GC Green Cross Receives IND Approval for High-Immunogenic Flu Vaccine for Seniors

As the aging population grows rapidly, the importance of flu prevention strategies tailored for older adults is increasing. GC Green Cross has received approval from the Ministry of Food and Drug Safety for the clinical trial plan (IND) of its high-immunogenic flu vaccine, 'GC3114B,' designed for seniors.

According to GC Green Cross, the Phase 2/3 clinical trial will evaluate the immunogenicity and safety of GC3114B in individuals aged 65 and older through a direct comparison with an active control group. The company plans to begin dosing the first patients in the Phase 2 trial in the second half of this year, with the Phase 3 trial to be conducted as a multinational study.

The high-immunogenic flu vaccine is designed to enhance immune responses in older adults, who typically have a weaker immune response compared to younger populations. This can be achieved through higher antigen content or by using adjuvants to boost the immune response.

Globally, the use of high-immunogenic flu vaccines is expanding. The Advisory Committee on Immunization Practices (ACIP) under the Centers for Disease Control and Prevention (CDC) in the United States recommends administering high-immunogenic vaccines to individuals aged 65 and older before standard-dose vaccines.

In South Korea, as the country enters a super-aged society, the need for differentiated flu prevention options for older adults is growing. Recently, the Korea Disease Control and Prevention Agency has been reviewing the introduction of high-immunogenic flu vaccines into the National Immunization Program (NIP).

In line with this, GC Green Cross aims to enter the NIP market, establishing a foundation for self-sufficiency in high-immunogenic flu vaccines, which are currently reliant on imports, while also pursuing global market expansion.

Lee Jae-woo, head of the development division at GC Green Cross, stated, "As the aging population grows rapidly, the importance of flu prevention strategies tailored for older adults is increasing. Based on our long-standing research and development and production capabilities, we will expand our portfolio to include high-immunogenic flu vaccines, thereby enhancing our business competitiveness."

Meanwhile, analysts estimate that GC Green Cross will achieve consolidated sales of 1.98 trillion won and an operating profit of 77.1 billion won this year, aligning with the company's annual sales and operating profit guidance.

Next year, significant growth in revenue and profitability is expected. According to iM Securities, consolidated sales are projected to reach 2.13 trillion won, a 7.8% increase from this year's estimate, while operating profit is expected to rise by 60.7% to 123.9 billion won.