2025年创新前行全球共进：临床试验发展的新篇章研究报告

EAdvancing

InnovationandGlobalReach:TheNextChapter

in

China’sClinicalTrial

DevelopmentPharmaDJx

L.E.K.ClinicalDevelopment

ReportNovember2025ThesematerialsareintendedtosupplementadiscussionwithL.E.K.

Consulting.Theseperspectiveswill,therefore,onlybemeaningfultothoseinattendance.Thecontentsofthematerials

areconfidentialandsubjecttoobligations

ofnon-disclosure.Yourattentionisdrawntothefull

disclaimercontainedinthisdocument.•Overthe

pastdecade,China’s

clinicaldevelopment

landscape

has

undergonea

remarkabletransformation.The

markethasexpanded

rapidly,fueled

byfavorable

policyreformsandsustained

R&Dinvestmentfrom

pharmas.

This

evolution

has

laidastrongfoundationforthenext

phase

ofgrowth,

one

characterized

by

deeper

innovation,

greater

global

integration

of

Chinese

biopharmas/biotechsandthe

increasingadoptionofsmartertoolssuch

as

artificial

intelligence

(AI).

Asthe

industry

continuesto

mature,China

ispoisedtoemerge

as

a

leading

hub

globallyfor

innovation-driven

clinical

development.•

Thisreport,

produced

incollaborationwith

PharmaDJ,

providesacomprehensiveoverviewofthestrategic

trendsshaping

China’sclinicaltrialecosystemtoday.

It

highlights

notonlythe

progressmade

in

innovation,

globalization

andAI/smarter

clinicaltrialtools,

butalsotheopportunitiesfacing

both

multinationaland

Chinesecompanies.•Supportedbyacomprehensivesurvey

of

pharmaceuticalcompaniesand

contract

research

organizations

(CROs),

this

reportservesasastarting

pointformultinational

corporation

(MNC)

pharmas,

Chinese

biopharmas

and

biotechs,

and

CROsto

reassesshowthey

can

better

prepareforthefutureofdrug

R&D,

bydriving

greater

innovation,

efficiency

and

globalcollaboration.Foreword:Thisreportsummarizesthekeystrategictrends

ofclinical

development

in

China,

and

canbereferencedbypharmaceuticalcompaniesand

CROsto

supporttheir

R&D/service

strategies2

©2025L.E.K.ConsultingChina

hasestablishedastrongfoundationforclinicaltrialgrowth,

underpinned

byits

large

patient

base,favorable

policies

and

sustained

R&Dinvestmentfrompharmas.Trialvolume

inChinahasrisen

rapidlyfromroughlyone-thirdoftheU.S.

andone-halfofthe

European

levels

in2019toapproximately0.8×and

1.1

×respectively

by2024,positioningChinaasamajorglobalplayer

inclinical

development.

Asthesectorentersits

nextphaseofgrowth,threestrategictrendsareexpectedtoshapethefuture

ofChina’sclinicaltrial

landscape:•

Developmentofmore

innovativeanddifferentiatedtherapies:Chinese

biopharmas

and

biotechs

are

increasing

investment

in

first-in-classand

best-in-classassets,next-generationmodalities,andnewtechnology

platforms,

gaining

strongerglobal

recognition.The

surge

inPhaseIIand

IIItrials

highlights

China’sgrowingcapability

toadvance

innovationsfromearlyto

late

stages,creating

rising

opportunities

forclinicaldevelopmentindustryparticipants.While

homogeneouscompetition

persists,companiesare

driving

differentiation

through

earlycombination

planning,indicationexpansionandstrategicassetprioritization.•ContinuedglobalizationofChinese

innovation:Globalization

remainsastrategic

imperativeforChinese

biopharmas/biotechs,withrisingChina-to-globaltrialsand

licensingdeals

reachingrecordhighs.Thiscreatesexpandingopportunitiesfor

MNCpharmastoaccessdifferentiated,early-stageChineseassetsthatenhanceglobal

portfolios,andfor

CROsequippedwith

global-standard

quality

systems,regulatoryexpertiseand

multiregionalexecutioncapabilitiestoplaya

pivotal

role

in

supporting

cross-borderclinicaldevelopment.•Adoptionof

AIandsmarterclinicaltrialtools:

AIisemergingas

a

transformative

enableracross

the

drug

R&D

life

cycle.

Within

clinicaldevelopment,industryparticipantsshowgrowing

interest

inadoptingAI,withthehighestnear-termpotentialin

data

analysisandmanagement.PharmasandCROsneedtoproactively

integrate

AI

intotheirclinicaldevelopmentcapabilitiestoenhance

efficiencyand

improvetrialquality.Executivesummary:ThreestrategictrendsareshapingthefutureofChina’s

clinical

trial

landscape3

©2025L.E.K.Consulting4

©2025L.E.K.ConsultingAgenda•

Contextofclinicaltrial

development

in

China•

Futurestrategictrendsofclinicaltrialdevelopment

in

China•

Nextstep

questions•

Resourcesand

references•

AbouttheauthorsPopulation(2024)340m4%450m

6%1.4bn17%

ofglobalAged

population(agedover

65

,2024)60m7%100m

14%220m26%of

globalGDP(Trillions

of

USD,2024)29.226%19.4

17%18.717%of

globalForecastedfive-yearGDPgrowth(percentage,2025-29)2%1.3%4%AverageGNIper

capita

(USD,

2024)83,66044,09013,660Healthspending(percentageofGDP,2023)18%10%7%Pharmaceuticalmarketsize(Billionsof

USD,2024)800450250Numberofglobaltop100biopharmas(2024)253013China

hasastrongfoundationforhealthcaremarket

growth,

basedonthe

key

economic

and

healthcare

indexescomparisonofChina,the

USand

EuropeanUnion

countriesNo.1totalandaged

populationSolidgrowing

economyThird

largestdrug

marketNote:GDP:grossdomesticproduct;GNI:GrossNational

IncomeSource:WorldBank,

USFederal

ReserveSystem,

EuropeanCommission,

International

MonetaryFund

(IMF),

IQVIA,

GrandView

report,

L.E.K.

analysisKeyeconomicand

healthcare

indexesofChina,

USand

EU5

©2025L.E.K.Consulting●

China U.S

EU. Opportunities

ChallengesChina

hasandwillcontinuetohavethe

largestpatient

poolwith

betteraffordability,thoughfacingseveralchallengessuchaspricepressure

and

lack

of

patientawarenessNote:VBP:value-basedprocurement;

DRG:diagnosis-relatedgroup;

DIP:diagnosis-interventionpacket;

GDP:gross

domestic

product;

QoL:

qualityof

life;

CXOs:

contract

organizations;

CRO:

contract

researchorganization;CMO:contractmanufacturingorganizationSource:WorldBank,

United

Nations,CentreforEconomics

andBusinessResearch,

L.E.K.

analysisMorehealthcarefront-tier

R&DStreamlined

registrationandaccessWiderhealthcarecoverageSustainedfundingRegulatory

upgradesReimbursement

reformsSteadyincreasein

health

spending

asa

shareofGDPIncreasing

affordabilityWorld’ssecond-largest

economyRisingawarenessonhealth

&

QoL

and

healthcarequalityLargest

patient

baseforlungcancer,

livercancer,diabetes,

hypertension,etc.Regionaleconomydisparities

(flexiblecommercialtacticsare

required)RevaluationofhealthcarecapitalmarketinChinaraiseshurdlesforfinancial

fundingDigital

health

innovationon

the

riseWorldclass

local

CXOs

(e.g.,CRO,

CMO)Upsurge

oflifescience

talentsInfrastructure,dataprivacy

and

paymentmodelfornewtechnologies

areyettobeimprovedLackofpatientdiseaseawareness(pharmasarerequiredto

invest

inpatient

education

and

management)Price

pressurecausedbyVBP,

DRG/DIP,homogeneouscompetition,etc.OpportunitiesandchallengesofChina

healthcare

market6

©2025L.E.K.ConsultingHealthcareremainsastrategicnational

priority

Policy$

EconomyTechnologySocietyChinaclinicaltrialvolume

hasreturnedtogrowthafter

a

dip

in2022,

with

Chinese

pharmas’

in-Chinatrialsaccountingfor~75%oftotalnew

trialstartsNote:*Including

Phase

Ito

Phase

IVtrials

sponsoredbyindustry,excludingbioequivalence

(BE)

trialsand

investigator-initiatedtrials

(IIT);

MNC=multinational

corporation;

CAGR=compoundannual

growth

rateSource:

DXY;Trialtrove;

L.E.K.researchandanalysisChina

newlystartedclinicaltrials

bysponsortype*

(2019-24)ChinaforChinaMNC

in

China21-22(8%)(8%)(7%)(10%)22-2314%(15%)25%(9%)23-2412%2%13%10%3,0002,5002,0001,5001,000500019-2413%8%16%7%19-2127%37%25%24%2,2983231,5484272531,8083512,1242981,44238427%1,6922411,1423092019

20

21

22

23

247

©2025L.E.K.Consulting1,4341729852772,051385TotalChinatoglobal13%2,412Numberoftrials2,694258CAGR

%-8%Numberofnewlystarted

clinical

trials

in

ChinaNumberofnewly

startedclinicaltrials

in

U.S.

(2019-24)Numberofclinicaltrials

U.S.(2019-24)ChinaCAGR=14%2,3742,0971,7751,41223

245,0004,0003,0002,0001,0000CAGR=(3%)3,8373,5433,0612019

20

21

22

23

245,0004,0003,0002,0001,0000CAGR=(4%)2,9772,446

2,272

2,0872019

20

21

22

23

24

Favorablepolicy

China’sgovernment

has

launchedaseriesofpoliciesto

boostinnovativedrugs,emphasizingfull-chain

integration

andquality

growth

Accelerated

innovationRapid

rise

inearly-phaseand

FIC

trialsshows

China

is

closingthegapwithglobal

innovation

leadersIn-Chinatrialvolume

hasrisen

rapidlycomparedto

U.S.andEurope,

positioningChina

as

a

major

globalplayerin

clinical

developmentNote:Only

including

PhaseIto

PhaseIIItrials

sponsoredby

industry

with

at

least

one

site

in

China

or

U.S

.

orEurope,

excluding

bioequivalence

(BE)trials,

Phase

IVtrials

and

investigator-initiatedtrials

(IIT);

FIC=first-inclassSource:

DXY,Trialtrove,

L.E.K.researchandanalysis5,0004,0003,0002,0001,2341,00002019Numberofnewlystarted

clinical

trials

in

EUR

(2019-24)Number

ofclinicaltrialsEUR●

Continuous

R&D

investmentGrowing

R&Dspendand

patent

output;

China

nowhas

four

ofthetop25

pharmacompaniesby

pipeline

size8

©2025L.E.K.ConsultingKeydriversofChina’sclinicaltrialvolumegrowthNumberofclinicaltrials20

21

222,8492,5393,3103,6183,1461,914Favorablepolicy:

Healthcare

industry

hasbenefitedfromstrongergovernment

policysupportandaprogressivelymaturingregulatoryenvironment,mostnotably

in

pharmaVolumebased

procure-mentNote:

IP:intellectual

property;

NMPA:

NationalMedicalProductsAdministration;

ICH:The

InternationalCouncilforHarmonizationofTechnicalRequirements

forPharmaceuticalsfor

Human

Use;

