SK bioscience, a global innovator in vaccines and biotechnology, announced that Indonesia's Food and Drug Agency, BPOM (Badan Pengawas Obat dan Makanan), has approved the Biologics License Application (BLA) for the world's first quadrivalent cell-cultured influenza vaccine, SKYCellflu Quadrivalent prefilled syringe. This is the first time a domestically made influenza vaccine has received approval in Indonesia.

Following this approval of SKYCellflu for the Northern Hemisphere influenza strains, SK bioscience anticipates fast-tracked approval of flu vaccine for the Southern Hemisphere in Indonesia.

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 doesn't require antibiotic or preservative administration.

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."