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GB224 10mg
GB224 10mg is a Biologic drug developed by Genor Biopharma Co., Ltd.. It is currently in Phase 1 development. Also known as: Gerilimzumab injection, Methotrexate (MTX).
GB224 10mg is being studied in a clinical trial for the treatment of Rheumatoid Arthritis. The study, NCT04179513, is a Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetics of GB224 in patients with Rheumatoid Arthritis.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | GB224 10mg |
|---|---|
| Also known as | Gerilimzumab injection, Methotrexate (MTX) |
| Sponsor | Genor Biopharma Co., Ltd. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Phase Ⅰ Clinical Trial of Gerilimzumab Injection in Healthy Subjects (PHASE1)
- A Study to Evaluate the Safety and Tolerability of Multiple Doses of Gerilimzumab in Rheumatoid Arthritis Patients (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:
- GB224 10mg CI brief — competitive landscape report
- GB224 10mg updates RSS · CI watch RSS
- Genor Biopharma Co., Ltd. portfolio CI
Frequently asked questions about GB224 10mg
What is GB224 10mg?
Who makes GB224 10mg?
Is GB224 10mg also known as anything else?
What development phase is GB224 10mg in?
Related
- Manufacturer: Genor Biopharma Co., Ltd. — full pipeline
- Also known as: Gerilimzumab injection, Methotrexate (MTX)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing