Investor Presentaiton
Appendix (Research and Development)
Main Events / Targets for FY2022 (as of May 15, 2023)
Psychiatry
&
Neurology
✓ ulotaront
(SEP-363856)
✓
✓ Completed action/target
Revisions since the announcement of January 2023 are shown in red
Adjunctive major depressive disorder
✓ Generalized anxiety disorder
Start clinical studies for two new indications
Advance Phase 3 study in the U.S. and Phase 2/3 study in Japan and China for schizophrenia
SEP-4199: Advance Phase 3 studies for Bipolar I depression
Oncology
☑ relugolix (Europe) Obtain approval for prostate cancer
Advance early Phase studies
Regenerative ☐ Allogeneic iPS cell-derived products (AMD: age-related macular degeneration): Start clinical study in Japan
Allogeneic iPS cell-derived products (Parkinson's disease): Start clinical study in the U.S.
medicine/
Cell therapy
Infectious
Diseases
Others
Frontier
✓
Start construction of manufacturing plant in the U.S (for RETHYMICⓇ and allogeneic iPS cell-derived products)
KSP-1007 (Antimicrobial resistance) : Complete Phase 1 study in the U.S.
universal influenza vaccine, malaria vaccines: Promote joint research and development projects
relugolix : (U.S.)
(Europe)
Obtain approval for endometriosis
Submit MAA for endometriosis
✓ Launch products: ✓ (Japan) MELTz Neurorehabilitation device for hand/fingers
(U.S.) VR contents for mental health (brand name: First Resort, general wellness product)
Promoting the current themes and generating evidence data for maximizing the value of the launched products:
Digital device for relieving BPSD, etc.
Sumitomo Pharma
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