| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (frommouse) |
| Target | PD-1 |
| Clinical data | |
| Trade names | Hetronifly |
| Other names | HLX10 |
| Routes of administration | Intravenous |
| Drug class | Antineoplastic agent |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
Serplulimab, sold under the brand nameHetronifly, is amonoclonal antibody used for the treatment ofcancers.[1][3]
Serplulimab, in combination withcarboplatin andetoposide, isindicated for the first-line treatment of adults with extensive-stage small cell lung cancer.[1]
It was approved for medical use in China in 2022, for the treatment of microsatellite instability-highsolid tumors[3] and squamousnon-small cell lung cancer,[4] and in 2023 for the treatment of extensive-stagesmall cell lung cancer (ES-SCLC) andesophageal squamous cell carcinoma.[5]
In December 2023, theIndonesian Food and Drug Authority approved serplulimab for medical use in Indonesia.[6]
In September 2024, theCommittee for Medicinal Products for Human Use of theEuropean 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 (ES-SCLC).[1] The applicant for this medicinal product is Henlius Europe GmbH.[1] Serplulimab was authorized for medical use in the European Union in February 2025.[1][2]
Serplulimab is theInternational nonproprietary name.[7]
