Last reviewed 2026-05-14 · How we verify

GC FLU Quadrivalent

Medigen Vaccine Biologics Corp. · Phase 3 active Biologic

GC FLU Quadrivalent is a Inactivated influenza vaccine Biologic drug developed by Medigen Vaccine Biologics Corp.. It is currently in Phase 3 development for Seasonal influenza prevention in adults and children.

GC FLU Quadrivalent is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against four strains of influenza virus.

GC FLU Quadrivalent is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against four strains of influenza virus. Used for Seasonal influenza prevention in adults and children.

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	GC FLU Quadrivalent
Sponsor	Medigen Vaccine Biologics Corp.
Drug class	Inactivated influenza vaccine
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

The vaccine contains inactivated (non-infectious) antigens from four influenza virus strains (two A subtypes and two B lineages), which are presented to the immune system to generate humoral and cellular immune responses. This primes the body to recognize and neutralize circulating influenza viruses, reducing infection risk and severity.

Approved indications

Seasonal influenza prevention in adults and children

Common side effects

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

Key clinical trials

A Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (PHASE3)
A Multicenter, Double-blind, Parallel Phase III Study (PHASE3)
Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine) (PHASE1, PHASE2)
A Phase I/IIa Study of GC3110A (Quadrivalent Influenza Vaccine) (PHASE1, 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:

GC FLU Quadrivalent CI brief — competitive landscape report
GC FLU Quadrivalent updates RSS · CI watch RSS
Medigen Vaccine Biologics Corp. portfolio CI

Frequently asked questions about GC FLU Quadrivalent

What is GC FLU Quadrivalent?

GC FLU Quadrivalent is a Inactivated influenza vaccine drug developed by Medigen Vaccine Biologics Corp., indicated for Seasonal influenza prevention in adults and children.

How does GC FLU Quadrivalent work?

GC FLU Quadrivalent is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against four strains of influenza virus.

What is GC FLU Quadrivalent used for?

GC FLU Quadrivalent is indicated for Seasonal influenza prevention in adults and children.

Who makes GC FLU Quadrivalent?

GC FLU Quadrivalent is developed by Medigen Vaccine Biologics Corp. (see full Medigen Vaccine Biologics Corp. pipeline at /company/medigen-vaccine-biologics-corp).

What drug class is GC FLU Quadrivalent in?

GC FLU Quadrivalent belongs to the Inactivated influenza vaccine class. See all Inactivated influenza vaccine drugs at /class/inactivated-influenza-vaccine.

What development phase is GC FLU Quadrivalent in?

GC FLU Quadrivalent is in Phase 3.

What are the side effects of GC FLU Quadrivalent?

Common side effects of GC FLU Quadrivalent include Injection site pain, erythema, or swelling, Myalgia, Headache, Fatigue, Low-grade fever.

Drug class: All Inactivated influenza vaccine drugs
Manufacturer: Medigen Vaccine Biologics Corp. — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for Seasonal influenza prevention in adults and children

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