Shanghai Henlius Biotech, Inc. (Henlius) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of Serplulimab (EU trade name: HETRONIFLY®) 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 carcinoma (sqNSCLC).
The CHMP opinion will be forwarded to the European Commission, which is expected to deliver a final decision within two months. A positive Commission decision would grant a centralised marketing authorisation valid across all European Union member states and European Economic Area countries, including Iceland, Liechtenstein and Norway.
Regulatory support rests on data from a randomised, double-blind, international phase 3 study that met its pre-specified primary endpoint and demonstrated favourable safety and tolerability. Manufacturing readiness is underpinned by multiple Good Manufacturing Practice certificates awarded by the Netherlands Health and Youth Care Inspectorate in December 2023, confirming compliance with EU GMP standards.
Serplulimab is an anti-PD-1 monoclonal antibody already approved in mainland China for four indications—sqNSCLC, extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous NSCLC—and in the EU for ES-SCLC, ESCC and non-squamous NSCLC. Additional approvals have been secured in the United Kingdom, Indonesia, Cambodia, Thailand, Malaysia, Singapore, India and other territories. Henlius licensed European and Indian commercial rights to Intas Pharmaceuticals in October 2023.
Clinical development remains active. Ongoing or recently completed trials include: • U.S. and Japan bridging studies for ES-SCLC; • A Chinese phase 3 study in neo-/adjuvant gastric cancer that has met its primary endpoint and obtained Breakthrough Therapy Designation with priority review status; • A global phase 3 trial in limited-stage SCLC combining serplulimab with chemotherapy and radiotherapy; • Multinational phase 2/3 work in metastatic colorectal cancer pairing serplulimab with bevacizumab and chemotherapy; • Early-stage investigations of combinations with HLX07 (anti-EGFR) and HLX43 (PD-L1–targeting ADC) across solid tumours.
According to IQVIA MIDAS™ data, global sales of PD-1 monoclonal antibody therapies are projected to reach approximately US$50.87 billion in 2025, underscoring the commercial significance of the CHMP recommendation for Serplulimab.
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