The CHMP recommends approving Serplulimab in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC). The CHMP's opinion will be submitted to the European Commission (EC), which will consider this recommendation and make a final decision within the next two months. Upon approval by the EC, the centralized marketing authorization for Serplulimab will be effective in all European Union member states and the European Economic Area (EEA) countries of Iceland, Liechtenstein, and Norway.

This positive CHMP opinion is primarily based on a randomized, double-blind, international multicenter Phase 3 clinical study. The study results demonstrate that Serplulimab combined with carboplatin and nab-paclitaxel for the first-line treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer provides significant benefits, meeting the pre-specified primary endpoints, and exhibits a favorable safety and tolerability profile. In December 2023, the group received several GMP certificates from the Dutch Health and Youth Care Inspectorate, indicating that the production lines related to Serplulimab comply with EU GMP standards.

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