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Gentuximab Injection
Gentuximab Injection is a VEGF inhibitor monoclonal antibody Small molecule drug developed by Changchun GeneScience Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Metastatic colorectal cancer, Non-small cell lung cancer. Also known as: Almonertinib.
Gentuximab is a monoclonal antibody that targets and inhibits vascular endothelial growth factor (VEGF) to suppress tumor angiogenesis and blood vessel formation.
Gentuximab Injection is being studied in clinical trials for the treatment of adenocarcinoma of the stomach, solid tumors, and advanced gastric or gastroesophageal junction cancer. The exact mechanism of Gentuximab Injection is currently unknown.
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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 | Gentuximab Injection |
|---|---|
| Also known as | Almonertinib |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Drug class | VEGF inhibitor monoclonal antibody |
| Target | VEGF (Vascular Endothelial Growth Factor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Gentuximab binds to VEGF, a key signaling molecule that promotes the growth of new blood vessels supplying tumors. By blocking VEGF, the drug starves tumors of their blood supply, inhibiting tumor growth and metastasis. This anti-angiogenic mechanism is designed to work as a standalone therapy or in combination with chemotherapy in solid tumors.
Approved indications
- Metastatic colorectal cancer
- Non-small cell lung cancer
Common side effects
- Hypertension
- Proteinuria
- Hemorrhage
- Thromboembolism
- Gastrointestinal perforation
Key clinical trials
- Gentuximab Combined With Paclitaxel Compared With Placebo Combined With Paclitaxel for Gastric Adenocarcinoma. (PHASE3)
- A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer (PHASE1, PHASE2)
- Pharmacokinetics and Tolerancebility Studies of Gentuximab Injection in the Treatment ofPatients With Late Recurrence of Metastatic Solid Tumors in China (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:
- Gentuximab Injection CI brief — competitive landscape report
- Gentuximab Injection updates RSS · CI watch RSS
- Changchun GeneScience Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Gentuximab Injection
What is Gentuximab Injection?
How does Gentuximab Injection work?
What is Gentuximab Injection used for?
Who makes Gentuximab Injection?
Is Gentuximab Injection also known as anything else?
What drug class is Gentuximab Injection in?
What development phase is Gentuximab Injection in?
What are the side effects of Gentuximab Injection?
What does Gentuximab Injection target?
Related
- Drug class: All VEGF inhibitor monoclonal antibody drugs
- Target: All drugs targeting VEGF (Vascular Endothelial Growth Factor)
- Manufacturer: Changchun GeneScience Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer
- Indication: Drugs for Non-small cell lung cancer
- Also known as: Almonertinib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing