2024年中國創(chuàng)新藥物研發(fā)趨勢報告（英文版）-醫(yī)藥魔方

2024/8/110:29ChineseinnovativedrugR&Dtrendsin2024

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FROMTHEANALYST'SCOUCH31July2024

ChineseinnovativedrugR&Dtrendsin2024

ByZimengChen,HuiZhong,HongxiHu,FanpuKong,WannianLiang&GuanqiaoLi

TheincreasedfocusofChinesecompaniesoninnovativedrugsledtotheapprovalof30medicinesdiscoveredinChinain2023,accountingfor37%ofnewdrugsapprovedinChinaoverall.Here,withtheaimofilluminatingtheevolutioninpharmaceutical

R&DinChinainrecentyears,weoverviewthecurrentpipelineofdomesticinnovativedrugcandidatesandcompareitwithourpreviousanalysisfrom2021(

Nat.Rev.Drug

Discov.-21,553–554;2022

).Fordetailsofthedatasetandanalysis,seeSupplementaryBox1.

Analysis

Overalltrends.ThenumberofinnovativeproductsinthepipelinesofChinese

companieson1January2024nearlydoubledcomparedwithJuly2021,risingfrom2,251to4,391(Fig.1andSupplementaryFig.1).Therateofgrowthwasgreaterfor?rst-in-class(FIC)products(100%;from418to836)andfast-follower(FF)agents(123%;from473to1,053)thanforme-tooproducts(95%;from923to1,803).

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Fig.1|OverviewoftheinvestigationaldrugpipelineinChinain2021and2024,by

innovationlevelandproducttype.Drugswithnoveltargetsornovelmechanismofaction

(MoAs)weredefinedaseitherfirst-in-classorfast-followerbasedonwhetherornottheyhave

class-leadingclinicaldevelopmentstatusworldwide,respectively.Drugswiththesametargets

andsimilarMoAsasalready-approveddrugclasseswereconsideredme-too.Drugsformingpart

offixed-dosecombinations(FDCs)areassignedtoanFDCgroupandthoselackingsufficient

informationforcategorizationwereplacedina'notavailable'group.Theagentswerealso

classifiedintofivemaingroupsbasedonproducttype:smallmolecules,monoclonalantibodies,recombinantproteins,vaccinesandnext-generationagents(includingcelltherapies,gene

therapies,nucleic-acid-baseddrugsandvaccines,antibody-drugconjugates(ADCs),bi-/multi-specificantibodies,proteolysis-targetingchimeras(PROTACs)andoncolyticviruses),withan

‘Others’groupforthosenotfittingintothesecategories.SeeSupplementaryinformationfordetails.

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Ofthe836FICproductsin2024,249werelistedasFICin2021,andthemajority(477)haveenteredclinicaldevelopmentmorerecently.Interestingly,60candidates

progressedfromFFstatusin2021toFICin2024,indicatingthattheirdevelopment

paceeithercaughtupwithorsurpassedglobalcounterparts.Forexample,

izalontamab,abispeci?cantibodytargetingEGFRandHER3,wasaphaseIIIFICproductin2024(SupplementaryTable1)andaphaseIFFproductin2021.

Meanwhile,19FICproductsand73FFproductsfrom2021werereclassi?edasme-tooproductsin2024,highlightingthe?erceglobalcompetition.

Trendsforproducttypes.Amongthecategoriesofproductswede?ned(Fig.1),

next-generationcandidates—includingcelltherapies,genetherapies,bi-ormulti-

speci?cantibodies,antibody–drugconjugates(ADCs),nucleic-acid-basedproductsandothers—haveseenthegreatestgrowth,from613to1,709(179%).Thishas

elevatedtheproportionofnext-generationproductsfrom27%in2021to39%in2024,overtakingsmall-moleculedrugs.Next-generationproductsnowconstitutethe

majorityofFFpipelines(risingfrom35%to53%)aswellasFICpipelines(risingfrom52%to62%).

Withinthenext-generationproductcategory,celltherapiescontinuetodominate(Fig.1),althoughtheirproportionhasslightlydecreasedsince2021(from66%to

62%).Bi-ormulti-speci?cantibodiesandADCsranksecondandthird.Nucleic-acid-basedproductshaveseenthemostgrowth,expandingfrom24to108.

Theapplicationofemergingtechnologyplatformshasvariedacrosstherapeuticareas,withoncologyattheforefrontintheiradoption(SupplementaryFig.2).

However,smallmoleculescontinuetodominateinareassuchas

endocrine/metabolicdiseases,neurologyandgastrointestinaldiseases.Withinthenext-generationcategory(SupplementaryFig.3),celltherapieshaveexpanded

beyondoncologyintoareassuchasimmunologicaldisorders;forexample,chimericantigenreceptor(CAR)Tcelltherapiesareshowingpromisefordiseasessuchas

lupus.Furthermore,nucleic-acid-basedvaccineshavegainedprominenceforinfectiousdiseasesafterthesuccessoftheplatforminCOVID-19,andasix-fold

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increaseingenetherapyproductsindevelopmentforophthalmologyindicationsre?ectstheirpotentialfortreatinghereditaryeyedisorders.

Newtargetsandtargetcombinations.Lookingatthetargetlandscapein2024,295newtargetshadbeenaddedtothe375targetsin2021,togiveatotalof670targets,including220oncologytargets,349non-oncologytargetsand101forboth.In

addition,theapplicationofnewtechnologieshasincreasedthenumberofmulti-targetcombinations,from207in2021to454in2024.

Analysisofthetoptenoncologytargetsin2021and2024(SupplementaryFig.4)

revealsthatseventargetshaveconsistentlyappearedonbothlists,withCD19and

HER2remainingthetoptwo.WhilethemajorityofCD19-targetedproductsarecelltherapies,candidatestargetingHER2arebasedonavarietyoftechnologyplatforms.ThisdiversityhasledtoHER2rankingthehighestamongFICtargets(Fig.2).The

emergenceoftargetssuchasCLDN18.2,CD7andCD276(B7-H3)isprimarilybeingenabledbynext-generationtechnologiessuchascelltherapiesandADCs.

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Fig.2|Topfivetargetsofoncologyandnon-oncologyagentsintheinvestigationaldrugpipelineinChinain2024.AgentswereclassifiedbasedontheirinnovationlevelasinFig.1andbytheproducttype.Agentsengagedmultipletargetsareindicatedbya‘/’symbol(suchas

CD19/CD22).Ab,antibody;RV,rabiesvirus;HPV,humanpapillomavirus.SeeSupplementaryFig.

4fordetailsandanexpandedversionofthefigure.

Fornon-oncologydiseases,thecontinuedexpansionincandidatestargetingSARS-CoV-2-relatedtargetsandincreasedfocusonotherinfectiousdiseasesarenotable.Fivenoveltargets,allrelatedtoinfectiousdiseases,haveenteredthetopten

(SupplementaryFig.4),includingrabiesvirus,humanpapillomavirus,Streptococcuspneumoniae,varicella-zostervirusandin?uenzavirus.

Theglucagon-likepeptide1receptor(GLP1R)isnexttoSARS-CoV-2-relatedtargets.TargetingGLP1Risbene?cialfordiabetesmanagement,weightlossand

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cardiovascularprotection.AgentsthattargetGLP1Raswellastargetssuchasthe

gastricinhibitorypolypeptidereceptor(GIPR)ortheglucagonreceptor(GCGR)showpromiseinimprovingon?rst-generationdrugs.Newdrugapplicationshavebeen

submittedforthreeproductsamongthe33GLP1Ragonistsand21dual-target

agonists,includingmazdutide,theleadingGLP1R/GCGRagonistglobally,aswellastwolong-actingGLP1RagonistsdiscoveredinChina,PB-119andsupaglutide.

Contributiontotheglobalpipeline.Domesticagentshavecontinuedtoentertheglobalpipeline;eightChineseinnovativedrugshaveenteredoverseasmarketssinceJuly2021,withsevenofthesebeinglicensedouttointernationalpartners.Inthe2024pipeline,465locallydiscoveredcandidatesareatthesamestageofdevelopmentinbothChinaandabroad,indicatingatrendtowardssimultaneousR&De?orts.

Moreover,the2024pipelineincluded101out-licensedproducts,a135%increasefromtheprevious43products(SupplementaryFig.5).Notably,theproportionofthese

productsthatareFICincreasedfrom16%to28%,includingsevenbi-ormulti-speci?cantibodies,fourADCs,fourCARTcelltherapiesandoneTCRTcelltherapy.

Finally,amongthe2,623productsthatenteredclinicaldevelopmentsinceJuly2021,theproportionofme-toodrugsdecreasedto35%comparedto50%ofproductsalsoin2021pipelines,indicatingamovetowardsdruginnovationwithhigherpotential

forclinicalvalue.Asnewtechnologiesadvanceandthefocussharpensonaddressingclinicalneeds,China'sR&De?ortsarepoisedtoleadtopioneeringa