The approval paves the way for exports to the world’s fourth most populous country. SK Bioscience aims to take advantage of the advantages of cell culture vaccines and continue to grow as a global vaccine brand beyond Korea.
SEONGNAM, South Korea , Oct. 23, 2024 /PRNewswire/ — SK Biosciences, a global innovative vaccine and biotechnology company committed to promoting human health from prevention to treatment, today announced that it has been awarded the Indonesian Food and Drug Administration BPOM ( Badan Pengawas Obat dan) announced as follows: Makanan) has approved a Biologics License Application (BLA) for SKYCellflu Tetravalent Prefilled Syringe, the world’s first tetravalent cell culture influenza vaccine. This is the first time that a domestically produced influenza vaccine has been approved in Indonesia.
Indonesia is the world’s fourth most populous country with more than 280 million people and a rapidly growing pharmaceutical market. According to global market research firm Innsight10, the Indonesian influenza vaccine market is expected to grow from USD 38.5 million in 2022 to USD 69.1 million in 2030.
Indonesia’s elongated geography straddles both the northern and southern hemispheres, making it subject to the World Health Organization’s influenza vaccination guidelines for both regions.
Following this approval of SKYCellflu against Northern Hemisphere influenza strains, SK Biosciences is looking forward to swift approval of the influenza vaccine against Southern Hemisphere influenza strains by the Indonesian Food and Drug Administration.
SKYCellFlu is the world’s first cell culture-based influenza vaccine to receive WHO Prequalification (PQ) certification and has demonstrated acceptable immunogenicity and safety across clinical trials. This is the only cell culture influenza vaccine currently available in South Korea.
Compared to egg-based vaccines, the shorter production schedule makes them better suited for rapid responses to pandemics and emerging variants. SKYCellflu also requires no antibiotics or preservatives.
Additionally, cell culture vaccines are less likely to mutate during the production process than vaccines produced in fertilized eggs, allowing them to more accurately match circulating influenza strains.
In SK Bioscience’s research, SKYCellflu production cells and fertilized eggs were subcultured 15 times. Passaging, also called cell passaging, is the removal of the medium and transfer of cells from a previous culture to fresh growth medium, a procedure that allows for further growth of a cell line or lines.
As a result of the research, mutations were found in three proteins within the virus using the fertilized egg method, but no mutations were found in the cells used to manufacture SKYCellflu. These findings were presented at the 2019 Inter-Scientific Working Group on Korean Influenza (KIWI) Symposium.
SKYCellflu has already been approved in multiple countries in Asia, including Malaysia, Thailand, Myanmar, Iran, Singapore, Pakistan, Mongolia and Brunei. It was approved in Chile last year, making it the first approval in the South American market. SK Bioscience plans to pave the way for full-scale expansion into the global export market.
Ahn Jae-young, CEO of SK Bioscience, said, “We are very encouraged that the vaccine developed by our company has been approved around the world. This is an important step in expanding our global export market. ” he said. Furthermore, “SK Bioscience has grown into a global vaccine brand that goes beyond Korea, as our vaccines, including vaccines for shingles, chickenpox, and typhoid fever, have received WHO PQ certification and global approval one after another. I am confident that we will continue to do so,” he added.
About SK Bioscience
SK Bioscience is an innovative vaccine and biotechnology company working to develop and manufacture vaccines to enable more equitable access to vaccines around the world. SK Bioscience has been dedicated to improving the health of people around the world, from prevention to treatment, by leveraging the strength of cutting-edge technology. In collaboration with national and international governments, regulators, healthcare providers, doctors, and medical experts, all of our colleagues at SK will work together to deliver high-quality vaccines to those who need them and provide better public health solutions. I am working hard on this.
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contact
SK Bioscience Communication Team
Jin Changhyun (jin99@sk.com)
Jeannie S. Pak (j.pak@sk.com)
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Source SK Bioscience
