Serplulimab clinical trials
Serplulimab is named as an intervention in 84 current clinical trials in our China, Japan, USA, Spain, Egypt, Germany, Netherlands, Poland, Austria, Czechia and South Korea registers. 47 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Shanghai Henlius Biotech (14). The most-studied condition is Gastric Cancer.
Where Serplulimab is approved
All regulators →Of the three regulators tracked here, the first to approve Serplulimab was the EU, on 3 Feb 2025.
- 1 EU orphan designation, most recently for treatment of small cell lung cancer (20 Feb 2025, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
How Serplulimab works
All drug targets →- Programmed cell death protein 1 antagonist AntagonistTarget: PDCD1 programmed cell death 1✓ In ChEMBL and the Guide to Pharmacology
- Breast cancerPhase 3
- Cervical cancerPhase 3
- Gastric cancerPhase 3
- Hepatocellular carcinomaPhase 3
- Malignant pancreatic neoplasmPhase 3
- Nasopharyngeal carcinomaPhase 3
- Pancreatic ductal adenocarcinomaPhase 3
- Pancreatic neoplasmPhase 3
- Rectal cancerPhase 3
- Colorectal adenocarcinomaPhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4594550, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 13796, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Serplulimab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Serplulimab. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Serplulimab with carboplatin and etoposide for untreated extensive-stage small-cell lung cancer NICE TA1167 | Recommended | 18 Jun 2026 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Serplulimab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: HetroniflyEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Serplulimab
84 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Serplulimab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Serplulimab on the HPRA medicines list.
- HETRONIFLY 10 mg/ml concentrate for solution for infusionAccord Healthcare S.L.U. · EU/1/24/1870/001
Supply shortages
No entry for Serplulimab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Serplulimab
108 conditionsAll 108 conditions
| Condition (as registered) | Trials |
|---|---|
| Gastric Cancer | 4 |
| Immunotherapy | 4 |
| Small Cell Lung Cancer | 3 |
| Colorectal Cancer | 3 |
| Non Small Cell Lung Cancer | 3 |
| pMMR | 3 |
| Non-small Cell Lung Cancer | 2 |
| Biliary Tract Cancer | 2 |
| Neoadjuvant Therapy | 2 |
| Breast Cancer | 2 |
| Gastric Adenocarcinoma | 2 |
| Small-cell Lung Cancer | 2 |
| Rectal Cancer | 2 |
| Cervical Cancer | 2 |
| SCLC, Extensive Stage | 2 |
| MSS | 2 |
| Neurofibromatosis Type 2 | 2 |
| Vestibular Schwannoma | 2 |
| Advanced Solid Tumor | 2 |
| Tumor Associated Lymph Node T Cell | 2 |
| Extensive Stage Small Cell Lung Cancer | 1 |
| Advanced/Metastatic Malignant Solid Tumors | 1 |
| Limited-Stage Small Cell Lung Cancer | 1 |
| Urothelial Carcinoma | 1 |
| HER2 | 1 |
| Cervical Cancers | 1 |
| NSCLC | 1 |
| Advanced Gastric or Gastroesophageal Junction Adenocarcinoma | 1 |
| Locally Advanced Colorectal Cancer | 1 |
| Colorectal Adenocarcinoma | 1 |
| Extensive-stage Small-cell Lung Cancer | 1 |
| Locally Advanced Nasopharyngeal Carcinoma | 1 |
| Locally Advanced Low Rectal Adenocarcinoma | 1 |
| pMMR (Microsatellite Stable Rectal Cancer) | 1 |
| Relapse | 1 |
| Locally Advanced Gastric Cancer | 1 |
| Gastroesophageal Junction Adenocarcinoma | 1 |
| Non-Clear Cell Renal Cell Carcinoma | 1 |
| Carcinoma, Hepatocellular | 1 |
| Esophageal Squamous Cell Carcinoma (ESCC) | 1 |
| Moderately Hypofractionated Radiotherapy | 1 |
| Serplulimab | 1 |
| pMMR/MSS | 1 |
| Stomach Neoplasms | 1 |
| Immune Checkpoint Inhibitors | 1 |
| Triple Negative Breast Cancer | 1 |
| Locally Advanced | 1 |
| Resectable Esophageal Squamous Cell Carcinoma | 1 |
| Early Lung Cancer | 1 |
| Unresectable Colon Cancer Peritoneal Metastases | 1 |
| PMMR/Ras/BRAF Wild-type | 1 |
| Liver Metastases | 1 |
| Non-clear Cell Renal Cell Carcinoma | 1 |
| Refractory Pancreatic Ductal Adenocarcinoma | 1 |
| Refractory Pancreatic Adenocarcinoma | 1 |
| Esophageal Squamous Cell Carcinoma | 1 |
| Esophagogastric Junction Adenocarcinoma | 1 |
| Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast Cancer | 1 |
| MSI-L | 1 |
| Locally Advanced Rectal Carcinoma | 1 |
| Solid Tumor Cancer | 1 |
| Gastric Neoplasms | 1 |
| Resectable Stage II-IIIa Squamous NSCLC | 1 |
| Metastatic Colorectal Cancer (CRC) | 1 |
| Locally Advanced Rectal Cancer | 1 |
| Squamous NSCLC | 1 |
| Locally Advanced Colon Cancer | 1 |
| Colon Cancer | 1 |
| NSCLC (Non-small Cell Lung Cancer) | 1 |
| Extensive-Stage Small Cell Lung Cancer | 1 |
| HR+/HER2- Breast Cancer | 1 |
| Rectal Neoplasms | 1 |
| Rectal Adenocarcinoma | 1 |
| Gastric Cancer Stage III | 1 |
| NSCLC Stage IV | 1 |
| Metastatic Colorectal Cancer | 1 |
| Colorectal Cancer (Locally Advanced or Metastatic) | 1 |
| Colorectal Cancer Microsatellite Stable (MSS) | 1 |
| NF2-related Schwannomatosis | 1 |
| NF2 | 1 |
| Colorectal Carcinoma | 1 |
| Oligometastases | 1 |
| Esophageal Carcinoma | 1 |
| Malignant Ascites | 1 |
| Advanced Solid Tumors | 1 |
| Serplulimab Injection | 1 |
| Rectal Cancer Patients | 1 |
| Locally Advanced Rectal Cancer (LARC) | 1 |
| ESCC | 1 |
| Pancreas Cancer | 1 |
| Stage III Gastric Cancer | 1 |
| Colon Cancer Adenocarcinoma | 1 |
| Breast Cancer Invasive | 1 |
| Advanced Colorectal Carcinoma | 1 |
| Non-vestibular Schwannoma | 1 |
| Meningioma | 1 |
| Adenocarcinoma of the Stomach | 1 |
| Adenocarcinoma of Esophagogastric Junction | 1 |
| Proficient Mismatch Repair | 1 |
| Gastroesophageal Junction (GEJ) Adenocarcinoma | 1 |
| Carcinoma of Head and/or Neck | 1 |
| Total Neoadjuvant Therapy | 1 |
| Radiotherapy | 1 |
| Breast Cancer (Triple Negative Breast Cancer (TNBC)) | 1 |
| ICC | 1 |
| Nasopharangeal Cancer | 1 |
| Unresectable Locally Recurrent Rectal Cancer | 1 |
| Metastatic Triple-Negative Breast Carcinoma | 1 |
Sponsors
lead sponsor per trial+ 27 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Serplulimab trials
How many clinical trials are testing Serplulimab?
84 current trials in our China, Japan, USA, Spain, Egypt, Germany, Netherlands, Poland, Austria, Czechia and South Korea registers name Serplulimab (also registered as HLX10) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Serplulimab trials recruiting patients?
Yes. 47 of the 84 trials are recruiting: 45 with sites in China, 2 with sites in Japan, 1 with sites in Spain and 1 with sites in South Korea. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Serplulimab clinical trials?
Shanghai Henlius Biotech (14), Fudan University (8), Sun Yat-sen University (6) and Tianjin Medical University Cancer Institute and Hospital (4), among 42 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Serplulimab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Serplulimab, for example HETRONIFLY 10 mg/ml concentrate for solution for infusion (Accord Healthcare S.L.U.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Serplulimab shortage?
Not in the lists we track: Serplulimab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Serplulimab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Serplulimab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Serplulimab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.