SK bioscience's Influenza Vaccine ‘SkyCellflu’ Approved in Indonesia

SK bioscience announced that its quadrivalent cell-culture influenza vaccine, SkyCellflu Quadrivalent Pre-filled Syringe(SkyCellflu), has obtained final market authorization from the Indonesian National Agency of Drug and Food Control (BPOM). This marks the first time that a flu vaccine developed in Korea has been approved for use in Indonesia.

Indonesia, with a population of approximately 280 million, the fourth largest in the world, is Southeast Asia’s largest economy and its pharmaceutical market is rapidly growing. According to the global market research firm InsightTen, Indonesia’s flu vaccine market is expected to grow from around USD 38.5 million (KRW 53 billion) in 2022 to USD 69.1 million (KRW 93 billion) by 2030.

Geographically spanning both the Northern and Southern Hemispheres, Indonesia is influenced by the World Health Organization (WHO) guidelines for flu vaccinations in both hemispheres. As a result, continuous vaccine supply is necessary throughout the year, allowing suppliers to benefit from reduced manufacturing costs through continuous facility operations. SK bioscience, having obtained approval for its flu vaccine for use in the Northern Hemisphere, expects swift approval for the Southern Hemisphere version by Indonesian health authorities.

SkyCellflu is the world’s first cell-culture-based flu vaccine to receive WHO Prequalification (PQ) certification, after demonstrating excellent immunogenicity and safety in clinical trials. WHO PQ is an internationally recognized certification required for global distribution of medicines and vaccines. Currently, SkyCellflu is the only flu vaccine available in Korea produced using a cell-culture method.

According to SK bioscience, cell-culture vaccines do not rely on egg-based production, making them safer for people with egg allergies. Additionally, cell-culture vaccines have shorter production times compared to traditional egg-based vaccines, allowing for rapid production during pandemics. The cell-culture method also lowers the risk of virus mutations during manufacturing, resulting in a higher match between the vaccine and circulating virus strains.

Thanks to these advantages, SkyCellflu has secured market authorization in several Asian countries, including Malaysia, Thailand, Myanmar, Iran, and Singapore, and received approval last year in Chile, a key hub in Latin America. SK bioscience plans to further expand SkyCellflu’s global presence based on these market approvals.

Ahn Jae-yong, CEO of SK bioscience, remarked, “It is very encouraging to see vaccines developed with our own technology gaining approval worldwide and opening new export opportunities. With SK's various vaccines, such as those for shingles, chickenpox, and typhoid fever, continuously securing WHO PQ certification and national approvals, we are looking forward to growing as a global vaccine brand beyond Korea.”