Development Pipeline | CHUGAI PHARMACEUTICAL CO., LTD.

Chugai's development pipeline is categorized to Oncology, Neuroscience, Hematology, Ophthalmology, Other diseases, and Response to Requests from the MHLW ... Home InvestorRelations MainProducts/DevelopmentPipeline DevelopmentPipeline Chugai’sdevelopmentpipelineiscategorizedtoOncology,Neuroscience,Hematology,Ophthalmology,Otherdiseases,andResponsetoRequestsfromtheMHLWReviewCommitteeonUnapprovedDrugsandIndicationswithHighMedicalNeeds. ViewthestatusofourcurrentdevelopmentpipelineasofJul21,2022inaPDFformat. DevelopmentPipeline(alldiseaseareas)[PDF448KB] OverviewofDevelopmentPipeline[PDF506KB] Oncology Neuroscience Hematology Ophthalmology Otherdiseases ResponsetoRequestsfromtheMHLWReviewCommitteeonUnapprovedDrugsandIndicationswithHighMedicalNeeds BasicInformationonDevelopmentPipeline**Excludeproductsthathavealreadyobtainedregulatoryapproval Oncology In-house/Roche/Others Modality/Administration Genericname,DevelopmentCode,ModeofAction Indication BasicInformation In-house mid-sizemoleculeOral LUNA18RASinhibitor Solidtumors LUNA18,thefirstprojectinmid-sizemoleculedrugproject,isanorallyadministrablecyclicpeptidemoleculecreatedbyChugai’suniqueAPOLLO*platform.Itinhibitsprotein-proteininteractionbetweenRASandGEFtoretainRASinaninactivestate.LUNA18exhibitsgrowthinhibitoryactivityagainsttumorcellswithvariousRASalterations(mutationsoramplifications)andcanbeexpectedtohaveanti-tumoreffectsagainstcancerswithRASalterationswheretherearenotherapeuticdrugsyet. *APOLLO:Artificial,Peptidic,Orallyavailable,LimitlesslyLocalizableOmicron In-house antibodyIV codrituzumab/GC33Anti-Glypican-3humanizedmonoclonalantibody HCC GC33,ahumanizedmonoclonalantibodycreatedbyChugai,targetsglypican-3(GPC3),whichisspecificallyexpressedinhepatocellularcarcinoma. In-house antibodyIV ERY974Anti-Glypican-3/CD3bispecificantibody Solidtumors ERY974isthefirstT-cellredirectingantibody(TRAB)developedbyChugai.TRABisabispecificantibodythatcreatesashortbridgebetweenCD3onTcellsandtumorantigenontumorcellstoactivateTcellsinatumorantigen-dependentmanner,andisexpectedtodemonstratestrongcytotoxicityagainsttumorcells. In-house antibodyIV STA551Anti-CD137agonisticSwitchantibody Solidtumors STA551,a“switchantibody,”isthefirstapplicationofswitchantibodytechnology,whichwasdevelopedbyChugai.Switchantibodiesbindtothetargetantigenonlywherethereisahighconcentrationofacertain“switch”molecule,whichisconcentratedspecificallyatthediseasedsite.STA551bindstoCD137andactivatesTcellsinthepresenceoftheswitchmoleculeATP,butnotintheabsenceofATP.Itthereforepromisestoactselectivelyontumors. In-house(licensedouttoRoche) antibodyIV SOF10/RG6440Anti-latentTGF-β1monoclonalantibody Solidtumors SOF10,amonoclonalantibodycreatedbyChugai,bindstolatentTGF-β1andinhibittheactivation.Bychangingtheimmunosuppressivetumormicroenvironment,suchasdevelopingfibrosisoftumortissue,ananti-tumoreffectisexpectedagainstcancerswhereanti-cancerdrugsdonotrespond. In-house smallmoleculeOral SPYK04― Solidtumors SPYK04isasmallmoleculedrugdevelopedin-housebyChugai. In-house(licensedoutto3rdparty) smallmoleculeOral CKI27RAF/MEKinhibitor OvariancancerNSCLC CKI27isanoralRAF/MEKinhibitordevelopedin-housebyChugai.InJanuary2020,ChugaigrantedVerastemOncologyanexclusiveworldwidelicensetomanufacture,developandcommercializeCKI27. Roche antibodyIV tiragolumab/RG6058Anti-TIGIThumanmonoclonalantibody NSCLCNSCLC(stageIII)Esophagealcancer RG6058isananti-TIGITmonoclonalantibodyin-licensedfromRoche.TIGITisanimmunecheckpointexpressedonthesurfaceofNKcellsandTcellsthatbindstopoliovirusreceptors(PVR)expressedontumorcellsurfaces.Thisbindingisthoughttoallowthecancercellstoevadeattackbyimmunecells.RG6058restoresandmaintainstheimmuneresponseofNKcellsandTcellsbyblockingthebindingofTIGITtoPVR,andisthusexpectedtodemonstrateefficacyagainstcancercells. Roche antibodyIV mosunetuzumab/RG7828Anti-CD20/CD3bispecificantibody Follicularlymphoma RG7828isabispecificantibodyin-licensedfromRoche.ItisexpectedtoactivateTcellsandattacktumorcellsbycrosslinkingCD3onTcellstoCD20onBcells. Roche antibodyIV cibisatamab/RG7802Anti-CEA/CD3bispecificantibody Solidtumors RG7802,abispecificantibodyin-licensedfromRoche,isexpectedtoactivateTcellsandattacktumorcellsbycrosslinkingCD3onT-cellstocarcinoembryonicantigen(CEA)ontumorcells. Roche antibodyIV glofitamab/RG6026Anti-CD20/CD3bispecificantibody Hematologictumors RG6026isabispecificantibodyin-licensedfromRoche.Bycross-linkingCD3onTcellswithCD20onBcells,itisexpectedtocauseT-cellactivationandproliferationandattackonthetargetBcellsthroughcytokinerelease,resultinginantitumoreffect. Roche antibodyIV RG6194Anti-HER2/CD3bispecificantibody Solidtumors RG6194,ananti-HER2/CD3bispecificantibodyin-licensedfromRoche,isexpectedtoactagainstHER2-expressingcancercellsbyinducingandactivatingTcells. Roche smallmoleculeOral ipatasertib/RG7440AKTinhibitor Prostatecancer RG7440isanAKTinhibitorin-licensedfromRoche. Roche smallmoleculeOral giredestrant/RG6171SelectiveEstrogenReceptorDegrader(SERD) BreastcancerBreastcancer(adjuvant) RG6171isaselectiveestrogenreceptordegrader(SERD)in-licensedfromRoche.Itisexpectedtoexertastrongeranti-estrogeneffectbypromotingthedegradationofERaswellascompetitivelyinhibitingestrogenreceptorbinding. Roche smallmoleculeOral pralsetinib/RG6396RETinhibitor NSCLC RG6396isaRETinhibitordesignedtoselectivelytargetrearrangedduringtransfection(RET)alterations,includingfusionsandmutations,regardlessofthetissueoforigin. Roche smallmoleculeOral cobimetinib/RG7421MEKinhibitor Solidtumors RG7421isanMEKinhibitorin-licensedfromRoche. Neuroscience In-house/Roche/Others Modality/Administration Genericname,DevelopmentCode,ModeofAction Indication BasicInformation In-house(licensedouttoRoche) antibodySC GYM329/RG6237Anti-latentmyostatinsweepingantibody NeuromusculardiseaseSpinalmuscularatrophy GYM329,createdbyChugai,isanext-generationantibodythatappliesChugai’sproprietaryantibodyengineeringtechnologies,includingitsrecyclingantibodyandsweepingantibodytechnologies.Latentmyostatinisaninactiveformthatismainlysecretedfrommusclecells,andisactivatedbyBMP-1andotherproteindegradingenzymes.Activatedmyostatininhibitsmusclegrowthandhypertrophy,andbyinhibitingmyostatin,GYM329isexpectedtoimprovethevariousconditionsassociatedwithmuscleatrophyandlossofmuscularstrength. Roche antibodySC gantenerumab/RG1450Anti-amyloid-betahumanmonoclonalantibody Alzheimer’sdisease RG1450targetsaggregateamyloidbeta,withahighbindingaffinitytoplaquesinparticular.Itisexpectedtoreducecognitivedeteriorationbyremovingamyloidbetainthebrain. Roche antibodyIV prasinezumab/RG7935Anti-α-synucleinmonoclonalantibody Parkinson’sdisease RG7935isamonoclonalantibodythattargetsα-synuclein.Itslowstheexpansionofnervecelldeathbyinhibitingthecell-to-cellpropagationofaggregatedformsofneurotoxicα-synuclein,andisexpectedtoreduceanddelayprogressionofthedisease. Roche antibodyIV semorinemab/RG6100Anti-tauhumanizedmonoclonalantibody Alzheimer’sdisease RG6100bindstotauproteinsfoundintheextracellularspaceofthebrain,andisexpectedtoslowthedeteriorationofcognitivefunctionsinAlzheimer’sdiseasebyhaltingthepropagationoftauvianeurons. Roche antibodyIV RG6102Anti-amyloidbeta/TfR1fusionprotein Alzheimer’sdisease RG6102isgantenerumab(RG1450)withanoveltransferrinreceptor(TfR1)bindingAbmoietytoachieveefficienttransportovertheBBBandtargetAβengagementinthebrain.ItispotentialforsuperiorAβclearanceinbraintodelayprogressionofAlzheimer’sdisease. Roche nucleicacidIV tominersen/RG6042AntisenseoligonucleotidetargetingHTTmRNA Huntington’sdisease RG6042isanASOtargetinghumanHTTmRNA,whichisbelievedtobethecauseofHuntington’sdisease.IthasthepotentialtodelayorslowdiseaseprogressioninpeoplewithHuntington’sdiseasebybindingspecificallytoHTTmRNA,afterwhichsynthesisoftheHTTproteinisinhibited. Roche genetherapyIntramuscularinjection RG6356/SRP-9001Micro-dystrophingenetherapy Duchennemusculardystrophy(DMD) RG6356isaninvestigationalgenetransfertherapydevelopedfortargetedmuscleexpressionofmicro-dystrophin,ashortened,functionaldystrophinprotein,thataddressesthegeneticcauseofDMD.SareptamanagestheglobalstudyincludingJapan. Roche smallmoleculeOral ralmitaront/RG7906PartialTAAR1agonist Schizophrenia RG7906hasthenovelpharmacologicalactionofworkingasapartialagonistoftraceamino-associatedreceptorType1(TAAR1). Hematology In-house/Roche/Others Modality/Administration Genericname,DevelopmentCode,ModeofAction Indication BasicInformation In-house(licensedouttoRoche) antibodySC crovalimab(SKY59)/RG6107Anti-C5recyclingantibody Paroxysmalnocturnalhemoglobinuria(PNH)Atypicalhemolyticuremicsyndrome(aHUS)Chronicsicklecelldisease SKY59isarecyclingantibodydiscoveredbyChugaithatinhibitstheC5complementcomponent.Theonsetofanumberofdiseasesisreportedtobecausedbycomplementactivation.SKY59isexpectedtoinhibitcleavageofC5toC5aandC5b,thussuppressingcomplementactivationandimprovingdiseaseconditions.InPNH,SKY59mayhaveasuppressiveeffectonhemolysisbypreventingthedestructionofredbloodcells.ApplicationofmultipleChugaiproprietaryantibodyengineeringtechnologiesresultedinaprolongedhalf-life,andtheantibodyisbeingdevelopedasasubcutaneousself-injection. In-house antibodySC NXT007Anti-coagulationfactorIXa/Xbispecificantibody HemophiliaA NXT007,createdbyChugai,isabispecificantibodythatstimulatesbloodcoagulationusingthesamemodeofactionasHemlibra.ItisappliedwithChugai’santibodyengineeringtechnologiesFAST-Ig,whichenhanceslarge-scaleproductionofthebispecificantibodyandACT-Fc,whichisexpectedtoimproveantibodypharmacokinetics.NXT007isexpectedtoachievethelevelsofhemostasisfoundinhealthyadultsandchildren,andisbeingdevelopedtoimproveconvenience,includingtheadministrationdevice. Ophthalmology In-house/Roche/Others Modality/Administration Genericname,DevelopmentCode,ModeofAction Indication BasicInformation Roche antibodyinjectionviaimplant ranibizumab(PortDeliverySystem)/RG6321 NeovascularAge-relatedmaculardegeneration(nAMD)Diabeticmacularedema “RG6321”isPortDeliverySystemwithranibizumab.RanibizumabisaFabfragmentofarecombinanthumanizedmonoclonalantibodyagainstvascularendothelialgrowthfactorA(VEGF-A),andisalreadysoldandsuppliedworldwideasLucentis®forintravitrealadministration.Thisproductisexpectedtomaintainvisualacuitywithoutfrequentdosingbythelong-termandsustainedreleaseofranibizumabfromocularimplantwiththehighestformulationconcentration. Otherdiseases In-house/Roche/Others Modality/Administration Genericname,DevelopmentCode,ModeofAction Indication BasicInformation In-house antibodySC AMY109― Endometriosis AMY109isthethirdtherapeuticantibodytoapplytherecyclingantibodyengineeringtechnologycreatedbyChugai.Itsapproachdiffersfromhormonetherapy,whichisthestandardtreatmentforendometriosis,anditsanti-inflammatoryactionisexpectedtoprovidenewvaluetopatients. In-house(licensedoutto3rdparty) antibodySC nemolizumab/CIM331Anti-IL-31receptorAhumanizedmonoclonalantibody AtopicdermatitisPrurigonodularisChronickidneydiseaseassociatedpruritus CIM331(nemolizumab)isananti-IL-31receptorAhumanizedmonoclonalantibodyoriginatingfromChugai.ThedrugisexpectedtoimproveitchingandskininflammationinatopicdermatitisbyblockingIL-31,aproinflammatorycytokine,frombindingtoitsreceptor.InJuly2016,ChugaienteredintoagloballicenseagreementgrantingGaldermaS.A.ofSwitzerlandexclusiverightsforthedevelopmentandmarketingofnemolizumabworldwide,withtheexceptionofJapanandTaiwan.InSeptember2016,ChugaienteredintoalicenseagreementgrantingMaruhoCo.,Ltd.,therightsforthedevelopmentandmarketingofnemolizumabintheskindiseaseareafortheJapanesemarket.InMarch2022,Maruhoreceivedregulatoryapprovalfornemolizumabinthetreatmentofitchingassociatedwithatopicdermatitis(onlywhenexistingtreatmentisinsufficientlyeffective)inJapan.(Productname:Mitchga) In-house(licensedoutto3rdparty) smallmoleculeOral OWL833Oralnon-peptidicGLP-1receptoragonist Type2diabetesObesity OWL833isanoralnon-peptidicGLP-1receptoragonistcreatedbyChugai.GLP-1agonistshavepotenthypoglycemicactionandinduceweightloss,butconvenienceforpatientshasbeenanissuebecausetheyareconventionallyadministeredinasubcutaneousinjection.BecauseOWL833isorallybioavailable,itiseasierforpatientstotake,andisthusexpectedtocontributetothetreatmentofdiabetes,includingthroughimprovementofdrugadherence.InSeptember2018,ChugailicensedtheworldwidedevelopmentandcommercializationrightsforOWL833toEliLillyandCompany. ResponsetoRequestsfromtheMHLWReviewCommitteeonUnapprovedDrugsandIndicationswithHighMedicalNeeds(AsofJuly21,2022) DevelopmentRequest