Serplulimab

Serplulimab, sold under the brand name Hetronifly, is a monoclonal antibody used for the treatment of cancers.^[1][3]

Serplulimab

Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	PD-1
Clinical data
Trade names	Hetronifly
Other names	HLX10
Routes of administration	Intravenous
Drug class	Antineoplastic agent
ATC code	L01FF12 (WHO)
Legal status
Legal status	EU: Rx-only[1][2] CN: Rx-only
Identifiers
CAS Number	2231029-82-4
DrugBank	DB17451
UNII	S3GQZ2K36V
KEGG	D12751

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.^[1]

Society and culture

Legal status

It was approved for medical use in China in 2022, for the treatment of microsatellite instability-high solid tumors^[3] and squamous non-small cell lung cancer,^[4] and in 2023 for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma.^[5]

In December 2023, the Indonesian Food and Drug Authority approved serplulimab for medical use in Indonesia.^[6]

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 (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]

Names

Serplulimab is the International nonproprietary name.^[7]