Meiji Seika Pharma receives Japan approval for two-dose vial of KOSTAIVE® COVID-19 vaccine

Arcturus Therapeutics Holdings Inc.

Approval granted August 28, 2025 for new two-dose vial presentation of KOSTAIVE® (ARCT-2301) in Japan.
Vaccine targets SARS-CoV-2 Omicron sub lineage JN.1 variant XEC; induces neutralizing antibodies against multiple variants.
Meiji Seika Pharma plans to begin supply of the new presentation starting late September 2025.
Non-clinical data shows neutralizing antibodies against JN.1, XEC, LP.8.1, XFG, and NB.1.8.1 variants.
Distribution in Japan is under a prior agreement between Meiji and CSL Seqirus, partner of Arcturus.

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