Meiji Seika Pharma Co., Ltd. (hereafter “Meiji Seika Pharma”) has submitted an application 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 including the Omicron subvariant JN.1, to include domestic manufacturing sites in Japan. KOSTAIVE^® was generated by Arcturus Therapeutics, a major shareholder of our group company, ARCALIS, 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, in December 2024.

News Release of Meiji Seika Pharma
https://www.meiji.com/global/news/2024/pdf/241001_01.pdf