Serplulimab

Serplulimab, sold under the brand name Hetronifly, is a monoclonal antibody used for the treatment of cancers.

Medical uses

Serplulimab, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer.

It was approved for medical use in China in 2022, for the treatment of microsatellite instability-high solid tumors and squamous non-small cell lung cancer, and in 2023 for the treatment of extensive-stage small cell lung cancer and esophageal squamous cell carcinoma.
In December 2023, the Indonesian Food and Drug Authority approved serplulimab for medical use in Indonesia.
In September 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Hetronifly, intended for the treatment of extensive-stage small cell lung cancer. The applicant for this medicinal product is Henlius Europe GmbH. Serplulimab was authorized for medical use in the European Union in February 2025.