GC Green Cross announced that it has obtained IND approval from the Korean Ministry of Food and Drug Safety (MFDS) for clinical Phase 2/3 testing of its high‑immunogenicity influenza vaccine candidate GC3114B.
The trial will enroll adults aged 65 and older and will compare the immunogenicity and safety of GC3114B directly with an active control vaccine.
The company plans to start dosing the first patients in the Phase 2 portion in the second half of this year, and intends to expand to a multinational Phase 3 study thereafter.
The development aims to reduce reliance on imported influenza vaccines in South Korea and eventually qualify for inclusion in the national immunization program (NIP).
規制動向2026年9月16日•3分で読めます
GC Green Cross Secures IND for High‑Immunogenicity Elderly Flu Vaccine GC3114B
GC Green Cross received MFDS IND approval to start Phase 2/3 trials of its high‑immunogenicity influenza vaccine candidate GC3114B in adults 65+, targeting domestic self‑sufficiency and future NIP inclusion.
Pharmacountryチームがまとめました · 出典： KPA News
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