News & Events

Nov 28, 2023

Meiji Seika Pharma Receives Manufacturing and Marketing Approval of “ARCT-154”, Self-Amplifying mRNA Vaccine against COVID-19, from MHLW in Japan

Meiji Seika Pharma Co., Ltd. has received approval for the manufacturing and marketing of “Kostaive™TM for Intramuscular Injection” (ARCT-154), a self-amplifying mRNA vaccine against COVID-19, from the Ministry of Health, Labour and Welfare (MHLW) in Japan. Kostaive™TM is indicated for prevention of COVID-19 by primary immunization (2 doses) and booster immunization (1 dose) in adults(1dose) in adults. This is the world’s first approved replicon vaccine applying self-amplifying mRNA technology.

Press release of Meiji Holdings;

Under the agreement with CSL Seqirus signed on 11 April (press release: https://www.axcelead-hd.com/1282/), Meiji Seika Pharma will be responsible for obtaining marketing authorisation, distribution and sales of ARCT-154 in Japan.
ARC-154 will be produced in our mRNA drug manufacturing facility in Minamisoma City, Fukushima Prefecture, from drug substance to drug product in Japan.


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