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PD1 antibody
PD1 antibody is a PD-1 inhibitor Small molecule drug developed by HRYZ Biotech Co.. It is currently in Phase 3 development for Non-small cell lung cancer, PD-L1 positive, Melanoma, Head and neck squamous cell carcinoma. Also known as: SHR-1210, Sintilimab Injection.
PD1 antibody works by binding to the PD-1 receptor on T cells, blocking its interaction with PD-L1 and allowing the immune system to attack cancer cells.
The PD1 antibody is used to treat various conditions, including EBV Infection, Gastric and Esophagogastric Junction Adenocarcinoma, Recurrent Nasopharyngeal Carcinoma, and Unresectable Nasopharyngeal Carcinoma. The PD1 antibody targets the programmed cell death protein 1 (PD-1) to modulate the immune system, although its exact mechanism is not specified.
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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 | PD1 antibody |
|---|---|
| Also known as | SHR-1210, Sintilimab Injection |
| Sponsor | HRYZ Biotech Co. |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This mechanism of action is based on the principle of immune checkpoint inhibition, where the PD-1/PD-L1 pathway is exploited to enhance anti-tumor immunity. By blocking this pathway, PD1 antibody enables the immune system to recognize and target cancer cells more effectively.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
- Melanoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Renal cell carcinoma
- Gastric cancer
- Microsatellite instability-high (MSI-H) solid tumors
- Triple-negative breast cancer
Common side effects
- Pneumonitis
- Hypothyroidism
- Hyperthyroidism
- Diarrhea
- Fatigue
- Nausea
- Rash
- Pruritus
Key clinical trials
- BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia (PHASE1)
- A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (PHASE3)
- A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors) (PHASE1)
- Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma (PHASE2)
- Nivolumab and Ipilimumab in Treating Patients With Rare Tumors (PHASE2)
- Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors (PHASE1)
- A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma (PHASE2)
- Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer (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:
- PD1 antibody CI brief — competitive landscape report
- PD1 antibody updates RSS · CI watch RSS
- HRYZ Biotech Co. portfolio CI
Frequently asked questions about PD1 antibody
What is PD1 antibody?
How does PD1 antibody work?
What is PD1 antibody used for?
Who makes PD1 antibody?
Is PD1 antibody also known as anything else?
What drug class is PD1 antibody in?
What development phase is PD1 antibody in?
What are the side effects of PD1 antibody?
What does PD1 antibody target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: HRYZ Biotech Co. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer, PD-L1 positive
- Indication: Drugs for Melanoma
- Indication: Drugs for Head and neck squamous cell carcinoma
- Also known as: SHR-1210, Sintilimab Injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing