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approved egg-derived TIV
approved egg-derived TIV is a Biologic drug developed by UMN Pharma Inc.. It is currently in Phase 3 development. Also known as: Influenza HA vaccine "SEIKEN".
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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).
| 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 | approved egg-derived TIV |
|---|---|
| Also known as | Influenza HA vaccine "SEIKEN" |
| Sponsor | UMN Pharma Inc. |
| Modality | Biologic |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Study of ASP7374, Cell-culture-derived Influenza Vaccine (PHASE3)
- Phase-3 Study of ASP7374, Cell-culture-derived Influenza Vaccine (PHASE3)
- Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age (PHASE3)
- Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age (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:
- approved egg-derived TIV CI brief — competitive landscape report
- approved egg-derived TIV updates RSS · CI watch RSS
- UMN Pharma Inc. portfolio CI
Frequently asked questions about approved egg-derived TIV
What is approved egg-derived TIV?
Who makes approved egg-derived TIV?
Is approved egg-derived TIV also known as anything else?
What development phase is approved egg-derived TIV in?
Related
- Manufacturer: UMN Pharma Inc. — full pipeline
- Also known as: Influenza HA vaccine "SEIKEN"
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing