The Microbiological Validation Support Center has launched joint development with Baxdime and the Catholic University of Korea Medical School.

The Jeonnam Hwasun Microbiology Demonstration Support Center (Director Jo Min, hereinafter referred to as the Center) announced on the 3rd that it will jointly develop a 'next-generation Japanese encephalitis vaccine' with Baxdime (CEO Kim Seong-jae) and the Catholic University of Korea College of Medicine, Department of Microbiology (Professor Seo Sang-wook's research team).

The center plans to upgrade its processes to enable mass production in GMP facilities by the first half of 2025, based on research results secured by Baxdime and the Catholic University of Korea's Department of Microbiology. This development phase is particularly crucial in the entire new drug development cycle, as vaccine safety and approval are determined during the clinical trial phase.

This next-generation Japanese encephalitis vaccine utilizes recombinant virus-like particle production technology, offering superior productivity and quality control compared to existing first-generation live and killed vaccines. Furthermore, with the recent publication of research findings showing that existing vaccines are ineffective against the currently prevalent Japanese encephalitis virus type 5 strain, the need for next-generation vaccine development has become even more urgent.

Founded in 2021, Vaxdime is a bio-venture company leading the development of innovative vaccines based on its "microorganism-based rapid protein antigen production source technology." Based on its proven technology, which offers higher safety and cost-effectiveness compared to existing vaccines, Vaxdime possesses the fundamental technology to address emerging infectious diseases, earning recognition for its competitiveness in the next-generation vaccine market. In addition to the Japanese encephalitis vaccine, the company is focusing on developing future pandemic vaccines, including influenza vaccines.

Since its establishment in 2017 with support from the Ministry of Trade, Industry and Energy and Hwasun County, Jeollanam-do, the center has successfully completed process development for over 30 products, demonstrating its confidence in this project. Recently, the center renewed its GMP compliance certificate in November 2024, strengthening its role as a public CDMO (Contract Development and Manufacturing Organization).

Baxdime and the Catholic University of Korea's Department of Microbiology, led by Professor Sang-Wook Seo, announced that they will submit an investigational new drug (IND) application to the Ministry of Food and Drug Safety in 2025. They emphasized the imperative for developing a new vaccine, given recent research confirming the high fatality rate of Japanese encephalitis type 5 virus prevalent in Korea and the low protective efficacy of existing vaccines.

Meanwhile, according to UNICEF's Japanese encephalitis market report, the Japanese encephalitis vaccine market size is projected to grow from KRW 3.2 trillion in 2023 to KRW 5.5 trillion in 2031. The development of this next-generation vaccine is expected to meet this market demand.


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