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HLX10
HLX10 is a PD-L1 inhibitor Small molecule drug developed by Shanghai Henlius Biotech. It is currently in Phase 3 development for Non-small cell lung cancer, Gastric cancer, Esophageal cancer. Also known as: Recombinant humanized anti-PD-1 monoclonal antibody injection, Serplulimab, Anti-PD-1 Humanized Monoclonal Antibody, SERPLULIMAB.
HLX10 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.
Serplulimab, also known as HLX10, is an antibody that targets the programmed cell death protein 1 (PD-1) as an antagonist. It is being studied in clinical trials for various types of cancer, including small cell lung cancer, squamous non-small cell lung cancer, and esophageal squamous cell carcinoma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | HLX10 |
|---|---|
| Also known as | Recombinant humanized anti-PD-1 monoclonal antibody injection, Serplulimab, Anti-PD-1 Humanized Monoclonal Antibody, SERPLULIMAB, anti-PD-1 monoclonal antibody |
| Sponsor | Shanghai Henlius Biotech |
| Drug class | PD-L1 inhibitor |
| Target | PD-L1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
HLX10 targets programmed death ligand 1 (PD-L1) on tumor cells and immune cells, preventing the PD-L1/PD-1 interaction that normally suppresses T-cell activation. By blocking this immune checkpoint, the drug allows cytotoxic T lymphocytes to recognize and attack cancer cells more effectively. This mechanism is used across multiple solid tumors where PD-L1 expression is associated with immune evasion.
Approved indications
- Non-small cell lung cancer
- Gastric cancer
- Esophageal cancer
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
Key clinical trials
- Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer. (PHASE2)
- Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC (PHASE2)
- Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer (PHASE2)
- A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (PHASE2)
- 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 High-Risk Locally Advanced Rectal Cancer (PHASE3)
- A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC (PHASE2)
- 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 (PHASE2)
- 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 (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- HLX10 CI brief — competitive landscape report
- HLX10 updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI
Frequently asked questions about HLX10
What is HLX10?
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Related
- Drug class: All PD-L1 inhibitor drugs
- Target: All drugs targeting PD-L1
- Manufacturer: Shanghai Henlius Biotech — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Gastric cancer
- Indication: Drugs for Esophageal cancer
- Also known as: Recombinant humanized anti-PD-1 monoclonal antibody injection, Serplulimab, Anti-PD-1 Humanized Monoclonal Antibody, SERPLULIMAB, anti-PD-1 monoclonal antibody
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing