Henlius Biotech Receives Approval for Serplulimab in Extensive-Stage Small Cell Lung Cancer Treatment
Thursday, February 06, 2025
Henlius Biotech received approval from the European Commission (EC) for its anti-PD-1 monoclonal antibody (mAb), HANSIZHUANG (serplulimab), marketed in Europe as Hetronifly®.
Lung cancer remains the leading cause of cancer-related deaths worldwide. According to GLOBOCAN 2022, over 2.48 million new cases were recorded globally, representing 12.4% of all new cancer diagnoses.
Small cell lung cancer (SCLC) accounts for 15% to 20% of all lung cancers and is known for its aggressive nature, early metastasis, and poor prognosis. Around 30% to 40% of patients are diagnosed at a limited stage, with the remainder at an extensive stage.
The treatment is authorised for use in combination with carboplatin and etoposide as a first-line option for adults with extensive-stage small cell lung cancer (ES-SCLC). This approval makes serplulimab the first and only anti-PD-1 mAb available in the EU for this indication.
Serplulimab is also the first anti-PD-1 mAb globally to be approved for first-line treatment of ES-SCLC. Henlius has focused on developing serplulimab for lung and gastrointestinal cancers. Clinical trials have involved over 4,800 participants worldwide.
In 2023, Henlius partnered with Intas Pharmaceuticals, granting exclusive development and commercialisation rights for serplulimab across more than 50 countries, including those in Europe and India.
The latest approval extends to all 27 EU member states and the European Economic Area (EEA), which includes Norway, Iceland, and Liechtenstein. Commercialisation in Europe will be managed by Intas’ subsidiary, Accord Healthcare Ltd.
In September 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended serplulimab for approval in the EU. The EC’s decision is based on findings from the ASTRUM-005 study, a Phase 3 clinical trial assessing the efficacy and safety of serplulimab combined with chemotherapy compared to chemotherapy alone.
Following the approval in China, Southeast Asia, and now the EU, serplulimab has become the world’s first anti-PD-1 mAb to receive authorisation for first-line treatment of ES-SCLC.
Henlius is also conducting a comparative clinical trial in the United States, evaluating serplulimab against atezolizumab, the current standard of care, to support a future regulatory submission in the U.S.
Source: henlius.com
