FY2022 Q3 Financial and R&D Update
DS-5670
Current development status
TLR of Ph1/2/3 booster vaccination study obtained in Nov 2022, regulatory
submission in Japan achieved in Jan 2023
FY2022
H1
■ Development of booster vaccination (Original strain)
- TLR of Ph1/2/3 study part 2 was obtained in Nov 2022 and primary endpoint was
achieved
- Regulatory submission in Japan was achieved in Jan 2023
FY2023
H1
H2
H2
Booster vaccination Ph1/2/3 study
Primary vaccination Ph3 study
Subvariant vaccine
Ph3 study
Development of primary vaccination (Original strain)
-
- Sep 2022: Ph3 study started in Japan
Primary vaccination Ph3 study
Subjects: Healthy adults with no history of COVID-19 vaccination
Confirm non-inferiority of neutralizing antibodies against SARS-CoV-2 (original strain) levels in blood for
DS-5670 to ComirnatyⓇ
■Development of BA.4-5 subvariant vaccine
- Planning to start clinical study in FY2023 H1
The clinical development of DS-5670 is being conducted through "Vaccine development project" promoted by the Japan Agency for Medical Research and
Development (AMED) and "Urgent improvement project for vaccine manufacturing systems" supported by the Ministry of Health, Labour and Welfare (MHLW)
Daiichi-Sankyo
TLR: top line results
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