# Serplulimab

Source: https://onco.cc/drugs/serplulimab/  
OnCo record `serplulimab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Serplulimab is a Chinese PD-1 antibody with the largest survival gain of any first-line small-cell lung cancer immunotherapy trial, approved in China, Europe, and the UK but not yet the US.

## Summary

Serplulimab is a humanised IgG4 antibody against PD-1, given at 4.5 mg/kg every 3 weeks with carboplatin-etoposide and then as maintenance for up to 2 years. In ASTRUM-005 it produced OS 15.4 versus 10.9 months (HR 0.63) in extensive-stage SCLC, the largest survival gain among the first-line chemo-immunotherapy trials. It is approved in China (2022, the first PD-1 antibody for ES-SCLC), the EU (2025), the UK, India and Korea; Henlius develops it with Accord in Europe. In the US a bridging trial versus atezolizumab (ASTRIDE) has fully enrolled and the FDA decision is pending. Immune-related adverse events occurred in 37% of patients, with hypothyroidism in 12% and pneumonitis in 4%. It is a PD-1 drug whose data match or exceed the established Western options, but whose reach still depends on regulators outside China.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Hansizhuang / Hetronifly
- Code: HLX10
- Modality: Monoclonal antibody (anti-PD-1)
- Mechanism: Humanised IgG4 anti-PD-1.
- Approvals: China 2022: First-line ES-SCLC with chemotherapy; EU 2025: First-line ES-SCLC with carboplatin-etoposide; England (NICE) 2026: Untreated extensive-stage small-cell lung cancer, with carboplatin and etoposide
- Dosing: Intravenous; 4.5 mg/kg every 3 weeks with carboplatin-etoposide, then maintenance until progression or 2 years

## Sources

- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Serplulimab
- NICE TA1167: serplulimab with carboplatin and etoposide for untreated extensive-stage small-cell lung cancer: https://www.nice.org.uk/guidance/ta1167

## Connected records

- cancers: [Extensive-stage small-cell lung cancer](https://onco.cc/cancers/extensive-stage-sclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- companies: [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/)
- terms: [Limited-stage vs extensive-stage (small-cell lung cancer)](https://onco.cc/terms/limited-extensive-stage/), [Lung cancer drugs in England: what NICE has recommended](https://onco.cc/terms/lung-uk-drug-access/)
- trials: [16-Hour Fasting Plus Serplulimab and CAPEOX as Neoadjuvant Therapy in pMMR/MSS Advanced Mid-to-Low Rectal Cancer](https://onco.cc/trials/nct07779694/), [A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Meta](https://onco.cc/trials/nct04547166/), [A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients](https://onco.cc/trials/nct05787613/), [A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course R](https://onco.cc/trials/nct07113275/), [A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors](https://onco.cc/trials/nct06848699/), [A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer](https://onco.cc/trials/nct07358585/), [A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer](https://onco.cc/trials/nct07253142/), [A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy](https://onco.cc/trials/nct07604909/), [A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC](https://onco.cc/trials/nct07269782/), [A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab](https://onco.cc/trials/nct07318883/), [A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic P](https://onco.cc/trials/nct07336953/), [A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemot](https://onco.cc/trials/nct07543848/), [A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage](https://onco.cc/trials/nct05353257/), [A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.](https://onco.cc/trials/nct06349980/), [A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-cente](https://onco.cc/trials/nct05954429/), [ASTRUM-005](https://onco.cc/trials/astrum-005/), [JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment Failure](https://onco.cc/trials/nct07175389/), [Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MSS Locally Advanced Rectal Cancer (SERRAC](https://onco.cc/trials/nct07150949/), [Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer](https://onco.cc/trials/nct06368141/), [Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)](https://onco.cc/trials/nct07381400/), [Neoadjuvant Moderately Hypofractionated Radiotherapy Combined With Chemotherapy and Immunotherapy for High-risk pMMR/MSS Locally Advanced Rectal Cancer: A Prosp](https://onco.cc/trials/nct07527520/), [Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients](https://onco.cc/trials/nct06280495/), [Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)](https://onco.cc/trials/nct07283692/), [Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer (SMARTi-RC01)](https://onco.cc/trials/nct07134101/), [PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal Cancer](https://onco.cc/trials/nct07277842/), [Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC](https://onco.cc/trials/nct05239650/), [Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Br](https://onco.cc/trials/nct07487519/), [Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal Cancer](https://onco.cc/trials/nct06521866/), [SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases](https://onco.cc/trials/nct06850103/), [Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer](https://onco.cc/trials/nct05731726/), [Serplulimab Combined With CAPOX and Bevacizumab as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer](https://onco.cc/trials/nct07819604/), [Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy, HLX07and Serplulimab in LARC](https://onco.cc/trials/nct06542588/), [Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE)](https://onco.cc/trials/nct05988372/), [Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation](https://onco.cc/trials/nct06531291/), [Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study](https://onco.cc/trials/nct07583511/), [to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versu](https://onco.cc/trials/nct04301739/), [To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC](https://onco.cc/trials/nct05468489/), [Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy](https://onco.cc/trials/nct07506057/)
- people: [Ying Cheng](https://onco.cc/people/cheng-ying/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- institutions: [Jilin Cancer Hospital](https://onco.cc/institutions/jilin-cancer-hospital/)
- pathways: [Small cell lung cancer (KEGG map)](https://onco.cc/pathways/sclc-signalling/)

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JSON: https://onco.cc/api/v1/entities/serplulimab.json