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.”
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