Chinese biopharmaceutical company Shanghai Henlius Biotech Inc (HK:2696) announced on Wednesday that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as Hetronifly in Europe), has been officially approved by the European Commission (EC) for use in combination with carboplatin and etoposide as a first-line treatment for adult patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC).

Henlius said that serplulimab is the world's first anti-PD-1 mAb approved for first-line treatment of ES-SCLC. The company has carried out a differentiated and multi-dimensional layout of serplulimab in the fields of lung cancer and gastrointestinal cancer. To date, more than 4,800 subjects have been enrolled worldwide for clinical trials of serplulimab.

In 2023, Henlius entered into a collaboration with India-based Intas Pharmaceuticals, granting Intas exclusive rights to develop and commercialise serplulimab in over 50 countries across Europe and India.

The recent approval includes all 27 EU member states and the European Economic Area countries, which includes Norway, Iceland and Liechtenstein. Accord Healthcare Ltd, a subsidiary of Intas, leads the commercialisation in Europe.