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Nituzumab
Nituzumab is a Small molecule drug developed by Fujian Cancer Hospital. It is currently in Phase 2 development. Also known as: monoclonal antibody.
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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 | Nituzumab |
|---|---|
| Also known as | monoclonal antibody |
| Sponsor | Fujian Cancer Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Nituzumab (Taixinsheng ®） A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study on the Efficacy and Safety of Combined Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinomatreatment of Locally Advanced Nasopharyngeal Carcinoma (PHASE2)
- Clinical Study of Carbon Ion Radiotherapy for Pancreatic Cancer. (NA)
- Irinotecan Liposomes in Combination With Nituzumab for the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line or Higher Immunotherapy (PHASE2)
- Nituzumab Plus Serplulimab Combined With SBRT in Cervical Cancer (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:
- Nituzumab CI brief — competitive landscape report
- Nituzumab updates RSS · CI watch RSS
- Fujian Cancer Hospital portfolio CI
Frequently asked questions about Nituzumab
What is Nituzumab?
Who makes Nituzumab?
Is Nituzumab also known as anything else?
What development phase is Nituzumab in?
Related
- Manufacturer: Fujian Cancer Hospital — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: monoclonal antibody
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing