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GB226
GB226 is a Biologic drug developed by Genor Biopharma Co., Ltd.. It is currently in Phase 2 development. Also known as: Geptanolimab Injection, Geptanolimab, Recombinant humanized anti-PD-1 monoclonal antibody injection.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | GB226 |
|---|---|
| Also known as | Geptanolimab Injection, Geptanolimab, Recombinant humanized anti-PD-1 monoclonal antibody injection |
| Sponsor | Genor Biopharma Co., Ltd. |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors (PHASE1)
- APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC (PHASE1, PHASE2)
- Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma (PHASE1)
- Clinical Trial in Chinese Patients of B-cell Non-Hodgkin's Lymphoma(GB226) (PHASE2)
- Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib (PHASE1)
- Clinical Trial in Chinese Patients of Elapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma(GB226) (PHASE2)
- Clinical Trial in Chinese Patients of Relapsed and Refractory Peripheral T Cell Lymphoma (GB226) (PHASE2)
- A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive (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:
- GB226 CI brief — competitive landscape report
- GB226 updates RSS · CI watch RSS
- Genor Biopharma Co., Ltd. portfolio CI
Frequently asked questions about GB226
What is GB226?
Who makes GB226?
Is GB226 also known as anything else?
What development phase is GB226 in?
Related
- Manufacturer: Genor Biopharma Co., Ltd. — full pipeline
- Also known as: Geptanolimab Injection, Geptanolimab, Recombinant humanized anti-PD-1 monoclonal antibody injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing