我国基于临床缓解率替代终点上市抗癌新药的现状及特征研究
【中图分类号】 R979.1【文献标识码】A DOI：10.12114/j.issn.1007-9572.2024.0475
【Abstract】BackgroundCancerisaleading causeof death among residents in China，accounting for23.1%of all disease-relateddeaths.Toaddresstheurgentneedsof patientswithseverelylife-threateningdiseases，theNationalMedical Products Administration(NMPA)allowstheuseofclinicalresponserates(RRs)asasurogateendpoint tosupportconditional approvalofnewdrugs.ObjectiveToanalye thecurrntsituationandcharacteristicsofnewanticancerdrugsapprovedinChina basedonclinicalRRsasasurrogateendpoint.MethodsThisstudysystematicallycollcteddataonanticancerdrugsapproved bytheNMPAfromOl7to2O23，focusingonanticancerdrugsandtheirindicationsthatwereapprovedbasedonRRsassurrogate endpoint.Thestudyanalyzedtheinitialapproval typesof thesedrugs(includingregularappovalandconditionalapproval)， thetypesof eficacyendpointsusedforsubsequentconversiontoregularappoval，clinicaltreatmentlines，trialdesignsfor initialdrugapprovalandpost-marketingconfirmation，drug mechanismclassfications ......
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