The European Commission has approved a new indication for Hetronifly (serplulimab), China-based Shanghai Henlius Biotech’s (HKEX: 02696) anti-PD-1 antibody, covering first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma (sqNSCLC) in combination with carboplatin and nab-paclitaxel. The decision extends Hetronifly’s EU footprint, which already encompasses extensive-stage small cell lung cancer, esophageal squamous cell carcinoma, and non-squamous NSCLC, making serplulimab one of the few PD-1 inhibitors approved across multiple thoracic oncology indications in the EU.
Serplulimab is administered intravenously in combination with carboplatin and nab-paclitaxel. The approval covers all EU member states as well as Iceland, Liechtenstein, and Norway. The CHMP of the European Medicines Agency issued a positive opinion in May 2026 ahead of the EC’s formal decision. No accelerated approval conditions or biomarker selection requirements were stated in the company’s announcement.
In first-line sqNSCLC, serplulimab enters a competitive field anchored by Merck’s pembrolizumab (Keytruda), approved in the EU based on the Phase III KEYNOTE-407 trial using an identical carboplatin and nab-paclitaxel backbone, and by Regeneron and Sanofi’s cemiplimab (Libtayo), approved across NSCLC histologies regardless of PD-L1 expression. The broader landscape continues to evolve, though novel immunotherapy combinations have faced setbacks, underscoring the continued dominance of anti-PD-1 plus chemotherapy as the first-line standard. Commercially, Hetronifly is distributed in Europe through Accord Healthcare, a subsidiary of Intas Pharmaceuticals, under an exclusive license agreement signed in October 2023 that has since been restructured to cover additional markets.
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