Shanghai Henlius Biotech (HENLIUS) has received European Commission (EC) authorisation for a new indication of its anti-PD-1 monoclonal antibody serplulimab (EU trade name: HETRONIFLY). The therapy, combined with carboplatin and nab-paclitaxel, is now cleared as a first-line treatment for adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma (sqNSCLC) across all European Union member states as well as Iceland, Liechtenstein and Norway.
The EC decision is supported by a randomised, double-blind, international phase 3 trial that met its pre-specified primary endpoint, demonstrating significant efficacy alongside favourable safety and tolerability. Manufacturing readiness was confirmed in December 2023, when production lines obtained EU Good Manufacturing Practice certificates from the Netherlands’ Health and Youth Care Inspectorate. A positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use followed in May 2026.
Serplulimab has already been approved in China for multiple indications—including first-line sqNSCLC, extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), non-squamous NSCLC, and perioperative gastric cancer—and holds marketing authorisations in the United Kingdom and several Asian markets. In October 2023, HENLIUS licensed European and Indian commercial rights to Intas Pharmaceuticals and its subsidiary Accord Healthcare.
Global market data from IQVIA MIDAS™ indicate that PD-1 monoclonal antibodies generated approximately USD 50.87 billion in sales during 2025, underscoring the commercial significance of serplulimab’s broader European label.
According to HENLIUS, the newly approved indication will strengthen the company’s international footprint and expand access for sqNSCLC patients throughout the European Economic Area.
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