First Approval in Latin America... Number of Countries with Product Approval Reaches 11
Domestic Supply Expected to Resume This Year
"We Will Accelerate Overseas Market Approvals"
[Asia Economy Reporter Myunghwan Lee] SK Bioscience announced on the 2nd that it has obtained final product approval from the Chilean Public Health Institute for its quadrivalent cell-cultured influenza vaccine, 'Skycellflu Quadrivalent Prefilled Syringe' (hereinafter referred to as Skycellflu). This is the first time Skycellflu has received product approval in a Latin American country.
Latin America, with a population of over 600 million, accounts for about 6.4% of the world's population and approximately 6.5% of the global Gross Domestic Product (GDP). According to the global market research firm Market Data Forecast, the Latin American influenza vaccine market size is expected to grow from $450 million (approximately 554.5 billion KRW) last year to $660 million (approximately 812.8 billion KRW) by 2027, recording a compound annual growth rate (CAGR) of 7.87%.
Particularly, Chile, with a population of about 20 million, is relatively small compared to other countries but is experiencing increasing medical expenses due to rapid aging. In response, the Chilean government actively encourages foreign companies to enter the domestic market to provide medicines at reasonable prices.
SK Bioscience plans to expand the countries approving Skycellflu in the Latin American region, starting with Chile, to target the market.
Skycellflu is a cell-cultured influenza vaccine developed independently by SK Bioscience. Compared to traditional egg-based influenza vaccines, its production period is about half as long, allowing for rapid response to pandemics or emerging variant viruses. Additionally, since animal cells are cultured using sterile bioreactors, no antibiotics or preservatives are used, and because it is cell-cultured, it can be administered to people with egg anaphylaxis or egg allergies.
Skycellflu demonstrated immunogenicity and safety in a Phase 3 clinical trial involving 1,503 adults aged 19 and older at 10 domestic institutions, including Korea University Guro Hospital. Based on this, it became the first cell-cultured influenza vaccine to receive the World Health Organization (WHO) prequalification certification, which evaluates vaccine manufacturing processes, quality, and clinical trial results to certify safety and efficacy. In another Phase 3 trial conducted at eight institutions, including Korea University Ansan Hospital, involving 453 children and adolescents aged 6 months to under 19 years, immunogenicity and safety were also confirmed.
SK Bioscience plans to resume domestic supply of Skycellflu this year, aligning with the influenza vaccination season, after temporarily suspending it to focus on COVID-19 vaccine production. According to global market research firm IMS Data, Skycellflu held a 29% share of the domestic influenza vaccine market in 2020, ranking first in South Korea.
Jae-yong Ahn, President of SK Bioscience, said, "Skycellflu, whose production will resume this year, will expand its reach globally beyond Korea based on its already proven product competitiveness. Having gained prominence as a vaccine company recognized worldwide through the pandemic, SK Bioscience’s various self-developed vaccines will become known overseas."
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