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GR1501 high dose
GR1501 high dose is a PD-1 inhibitor Biologic drug developed by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer, PD-L1 positive.
GR1501 high dose is a small molecule that targets the PD-1 receptor.
GR1501 high dose is a small molecule that targets the PD-1 receptor. Used for Non-small cell lung cancer, PD-L1 positive.
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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 | GR1501 high dose |
|---|---|
| Sponsor | Genrix (Shanghai) Biopharmaceutical Co., Ltd. |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By binding to the PD-1 receptor, GR1501 high dose blocks the interaction with its ligand PD-L1, leading to the activation of T cells and enhanced anti-tumor immune response.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
Common side effects
- Pneumonitis
- Hypothyroidism
- Diarrhea
Key clinical trials
- Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis (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:
- GR1501 high dose CI brief — competitive landscape report
- GR1501 high dose updates RSS · CI watch RSS
- Genrix (Shanghai) Biopharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about GR1501 high dose
What is GR1501 high dose?
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Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Genrix (Shanghai) Biopharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer, PD-L1 positive
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing