On 5 February 2025, Shanghai Henlius Biotech announced that Hetronifly® (serplulimab) was approved by the European Commission for use in combination with carboplatin and etoposide as a first line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Hetronifly® is the first and only anti-PD-1 mAb approved in the European Union for ES-SCLC.
Hetronifly® received a positive opinion from the European Medicine Agency’s CHMP for ES-SCLC in September 2024. In December 2022, serplulimab received orphan drug designation from the EC for the treatment of SCLC. Henlius previously launched serplulimab as HANSIZHUANG® in certain Asian countries, including China.
Henlius entered an agreement with Intas Pharmaceuticals in October 2023, under which Intas received exclusive rights to develop and commercialise serplulimab in over 50 countries across Europe and India. Hetronifly® will be commercialised in Europe by Intas subsidiary Accord Healthcare.