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PD-1 inhibitor
PD-1 inhibitor is a PD-1 inhibitor Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 3 development for Metastatic non-small cell lung cancer, PD-L1 positive, Metastatic melanoma, Renal cell carcinoma. Also known as: Toripalimab, Camrelizumab, Camrelizumab (AiRuiKa™)、Toripalimab、Pembrolizumab(Keytruda), PD-1 immune checkpoint blockades.
PD-1 inhibitors block the PD-1 receptor on T cells, preventing the PD-L1 ligand from inhibiting T cell activation.
PD-1 inhibitors block the PD-1 receptor on T cells, preventing the PD-L1 ligand from inhibiting T cell activation. Used for Metastatic non-small cell lung cancer, PD-L1 positive, Metastatic melanoma, Renal 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 | PD-1 inhibitor |
|---|---|
| Also known as | Toripalimab, Camrelizumab, Camrelizumab (AiRuiKa™)、Toripalimab、Pembrolizumab(Keytruda), PD-1 immune checkpoint blockades, Oxaliplatin |
| Sponsor | Sun Yat-sen University |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This blockade allows T cells to recognize and attack cancer cells more effectively. PD-1 inhibitors have been shown to be effective in various types of cancer, including non-small cell lung cancer, melanoma, and kidney cancer. By blocking the PD-1 receptor, PD-1 inhibitors can enhance the body's immune response against cancer cells.
Approved indications
- Metastatic non-small cell lung cancer, PD-L1 positive
- Metastatic melanoma
- Renal cell carcinoma
Common side effects
- Pneumonitis
- Colitis
- Hypothyroidism
- Hyperthyroidism
- Fatigue
- Diarrhea
- Nausea
- Vomiting
- Rash
- Pruritus
Key clinical trials
- BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia (PHASE1)
- Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (PHASE1)
- Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy (PHASE2)
- Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma (PHASE2)
- Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors (PHASE1)
- A Clinical Study on the Safety, Tolerability and Efficacy of Neoantigen-based Personalized mRNA Therapy iNeo-Vac-R01 Plus PD-1 Inhibitor in Adjuvant Treatment of Liver Cancer Post Radical Resection (PHASE1, PHASE2)
- A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors (PHASE1, PHASE2)
- HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer (NA)
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:
- PD-1 inhibitor CI brief — competitive landscape report
- PD-1 inhibitor updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI
Frequently asked questions about PD-1 inhibitor
What is PD-1 inhibitor?
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What is PD-1 inhibitor used for?
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Is PD-1 inhibitor also known as anything else?
What drug class is PD-1 inhibitor in?
What development phase is PD-1 inhibitor in?
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What does PD-1 inhibitor target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Sun Yat-sen University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic non-small cell lung cancer, PD-L1 positive
- Indication: Drugs for Metastatic melanoma
- Indication: Drugs for Renal cell carcinoma
- Also known as: Toripalimab, Camrelizumab, Camrelizumab (AiRuiKa™)、Toripalimab、Pembrolizumab(Keytruda), PD-1 immune checkpoint blockades, Oxaliplatin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing