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Synonyms: HANSIZHUANG® (China) | Hetronifly® | HLX-10 | HLX10
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.
Ligand Activity Visualisation ChartsThese 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. ✖ |
| No information available. |
Summary of Clinical Use  |
| 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 |
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For extended ADME data see the following: European Medicines Agency (EMA) |
