ARCALIS Inc. (Head office: Kashiwa, Chiba; President & CEO: Tomoyuki Fujisawa; “ARCALIS”)  announced today that the construction plan of ARCALIS mRNA therapeutics and vaccine manufacturing facility had been adopted for the subsidy of “Project for Establishment of Biopharmaceutical Manufacturing Facilities to Strengthen the Vaccine Production System *1( “Project”),” publicly solicited by the Ministry of Economy, Trade and Industry. This construction plan is a joint project with Meiji Seika Pharma Inc. (Head Office: Chuo-ku, Tokyo; President: Daikichiro Kobayashi; “Meiji Seika Pharma”).

Under this adoption, ARCALIS constructs an Formulation and Fill-finished product plant next to Drug Substance plant^＊2 (Minamisoma-city Fukushima) to enable ARCALIS to accelerate the establishment of an integrated manufacturing value chain for mRNA drug substance and vaccine production. 

Subsidized Projects	mRNA therapeutics and vaccine formulation production plant construction plan mRNA
Overview of Normal time and Emergency-time Production	＜Normal-Operation＞ Contract manufacturing of APIs/formulations for clinical trials and commercial use of mRNA therapeutics and vaccines   ＜Emergency-Operation＞ Production of mRNA vaccines for contingency pandemic
Construction Period	Completion of the project by the end of 2026 after the decision to subsidize

^＊1 About “Project for Establishment of Biopharmaceutical Manufacturing Facilities to Strengthen the Vaccine Production System”

In order to prepare for infectious diseases that may become a threat in the future, this project supports the introduction of facilities to establish bases with dual-use facilities that can manufacture biopharmaceuticals according to the needs of companies in normal times and switch to vaccine production in the event of an infectious disease pandemic, as well as equipment installation support for the introduction of facilities for the development of bases equipped with vaccine formulation and filling facilities and part material production facilities for the pharmaceutical products.

^＊2 About ARCALIS Minamisoma Plant 

As a CDMO for mRNA therapeutics and vaccines, ARCALIS has started construction of an API manufacturing plant in Minamisoma City. From July 2023, we are working to establish a manufacturing system for the API for Replicon Vaccine (next-generation mRNA vaccine) developed by one of our founding shareholders, Arcturus Therapeutics, Inc. The company has already started construction of an API manufacturing plant in Minamisoma City, Fukushima Prefecture, Japan.