Ankylosingselected
selected 时间:2021-05-21 阅读:()
Item4.
InformationontheCompany1SelecteddevelopmentprojectsYearprojectenteredFormulation/currentPlannedfilingProject/CommonMechanismBusinessrouteofdevelopmentdates/currentproductnameofactionPotentialindicationfranchiseadministrationphasephaseABL001asciminibBCRABLinhibitorChronicmyeloidleukemia,3rdlineOncologyOral20162021/IIIACZ885canakinumabAntiinterleukin1beta2ndlinenonsmallcelllungcancerOncologySubcutaneousinjection20172021/IIImonoclonalantibody1stlinenonsmallcelllungcancerOncologySubcutaneousinjection20172021/IIIAdjuvantnonsmallcelllungcancerOncologySubcutaneousinjection20172022/IIIAVXS1011onasemno-SurvivalmotorneuronSpinalmuscularatrophyNeuroscienceIntravenousinfusion2018USapprovedgeneabepar-(SMN)gene(IVformulation)EUregistrationvovecreplacementtherapySpinalmuscularatrophyNeuroscienceIntrathecalinjection20182020/I(ITformulation)2AVXS201TBDMethylCpGbindingRettsyndromeNeuroscienceIntrathecalinjection20182023/Iprotein2(MECP2)genereplacementtherapyBYL7193alpelisibPI3KalphainhibitorPIK3CAmutanthormonereceptorpositiveOncologyOral2018USapproved(HR+)/humanepidermalgrowthfactorEUregistrationreceptor2negative(HER2)postmenopausaladvancedbreastcancer,2ndline(+fulvestrant)PIK3CA-relatedovergrowthspectrumOncologyOral20192020/IIITriplenegativebreastcancerOncologyOral20192023/IIIHormonereceptor-negative(HR-)/humanOncologyOral20192023/IIIepidermalgrowthfactorreceptor2-positive(HER2+)advancedbreastcancerOvariancancerOncologyOral20192023/IIIHeadandnecksquamouscellcarcinomaOncologyOral2019≥2024/IIICEE321TBDPan-JAKinhibitorAtopicdermatitisImmunology,Topical2019≥2024/IIHepatologyandDermatologyCFZ533iscalimabBlocking,nondepleting,SolidorgantransplantationImmunology,Intravenousinfusion20172023/IIantiCD40monoclonalHepatologyandantibodyDermatologySjgren'ssyndromeImmunology,Intravenousinfusion2018≥2024/IIHepatologyandDermatologyCosentyxsecukinumabAntiinterleukin17NonradiographicaxialspondyloarthritisImmunology,Subcutaneousinjection2015US/EUmonoclonalantibodyHepatologyandregistrationDermatologyPsoriaticarthritisheadtoheadstudyImmunology,Subcutaneousinjection20152020/IIIversusHumira(adalimumab)HepatologyandDermatologyAnkylosingspondylitisheadtoheadstudyImmunology,Subcutaneousinjection20152022/IIIversusSandozbiosimilarHyrimozHepatologyand(adalimumab)DermatologyHidradenitissuppurativaImmunology,Intravenousinfusion20172022/IIIHepatologyandDermatologyGiantcellarteritisImmunology,Intravenousinfusion2018≥2024/IIHepatologyandDermatologyLichenplanusImmunology,Intravenousinfusion2019≥2024/IIHepatologyandDermatologyCSJ117TBDAntithymicstromalSevereasthmaRespiratoryInhalation20182023/IIlymphopoietinmonoclonalantibodyfragmentECF843TBDBoundarylubricantDryeyeOphthalmologyEyedrops20172022/IIEntrestovalsartanandAngiotensinreceptor/ChronicheartfailurewithpreservedCardiovascular,Oral20122020/IIIsacubitrilneprilysininhibitorejectionfractionRenal(assodiumandMetabolismsaltcomplex)PostacutemyocardialinfarctionCardiovascular,Oral20152021/IIIRenalandMetabolism1ApprovedintheUSasZolgensmaforspinalmuscularatrophy(IVformulation)2TheFDAhasplacedapartialclinicalholdonAVXS-101intrathecaltrialsforspinalmuscularatrophypatientsbasedonfindingsinasmallpreclinicalanimalstudy.
3ApprovedintheUSasPiqrayforPIK3CAmutantHR+/HER2-postmenopausaladvancedbreastcancer,2ndline(+fulvestrant)Item4.
InformationontheCompany2YearprojectenteredFormulation/currentPlannedfilingProject/CommonMechanismBusinessrouteofdevelopmentdates/currentproductnameofactionPotentialindicationfranchiseadministrationphasephaseINC280capmatinibc-METinhibitorNonsmallcelllungcancerOncologyOral2014USregistrationSolidtumorsOncologyOral2019≥2024/IIJakaviruxolitinibJAK1/2inhibitorAcutegraftversushostdiseaseOncologyOral20162021/IIIChronicgraftversushostdiseaseOncologyOral20162021/IIIKAE609cipargaminPfATP4inhibitorMalariaEstablishedOral2012≥2024/IIMedicinesSeveremalariaEstablishedOral2019≥2024/IIMedicinesKAF156ganaplacideImidazolopiperazinesMalariaEstablishedOral2014≥2024/IIderivativeMedicinesKisqaliribociclibCDK4/6inhibitorHR+/HER2breastcancer(adjuvant)OncologyOral20182022/IIIKJX839inclisiranSmall-interferingRNAHyperlipidemiaCardiovascular,Subcutaneousinjection2019US/EU(PCSK9)RenalregistrationandMetabolismSecondarypreventionofcardiovascularCardiovascular,Subcutaneousinjection2019≥2024/IIIeventsinpatientswithelevatedlevelsRenalofLDL-CandMetabolismKymriahtisagen-CD19targetedchimericRelapsed/refractoryfollicularlymphomaOncologyIntravenousinfusion20172021/IIlecleucelantigenreceptorTcellimmunotherapyRelapsed/refractorydiffuselargeBcellOncologyIntravenousinfusion20182021/IIIlymphomain1strelapseRelapsed/refractorydiffuselargeBcellOncologyIntravenousinfusion2017≥2024/IIlymphoma(+pembrolizumab)LAM320clofazimineMycobacterialMultidrugresistanttuberculosisEstablishedOral20162021/IIIDNAbindingMedicinesLJC242tropifexor,FXRagonistandNonalcoholicsteatohepatitisImmunology,Oral2017≥2024/IIcenicrivirocCCR2/5inhibitorHepatologyand(infixed-doseDermatologycombination)LJN452tropifexorFXRagonistNonalcoholicsteatohepatitisImmunology,Oral2015≥2024/IIHepatologyandDermatologyLMI070branaplamSMN2RNAsplicingSpinalmuscularatrophyNeuroscienceOral2017≥2024/IImodulatorLNP023TBDFactorBinhibitorIgAnephropathyCardiovascular,Oral20182023/IIRenalandMetabolismC3glomerulopathyCardiovascular,Oral20182023/IIRenalandMetabolismParoxysmalnocturnalhemoglobinuriaCardiovascular,Oral20192023/IIRenalandMetabolismMembranousnephropathyCardiovascular,Oral2018≥2024/IIRenalandMetabolismLOU064TBDBTKinhibitorChronicspontaneousurticariaImmunology,Oral20172023/IIHepatologyandDermatology177Lu-TBDTargetedDNAMetastaticcastration-resistantOncologyIntravenousinfusion20182020/IIIPSMA-617destructionviaprostatecancerbeta-particleradiationLXE408TBDKinetoplastidVisceralleishmaniasisEstablishedOral2019≥2024/IIproteasomeinhibitorMedicinesMBG453TBDTIM-3antagonistMyelodysplasticsyndromeOncologyIntravenousinfusion20182021/IIAcutemyeloidleukemiaOncologyIntravenousinfusion2019≥2024/IIOMB157ofatumumabAntiCD20monoclonalRelapsingmultiplesclerosisNeuroscienceSubcutaneousinjection2015US/EUantibodyregistrationPDR001spartalizumabAntiPD1monoclonalMetastaticBRAFV600+OncologyIntravenousinfusion20172020/IIIantibodymelanoma(w/Tafinlar+Mekinist)Metastaticmelanoma(combo)OncologyIntravenousinfusion20172023/IIQBW251TBDCFTRpotentiatorChronicobstructivepulmonarydiseaseRespiratoryOral2017≥2024/IIQGE031ligelizumabHighaffinityantiIgEChronicspontaneousurticaria/Immunology,Subcutaneousinjection20172021/IIImonoclonalantibodychronicidiopathicurticariaHepatologyandDermatologyQMF149indacaterol,Longactingbeta2AsthmaRespiratoryInhalation2019EUregistrationmometasoneadrenergicagonistandfuroateinhaledcorticosteroid(infixeddosecombination)Item4.
