Meiji Seika Pharma Co., Ltd. (hereafter “Meiji Seika Pharma”) has received approval for a partial amendment to the manufacturing and marketing approval of “KOSTAIVE® for Intramuscular Injection”, a self-amplifying mRNA vaccine for protection against COVID-19, to include ARCALIS Minamisoma drug substance facility as one of the domestic manufacturing sites in Japan. KOSTAIVE® was generated by Arcturus Therapeutics, a major shareholder of our company, and Meiji Seika Pharma has received the manufacturing and marketing approval for the vaccine from the Ministry of Health, Labour and Welfare in Japan.
In collaboration with Meiji Seika Pharma, we are building an integrated domestic production system that covers the entire process from drug substance to drug product. Meiji Seika Pharma plans to start shipping domestically produced “KOSTAIVE^®”, using drug substances manufactured at our facility.

News Release of Meiji Seika Pharma
https://www.meiji.com/global/news/2025/pdf/250131_01.pdf