Meiji Seika Pharma Receives Approval for Adding Domestic Manufacturing Sites in Japan for KOSTAIVE®, a Self-amplifying mRNA Vaccine Against COVID-19

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TOKYO --(BUSINESS WIRE)-- Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan , President and Representative Director: Daikichiro Kobayashi) announced today that it 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 domestic manufacturing sites in Japan . Meiji Seika Pharma and ARCALIS Co., Ltd. (Headquarters: Minami-soma City, Fukushima Prefecture; President: Satoshi Takamatsu ) have been working together to establish an infrastructure that enables the integrated production of pharmaceuticals, from active ingredients to final products, within Japan . With this approval, ARCALIS’s Minami-soma facilities and Meiji Seika Pharmatech Co., Ltd. , a subsidiary of Meiji Seika Pharma , have been added as manufacturing sites. The technology transfer was managed and implemented by CSL Seqirus, the global licensor of KOSTAIVE®. As a result, domestically produced products, with active pharmaceutical ingredients manufactured at ARCALIS's Minami-soma facilities and formulated at Meiji Seika Pharmatech, are now able to be shipped for commercial use in Japan . “We are pleased with the approval of domestic manufacturing sites in Japan for KOSTAIVE®,” said Dr. Pad Chivukula, COO of Arcturus Therapeutics . “As a joint venture partner with ARCALIS , Arcturus is delighted to support this effort through the continued transfer of our next-generation technologies, including LUNAR® lipid nanoparticle formulation processes and STARR® sa-mRNA drug substance manufacturing.” About sa-mRNA mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response. About Meiji Seika Pharma Meiji Seika Pharma , since it launched penicillin in 1946, has been providing efficacious and high-quality pharmaceutical products including therapeutics and vaccines for infectious diseases, therapeutics for central nervous system diseases and generic drugs, to meet various medical needs. ( https://www.meiji.com/global/pharmaceuticals/ ) About Arcturus Therapeutics Arcturus Therapeutics Holdings Inc. , founded in 2013, is a commercial mRNA Medicines and vaccines Company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases. ( https://arcturusrx.com/ ) About CSL Seqirus CSL Seqirus, a subsidiary of CSL Limited, is one of the world's largest suppliers of influenza vaccines. The company has state-of-the-art manufacturing facilities in the U.S. , U.K. , and Australia , and leading research and development capabilities. ( https://www.cslseqirus.com ) About ARCALIS ARCALIS, Inc. is a joint venture company between Axcelead Inc. and Arcturus Therapeutics Inc. , which owns a group of world-class drug-discovery and healthcare platform companies. The company provides drug discovery support, as well as a contract development and manufacturing business (CDMO business), for mRNA medicines and vaccines. ( https://corp.arcalis.co.jp/en ) View source version on businesswire.com : https://www.businesswire.com/news/home/20250131312981/en/ Meiji Seika Pharma Public Relations Sayoko Taga [email protected] Arcturus Therapeutics Public Relations & Investor Relations Neda Safarzadeh VP, Head of IR/PR/Marketing (858) 900-2682 [email protected] Source: Arcturus Therapeutics Holdings Inc.

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