Last reviewed 2026-04-23 · How we verify

NBP607-QIV

SK Chemicals Co., Ltd. · Phase 3 active Biologic

NBP607-QIV is a Inactivated influenza vaccine Biologic drug developed by SK Chemicals Co., Ltd.. It is currently in Phase 3 development for Seasonal influenza prevention in adults and/or pediatric populations.

NBP607-QIV is a quadrivalent influenza vaccine designed to provide immunological protection against four strains of influenza virus.

NBP607-QIV is a quadrivalent influenza vaccine designed to provide immunological protection against four strains of influenza virus. Used for Seasonal influenza prevention in adults and/or pediatric populations.

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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-QIV
Sponsor	SK Chemicals Co., Ltd.
Drug class	Inactivated influenza vaccine
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

As a vaccine, NBP607-QIV works by stimulating the adaptive immune system to recognize and respond to four circulating influenza virus strains (typically two A subtypes and two B lineages). The vaccine preparation contains inactivated viral antigens that trigger antibody production and cellular immunity, enabling the immune system to mount a rapid and effective response upon exposure to wild-type influenza virus.

Approved indications

Seasonal influenza prevention in adults and/or pediatric populations

Common side effects

Injection site pain or erythema
Myalgia
Headache
Fatigue
Low-grade fever

Key clinical trials

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-QIV CI brief — competitive landscape report
NBP607-QIV updates RSS · CI watch RSS
SK Chemicals Co., Ltd. portfolio CI

Frequently asked questions about NBP607-QIV

What is NBP607-QIV?

NBP607-QIV is a Inactivated influenza vaccine drug developed by SK Chemicals Co., Ltd., indicated for Seasonal influenza prevention in adults and/or pediatric populations.

How does NBP607-QIV work?

NBP607-QIV is a quadrivalent influenza vaccine designed to provide immunological protection against four strains of influenza virus.

What is NBP607-QIV used for?

NBP607-QIV is indicated for Seasonal influenza prevention in adults and/or pediatric populations.

Who makes NBP607-QIV?

NBP607-QIV is developed by SK Chemicals Co., Ltd. (see full SK Chemicals Co., Ltd. pipeline at /company/sk-chemicals-co-ltd).

What drug class is NBP607-QIV in?

NBP607-QIV belongs to the Inactivated influenza vaccine class. See all Inactivated influenza vaccine drugs at /class/inactivated-influenza-vaccine.

What development phase is NBP607-QIV in?

NBP607-QIV is in Phase 3.

What are the side effects of NBP607-QIV?

Common side effects of NBP607-QIV include Injection site pain or erythema, Myalgia, Headache, Fatigue, Low-grade fever.

Drug class: All Inactivated influenza vaccine drugs
Manufacturer: SK Chemicals Co., Ltd. — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for Seasonal influenza prevention in adults and/or pediatric populations

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing