2024年中國在生物技術(shù)領(lǐng)域的創(chuàng)新能力如何研究報告（英文版）-美國信息技術(shù)與創(chuàng)新基金會

HowInnovativeIsChinain

Biotechnology?

SANDRABARBOSU|AUGUST2024

Chinausedtobeconsideredalaggardinbiotech.Butwithacomprehensivenationalstrategyandextensiveresourcesnowsupportingtheindustry,itisbecomingmoreinnovative.Infact,severalindicatorssuggestitisnarrowingtheinnovationgapwithgloballeadersintheWest.

KEYTAKEAWAYS

RecentChinesegovernmentpolicieshaveemphasizeddomesticbiotechinnovation.Anewnationalstrategyhasbeencrucialtothesector’sgrowth.

Severalfactorsarespurringgrowth,includingsubsidies,financialincentives,science

parks,start-upincubators,talentrecruitmentschemes,public-privatepartnerships,andreformstoexpeditedrugreviewandenhanceIPprotection.

IndicatorssuggestChinesebiotechisbecomingmoreinnovative.Forexample,theU.S.FDAapprovedthreenewChinesedrugsin2023.

China’sout-licensingdealsgrewfrom15in2019to33in2023,withthelargest

increasebeinginoncology.Thesedealsconsistedofarangeoftherapeuticmodalities,involvingbothsmallmoleculeandbiologics.

ClinicaltrialactivityinChinamorethandoubledfrom2,979trialsin2017to6,497trialsin2021.Inoncology,Chinesetrialsgrew146percentfrom1,040in2017to2,564in2021,thehighestforanycountry.

Chinastilllagsbehindinitsabilitytoturnscienceintoproducts.Americaremainsahead,leveragingitssophisticatedecosystemofnationalfundingsources,VCstart-upfunding,pharmaR&Dinvestment,robustIP,andstrongcommercializationability.

Chinaincreaseditsglobalshareofvalue-addedpharmaceuticalsoutputfromroughly5.6percentin2002to24.2percentin2019.

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE2

CONTENTS

KeyTakeaways 1

ExecutiveSummary 3

BackgroundandMethodology 4

ImportanceofBiotechnologyandtheU.S.Role 4

China’sBiotechnologyIndustry 5

HowInnovativeIsChina’sBiotechIndustry? 6

NewDrugs 7

Out-LicensingDeals 8

ClinicalTrials 10

InnovationInputstoChina’sBiotechSector 13

ScientificPublications 13

BiologicalManufacturing 15

GenomeandGeneticSequencingandAnalysis 16

GeneticEngineering 18

NovelAntibioticsandAntivirals 19

Patents 20

VentureCapital 22

CompanyCaseStudies 23

BeiGene 23

HengruiPharmaceuticals 25

China’sGovernmentPoliciesSupportingtheBiotechSector 26

EarlyBuildingBlocks 26

NationalBiotechnologyStrategy 27

High-TechParks 28

RegulatoryEnvironment 29

IPProtection 30

IPTheft 30

ScientificTalent 31

PriceControls 32

WhatShouldAmericaDo? 33

Conclusion 35

Endnotes 36

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE3

EXECUTIVESUMMARY

Austrian-CzechscientistGregorMendellaidthemathematicalfoundationofthescienceof

geneticswhenheidentifiedgenesasthefundamentalunitofinheritancein1865.

1

Nearly90yearslater,in1953,theworkofscientistsJamesD.Watson,FrancisH.C.Crick,Maurice

Wilkins,andRosalindFranklinledtothediscoveryofthestructureofDNA,themolecule

containinghumangenes.

2

Theirdiscoverymarkedthebeginningofmodernbiotechnology,whichhasawiderangeofapplications,includinginhumanhealth,theprimaryfocusofthisreport.

Thebiotechnologyindustryuseslivingorganismsandbiologicalprocessestodevelopdrugs,drawingonareasincludingmolecularbiology,syntheticbiology,geneticengineering,

bioinformatics,and-omicstechnologies,amongothers,fordrugdiscoveryanddevelopment.

Biotechisonebranchofthebroaderbiopharmaceuticalsector,whichencompassesbiotechandpharmaceuticalcompanies.Bothproducemedicines,butfromdifferentsourcesandthrough

differentmodalities.Whilebiotechfocusesonthedevelopmentofbiologics,whicharelarge,

complexmoleculesderivedfromlivingorganisms,suchasmonoclonalantibodies,vaccines,andgenetherapies,pharmafocusesonmedicineswithachemicalbasis,synthesizedfromchemicalcompounds,suchassmallmoleculedrugs.

3

TheUnitedStatesremainstheworld’sbiotechnologyleaderwiththehighestlevelofnewdrugdevelopment.AsophisticatedU.S.ecosystem,composedofnationalresearchfundingsources,venturecapitalandprivateequity(VC/PE)start-upfunding,largepharmaceuticalfirmsthat

supportlife-sciencesresearchanddevelopment(R&D),robustintellectualproperty(IP)

protections,andstrongcommercializationabilityhaveproducedagloballyuniqueenvironment

thatpowerfullysupportsdomesticbiotechnologyinnovation.Butthisleadershippositionisatriskwithoutacontinuallysupportivedomesticpolicyenvironmentamidstrobustforeigncompetition,particularlyfromChina.Untilrecently,China’splaybookwastoimitatetheadvancesof

industrializedcountries,butsincethe12thFive-YearPlan(2011–2015),theChinese

governmenthasshifteditsstrategytowardincentivizinginnovation,namingbiotechasastrategicemergingindustryandprovidingsubstantialsupport.

4

In2016,Chinacommitteditselfto

improvinghealthoutcomesfortheChinesepopulationthroughits“HealthyChina2030”

strategy,whichfocusesonmedicalinnovationandimprovingaccesstodrugs.

5

Morespecifically,Chinahasdevelopedacomprehensivenationalstrategytoenhancethe

innovationcapabilitiesofitsdomesticbiotechindustry.Thestrategyincludessubsidies;financialincentives;theinitiationofnationalreimbursementforinnovativetherapies;theestablishmentofhigh-techscienceparks,start-upincubators,andpublic-privatepartnerships;talentrecruitmentinitiatives;reformstoexpeditedrugreview,especiallyfordomesticproducts;andeffortsto

enhanceIPprotectiontofosterinnovation.Chinahassetseveralmilestonesandgoalsfortheindustry,suchasenhancingtheoriginalityofbiotechthroughnewtechnologiesandproducts,creatingabiotechinnovationplatform,andstrengtheningtheindustrializationofbiotech.

SeveralrecentindicatorssuggestthatChina’sdomesticbiotechindustryisindeedbecoming

moreinnovative.Theseincludeanuptickinthevolumeandqualityofbiotech-relatedscientificpublications,agrowingnumberofnovelChinesedrugsapprovedbytheU.S.FoodandDrug

Administration(FDA)andChina’sNationalMedicalProductsAdministration(NMPA),anincreaseinout-licensingdealsfromsmallChinesebiotechcompanies,particularlyinoncology,andariseinclinicaltrialsoccurringinChina.

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE4

Despiterecentprogress,Chinastillfaceschallengesincommercializingscientificdiscoveriesintomarket-readyproducts,suchasnoveltherapeutics.Doingsorequiresadifferentskillset

fromproducingscientificinnovations.TheUnitedStatescontinuestoleadinthisarea,

leveragingitssophisticatedecosystemcomprisingnationalfundingsources,VCstart-upfunding,pharmaceuticalR&Dinvestment,robustIPprotections,andstrongcommercializationabilities.

ForChinatorealizeitsambitionofbecomingaglobalbiotechsuperpower,itwillbeimportantforittodevelopacomprehensivebiotechecosystemandenhanceitscommercializationcapabilitiesthroughapproachessuchastechnologytransferfromresearchtoindustry.

BACKGROUNDANDMETHODOLOGY

ThecommonnarrativeisthatChinaisacopierandtheUnitedStatesistheinnovator.That

narrativeoftensupportsalackadaisicalattitudetowardtechnologyandindustrialpolicy.Afterall,theUnitedStatesleadsininnovation,sothereislittletoworryabout,withtheexceptionof

perhapsmakingsurethecountrydeepensitsscience,technology,engineering,andmathematics(STEM)skillbase.First,thisassumptionismisguidedbecauseinnovatorscanloseleadershiptocopierswithlowercoststructures,aswehaveseeninmanyU.S.industries,includingconsumerelectronics,semiconductors,solarpanels,telecomequipment,andmachinetools.

6

AsClaytonChristensenhasshown,followersoftenattackatthelowerendofthemarketthroughcopying

andsignificantcostadvantagesandworktheirwayuptowardhighervalue-addedandmore-

innovativesegments.

7

Second,itisnotclearthatChinaisasluggishcopierandalwaysdestinedtobeafollower.

ToassesshowinnovativeChineseindustriesare,theSmithRichardsonFoundationprovided

supporttotheInformationTechnologyandInnovationFoundation(ITIF)toresearchthequestion.Aspartofthisresearch,ITIFisfocusingonparticularsectors,includingthebiotechnology

industry.

Tobesure,itisdifficulttoassesstheinnovationcapabilitiesofanycountry’sindustries,butitisespeciallydifficultforChineseindustries.Inpart,thisisbecause,underPresidentXiJinping,

Chinadisclosesmuchlessinformationtotheworldthanitusedto,especiallyaboutitsindustrialandtechnologicalcapabilities.Notwithstandingthis,ITIFreliedonthreemethodstoassess

Chineseinnovationinbiotechnology.First,weconductedanin-depthcasestudyevaluationoftwobiotechnologycompaniesthatoriginatedinChinalistedonthe“2023EUIndustrialR&DInvestmentScoreboard.”Second,ITIFconductedinterviewsandheldafocusgrouproundtablewithglobalexpertsontheChinesebiotechnologyindustry,allowingparticipantstospeak

anonymously,unlesstheyexpressedtheywishedtobenamedinthereport.

8

Andthird,we

assessedglobaldataonbiotechnologyinnovation,includingscientificarticles,patents,andnoveldrugapplications.

IMPORTANCEOFBIOTECHNOLOGYANDTHEU.S.ROLE

Thebiotechnologyindustryusesmaterialsderivedfromlivingorganismstoproduceinnovationsthathelpimprovehumanlives.Thesector’snumerousapplicationsrangefromthedevelopmentoftherapeuticsanddiagnosticstoimprovehumanhealthtoenergyproduction,wastetreatment,andgeneticallymodifiedcropsforagriculture,amongothers.

9

Thisreportfocusesprimarilyonthehealthcareapplicationsofbiotechnology.

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE5

Biotechnologycanhelpadvancehumanhealthindifferentways.Itcansupportprecisionmedicinebytailoringtherapeuticstoindividualpatients,makingthemmoreeffectiveandreducingsideeffects.Methodssuchasgeneticsequencingandmoleculardiagnosticshelpidentifyspecificgeneticmutationsassociatedwithdiseasetodeterminethemostsuitabletherapiesbasedonindividuals’uniquegeneticprofiles.

10

Thebiotechindustryalsoenablestheproductionofbiologics,drugsderivedfromliving

organismsortheircomponents,suchastherapeuticproteins,monoclonalantibodies,andvaccines.Biologicsprovidetargetedtreatmentsforseriousdiseasessuchascancerand

autoimmunedisorders,inflammation-relatedconditions,hemophilia,anddiabetes,amongothers.

11

Biotechalsohasapplicationsingenetherapies.GeneeditingtechnologiessuchasCRISPR-Cas9enablescientiststomodifycells’DNA,whichcouldhelptreatgeneticdisordersbycorrecting

disease-causinggenemutations.Theseexamplesillustratetherangeofapplicationsofbiotechinhealthcare,andthewaysinwhichitsoutputsarecriticaltoimprovinghumanlives.

12

TheUnitedStatesremainsthegloballeaderinbiotech,withthehighestlevelofnewdrug

developmentintheworld.From2014to2018,U.S.-headquarteredenterprisesproducedalmosttwiceasmanynewchemicalorbiologicalentities(NCEsandNBEs)asEuropeanones,and

nearlyfourtimesasmanyasJapan.

13

Butthisleadershippositionisatriskwithoutamoresupportivedomesticpolicyenvironmentamidstrobustforeigncompetition,particularlyfromChina.

TheUnitedStatesowesitsbiotechnologyleadershiptoseveralfactors,includingstrongresearchuniversitiesandinstitutionssuchastheNationalInstitutesofHealth(NIH)andtheAdvanced

ResearchProjectsAgencyforHealth(ARPA-H)thatfundbasicresearch;supportivescience

policiessuchastheOrphanDrugActof1983andthePrescriptionDrugUserFeeAct(PDUFA)of1992thataimtoincentivizeinnovation;arobustIPprotectionregime,includingstrongpatentrightsandenforcementthatencourageinnovation;andtheexistenceofsupportiveinnovation

clustersofcollocateduniversities,companies,andincubators.Theseclustersfacilitate

knowledgeandresourcesharing,playingacriticalroleintransformingscientificideasfromthelaboratoryintocommercialproductssuchasnoveltherapeutics.

AccordingtoaMcKinseyBiocenturyreport,Chinahasseentherecentemergenceoffourleadingbiotechnologyclusters:theBohaiRimCluster,locatedinBeijing,Tianjin,andJianin;the

YangtzeRiverCluster,locatedinShanghai,Suzhou,andHangzhou;theMid-WestCluster,inWuhanandChengdu;andtheSouthChinaCluster,locatedinShenzhen,Guangzhou,and

Xiamen.Over8,500biotechandbiopharmacompaniesarefoundintheseleadingbiohubs.

14

CHINA’SBIOTECHNOLOGYINDUSTRY

TraditionalformsofbiotechnologyhaveexistedinChinasinceitsearliestdays.DuringtheSuiDynastyinthe6thand7thcenturies,asmallpoxvaccinewasdeveloped,whichbecamewidelyavailableinChinabytheMingDynasty,inthe14thcentury.

15

Morerecently,the1980swasaperiodofgrowthforChina’smodernbiotechindustry.In1987,Chinalaunchedthe863

Program,providingsupportto15scienceandtechnologysectors,onebeingbiotech,tostimulatethedevelopmentofadvancedtechnologies,particularlyingeneticengineering,vaccination,andgenetherapy.

16

Thiswasbothtoprepareforpublichealthcrisesandtorespondtointernational

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE6

competition,asothercountrieshadestablishedtheirownscienceandtechnologystrategies.Chinahasseensignificantgrowthinitslifesciencesindustriessincethestartofthecurrentcentury.

AccordingtodatafromtheNationalScienceFoundation(NSF),valueaddedoutputofChina’spharmaceuticalsindustryincreaseditsglobalsharefromroughly5.6percentin2002to24.2percentin2019.Atthesametime,theglobalsharefortheUnitedStatesandtheEuropeanUnionhavesteadilydeclined.(See

figure1

.)

Figure1:Globalsharesofvalueaddedinpharmaceuticals

17

40%

35%

30%

25%

20%

15%

10%

5%

0%

UnitedStatesChina

EU

200220042006200820102012201420162018

Untilrecentyears,China’splaybookwastoimitatetheadvancesofindustrializedcountries,butsincethe12thFive-YearPlan(2011–2015),theChinesegovernmenthasshifteditsstrategy

towardincentivizinginnovation,namingbiotechasastrategicemergingindustry,andsettingdevelopmentprioritiesfordrugs,biomedicalengineering,agriculture,andbiomanufacturing.

18

AccordingtotheNationalScienceFoundation(NSF),valueaddedoutputofChina’spharmaceuticalsindustryincreaseditsglobalsharefromroughly5.6percentin2002to24.2percentin2019.

HOWINNOVATIVEISCHINA’SBIOTECHINDUSTRY?

SeveralindicatorssuggestthatChinesebiotechisindeedhasbecomemoreinnovativeinrecentyears,followingitsgovernment’sstrategicshifttosupportinnovationinthesector.These

indicatorsincludeagrowingnumberofnovelChinesedrugs,ariseinR&Dcompanies,an

increaseinout-licensingdealsfromsmallChinesebiotechcompanies,particularlyinoncology,andasurgeinclinicaltrialstakingplaceinChina.

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE7

Chinesebiotechcompaniesareincreasinglyestablishingglobalfootprints.Outofthetop10Chinesebiotechnologycompanies,9haveestablishedoverseasoperationsinmorethan15countries,includingoverseasR&Dcenters,offices,andmanufacturingsites.

19

Thebuildingblocksofbiomedicalinnovationhavebeenchangingtofacilitateresearchinto

complexconditionssuchascancerandthedevelopmentofnewtypesofdrugs.Notably,geneticdatabasesarebecomingtheholygrailofdrugdiscoveryanddevelopment,andtheChinese

governmenthassupportedthecreationofgeneandcellbanks.Yet,ScottM.Moore,practice

professorofpoliticalscience,UniversityofPennsylvania,explainsthatwhileChina’slarge

databasescanhelpspurinnovationinareassuchascancertherapeuticsandCAR-Tcelltherapy,therearealsologisticalissues,includinginconsistenthospitalrecordkeeping,andchallenges

surroundinghowdataisstructuredandcoded,thatChinastillneedstoovercome.

20

Chinesebiotechcompaniesareincreasinglyestablishingglobalfootprints.

NewDrugs

A2023studyfindsthatthenumberofChinesedomesticmedicineapprovalsincreasedbetween

2011and2021.

21

(See

figure2,

recreatedfromthestudy.)

22

Figure2:NumberofNMPAdomesticandimporteddrugapprovalsinChina

23

70

80

60

50

40

30

20

10

0

20112012201320142015201620172018201920202021

ImportedDomestic

In2023,Chinahadfivefirst-in-classdomesticdrugapprovals,asignthatdomesticinnovationisincreasing.ThefivedrugsapprovedwereGlumetinib(HaiheBiopharma),Leritrelvir(Raynovent),Anaprazole(XuanzhuBiopharma),Pegol-Sihematide(HansohPharma),andZuberitamab(BioRayBiopharmaceutical).

24

Thesedrugstreatarangeofconditions:mildormoderateCOVID-19

symptoms,acidreflux,anemiainchronickidneydisease,andcancer.Alsoin2023,theFDA

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE8

approvedthreenewChinesedrugs:Loqtorzi(toripalimab),thefirstFDA-approveddrugfor

nasopharyngealcancer,Fruzaqla(fruquintinib)formetastaticcolorectalcancer,andRyzneuta(efbemalenograstim)forthetreatmentofchemotherapy-associatedneutropenia.

25

Anindustryexperthighlightsthatbeyondthefocusontrulynovel,first-in-classdrugs,twootherkindsofinnovationareimportantinthebiotechindustry:first,innovationusingtheresourcesofbruteforce,andsecond,innovationthatimprovescurrenttechnologies.Focusingonlyonfirst-in-classinnovationmightobscuretheothertwo,whicharealsocriticalforthedevelopmentoftheindustry,andcanalsoserveasbuildingblocksforthefirsttypeofinnovation.

Inrecentyears,Chinahasfocusedondevelopingnoveldrugtypes,includingmonoclonaland

CAR-Tcellproducts,whichshowpromiseincancerimmunotherapy.AnindustryexpertexplainsthatChinesebiotechcompaniesareconductinginnovativeworkincutting-edgemodalitiesandsmallmoleculedrugs,andthatthenumberofcompanieswithinnovativedrugR&Dpipelinesisontherise.CitelinefindsthattheshareofcompaniesinvolvedinpharmaR&DheadquarteredinChinahasincreasedfrom5percentin2017to16percentin2024.

26

(See

figure3.)

60%

50%

40%

30%

20%

10%

0%

Figure3:ShareofglobalcompaniesinvolvedinbiopharmaceuticalR&D

27

20172018201920202021202220232024

UnitedStatesChina

WhileFDAapprovalisonevaluablemeasureofnewproductinnovation,GeorgeBaeder,a

biotechexecutivewith30yearsofexperienceinChina,explainsthatanequallyinteresting

innovationmeasureisthenumberofinnovativeChinesedrugslicensedbyforeignmultinationalcompanies(MNCs).

28

Out-LicensingDeals

AccordingtoaNovember2023McKinseyBioCenturyreport,Chinaevincesincreasingnumbersofout-licensingdeals,suggestinggrowingconfidenceofMNCsinthequalityofChinesebiotech

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE9

products.Thisnumbermorethandoubledfrom15in2019to33in2023.(See

figure4,

recreatedfromthereport.)

29

Thelargestrisehasbeeninoncology,whichexperiencedanearlyfourfoldincreasefromsevenout-licensingdealsin2019to27in2023,accountingforthe

greatestshareofout-licensingdeals.(See

figure5,

recreatedfromthereport.)

30

Figure4:NumberofChineseout-licensingdeals

31

30

35

25

20

15

10

5

0

20192020202120222023(Jan–Nov)

Figure5:NumberofChineseout-licensingdealsbytherapeuticarea

32

30

35

25

20

15

10

5

0

20192020202120222023(Jan–Nov)

Others

ImmunologyMetabolic

Neurology

Anti-infectionsOncology

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE10

Forexample,inMay2023,RocheannouncedapartnershipwithChinesebiotechcompanyZionPharma,throughwhichitwillpayZion$70millionupfrontforaneworallydeliveredbreast

cancerdrug.Thedrug,whichtargetstheHER2protein,iscurrentlyinPhase1clinicaltrialsintheUnitedStatesandChina.

33

InJanuary2021,Novartisannouncedacollaborationand

licensingagreementwithBeiGenetodevelopandcommercializeBeiGene’santi-PD-1antibodytisleziumabintheUnitedStates,EuropeanUnion,andothercountries.

34

In2021,EliLilly

entereda$1.5billiondealwithChina’sRegorTherapeuticsforamulti-yearresearch

collaborationandlicensingagreementtodevelopnewtherapiesformetabolicdisorders,leveragingRegor’sComputerAcceleratedRationalDiscovery(CARD)platform.

35

Andin

December2023,GSKenteredintoanexclusivelicenseagreementwithChinesecompanyHansohPharmaforanantibody-drugconjugate(ADC)targetingsolidtumors.

36

Beyonddrugs,theindustryisalsomakingadvancesinmulti-cancerearlydetection(MCED)

tests,whichinvolvetheapplicationofgenomesequencingtechniquestodetectcommoncancerfeaturesintheblood.ThroughtheChinesegovernment’ssupport,MCEDdeveloperscanaccessstatecapital,academicbiobanks,andotherresources.ThisgivesthemanadvantageovertheirAmericancounterparts,whichdonothaveaccesstothesameresourcesandthushavetorely

heavilyonprivatesectorinvestmenttoobtainthem.

ImportantChineseMCEDplayersincludeBurningRockDx,SeekIn,BerryOncology,Singlera

Genomics,andGeneSeeq.In2023,SeekInandDutchOncoInventeredapartnershipthat

enhancedChina’sinternationalcollaborationandexpandedtheglobalaccessibilityofMCED

tests.

37

ScientistsinChinahavealsorecentlycreatedanAI-basedtestthatcandetectcancer,includingpancreatic,gastric,andcolorectalcancer,usingasinglespotofdriedblood.This

techniqueischeapandeasytoperformandtransport,makingitmoreaccessibletounderservedpopulationsandless-developedcountries.

38

Butasthemortalityratesfrominfectiousdiseasesfell,China’sfocusshiftedtochronicdiseases,suchascardiovascularandmetabolicdisorders,andeventually,oncology.Chinaseizedtheopportunitytodeveloptreatmentsforthesediseasesatlowercoststructures.

BaedersaysthattheChinesebiotechindustry’sfocusoncancer—asevidencedbyitsnovel

drugs,out-licensingdeals,anddiagnostictestsinthistherapeuticarea—isrelativelynew.andmotivatedinlargepartbyChina’sagingpopulationandtherisingincidenceofcancer.This

combinationmakesChinaoneofthelargestandfastestgrowingcountriesfornewcancer

diagnosisandtreatment.Previously,itsdomesticbiopharmaceuticalindustryfocusedonone

healthcarepriority:bringingdowninfectiousdisease.ThisledChinatobecomethegloballeaderinpenicillinproduction,vaccines,andotherantibiotics.Butasthemortalityratesfrom

infectiousdiseasesfell,China’sfocusshiftedtochronicdiseases,suchascardiovascularandmetabolicdisorders,andeventually,oncology.Chinaseizedtheopportunitytodevelop

treatmentsforthesediseasesatlowercoststructures.

39

ClinicalTrials

Byseveralmeasures,ChinahasalreadyovertakentheUnitedStatesasasiteforclinical

development.Accordingtoa2022reportfromGlobalDataHealthcareConsulting,clinicaltrialactivitybetween2017and2021morethandoubledinChina,from2,979trialsin2017to

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE11

6,497trialsin2021,whiletheUnitedStatessawonlya10percentincreaseduringthistime,from4,557to5,008trials.

40

Inoncology,thenumberofclinicaltrialsgrewfrom1,040in2017to2,564in2021,a146

percentincrease.Meanwhile,intheUnitedStates,oncologyclinicaltrialsgrewfrom1,664in

2017to1,690in2021,a1.56percentincrease.(See

figure6

forU.S.clinicaltrials,and

figure

7

forChinesetrialsinthetopfivetherapeuticareas.)

41

1,800

1,600

1,400

1,200

1,000

800

600

400

200

Figure6:Numberoftrialsintopfivetherapeuticareas,UnitedStates

42

0

OncologyCentralnervousInfectiousCardiovascularGastrointestinal

systemdiseases20172021

ThenumberofclinicaloncologytrialsinChinaincreased146percentfrom2017to2021.Meanwhile,thenumberofclinicaloncologytrialsintheUnitedStatesgrew1.56percent.

INFORMATIONTECHNOLOGY&INNOVATIONFOUNDATION|AUGUST2024PAGE12

3,000

2,500

2,000

1,500

1,000

500

0

Figure7:Numberoftrialsintopfivetherapeuticareas,China

43

OncologyCentralnervousInfectiousCardiovascularGastrointestinal

systemdiseases20172021

AnalysisfromVitalTransformation,ahealthcareeconomicsconsultancy,alsoshowsasurgeinChineseclinicaltrialsforAlzheimer’s,fromjustonetrialineachof2020–2022,to23trialsin2023.(See

figure8.)

44

Figure8:NumberofAlzheimer’sdiseaseclinicaltrialsoriginatingfromChinesepharmacompanies

45

20

25

15

10

5

0

2020202120222023

INFORMATIONTECHNOLOGY&INNOVATI