Saturday, December 20, 2025

SK Bioscience, Applies for Phase 1/2 IND of 'Flu Vaccine' Using Immunoenhancer

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2025-07-17 09:41:24
Updated
2025-07-17 09:41:24
First domestic flu vaccine using immunoenhancer, enhancing technology
Securing interim results by 2027, targeting high immunogenicity market
Researchers at SK Bioscience are analyzing research results. Provided by SK Bioscience


[Financial News] SK Bioscience announced on the 17th that it will start developing a flu vaccine using an immunoenhancer.
The plan is to complement the limitations of existing vaccines by inducing a stronger immune response in the elderly or those with weakened immunity.
SK Bioscience has submitted a clinical trial plan (IND) for the new flu vaccine candidate 'NBP607B', which applies an immunoenhancer to the existing self-developed flu vaccine 'SkyCellflu', to the Ministry of Food and Drug Safety.
This vaccine is being developed to enhance the preventive effect of existing vaccines using immunoenhancement technology. SK Bioscience has previously utilized an immunoenhancer in the COVID-19 vaccine 'SkyCovione', and this development is an attempt to expand that technology into the flu domain.
NBP607B applies the immunoenhancer from the Swiss non-profit vaccine research organization 'VFI'. This substance, composed of various immunoenhancing components, is expected to induce sufficient immune responses and antibody production even in the elderly. 
The clinical phase 1/2 of NBP607B will start targeting the elderly domestically and internationally in line with the flu season in the Northern Hemisphere this year. It will evaluate immunogenicity and safety in approximately 320 subjects by comparing with an already approved high immunogenicity vaccine as a control drug, with interim results expected by 2027.
This is the first time a domestic company has submitted a clinical trial plan for developing a high immunogenicity flu vaccine using an immunoenhancer.
If SK Bioscience succeeds in developing this vaccine, it plans to use it as a platform to expand to other vaccines while securing differentiated competitiveness in the global high-value-added vaccine market.
Recently, major health authorities worldwide have recommended high immunogenicity vaccines for the elderly, and SK Bioscience's actions are expected to gain momentum.
SkyCellflu has already been recognized for its technology through an advanced platform as a cell-cultured flu vaccine. It was the first cell-cultured flu vaccine in the world to receive WHO prequalification (PQ) and has received product approval in 11 countries to date, supplying products to the international procurement market through UNICEF and PAHO.
An Jae-yong, CEO of SK Bioscience, said, "We will create a specialized market with high immunogenicity products while expanding to a platform applicable to other vaccines, leading to the development of vaccines for various infectious diseases."

vrdw88@fnnews.com Kang Jung-mo Reporter