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PD-1 blocking antibody
PD-1 blocking antibody is a PD-1 inhibitor Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 3 development for Advanced or metastatic solid tumors (specific indications under investigation in Phase 3). Also known as: JS001, irradiation, PD-1 Blockade, PD-1 blockade.
This drug blocks the PD-1 checkpoint protein on immune cells, allowing them to recognize and attack cancer cells.
Pembrolizumab is a PD-1 blocking antibody used to treat various types of cancer, including pleural mesothelioma, breast cancer, and angiosarcoma. It is administered as a small molecule intervention, typically in combination with other treatments such as gemcitabine and vinorelbine.
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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 blocking antibody |
|---|---|
| Also known as | JS001, irradiation, PD-1 Blockade, PD-1 blockade, Camrelizumab |
| 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
PD-1 is an inhibitory receptor on T cells that cancer cells exploit to evade immune detection by engaging its ligands (PD-L1/PD-L2). By blocking PD-1 with a monoclonal antibody, the drug releases the 'brakes' on the immune system, restoring T cell activation, proliferation, and anti-tumor cytotoxicity. This mechanism has proven effective across multiple solid and hematologic malignancies.
Approved indications
- Advanced or metastatic solid tumors (specific indications under investigation in Phase 3)
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Immune-related pneumonitis
- Immune-related hepatitis
- Rash
- Decreased appetite
Key clinical trials
- Nivolumab and Ipilimumab in Treating Patients With Rare Tumors (PHASE2)
- A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma (PHASE2)
- BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia (PHASE2)
- Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma (PHASE2)
- Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma (PHASE2)
- Neoadjuvant Sacituzumab Govitecan Plus Tagitanlimab for Resectable Head and Neck Squamous Cell Carcinoma (PHASE2)
- Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis (PHASE1, PHASE2)
- Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma (PHASE2)
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 blocking antibody CI brief — competitive landscape report
- PD-1 blocking antibody updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI
Frequently asked questions about PD-1 blocking antibody
What is PD-1 blocking antibody?
How does PD-1 blocking antibody work?
What is PD-1 blocking antibody used for?
Who makes PD-1 blocking antibody?
Is PD-1 blocking antibody also known as anything else?
What drug class is PD-1 blocking antibody in?
What development phase is PD-1 blocking antibody in?
What are the side effects of PD-1 blocking antibody?
What does PD-1 blocking antibody 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 Advanced or metastatic solid tumors (specific indications under investigation in Phase 3)
- Also known as: JS001, irradiation, PD-1 Blockade, PD-1 blockade, Camrelizumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing