China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced that it has received marketing approval from the European Commission (EC) for its serplulimab, combined with carboplatin and etoposide, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) under the trade name Hetronifly. This approval marks serplulimab as the first and only anti-PD-1 monoclonal antibody (mAb) approved in the EU for the treatment of ES-SCLC.
Approval Based on ASTRUM-005 Study Results
The EC’s approval is based on the results from the ASTRUM-005 study, which enrolled 585 subjects, 31.5% of whom were Caucasian, from 128 centers across China, Poland, Türkiye, Georgia, and other regions. Serplulimab was awarded orphan drug designation (ODD) for small cell lung cancer (SCLC) by the EC in December 2022 and was recommended for approval by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in September of last year.
Global Approvals and Partnerships
Serplulimab has been approved by China’s National Medical Products Administration (NMPA) for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsqNSCLC) since March 2022. The drug was also approved in Indonesia in December 2023 for use in ES-SCLC. In October 2023, exclusive development and commercialization rights to serplulimab were licensed to India-based Intas Pharmaceuticals Ltd. for the territories of Europe and India.-Fineline Info & Tech
