The European Commission has granted approval for an expanded indication of HENLIUS (HKEX: 02696)'s self-developed Serplulimab injection. This new approval covers the use of 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).
This regulatory decision means that the newly approved indication for Serplulimab is now authorized across all European Union member states, as well as in Iceland, Liechtenstein, and Norway, which constitute the European Economic Area (EEA).
The approval was primarily based on the positive results from a randomized, double-blind, international multi-center Phase 3 clinical study. The study demonstrated that Serplulimab combined with carboplatin and nab-paclitaxel provided significant clinical benefit as a first-line treatment for unresectable, locally advanced, or metastatic sqNSCLC, meeting the pre-specified primary endpoints while showing a favorable safety and tolerability profile.
In December 2023, the company received several Good Manufacturing Practice (GMP) certificates from the Dutch Health and Youth Care Inspectorate, confirming that the production lines for Serplulimab comply with EU GMP standards. Furthermore, in May 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of this expanded indication.
Serplulimab is an innovative anti-PD-1 monoclonal antibody independently developed by HENLIUS. In mainland China, its approved indications already include first-line treatment of sqNSCLC, extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsNSCLC) in combination with chemotherapy, as well as for neoadjuvant/adjuvant treatment of gastric cancer in combination with chemotherapy. In the EU, its approved indications now cover first-line treatment of sqNSCLC, ES-SCLC, ESCC, and nsNSCLC in combination with chemotherapy.
Additionally, Serplulimab has been approved for marketing in several other countries and regions, including the United Kingdom, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India. It has also been granted Orphan Drug Designation by regulatory authorities in countries such as the United States, Switzerland, and South Korea.
In October 2023, HENLIUS entered into a licensing agreement with Intas Pharmaceuticals Ltd., granting exclusive rights to Intas and its European subsidiary, Accord Healthcare, to commercialize Serplulimab in specified European regions and India.
The company is also systematically advancing multiple global clinical trials for Serplulimab and its combination therapies, covering a broad range of indications including lung cancer, head and neck squamous cell carcinoma, and colorectal cancer.
According to data from IQVIA MIDAS™, a leading provider of information and strategic consulting services for the global pharmaceutical and healthcare industry, the global sales of targeted PD-1 monoclonal antibody drugs reached approximately $50.871 billion in 2025.
The approval of this new indication for Serplulimab in the EU represents further recognition from the international mainstream market, which is expected to enhance the global influence of the company's product and benefit a greater number of patients worldwide.
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