serplulimab   Click here for help

GtoPdb Ligand ID: 13796

Synonyms: HANSIZHUANG® (China) | Hetronifly® | HLX-10 | HLX10
Approved drug Immunopharmacology Ligand
serplulimab is an approved drug
Compound class: Antibody
Comment: Serplulimab (HLX10) is a humanized IgG4 anti-programmed cell death 1 (PD-1) monoclonal antibody [1]. It is designed to block the inhibitory PD-1/PD-L1/2 immune checkpoint and restore T cell-mediated anti-tumour immunity.
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Ligand Activity Visualisation Charts

These are box plot that provide a unique visualisation, summarising all the activity data for a ligand taken from ChEMBL and GtoPdb across multiple targets and species. Click on a plot to see the median, interquartile range, low and high data points. A value of zero indicates that no data are available. A separate chart is created for each target, and where possible the algorithm tries to merge ChEMBL and GtoPdb targets by matching them on name and UniProt accession, for each available species. However, please note that inconsistency in naming of targets may lead to data for the same target being reported across multiple charts.

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View interactive charts of activity data across species
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Summary of Clinical Use Click here for help
The EMA and FDA granted serplulimab (as Hetronifly®) orphan drug designation as first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC). Under these conditions serplulimab is used in combination with the chemotherapy drugs carboplatin and etoposide. By December 2024, the Chinese drug regulator (NMPA) had approved serplulimab to treat several solid tumour types, including ES-SCLC, squamous NSCLC, and esophageal squamous cell carcinoma (ESCC). The EMA issued full approval for the ES-SCLC indication in February 2025.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT06334757 Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure Phase 2 Interventional Henan Cancer Hospital
NCT06368141 Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer Phase 2 Interventional Ruijin Hospital
NCT06812260 A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients with ES-SCLC Phase 2 Interventional Shanghai Henlius Biotech
NCT05353257 A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer Phase 3 Interventional Shanghai Henlius Biotech
NCT05221658 A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC Phase 2 Interventional Shanghai Henlius Biotech
External links Click here for help
For extended ADME data see the following:

European Medicines Agency (EMA)