SK bioscience is making a strategic move to develop a next-generation flu vaccine that utilizes immune-boosting agents, aiming to overcome the limitations of existing vaccines and achieve technological advancements and platform expansion.
On July 17, SK bioscience announced that it has submitted a clinical trial application to the Ministry of Food and Drug Safety for its new flu vaccine candidate, 'NBP607B', which incorporates an immune booster into its proprietary flu vaccine 'SKYCellflu'.
NBP607B is a vaccine enhanced with an immune booster from the Swiss non-profit Vaccine Formulation Institute (VFI), anticipated to induce strong immune responses even in high-risk groups such as the elderly and immunocompromised individuals. This development extends the immune-enhancing technology SK bioscience accumulated from its COVID-19 vaccine, 'SKYCovione', to the flu vaccine sector.
SK bioscience has been conducting preclinical research on NBP607B since 2023, securing meaningful results. The company plans to initiate Phase 1/2 clinical trials targeting elderly populations during the upcoming influenza season in the Northern Hemisphere, evaluating immunogenicity and safety in approximately 320 participants. These trials will use a licensed high-immunity flu vaccine as a comparator, aiming for interim results by 2027.
This marks the first instance of a Korean company conducting clinical trials for a high-immunity flu vaccine using an immune booster. SK bioscience aims to leverage successful vaccine development as a platform for technological expansion into other vaccines, enhancing competitiveness in the high-value global vaccine market.
The global health authorities' recommendations for high-immunity vaccines bolster SK bioscience's efforts. The Advisory Committee on Immunization Practices (ACIP) under the US Centers for Disease Control and Prevention (CDC) recommends high-dose or immune-enhanced flu vaccines for individuals aged 65 and over, supported by the World Health Organization (WHO) for high-risk groups. The Korea Disease Control and Prevention Agency also considers including domestically produced high-immunity vaccines in the National Immunization Program (NIP) if certain criteria are met.
Industry experts anticipate a surge in demand for high-immunity vaccines. According to Mordor Intelligence, the global vaccine market is projected to grow from $83.9 billion in 2025 to $114.8 billion by 2030, with a compound annual growth rate of 6.5%. With the acceleration of aging populations, the demand for vaccines targeting high-risk groups is expected to rise significantly.
SK bioscience’s SKYCellflu, the world’s first cell-culture influenza vaccine to receive the WHO prequalification, is currently licensed in 11 countries, with ongoing international procurement through UNICEF and the Pan American Health Organization (PAHO).
SK bioscience CEO Ahn Jae-yong said, "Combining the proven technology of SKYCellflu with our experience in developing immune-enhancing vaccines increases the likelihood of success. We aim to create a specialized market for high-immunity vaccines and expand our vaccine platform to respond to various infectious diseases."
