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SEONGNAM, South Korea - SK bioscience, a prominent player in the Biotechnology industry with a strong balance sheet showing more cash than debt, announced Thursday it has submitted an Investigational New Drug (IND) application to South Korea’s Ministry of Food and Drug Safety for Phase 1/2 clinical trials of its new influenza vaccine candidate, NBP607B.
The candidate incorporates an adjuvant into the company’s existing cell-based influenza vaccine, SKYCellflu, to enhance protective efficacy. The adjuvant, developed by the Swiss-based non-profit Vaccine Formulation Institute, contains multiple immune-boosting components intended to strengthen immune responses in elderly individuals. According to InvestingPro data, analysts anticipate sales growth for SK bioscience in the current year, potentially boosted by such innovative developments.
The planned clinical trial will enroll approximately 320 older adults in Korea and abroad during the upcoming Northern Hemisphere flu season. The study aims to evaluate the vaccine’s immunogenicity and safety compared to an approved high-immunogenicity flu vaccine, with interim results expected by 2027.
This marks the first attempt by a Korean company to develop a high-immunogenicity influenza vaccine using an adjuvant. The development aligns with recommendations from global health authorities, including the U.S. Centers for Disease Control and Prevention, which advises high-dose or adjuvanted influenza vaccines for adults aged 65 and older.
SK bioscience previously utilized adjuvant technology in its COVID-19 vaccine, SKYCovione, and is now expanding this approach to influenza vaccines. The company’s existing SKYCellflu vaccine has received World Health Organization prequalification and is currently approved in 11 countries.
"We believe the combination of our proven SKYCellflu platform and our experience in adjuvanted vaccine development positions us well for success," said Jaeyong Ahn, CEO of SK bioscience, according to the company’s press release. The company’s stock has shown strong returns over the last three months, reflecting market confidence in its development pipeline. InvestingPro offers additional insights with 8 more key tips about SK bioscience’s financial health and market position.
In other recent news, SK bioscience has been cleared in a patent infringement lawsuit against Pfizer concerning its pneumococcal conjugate vaccine, PCV13. The Supreme Court of Korea ruled that SK bioscience’s exports of PCV13 vaccine components to Russia did not infringe on Pfizer’s patents. This decision allows SK bioscience to continue its plans to export PCV13 components to regions with high vaccine demand, such as Southeast Asia and Latin America. The company is also working on a 21-valent pneumococcal conjugate vaccine in collaboration with Sanofi, which entered Phase 3 clinical trials in late 2024. Additionally, SK bioscience is developing a next-generation vaccine aimed at providing broader protection. Despite being the first to develop Korea’s 13-valent pneumococcal conjugate vaccine, SKYPneumo, in 2016, SK bioscience faced a manufacturing and sales ban in Korea until 2027 due to the patent dispute. The company plans to manufacture and sell the vaccine domestically post-2027. Furthermore, SK bioscience recently invalidated a Moderna patent in Korea related to mRNA vaccine technology, reducing patent risks and fostering innovation among domestic biotech firms.
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