Daiichi Sankyo Seeks Approval In Japan For Its mRNA-Based COVID-19 Vaccine

Author: Vandana Singh | January 13, 2023 12:16pm

Daiichi Sankyo (OTC:DSKYF) (OTC:DSNKY) has filed for marketing approval of DS-5670 to the regulatory authorities in Japan. DS-5670 is an mRNA COVID-19 vaccine proposed as a booster vaccine to prevent COVID-19.
The application is based on the results of a phase 1/2/3 trial (original strain) in approximately 5,000 healthy adult and elderly subjects who received the primary series (two doses) of an mRNA vaccine approved in Japan.
Daiichi Sankyo started prior assessment consultations for drugs with the Pharmaceuticals and Medical Devices Agency in September 2022 based on non-clinical, clinical, and quality data available to obtain marketing approval earlier.
In addition, Daiichi Sankyo plans to develop DS-5670 for the Omicron strain to respond to new variants of the coronavirus in parallel with the development for the original strain.
DS-5670 uses a novel nucleic acid delivery technology discovered by Daiichi Sankyo, designed to produce antibodies against the receptor binding domain (RBD) of the spike protein of the novel coronavirus.
Furthermore, Daiichi Sankyo aims for mRNA vaccines that can be distributed in refrigerated temperatures (2-8°C).
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