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EU-sourced Keytruda®
Keytruda (pembrolizumab) is a monoclonal antibody that blocks the PD-1 checkpoint protein on immune cells, allowing them to recognize and attack cancer cells.
Keytruda (pembrolizumab) is a monoclonal antibody that blocks the PD-1 checkpoint protein on immune cells, allowing them to recognize and attack cancer cells. Used for Metastatic melanoma, Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma.
At a glance
| Generic name | EU-sourced Keytruda® |
|---|---|
| Sponsor | Shanghai Henlius Biotech |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pembrolizumab binds to programmed death receptor-1 (PD-1) on T cells, preventing interaction with its ligands (PD-L1 and PD-L2) expressed on tumor cells and immune cells. This blockade restores anti-tumor immune responses by reinvigorating exhausted T cells. The mechanism enables the immune system to mount a sustained attack against malignant cells that would otherwise evade immune surveillance.
Approved indications
- Metastatic melanoma
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma
- Hodgkin lymphoma
- Urothelial carcinoma
- Gastric cancer
- Cervical cancer
- Renal cell carcinoma
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Decreased appetite
- Immune-mediated pneumonitis
- Immune-mediated colitis
- Immune-mediated hepatitis
- Immune-mediated thyroiditis
- Rash
Key clinical trials
- A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study) (PHASE3)
- A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer (PHASE3)
- Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects (PHASE1)
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:
- EU-sourced Keytruda® CI brief — competitive landscape report
- EU-sourced Keytruda® updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI