Sumitomo Dainippon Pharma Annual Report 2017

Brand name /Product codeGeneric nameProposed indicationDevelopment locationSubmittedPhase 1Phase 3Phase 2(As of July 28, 2017)SUN-101glycopyrronium bromideChronic obstructive pulmonary disease (COPD)U.S.Respiratory AreaOther AreasDSP-1747obeticholic acidNonalcoholic steatohepatitis (NASH)JapanDSP-6952TBDIBS with constipation, Chronic idiopathic constipationJapanAMD(age-related macular degeneration)Parkinson’s disease(Designated as a “SAKIGAKE” Product in Feb. 2017)Retinitis pigmentosaSpinal Cord InjuryChronic StrokeSanBioAlloMSCNorth AmericaAlloiPS cellJapanAlloiPS cellGlobalAlloiPS cellGlobalAlloiPS cellGlobalRIKENKeio UnivOsaka National HospitalHealiosRIKENKyoto UnivCiRAPartneringRegion(planned)Cell type2017201820192020-2022Schedule for practical use (Calendar year)Clinical researchApproval TargetApproval Target(As of July 28, 2017)* Start of clinical studies originally scheduled in 2017 may be delayed due to changes in non-clinical study plans.*Phase 3Phase 2bInvestigator-initiated clinical studyClinical researchClinical researchInvestigator or corporate initiated clinical studyOther AreasRegenerative Medicine / Cell Therapy FieldGlycopyrronium bromide (SUN-101)SUN-101 is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the proprietary investigational eFlow® closed system nebulizer. A New Drug Application was submitted to the U.S. Food and Drug Administration (FDA) for In the regenerative medicine and cell therapy field, we are pursuing multiple R&D projects aiming for early commercialization.Furthermore, establishing manufacturing capability for regenerative medicines is one of the highest priority issues ahead of practical use. Consequently, we started construction of a cell production and processing facility at our Central Research Laboratories (Suita, Osaka), with the objective of commencing operations during fiscal 2017.the long-term, maintenance treatment of chronic obstructive pulmonary disease (COPD). In May 2017, we received a Complete Response Letter from the FDA, and we resubmitted the NDA to address the requests indicated in the letter in June. We are preparing for product launch during fiscal 2017.Regenerative Medicine / Cell Therapy Business PlanResearch & Development25Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017

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