SK Bioscience Flu Vaccine Obtains Product Approval in Indonesia

SK Bioscience announced on the 23rd that its quadrivalent cell-cultured influenza vaccine, 'Skycellflu4 Quadrivalent Prefilled Syringe,' which was developed as the world's first, recently received final product approval from the Indonesian Food and Drug Monitoring Agency (BPOM). This is the first time a domestically produced influenza vaccine has been approved in Indonesia.

Photo of the export product of SK Bioscience's influenza vaccine 'Skycellflu' [Photo by SK Bioscience]

Indonesia, with a total population of approximately 280 million, ranking fourth in the world by population, has the largest economy in Southeast Asia, and its pharmaceutical market is also rapidly growing. According to the global market research firm Insight Ten, Indonesia's influenza vaccine market size is expected to increase from $38.5 million (about 52.7 billion KRW) in 2022 to $69.1 million (about 92.6 billion KRW) by 2030.

Geographically spanning both the Northern and Southern Hemispheres, Indonesia is uniquely influenced simultaneously by the World Health Organization (WHO)'s influenza vaccination guidelines for both hemispheres. Therefore, continuous vaccine supply is needed from the first half to the second half of the year, and suppliers can expect cost reductions from continuous operation of production facilities. Since SK Bioscience has obtained approval for the influenza vaccine used in the Northern Hemisphere, it is expected that approval for the Southern Hemisphere influenza vaccine by Indonesian health authorities will also proceed quickly.

Skycellflu is an influenza vaccine that has demonstrated excellent immunogenicity and safety through clinical trials and is the world's first cell-cultured influenza vaccine to receive WHO prequalification (PQ) certification. It is also the only influenza vaccine currently available domestically that uses the cell-cultured method. The cell-cultured method does not use fertilized eggs, making it relatively safe for people with egg allergies to receive the vaccine, and the production period is relatively short, allowing for rapid production in emergencies such as pandemics. Additionally, in terms of stability, the possibility of virus mutation during production is lower compared to vaccines produced using fertilized eggs.

In fact, in SK Bioscience's own research, when 15 serial passages were conducted using both the cells for Skycellflu production (cell-cultured method) and fertilized eggs, mutations were found in three viral proteins in the fertilized egg method, whereas no mutations were detected in the cells used for Skycellflu production. This research result was officially presented at the 2019 Korea Influenza Scientific Working Group Symposium (KIWI).

Building on these strengths, Skycellflu has consecutively obtained product approvals in Asian countries such as Malaysia, Thailand, Myanmar, Iran, Singapore, Pakistan, Mongolia, and Brunei, and last year it was approved in Chile, a major hub in Latin America.

Ahn Jae-yong, CEO of SK Bioscience, said, “It is very encouraging that vaccines developed with our technology are being approved worldwide and opening export routes. Not only for influenza but also for various SK vaccines such as shingles, chickenpox, and typhoid, which are continuously securing WHO PQ certification and country-specific approvals, please look forward to our growth as a global vaccine brand beyond Korea.”

This content was produced with the assistance of AI translation services.