[Asia Economy Reporter Chunhee Lee] SK Bioscience announced on the 12th that its typhoid vaccine 'SkyTyphoid Multi (NBP618)', jointly developed with the International Vaccine Institute (IVI), has received export product approval from the Ministry of Food and Drug Safety.
With this product approval, SK Bioscience has secured its sixth proprietary vaccine following ▲trivalent cell-cultured influenza vaccine ▲quadrivalent cell-cultured influenza vaccine ▲shingles vaccine ▲varicella vaccine ▲pneumococcal conjugate vaccine.
SkyTyphoid was initiated in 2013 by SK Bioscience and IVI applying conjugate vaccine production technology. From the early stages of research and development, the Bill & Melinda Gates Foundation (BMGF) provided funding, with SK Bioscience responsible for R&D, manufacturing, and regulatory approval, and IVI handling global clinical trials.
SkyTyphoid is a polysaccharide-protein conjugate vaccine developed by conjugating the polysaccharide of the typhoid antigen to the diphtheria toxoid protein (diphtheria toxoid) serving as a carrier. Compared to existing oral live vaccines or polysaccharide vaccines, it is expected to provide excellent immunogenicity and long-term preventive effects with a single dose. Additionally, by applying protein conjugation technology, it can be administered to infants aged 6 months to under 2 years.
The global market size for typhoid vaccines is predicted to expand from $262.81 million (approximately KRW 314.1 billion) in 2019 to $525.32 million (approximately KRW 629.6 billion) by 2027, growing at an average annual rate of 9.3%.
SK Bioscience confirmed immunogenicity and safety in a Phase 3 clinical trial conducted in Nepal involving 2,160 healthy individuals aged over 6 months to under 45 years in collaboration with IVI. In clinical trials comparing SkyTyphoid with other WHO prequalified polysaccharide-protein conjugate typhoid vaccines, SkyTyphoid demonstrated equivalent immunogenicity and was confirmed to be safely administered across all age groups in the clinical cohort.
The clinical results were published and validated in 'The Lancet Infectious Diseases,' a sister journal of The Lancet and a leading journal in the field of infectious diseases. Clinical studies conducted in the Philippines are also scheduled to be published soon in another Lancet-affiliated journal.
Based on the clinical results and Ministry of Food and Drug Safety product approval, SK Bioscience plans to proceed with the WHO PQ certification process. SK Bioscience aims to obtain WHO PQ certification in collaboration with IVI and begin global supply of SkyTyphoid as early as next year. The production and supply of SkyTyphoid will be carried out entirely at SK Bioscience's Andong L-House facility.
Jerome Kim, Secretary-General of IVI, said, “This marks the commercialization of another new vaccine through exemplary global public-private cooperation,” adding, “IVI will continue to accelerate vaccine discovery, development, and distribution for global public health in collaboration with vaccine developers worldwide, including SK Bioscience.”
Jaeyong Ahn, President of SK Bioscience, said, “We are pleased that research conducted over more than a decade through global cooperation has led to innovative results,” and added, “Through rapid global approvals, we will contribute to freeing children in low- and middle-income countries from typhoid.”
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