InformationontheCompany3YearprojectenteredFormulation/currentPlannedfilingProject/CommonMechanismBusinessrouteofdevelopmentdates/currentproductnameofactionPotentialindicationfranchiseadministrationphasephaseQVM149indacaterol,Longactingbeta2AsthmaRespiratoryInhalation2019EUregistrationmometasoneadrenergicagonist,furoate,longactingmuscarinicglyco-antagonistandinhaledpyrroniumcorticosteroidbromide(infixeddosecombination)RTH2584brolucizumabAntiVEGFsinglechainNeovascular(wet)agerelatedmacularOphthalmologyIntravitrealinjection2019USapprovedantibodyfragmentdegenerationEUregistrationDiabeticmacularedemaOphthalmologyIntravitrealinjection20172021/IIIRetinalveinocclusionOphthalmologyIntravitrealinjection20182023/IIIProliferativediabeticretinopathyOphthalmologyIntravitrealinjection20192023/IIISAF312TBDTRPV1antagonistChronicocularsurfacepainOphthalmologyTopical2019≥2024/IISEG1015crizanlizumabPselectininhibitorSicklecelldiseaseOncologyIntravenousinfusion2019USapprovedEUregistrationTQJ230TBDAnti-apo(a)antisenseSecondarypreventionofcardiovascularCardiovascular,Subcutaneousinjection2018≥2024/IIIoligonucleotideeventsinpatientswithelevatedlevelsRenalandoflipoprotein(a)MetabolismUNR844TBDReductionofPresbyopiaCardiovascular,Eyedrops2017≥2024/IIdisulfidebondsRenalandMetabolismVAY736ianalumabAntiBAFF(BcellAutoimmunehepatitisImmunology,Subcutaneousinjection2016≥2024/IIactivatingfactor)HepatologyandmonoclonalantibodyDermatologyPrimarySjgren'ssyndromeImmunology,Subcutaneousinjection2015≥2024/IIHepatologyandDermatologyVPM087TBDInterleukin-1betaColorectalcancer,1stline;OncologyIntravenousinfusion2018≥2024/Ineutralizationrenalcellcarcinoma,1stlinemonoclonalantibodyXolairomalizumabAntiIgEmonoclonalNasalpolypsRespiratorySubcutaneousinjection2017US/EUantibodyregistrationFoodallergyRespiratorySubcutaneousinjection20192021/IIIZPL389adriforantHistamineH4receptorAtopicdermatitisImmunology,Oral2017≥2024/IIantagonistHepatologyandDermatology4ApprovedintheUSasBeovuforneovascular(wet)agerelatedmaculardegeneration5ApprovedintheUSasAdakveoforsicklecelldisease
InformationontheCompany1SelecteddevelopmentprojectsYearprojectenteredFormulation/currentPlannedfilingProject/CommonMechanismBusinessrouteofdevelopmentdates/currentproductnameofactionPotentialindicationfranchiseadministrationphasephaseABL001asciminibBCRABLinhibitorChronicmyeloidleukemia,3rdlineOncologyOral20162021/IIIACZ885canakinumabAntiinterleukin1beta2ndlinenonsmallcelllungcancerOncologySubcutaneousinjection20172021/IIImonoclonalantibody1stlinenonsmallcelllungcancerOncologySubcutaneousinjection20172021/IIIAdjuvantnonsmallcelllungcancerOncologySubcutaneousinjection20172022/IIIAVXS1011onasemno-SurvivalmotorneuronSpinalmuscularatrophyNeuroscienceIntravenousinfusion2018USapprovedgeneabepar-(SMN)gene(IVformulation)EUregistrationvovecreplacementtherapySpinalmuscularatrophyNeuroscienceIntrathecalinjection20182020/I(ITformulation)2AVXS201TBDMethylCpGbindingRettsyndromeNeuroscienceIntrathecalinjection20182023/Iprotein2(MECP2)genereplacementtherapyBYL7193alpelisibPI3KalphainhibitorPIK3CAmutanthormonereceptorpositiveOncologyOral2018USapproved(HR+)/humanepidermalgrowthfactorEUregistrationreceptor2negative(HER2)postmenopausaladvancedbreastcancer,2ndline(+fulvestrant)PIK3CA-relatedovergrowthspectrumOncologyOral20192020/IIITriplenegativebreastcancerOncologyOral20192023/IIIHormonereceptor-negative(HR-)/humanOncologyOral20192023/IIIepidermalgrowthfactorreceptor2-positive(HER2+)advancedbreastcancerOvariancancerOncologyOral20192023/IIIHeadandnecksquamouscellcarcinomaOncologyOral2019≥2024/IIICEE321TBDPan-JAKinhibitorAtopicdermatitisImmunology,Topical2019≥2024/IIHepatologyandDermatologyCFZ533iscalimabBlocking,nondepleting,SolidorgantransplantationImmunology,Intravenousinfusion20172023/IIantiCD40monoclonalHepatologyandantibodyDermatologySjgren'ssyndromeImmunology,Intravenousinfusion2018≥2024/IIHepatologyandDermatologyCosentyxsecukinumabAntiinterleukin17NonradiographicaxialspondyloarthritisImmunology,Subcutaneousinjection2015US/EUmonoclonalantibodyHepatologyandregistrationDermatologyPsoriaticarthritisheadtoheadstudyImmunology,Subcutaneousinjection20152020/IIIversusHumira(adalimumab)HepatologyandDermatologyAnkylosingspondylitisheadtoheadstudyImmunology,Subcutaneousinjection20152022/IIIversusSandozbiosimilarHyrimozHepatologyand(adalimumab)DermatologyHidradenitissuppurativaImmunology,Intravenousinfusion20172022/IIIHepatologyandDermatologyGiantcellarteritisImmunology,Intravenousinfusion2018≥2024/IIHepatologyandDermatologyLichenplanusImmunology,Intravenousinfusion2019≥2024/IIHepatologyandDermatologyCSJ117TBDAntithymicstromalSevereasthmaRespiratoryInhalation20182023/IIlymphopoietinmonoclonalantibodyfragmentECF843TBDBoundarylubricantDryeyeOphthalmologyEyedrops20172022/IIEntrestovalsartanandAngiotensinreceptor/ChronicheartfailurewithpreservedCardiovascular,Oral20122020/IIIsacubitrilneprilysininhibitorejectionfractionRenal(assodiumandMetabolismsaltcomplex)PostacutemyocardialinfarctionCardiovascular,Oral20152021/IIIRenalandMetabolism1ApprovedintheUSasZolgensmaforspinalmuscularatrophy(IVformulation)2TheFDAhasplacedapartialclinicalholdonAVXS-101intrathecaltrialsforspinalmuscularatrophypatientsbasedonfindingsinasmallpreclinicalanimalstudy.
3ApprovedintheUSasPiqrayforPIK3CAmutantHR+/HER2-postmenopausaladvancedbreastcancer,2ndline(+fulvestrant)Item4.
InformationontheCompany2YearprojectenteredFormulation/currentPlannedfilingProject/CommonMechanismBusinessrouteofdevelopmentdates/currentproductnameofactionPotentialindicationfranchiseadministrationphasephaseINC280capmatinibc-METinhibitorNonsmallcelllungcancerOncologyOral2014USregistrationSolidtumorsOncologyOral2019≥2024/IIJakaviruxolitinibJAK1/2inhibitorAcutegraftversushostdiseaseOncologyOral20162021/IIIChronicgraftversushostdiseaseOncologyOral20162021/IIIKAE609cipargaminPfATP4inhibitorMalariaEstablishedOral2012≥2024/IIMedicinesSeveremalariaEstablishedOral2019≥2024/IIMedicinesKAF156ganaplacideImidazolopiperazinesMalariaEstablishedOral2014≥2024/IIderivativeMedicinesKisqaliribociclibCDK4/6inhibitorHR+/HER2breastcancer(adjuvant)OncologyOral20182022/IIIKJX839inclisiranSmall-interferingRNAHyperlipidemiaCardiovascular,Subcutaneousinjection2019US/EU(PCSK9)RenalregistrationandMetabolismSecondarypreventionofcardiovascularCardiovascular,Subcutaneousinjection2019≥2024/IIIeventsinpatientswithelevatedlevelsRenalofLDL-CandMetabolismKymriahtisagen-CD19targetedchimericRelapsed/refractoryfollicularlymphomaOncologyIntravenousinfusion20172021/IIlecleucelantigenreceptorTcellimmunotherapyRelapsed/refractorydiffuselargeBcellOncologyIntravenousinfusion20182021/IIIlymphomain1strelapseRelapsed/refractorydiffuselargeBcellOncologyIntravenousinfusion2017≥2024/IIlymphoma(+pembrolizumab)LAM320clofazimineMycobacterialMultidrugresistanttuberculosisEstablishedOral20162021/IIIDNAbindingMedicinesLJC242tropifexor,FXRagonistandNonalcoholicsteatohepatitisImmunology,Oral2017≥2024/IIcenicrivirocCCR2/5inhibitorHepatologyand(infixed-doseDermatologycombination)LJN452tropifexorFXRagonistNonalcoholicsteatohepatitisImmunology,Oral2015≥2024/IIHepatologyandDermatologyLMI070branaplamSMN2RNAsplicingSpinalmuscularatrophyNeuroscienceOral2017≥2024/IImodulatorLNP023TBDFactorBinhibitorIgAnephropathyCardiovascular,Oral20182023/IIRenalandMetabolismC3glomerulopathyCardiovascular,Oral20182023/IIRenalandMetabolismParoxysmalnocturnalhemoglobinuriaCardiovascular,Oral20192023/IIRenalandMetabolismMembranousnephropathyCardiovascular,Oral2018≥2024/IIRenalandMetabolismLOU064TBDBTKinhibitorChronicspontaneousurticariaImmunology,Oral20172023/IIHepatologyandDermatology177Lu-TBDTargetedDNAMetastaticcastration-resistantOncologyIntravenousinfusion20182020/IIIPSMA-617destructionviaprostatecancerbeta-particleradiationLXE408TBDKinetoplastidVisceralleishmaniasisEstablishedOral2019≥2024/IIproteasomeinhibitorMedicinesMBG453TBDTIM-3antagonistMyelodysplasticsyndromeOncologyIntravenousinfusion20182021/IIAcutemyeloidleukemiaOncologyIntravenousinfusion2019≥2024/IIOMB157ofatumumabAntiCD20monoclonalRelapsingmultiplesclerosisNeuroscienceSubcutaneousinjection2015US/EUantibodyregistrationPDR001spartalizumabAntiPD1monoclonalMetastaticBRAFV600+OncologyIntravenousinfusion20172020/IIIantibodymelanoma(w/Tafinlar+Mekinist)Metastaticmelanoma(combo)OncologyIntravenousinfusion20172023/IIQBW251TBDCFTRpotentiatorChronicobstructivepulmonarydiseaseRespiratoryOral2017≥2024/IIQGE031ligelizumabHighaffinityantiIgEChronicspontaneousurticaria/Immunology,Subcutaneousinjection20172021/IIImonoclonalantibodychronicidiopathicurticariaHepatologyandDermatologyQMF149indacaterol,Longactingbeta2AsthmaRespiratoryInhalation2019EUregistrationmometasoneadrenergicagonistandfuroateinhaledcorticosteroid(infixeddosecombination)Item4.
InformationontheCompany3YearprojectenteredFormulation/currentPlannedfilingProject/CommonMechanismBusinessrouteofdevelopmentdates/currentproductnameofactionPotentialindicationfranchiseadministrationphasephaseQVM149indacaterol,Longactingbeta2AsthmaRespiratoryInhalation2019EUregistrationmometasoneadrenergicagonist,furoate,longactingmuscarinicglyco-antagonistandinhaledpyrroniumcorticosteroidbromide(infixeddosecombination)RTH2584brolucizumabAntiVEGFsinglechainNeovascular(wet)agerelatedmacularOphthalmologyIntravitrealinjection2019USapprovedantibodyfragmentdegenerationEUregistrationDiabeticmacularedemaOphthalmologyIntravitrealinjection20172021/IIIRetinalveinocclusionOphthalmologyIntravitrealinjection20182023/IIIProliferativediabeticretinopathyOphthalmologyIntravitrealinjection20192023/IIISAF312TBDTRPV1antagonistChronicocularsurfacepainOphthalmologyTopical2019≥2024/IISEG1015crizanlizumabPselectininhibitorSicklecelldiseaseOncologyIntravenousinfusion2019USapprovedEUregistrationTQJ230TBDAnti-apo(a)antisenseSecondarypreventionofcardiovascularCardiovascular,Subcutaneousinjection2018≥2024/IIIoligonucleotideeventsinpatientswithelevatedlevelsRenalandoflipoprotein(a)MetabolismUNR844TBDReductionofPresbyopiaCardiovascular,Eyedrops2017≥2024/IIdisulfidebondsRenalandMetabolismVAY736ianalumabAntiBAFF(BcellAutoimmunehepatitisImmunology,Subcutaneousinjection2016≥2024/IIactivatingfactor)HepatologyandmonoclonalantibodyDermatologyPrimarySjgren'ssyndromeImmunology,Subcutaneousinjection2015≥2024/IIHepatologyandDermatologyVPM087TBDInterleukin-1betaColorectalcancer,1stline;OncologyIntravenousinfusion2018≥2024/Ineutralizationrenalcellcarcinoma,1stlinemonoclonalantibodyXolairomalizumabAntiIgEmonoclonalNasalpolypsRespiratorySubcutaneousinjection2017US/EUantibodyregistrationFoodallergyRespiratorySubcutaneousinjection20192021/IIIZPL389adriforantHistamineH4receptorAtopicdermatitisImmunology,Oral2017≥2024/IIantagonistHepatologyandDermatology4ApprovedintheUSasBeovuforneovascular(wet)agerelatedmaculardegeneration5ApprovedintheUSasAdakveoforsicklecelldisease
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