GC Green Cross Receives IND Approval for Phase 2/3 Clinical Trial of High-Immunogenicity Influenza Vaccine

Rising Demand for High-Immunogenicity Vaccines Amid Transition to a Super-Aged Society

GC Green Cross announced on September 4 that its clinical phase 2/3 investigational new drug (IND) application for its high-immunogenicity influenza vaccine candidate, "GC3114B," has been approved by the Ministry of Food and Drug Safety.

Nokshipja headquarters located in Giheung District, Yongin City, Gyeonggi Province.

This phase 2/3 clinical trial will evaluate the immunogenicity and safety of GC3114B in people aged 65 and older through a direct comparison with an active comparator group. The administration of the first patient in the phase 2 trial is scheduled to begin in the second half of this year, and starting from the phase 3 trial, the study will expand to a multinational clinical trial, according to the company.

GC3114B is designed to induce a stronger immune response in older adults by incorporating a higher antigen content than conventional standard-dose influenza vaccines.

Older adults may not develop a sufficient immune response after vaccination due to age-related decline in immune function. As a result, high-immunogenicity influenza vaccines are being increasingly adopted in the global market. The Advisory Committee on Immunization Practices (ACIP), under the U.S. Centers for Disease Control and Prevention (CDC), recommends that high-immunogenicity vaccines be prioritized over standard-dose vaccines for individuals aged 65 and over.

In Korea as well, as the country transitions into a super-aged society, there is a growing need for differentiated influenza prevention options for older adults. Recently, the Korea Disease Control and Prevention Agency (KDCA) has been reviewing the introduction of high-immunogenicity influenza vaccines in the National Immunization Program (NIP). In response, GC Green Cross plans to enter the NIP market, aiming to establish a foundation for self-sufficiency in high-immunogenicity influenza vaccines—currently dependent on imports—while simultaneously pursuing expansion into global markets.

Jaewoo Lee, Head of R&D at GC Green Cross, stated, "As society ages rapidly, the importance of tailored influenza prevention strategies for the elderly is growing even further. We will enhance our business competitiveness by expanding our vaccine portfolio to include high-immunogenicity influenza vaccines, leveraging the research, development, and manufacturing capabilities we have accumulated over many years."

This content was produced with the assistance of AI translation services.