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US-sourced Keytruda®
Keytruda is a monoclonal antibody that blocks the PD-1 receptor, preventing cancer cells from evading the immune system.
At a glance
| Generic name | US-sourced Keytruda® |
|---|---|
| Also known as | pembrolizumab |
| Sponsor | Shanghai Henlius Biotech |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
By binding to PD-1, Keytruda prevents the PD-1/PD-L1 interaction, allowing the immune system to recognize and attack cancer cells. This mechanism is known as immune checkpoint inhibition.
Approved indications
Common side effects
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 Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors (PHASE1)
- 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)
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:
- US-sourced Keytruda® CI brief — competitive landscape report
- US-sourced Keytruda® updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI