Back to discover
Drug

Serplulimab

Approved · EMA
Late-stage development

Also known as Immunoglobulin g4 (228-proline), anti-(human programmed cell death protein 1) (human-mus musculus monoclonal hlx10 .gamma.4-chain), disulfide with human-mus musculus monoclonal hlx10 .kappa.-chain, dimer.

RxNorm2629256UNIIS3GQZ2K36V
53
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Prospective, Randomized, Phase II, Multicenter Clinical Study of Serplulimab Combined with First-Line Targeted Therapy and Chemotherapy with or Without Radiation in the First-Line Treatment of Advanced Colorectal Cancer

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC

Clinical trial2026-07-10Primary completion · ClinicalTrials.gov

A Prospective Exploratory Study of a HIPEC Priming Strategy Followed by Serplulimab Combined With SOX/XELOX as Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Clinical trial2026-07-07Results expected Q2 2028 · ClinicalTrials.gov

Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: an Exploratory Phase II Single-arm Clinical Study

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Evaluation of Safety and Efficacy of Serplulimab Plus Chemotherapy in Patients With Histological Transformation From EGFR-mutated NSCLC to SCLC After Treatment: a Single-arm, Multicenter, Open-label Phase II Study

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Prospective, Multicentre, Double-blind Randomized Controlled Clinical Study of the Efficacy and Safety of Taurine Combined With Serplulimab and Chemotherapy Versus Serplulimab Combined With Chemotherapy for Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Clinical trial2026-06-09Results expected Q2 2027 · ClinicalTrials.gov

An Exploratory Study of Maintenance Lurbinectedin in Combination With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer

Clinical trial2026-06-08Results expected Q4 2026 · ClinicalTrials.gov

Multicenter, Single-arm, Phase II Exploratory Study of Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50%

Clinical trial2026-05-31Primary completion · ClinicalTrials.gov

A Phase II, Prospective, Randomized Study of Serplulimab Plus Second-Line Chemotherapy and Targeted Therapy vs Second-Line Chemotherapy and Targeted Therapy Alone in Patients With Early Relapse of Colorectal Cancer After Adjuvant Chemotherapy

Clinical trial2026-05-22Results expected Q3 2027 · ClinicalTrials.gov

Comparison of Teniposide, Cisplatin and Serplulimab Regimen With Etoposide, Cisplatin and Serplulimab Regimen for Treatment of Extensive Stage Small Lung Cancer, a Random, Open Label, Positive Control, Multicenter Study

Clinical trial2026-05-13Results expected Q2 2027 · ClinicalTrials.gov

NEOadjuvant SERplulimab Plus Weekly PaclitaxEl and carboplatiN in Triple-negative Breast Cancer: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Trial

Clinical trial2026-05-13Results expected Q4 2026 · ClinicalTrials.gov

Approval: Hetronifly (EMA)

Regulatory2025-02-03EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Serplulimab
Aliases & brands
Immunoglobulin g4 (228-proline), anti-(human programmed cell death protein 1) (human-mus musculus monoclonal hlx10 .gamma.4-chain), disulfide with human-mus musculus monoclonal hlx10 .kappa.-chain, dimer
RxNorm CUI
2629256
UNII
S3GQZ2K36V
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2025-02-03
Latest approval
2025-02-03
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2025-02-03Approval
Approval: Hetronifly (EMA)
Indication: Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is indicated for the first‑line treatment of adult patients with extensive‑stage small cell… Show full indication

Small cell lung cancer (SCLC) Hetronifly in combination with carboplatin and etoposide is indicated for the first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC). Non-small cell lung carcinoma (NSCLC) Hetronifly in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations and who have: locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC. Oesophageal squamous cell carcinoma (OSCC) Hetronifly in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

64 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
64
registered trials across all phases
53
Active studies
49
Recruiting
9
Late-stage (III+)
11
Discontinued
PHASE DISTRIBUTIONn = 64
Phase 13Phase 1 / 24Phase 248Phase 2 / 32Phase 33Phase 41Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Exploratory Clinical Study of FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer

Not yet recruitingPH IVYe Xun=422027

Induction Chemotherapy Combined With Serplulimab Induction/Maintenance Therapy and Omission of Concurrent Chemotherapy in Locally Advanced Nasopharyngeal Carcinoma (UNION-NPC-001): A Multicenter, Open-Label, Randomized, Controlled, Phase III, Non-Inferiority Clinical Trial

Not yet recruitingPH IIIUnion Hospital, Tongji Medical College, Huazhong University of Science and Technologyn=4562031

A Randomized, Double-Blind, Multicenter, Phase II/III Clinical Study to Evaluate HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Patients With Advanced Squamous Non-Small Cell Lung Cancer (sqNSCLC)

Not yet recruitingPH II/IIIShanghai Henlius Biotechn=7202031

Neoadjuvant Combination of Serplulimab and Bevacizumab With FOLFOX Versus FOLFOX Alone for Resectable Liver Metastases in RAS/BRAF Wild-Type, pMMR/MSS Colorectal Cancer Patients

RecruitingPH II/IIISun Yat-sen Universityn=1562029

A Multicenter, Prospective, Phase III Randomized Controlled Trial of PD-1 Antibody Plus FOLFOXIRI Combined With Radiotherapy Versus CAPOX Combined With Radiotherapy as Total Neoadjuvant Therapy for pMMR Locally Advanced Low Rectal Cancer

Not yet recruitingPH IIISun Yat-sen Universityn=3822028
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.