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NBP607-TIV
NBP607-TIV is a Therapeutic vaccine Biologic drug developed by SK Chemicals Co., Ltd.. It is currently in Phase 3 development for Influenza treatment and prevention.
NBP607-TIV is a therapeutic influenza vaccine designed to enhance immune response against multiple influenza virus strains.
NBP607-TIV is a vaccine used for the prevention of influenza. It is a quadrivalent vaccine, as indicated by its inclusion in ClinicalTrials.gov under the intervention "NBP607-QIV".
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | NBP607-TIV |
|---|---|
| Sponsor | SK Chemicals Co., Ltd. |
| Drug class | Therapeutic vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
As a therapeutic vaccine candidate, NBP607-TIV aims to stimulate both cellular and humoral immune responses against influenza antigens. The vaccine is being developed to provide broader protection and potentially therapeutic benefit in influenza-infected patients, moving beyond traditional prophylactic vaccination approaches.
Approved indications
- Influenza treatment and prevention
Common side effects
- Injection site reactions
- Fever
- Myalgia
Key clinical trials
- Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months (PHASE3)
- Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects (PHASE3)
- Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults (PHASE1)
- Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children Aged 6~35 Months (PHASE3)
- Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Healthy Children and Adolescents (PHASE3)
- Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents (PHASE3)
- Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects (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:
- NBP607-TIV CI brief — competitive landscape report
- NBP607-TIV updates RSS · CI watch RSS
- SK Chemicals Co., Ltd. portfolio CI
Frequently asked questions about NBP607-TIV
What is NBP607-TIV?
How does NBP607-TIV work?
What is NBP607-TIV used for?
Who makes NBP607-TIV?
What drug class is NBP607-TIV in?
What development phase is NBP607-TIV in?
What are the side effects of NBP607-TIV?
Related
- Drug class: All Therapeutic vaccine drugs
- Manufacturer: SK Chemicals Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Influenza treatment and prevention
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing