Serplulimab
drugOn this page
Also known as HLX-10Hlx10
Summary
Serplulimab (CHEMBL4594550) is a phase-3 clinical-stage antibody (ATC L01FF12) targeting PDCD1; indicated across 22 conditions including neoplasm and small cell lung carcinoma.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Antibody
- ATC class: L01FF12
- Targets: 1 (PDCD1)
- Indications: 22 conditions
- Clinical trials: 124
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4594550 |
| Name | Serplulimab |
| Type | Antibody |
| Max phase | 3 |
| ATC | L01FF12 |
Also known as: HLX-10, Hlx10, HLX10, Serplulimab, SERPLULIMAB
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| PDCD1 | programmed cell death 1 (CD279) | Antagonist | 8.19 | 0% | Q15116 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): PDCD1.
Top Reactome pathways
3 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Co-inhibition by PD-1 | 1 | PDCD1 |
| Potential therapeutics for SARS | 1 | PDCD1 |
| PD-L1(CD274) glycosylation and translocation to plasma membrane | 1 | PDCD1 |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| B cell apoptotic process | 1 |
| adaptive immune response | 1 |
| negative regulation of tolerance induction | 1 |
| negative regulation of T cell mediated immune response to tumor cell | 1 |
| negative regulation of B cell apoptotic process | 1 |
| apoptotic process | 1 |
| humoral immune response | 1 |
| negative regulation of inflammatory response | 1 |
| regulation of immune response | 1 |
| negative regulation of immune response | 1 |
| negative regulation of T cell receptor signaling pathway | 1 |
| negative regulation of T cell activation | 1 |
| positive regulation of T cell apoptotic process | 1 |
| regulatory T cell apoptotic process | 1 |
| immune system process | 1 |
Indications & clinical
Indications
22 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| neoplasm | 3 | MONDO:0005070 | EFO:0000616 |
| small cell lung carcinoma | 3 | MONDO:0008433 | EFO:0000702 |
| non-small cell lung carcinoma | 3 | MONDO:0005233 | EFO:0003060 |
| gastric neoplasm | 3 | MONDO:0021085 | MONDO:0001056 |
| breast neoplasm | 3 | MONDO:0021100 | MONDO:0007254 |
| hepatocellular carcinoma | 3 | MONDO:0007256 | EFO:0000182 |
| esophageal squamous cell carcinoma | 3 | MONDO:0005580 | EFO:0005922 |
| gastric adenocarcinoma | 3 | MONDO:0005036 | EFO:0000503 |
| carcinoma of esophagus | 3 | MONDO:0019086 | EFO:0002916 |
| head and neck squamous cell carcinoma | 2 | MONDO:0010150 | EFO:0000181 |
| colorectal carcinoma | 2 | MONDO:0024331 | EFO:1001951 |
| lung adenocarcinoma | 2 | MONDO:0005061 | EFO:0000571 |
| renal cell carcinoma | 2 | MONDO:0005086 | EFO:0000681 |
| nasopharyngeal neoplasm | 2 | MONDO:0005375 | EFO:0004252 |
| colonic neoplasm | 2 | MONDO:0005401 | MONDO:0021063 |
| malignant pancreatic neoplasm | 2 | MONDO:0009831 | EFO:1000359 |
| adenocarcinoma | 2 | MONDO:0004970 | MONDO:0003219 |
| colorectal neoplasm | 2 | MONDO:0005335 | MONDO:0005575 |
| neuroendocrine carcinoma | 1 | MONDO:0002120 | MONDO:0002120 |
3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 124.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 85 |
| PHASE3 | 13 |
| PHASE1/PHASE2 | 8 |
| PHASE1 | 8 |
| Not specified | 6 |
| PHASE2/PHASE3 | 3 |
| PHASE4 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT07446465 | PHASE4 | NOT_YET_RECRUITING | FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer |
| NCT04301739 | PHASE3 | NOT_YET_RECRUITING | to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC) |
| NCT04547166 | PHASE2/PHASE3 | RECRUITING | A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC) |
| NCT05353257 | PHASE3 | ACTIVE_NOT_RECRUITING | 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 |
| NCT05468489 | PHASE3 | ACTIVE_NOT_RECRUITING | To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC |
| NCT06280495 | PHASE2/PHASE3 | RECRUITING | Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients |
| NCT07113275 | PHASE3 | RECRUITING | A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in Locally Advanced Rectal Cancer |
| NCT07177443 | PHASE3 | NOT_YET_RECRUITING | Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma |
| NCT07277842 | PHASE3 | NOT_YET_RECRUITING | PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal Cancer |
| NCT07318883 | PHASE2/PHASE3 | NOT_YET_RECRUITING | A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer |
| NCT07336953 | PHASE3 | NOT_YET_RECRUITING | 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 Pancreatic Cancer (WGOG-PAN 006/ICSBR-2) |
| NCT03952403 | PHASE3 | UNKNOWN | A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) |
| NCT04033354 | PHASE3 | UNKNOWN | A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC |
| NCT04063163 | PHASE3 | COMPLETED | A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC |
| NCT04139135 | PHASE3 | UNKNOWN | A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer |
| NCT04465734 | PHASE3 | WITHDRAWN | A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC |
| NCT04806945 | PHASE3 | WITHDRAWN | A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer |
| NCT03941574 | PHASE2 | RECRUITING | A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy |
| NCT05239650 | PHASE2 | NOT_YET_RECRUITING | Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC |
| NCT05443646 | PHASE2 | RECRUITING | Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients |
| NCT05513573 | PHASE2 | ACTIVE_NOT_RECRUITING | Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC |
| NCT05585580 | PHASE2 | ACTIVE_NOT_RECRUITING | Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy |
| NCT05659251 | PHASE2 | ACTIVE_NOT_RECRUITING | Serplulimab Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma |
| NCT05731726 | PHASE2 | RECRUITING | Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer |
| NCT05765825 | PHASE2 | ACTIVE_NOT_RECRUITING | Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC |
| NCT05766800 | PHASE2 | RECRUITING | Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer |
| NCT05787613 | PHASE2 | ACTIVE_NOT_RECRUITING | 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 |
| NCT05872685 | PHASE2 | RECRUITING | Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05) |
| NCT05882513 | PHASE2 | ACTIVE_NOT_RECRUITING | Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer |
| NCT05882630 | PHASE1/PHASE2 | NOT_YET_RECRUITING | Surufatinib Combined With Serplulimab Plus Chemotherapy in the Treatment of Extensive-stage Small Cell Lung Cancer |
| NCT05954429 | PHASE2 | RECRUITING | A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study |
| NCT05957510 | PHASE2 | RECRUITING | Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment |
| NCT05975749 | PHASE2 | RECRUITING | Adjuvant Serplulimab and Trastuzuma and Chemotherapy in Her-2+ Gastric Cancer |
| NCT05988372 | PHASE2 | NOT_YET_RECRUITING | Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE) |
| NCT06099951 | PHASE2 | NOT_YET_RECRUITING | Total Neoadjuvant Treatment for pMMR Locally Advanced Low Rectal Cancer: Anti-PD-1 Antibody With FOLFOXIRI and Preoperative Radiation Therapy |
| NCT06295926 | PHASE2 | RECRUITING | Serplulimab Combined With CCRT for LS-SCLC. |
| NCT06349980 | PHASE2 | RECRUITING | 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. |
| NCT06354218 | PHASE2 | RECRUITING | Serplulimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age |
| NCT06368141 | PHASE2 | RECRUITING | Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer |
| NCT06394661 | PHASE2 | ACTIVE_NOT_RECRUITING | Serplulimab Plus Chemotherapy for Early-stage HR+/HER2- Breast Cancer |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.
4 molecules share ≥1 primary target. Top 4 by shared-target count:
| Molecule | Source | Status | Shared targets |
|---|---|---|---|
| PYRVINIUM | ChEMBL | Phase 4 (approved) | PDCD1 |
| RIFABUTIN | ChEMBL | Phase 4 (approved) | PDCD1 |
| Gefitinib | PubChem | Approved | PDCD1 |
| Pomalidomide | PubChem | Approved | PDCD1 |