mRNA Vaccine/Daiichi Sankyo:DS-5670販売を申請！
Demande de vente du DS-5670!
Antrag auf Verkauf von DS-5670!
Application for sales of DS-5670!
mRNA疫苗/第一三共：申請銷售DS-5670！
ー新型コロナ感染症で、日本製のｍＲＮＡワクチンー
第一三共：
2023/01/13
ー新型コロナウイルス感染症に対するｍＲＮＡワクチンー
ＤＳ－５６７０について、日本国内製造販売承認を申請した。
ＤＳ－５６７０
ｍＲＮＡワクチン
- ＤＳ－５６７０ワクチンは、
- 国内既承認ｍＲＮＡワクチン（起源株）の、
- 初回免疫（２回接種）完了後の、追加免疫用ワクチンです。
日本メーカーとして初の、mRNA COVID-19 ワクチンが登場した。
https://minkabu.jp/news/3491022
Vaccin ARNm/Daiichi Sankyo : Demande de vente du DS-5670 !
-Vaccin ARNM fabriqué au Japon pour une nouvelle infection corona-
Daiichi Sankyo :
2023/01/13
-vaccin à ARNm contre une nouvelle infection à coronavirus-
Nous avons demandé l’autorisation de fabrication et de commercialisation au Japon pour le DS-5670.
DS-5670
vaccin ARNm
Le vaccin DS-5670 est
Vaccin à ARNm approuvé au pays (souche d’origine),
Il s’agit d’un vaccin de rappel après avoir terminé la première immunisation (2 doses).
Le premier vaccin ARNm COVID-19 d’un fabricant japonais est apparu.
mRNA Vaccine/Daiichi Sankyo: Antrag auf Verkauf von DS-5670!
-In Japan hergestellter MRNA-Impfstoff gegen neue Koronainfektion-
Daiichi Sankyo:
13.01.2023
-mRNA-Impfstoff gegen neue Coronavirus-Infektion-
Wir haben die Herstellungs- und Vermarktungsgenehmigung in Japan für DS-5670 beantragt.
DS-5670
mRNA-Impfstoff
Der DS-5670-Impfstoff ist
Im Inland zugelassener mRNA-Impfstoff (Ursprungsstamm),
Dies ist eine Auffrischimpfung nach Abschluss der ersten Immunisierung (2 Dosen).
Der erste mRNA-COVID-19-Impfstoff eines japanischen Herstellers ist erschienen.
Daiichi Sankyo Submits Application for Marketing Approval of mRNA COVID-19 Vaccine (DS-5670) in Japan
Tokyo, Japan – (January 13, 2023) –
Daiichi Sankyo (TSE: 4568)
today announced the submission of an application for marketing approval of DS-5670 to the regulatory authorities in Japan.
DS-5670 is an mRNA vaccine,
being developed against the novel coronavirus infectious disease (COVID-19) and is proposed to be used as a booster vaccine for the prevention of COVID-19.
The application
is based on 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 up to now to obtain marketing approval at an earlier date.
In addition,
Daiichi Sankyo plans to move forward with the development of DS-5670 for the Omicron strain in order to respond to new variants of the coronavirus,
which continue to mutate,
in parallel with the development for the original strain.
Daiichi Sankyo is striving
to establish mRNA-vaccine-related technologies and the production and supply system in Japan
to ensure a prompt provision of vaccines in the event of outbreaks of emerging and reemerging infectious diseases, thereby contributing to protect safety and security in society and people’s health.
About DS-5670
DS-5670 is an mRNA vaccine
against COVID-19 using 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,
and thus expected to have safety and desirable prevention against COVID- 19.
Furthermore,
Daiichi Sankyo is aiming for mRNA vaccines that can be distributed in the refrigerated temperature range (2-8°C).
The clinical development of DS-5670
is being conducted through the “Vaccine development project”
promoted by the Japan Agency for Medical Research and Development and the “Urgent improvement
https://www.daiichisankyo.com/files/news/pressrelease/pdf/202301/20230113_E.pdf