Last reviewed 2026-04-23 · How we verify

GC Flu(Trivalent)

Green Cross Corporation · Phase 3 active Biologic

GC Flu(Trivalent) is a Inactivated influenza vaccine Biologic drug developed by Green Cross Corporation. It is currently in Phase 3 development for Seasonal influenza prevention in adults and children. Also known as: GC Flu Pre-filled Syringe Inj..

GC Flu(Trivalent) is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against three strains of influenza virus.

GC Flu(Trivalent) is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against three 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(Trivalent)
Also known as	GC Flu Pre-filled Syringe Inj.
Sponsor	Green Cross Corporation
Drug class	Inactivated influenza vaccine
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

The vaccine contains inactivated (killed) virus particles or viral antigens from three influenza strains (typically two A subtypes and one B type). When administered, it triggers both humoral and cellular immune responses, leading to the production of neutralizing antibodies and memory B cells that protect against infection with matching circulating flu strains.

Approved indications

Seasonal influenza prevention in adults and children

Common side effects

Injection site pain, redness, or swelling
Fever
Myalgia
Fatigue
Headache

Key clinical trials

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(Trivalent) CI brief — competitive landscape report
GC Flu(Trivalent) updates RSS · CI watch RSS
Green Cross Corporation portfolio CI

Frequently asked questions about GC Flu(Trivalent)

What is GC Flu(Trivalent)?

GC Flu(Trivalent) is a Inactivated influenza vaccine drug developed by Green Cross Corporation, indicated for Seasonal influenza prevention in adults and children.

How does GC Flu(Trivalent) work?

GC Flu(Trivalent) is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against three strains of influenza virus.

What is GC Flu(Trivalent) used for?

GC Flu(Trivalent) is indicated for Seasonal influenza prevention in adults and children.

Who makes GC Flu(Trivalent)?

GC Flu(Trivalent) is developed by Green Cross Corporation (see full Green Cross Corporation pipeline at /company/green-cross-corporation).

Is GC Flu(Trivalent) also known as anything else?

GC Flu(Trivalent) is also known as GC Flu Pre-filled Syringe Inj..

What drug class is GC Flu(Trivalent) in?

GC Flu(Trivalent) belongs to the Inactivated influenza vaccine class. See all Inactivated influenza vaccine drugs at /class/inactivated-influenza-vaccine.

What development phase is GC Flu(Trivalent) in?

GC Flu(Trivalent) is in Phase 3.

What are the side effects of GC Flu(Trivalent)?

Common side effects of GC Flu(Trivalent) include Injection site pain, redness, or swelling, Fever, Myalgia, Fatigue, Headache.

Drug class: All Inactivated influenza vaccine drugs
Manufacturer: Green Cross Corporation — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for Seasonal influenza prevention in adults and children
Also known as: GC Flu Pre-filled Syringe Inj.

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