SK bioscience announced on February 2 that its "SKYCellflu Quadrivalent prefilled syringe (SKYCellflu)" has been approved by Chile's Instituto de Salud Publica.
SKYCellflu is a cell culture-type flu vaccine developed by SK Bioscience.
This is the first time that SKYCellflu has been approved in a Latin American country.
Prior to this, SK Bioscience obtained approval for SKYCellflu in Southeast Asian countries such as Malaysia, Thailand, the Philippines, Myanmar, Iran, Singapore, Pakistan, Mongolia, and Brunei.
Starting with Chile, SK Bioscience plans to expand the number of countries approved for SKYCellflu in Central and South America to target the market.
In the case of Latin American countries, it is known that many countries use Chile's item approval as the criterion for their own item approval.
Latin America is a huge market with a population of more than 600 million, accounting for 6.4% of the world's population and accounting for about 6.5% of global GDP (as of 2019).
According to Market Data Forecast, a global market research firm, the Latin American flu vaccine market will grow from $450 million in 2022 (about KRW 554.5 billion) to $660 million in 2027 (about KRW 812.8 billion in Korean currency). is projected to grow at an average annual rate of 7.87%.
Compared to the existing fertilized egg-type flu vaccine, SKYCellflu has the advantage of being able to respond quickly to pandemics or the emergence of mutant viruses as the production period is about half short.
In addition, since animal cells are cultured through a state-of-the-art aseptic incubator, people with egg allergy can safely inoculate without using antibiotics or preservatives.
SKYCellflu proved excellent immunogenicity and safety in phase 3 clinical trials involving 1,503 adults aged 19 or older at 10 South Korean institutions, including Korea University Guro Hospital.
Based on this, for the first time among cell-cultured influenza vaccines, the World Health Organization (WHO) has obtained Pre-Qualification (PQ), which certifies safety and effectiveness by evaluating the manufacturing process, quality, and clinical test results of the vaccine.
It also proved excellent immunogenicity and safety in a phase 3 study conducted on 453 children and adolescents between the ages of 6 months and 19 years at a total of 8 institutions including Korea University Ansan Hospital.
Ahn Jae-yong, CEO of SK Bioscience, said, “SKYCellflu, whose production will resume this year, is planning to expand beyond the Korean market to the global market based on its proven product competitiveness.”