Product Indication DevelopmentStatus Firstdevelopmentrequest Xeloda Advancedorrecurrentgastriccancer ApprovedinFebruary2011 Tarceva Advancedorrecurrentpancreaticcancer ApprovedinJuly2011 Avastin Advancedorrecurrentbreastcancer ApprovedinSeptember2011 CellCept Pediatricrenaltransplant ApprovedinSeptember2011 Herceptin Q3WdosagemetastaticbreastcanceroverexpressingHER2 ApprovedinNovember2011 NeoadjuvantbreastcanceroverexpressingHER2 Kytril Gastrointestinalsymptomsassociatedwithradiotherapy ApprovedinDecember2011 Pulmozyme Improvementofpulmonaryfunctioninpatientswithcysticfibrosis ApprovedinMarch2012 Bactramin Treatmentandpreventionofpneumocystispneumonia ApprovedinAugust2012 Avastin Ovariancancer ApprovedinNovember2013 Seconddevelopmentrequest Avastin Recurrentglioblastoma ApprovedinJune2013(Malignantglioma) Herceptin Q1WdosagepostoperativeadjuvantbreastcanceroverexpressingHER2 ApprovedinJune2013 CellCept Lupusnephritis ApprovedinMay2016 Thirddevelopmentrequest Tamiflu Additionaldosageforneonatesandinfantsyoungerthan12months ApprovedinMarch2017 Xeloda Adjuvantchemotherapyinrectalcancer ApprovedinAugust2016 Avastin AdditionalQ2Wdosageandadministrationforovariancancer ApprovedinJune2022 Fourthdevelopmentrequest Copegus Improvementofviraemiaassociatedwithgenotype3chronichepatitisCorcompensatedcirrhosisrelatedtohepatitisCwhenadministeredincombinationwithsofosbuvir ApprovedinMarch2017 Xeloda Neuroendocrinetumor Submittedcompanyopinionandwaitingforevaluationbycommittee Avastin Cerebraledemainducedbyradiationnecrosis Submittedcompanyopinionandwaitingforevaluationbycommittee Neutrogin Combinationtherapywithchemotherapyincludingfludarabineforrelapsed/refractoryacutemyeloidleukemia ApprovedinJune2022 CellCept Preventionofgraft-versus-hostdiseaseinhematopoieticstemcelltransplantation ApprovedinJune2021 ViewinJapanese Home InvestorRelations MainProducts/DevelopmentPipeline DevelopmentPipeline MainProducts/DevelopmentPipeline MainProducts DevelopmentPipeline AppliedTechnology AboutChugai MessagefromtheCEO Chugai’sFiveStrengths CompanyOutline OurVision OurStrategy HistoryofChugaiPharmaceutical ChugaiGroup R&D DigitalTransformation"CHUGAIDIGITAL" Videos&Advertisements PressRoom News MediaConference InvestorRelations ManagementPolicy FinancialResults Reports&Downloads ShareholderInformation CorporateGovernance ESGatChugai MainProducts/DevelopmentPipeline SeehowChugaicomparestoothercompanies StrategicAlliancewithRoche Chugai’sFiveStrengths Events&Presentations Contacts&Information FAQs Recruitment ChugaiRecruitingSite Sustainability BasicPolicy(CreationofSharedValue) SustainabilityandBusinessStrategy SustainablePatient-CentricHealthcare GlobalHealth HumanResourcesandDiversity&Inclusion EthicsandCompliance SupplyChainManagement HumanRights SocialContribution GlobalEnvironment HealthandProductivityManagement Governance ExternalEvaluations ActivityReports Data Chugai'sTransparencyGuidelines Youarenowmovingtoanexternalwebsite. 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