FY2022 Q3 Financial and R&D Update slide image

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 29 29
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