Pipeline (as of July 2018) - 塩野義製薬

1 Pipeline (as of July 2018) AreasCode No.(Generic name)[Product name]Category(Administration)IndicationS tageOriginDevelopmentS-649266(Cefideroco l TosilateSulfate Hydrate)Cephem antibiotic(injection)Multidrug-resistant Gram-negative bacterialinfectionsGlobal: Phase IIIUSA: NDA submission(in preparation)In-houseIn-houseS-033188(bal oxavir marboxil)[Japan:Xofluza ]Anti-influenza virusinfection(oral)Influenza virus infectionJapan: Approval( )USA: NDA (Apr. 2018) Taiwan: NDA (Jun. 2018) Global: Phase IIIIn-houseShionogi/Roche(Switzerland)S- 033188(baloxavir marboxil)[Japan:Xofluza ]Anti-influenza virusinfection(oral, granule)Influenza virus infection Japan: NDA (Apr. 2018) In-houseShionogi/Roche(Switzerland) S-297995(naldemedine tosilate)[Symproic ]Peripheral opioidreceptor antagonist(oral)Opioid-inducedconstipati onUSA, Japan: Approval( )Europe:MAA submission( )In-houseIn-houseS-877489(lisdexamfetami nemesilate)DA and NE reuptakeinhibitor/releaser of DA,NE(oral)ADHD (pediatric)Japan: NDA submission( )Shire (Ireland)Shionogi/ShireS-877503(guanfaci nehydrochloride)[Intuniv ]Alpha-2A-adrenergicreceptor agonist(oral)ADHD (adult)Japan: Phase IIIS hire (Ireland)Shionogi/ShireS-120083 Analgesic agent forinflammatory pain(oral)Inflammatory painJapan: Phase IUSA: Phase IIShionogi/PurduePharma (USA)Shionogi/PurduePharma agent forneuropathic pain(oral)Neuropathic painJapan: Phase IIn-houseIn-houseS-117957 Agent for insomnia(oral)InsomniaUSA.

2 Phase IShionogi/PurduePharma (USA)Shionogi/PurduePharma agent forneuropathic pain(oral)Neuropathic painJapan: Phase IIn-houseIn-houseS-600918 Antitussive agent (oral) Refractory/unexpectedchronic coughJapan: Phase IIIn-houseIn-houseS-637880 Analgesic agent forneuropathic pain(oral)Neuropathic painJapan: Phase IIn-houseIn-houseLY248686(duloxetinehydr ochloride) Cymbalta SNRI (Serotonin norepinephrine reuptakeinhibitors)(oral)Depression (pediatric)Japan: Phase IIIEli Lilly(USA)Shionogi/Eli LillyJapan Y Y5receptor antagonist(oral)ObesityJapan: Phase IIUSA: Phase IIn-houseIn-houseS-707106 Insulin sensitizer(oral)Type 2 diabetesUSA: Phase IIaIn-houseIn-houseInfectiousdiseasePain /CNSM etabolicdisorderS-888711(lusutrombopag)[ Japan: Mulpleta ]Thrombopoetin (TPO)receptor agonist(oral)Thrombocytopeniaassociated with chronicliver diseaseJapan: Approval( )USA: NDA submission( )Europe:MAAsubmission( )In-houseIn-houseS-588410 Cancer peptide vaccine(injection)Esophageal cancerJapan: Phase IIIOncoTherapyScience, Inc.

3 (J)In-houseS-588410 Cancer peptide vaccine(injection)Bladder cancerJapan, Europe: Phase IIOncoTherapyScience, tablet ofJapanese cedar allergenextracts forimmunotherapy(sublingual)Allergic rhinitis causedby Japanese cedarallergenJapan: Phase IIStallergenes(France)In-houseS-488210 Cancer peptide vaccine(injection)Head and necksquamous cellcarcinomaEurope: Phase I/IIOncoTherapyScience, Inc.(Japan)In-houseS-222611(epertinib)HE R2/EGFR dualinhibitor(oral)Malignant tumorEurope: Phase I/IIIn-houseIn-houseS-770108 Anti-fibrosis(inhalation)Idiopathic pulmonaryfibrosisJapan: Phase IIn-houseIn-houseSR-0379 Cutaneous ulcer(topical)Cutaneous ulcer(Pressure ulcer, Diabeticulcer)Japan: Phase IIFunPep (Japan)In-houseS-005151 Stroke (injection)StrokeJapan: Phase IStemRIM (Japan)In-houseFrontierCategory(Administ ration)IndicationStageOriginDevelopmentI ntegrase inhibitor(oral)For the treatment of HIVinfection(DTG/rilpivirine 2-drug fixed dosecombination tablet)USA: Approved ( )Europe: Approved ( )(DTG/3TC 2-drug fixed dosecombination tablet for na ve patients)Global: Phase III(DTG+3TC 2-drug fixed dosecombination tablet for maintenancetherapy)Global: Phase IIIS hionogi-ViiVHealthcare LLCViiv Healthcare Ltd.

4 (UK)Integrase inhibitor(injection)For the treatment andprevention for HIVinfectionGlobal: Phase III (treatment)Global: Phase III (prevention)Shionogi-ViiVHealthcare LLCViiV Healthcare Ltd.(UK) for treatmentCollaboration amongViiV, HPTN, NIAIDand Gilead Sciences,Inc. (USA) forpreventionNon-peptide mimeticof TRH(oral)Spinocerebellar ataxiaJapan: Phase IIIIn-houseKissei PharmaceuticalCo., Ltd. (Japan)Selective estrogenreceptor modulator(oral)Vaginal drynessassociated withpostmenopausal VVAUSA: NDA submission( )QuatRx (USA)Duchesnay(Canada)Category(Administr ation)IndicationStageOriginDevelopmentNa tural opiumalkaloids(oral)For the treatment ofmoderate to severechronic painJapan: NDA submission( )Japan: Phase IIINappPharmaceuticalsLimited (UK)In-houseCompound erasedfrom the listS-033188(pediatric): Approval( )S-524101: Approval( )Janssen/Shionogi BACE inhibitor: Stop development( )Change of phaseS-033188:USA: NDA submission(in preparation) Global: Phase III USA: NDA submission( ) Taiwan: NDA submission( ) Global: Phase IIIS/GSK1349572 (DTG/rilpivirine 2-drug fixed dose combination tablet): Europe:MAA submission( ) Europe: Approved( )S/GSK1349572 (DTG/3TC 2-drug fixed dose combination tablet for maintenance therapy) Global.

5 Phase IIIO xycodone hydrochloride hydrate Japan: NDA submission( ) Japan: NDA submission( ) Japan:Phase IIIC ompound added tothe listS-600918(Refractory/unexpected chronic cough) : Japan: Phase IISR-0379: Japan: Phase IIS-005151: Japan: Phase I*: Long acting parenteral formulation<Drugs to acquire new indication requested by the Ministry of Health, Labour and Welfare>Generic name[Product name]Oxycodonehydrochloridehydrate[OxyCo ntin ]Since May 2018<Out-Licensing Activity>Code No.(Generic name)S/GSK1349572(dolutegravir)S/GSK1265 744 LAP*(cabotegravir)S-0373 Ospemifene[USA: Osphena]