Indian drugmaker Intas Pharmaceuticals has inked an exclusive deal with Shanghai Henlius Biotech for the development and commercialization of serplulimab in Europe and India.
Serplulimab, a recombinant humanized anti-PD-1 monoclonal antibody (MAb) injection, is the first monoclonal antibody developed by Henlius. It was granted orphan drug status by the US Food and Drug Administration (FDA) and the European Commission. Its marketing application for the first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is under review by the EMA.
Serplulimab gained approval in China in March 2022 for various indications, including MSI-H solid tumors, squamous non-small cell lung cancer, ES-SCLC, and esophageal squamous cell carcinoma.
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