This approval paves the way for exports to the world's fourth most populous country.
SK bioscience aims to continue to grow as a global vaccine brand beyond Korea by leveraging the advantages of cell-cultured vaccines.
SEONGNAM, South Korea, Oct. 23, 2024 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that Indonesia's Food and Drug Agency, BPOM (Badan Pengawas Obat dan Makanan), has approved the Biologics License Application (BLA) for the SKYCellflu Quadrivalent prefilled syringe, the world's first quadrivalent cell-cultured influenza vaccine. This is the first time a domestically made influenza vaccine has received approval in Indonesia.
Indonesia is the world's fourth most populous nation with over 280 million people, with rapidly growing pharmaceutical market. According to global market research firm Innsight10, Indonesia's flu vaccine market is projected to grow from USD 38.5 million in 2022 to USD 69.1 million in 2030.
Due to its elongated geography, spanning both Northern and Southern Hemispheres, Indonesia is impacted by the World Health Organization's flu vaccination guidelines for both regions.
Following this approval of SKYCellflu for the Northern Hemisphere influenza strains, SK bioscience anticipates fast-tracked approval of flu vaccine for Southern Hemisphere influenza strains by the Indonesian Food and Drug Agency.
SKYCellFlu is the world's first cell culture-based influenza vaccine to achieve WHO Prequalification (PQ) certification, demonstrating acceptable immunogenicity and safety across clinical trials. It is the only cell-cultured influenza vaccine currently available in Korea.
Compared to the egg-based vaccines, its shorter production timeline makes it more suited for rapid response to pandemics or the emerging variants. SKYCellflu also does not require antibiotic or preservative administration.
In addition, cell-cultured vaccines are less likely to mutate during the production process than those produced in fertilized eggs, allowing for a more accurate match to circulating influenza strains.
In SK bioscience's research, the company conducted subcultures 15 times by employing cells for SKYCellflu production and fertilized eggs. Subculturing, also referred to as passaging cells, is the removal of the medium and transfer of cells from a previous culture into fresh growth medium, a procedure that enables the further propagation of the cell line or cell strain.
The study results showed that mutations were found in three proteins within the virus in the fertilized egg method, while no mutations were found in the cells used for SKYCellflu production. These findings were presented at the 2019 Korea Interscience Working Group on Influenza (KIWI) Symposium.
SKYCellflu has already been approved in multiple Asian countries, including Malaysia, Thailand, Myanmar, Iran, Singapore, Pakistan, Mongolia, and Brunei. Last year, it was granted in Chile, marking its first approval in the South American market. SK bioscience plans to pave the way for a full-scale expansion into global export markets.
Jaeyong Ahn, CEO of SK bioscience, said, "It is very encouraging that our own developed vaccines are receiving approvals worldwide, a significant step for expanding our global export market." He added, "We are confident that SK bioscience will continue to grow into a global vaccine brand beyond Korea, as our vaccines, including shingles, chickenpox, and typhoid vaccines, are securing WHO PQ certifications and global approvals one after another."
About SK bioscience
SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions.
Contact
SK bioscience Communications Team
Changhyun Jin(jin99@sk.com)
Jeannie S. Pak(j.pak@sk.com)
SOURCE SK bioscience