RWE:

real-worldevidence;CTA:Clinical

TrialApplication;

DRG:diagnosis-relatedgroup;

DIP:diagnosis-interventionpacket;

NRDL:

National

Reimbursement

Drug

List;

GBA:The

GreaterBay

Area;

*

医保简易续约Source:

NMPA,

L.E.K.analysisR&DRegistrationPricingand

market

accessCommercializationManufacturingFull

chainSupport

high-qualityinnovativedrugdev.NRDLupdates(incl.simple

renewal*)Digital-ization

accelerationEarly

accessprograms(GBA,

Bo’Ao)Innovativemedicinefull-

chainsupportKeyregulatory

initiativesimpactingChina’s

healthcaremarket(2017-24)9

©2025L.E.K.ConsultingGenericqualityconsistencyevaluation（GQCE)Positiveforinnovative

drugsTwobatchesof

raredisease

listStreamlinedCTA

reviewtimelineAcceleratedregistrationpathsOpening

upofe-commerceMarketAuthoriza-

tion

HolderUrgently

needed

drug

listClinicaldata

protectionChina

NMPAjoining

ICHIncreased

IP

protectionRWE

for

registrationMedTech

localizationAlternative

paymentAnti-corruptionDRG/DIP•

TherapidgrowthofPhase

IIand

IIItrialsinChinademonstrates

Chinese

pharmas’strongwillingness

and

capabilitytoadvance

innovationsfromearly-tolate-stage

clinicaldevelopment•Phase

IIandIII

nowaccountforover50%oftotaltrials,indicating

rising

opportunitiesfortheclinicaldevelopment

ecosystem

participantsAcceleratedinnovativedrugdevelopment:China

hasbuiltastrong

foundation

in

early-phase

clinicaldevelopmentandis

nowrapidlyexpandingits

late-phase

development

capabilitiesCAGR%(2019-24)1433445%55%2019Phase

I

11

14%86%20192,5002,0001,5001,234Numberofnewlystartedclinicaltrials

in

China

by

phase*

(2019-24)NumberofclinicaltrialsCAGR%

(2019-24)15820CAGR%

(2019-24)201221Note:*Onlyincluding

Phase

Ito

PhaseIIItrials

sponsoredbyindustrywith

at

least

one

site

in

China,

excluding

bioequivalencetrials,

Phase

IVtrialsand

investigator-initiatedtrialsSource:

DXY,

L.E.K.analysisTotalPhase

III15Phase

II

20NewlystartedPhaseIIclinical

trials

in

China*

(2019,

2024)

NumberofclinicaltrialsNewlystartedPhaseIIIclinical

trials

in

China*

(2019,

24)

NumberofclinicaltrialsMNCsponsoredCNcompanysponsored10

©2025L.E.K.Consulting2,37428%28%27%22%51%20191,0005000Total6688004000800400043%24CNcompanysponsored

11%89%33%67%MNCsponsoredTotal27667624241086420CAGR=12%7.3

6.9CAGR=25%4.73.93.12018

19

20

21

22

23

24•

Underencouragingpolicy,Chinesepharmasaredevotingmoreeffortstodrugdevelopment,supportedbyrising

topbiopharmaR&Dspendingwitha

12%CAGRfrom2021to2024•ContinuousR&D

investmenthas

driven

steady

patentgrowthforChinese

pharmas,withtheirshareofpublishedpharmaPCT(PatentCooperationTreaty)applicationsrisingfrom7%in2015to22%

in2024ContinuousR&Dinvestment:

Robust

pharma

R&DexpenditureamongChinese

pharmashas

alsosustainedthe

underlying

growthofChinaclinicaltrials

inthepastR&Dpercentageofrevenue3.7%4.1%4.7%5.4%5.7%6.0%7.1%TotalR&DspendingofChinesetop50

biopharmaby

pharmaceutical

revenue(2018-24)Billions

of

USDSource:

DXY,Trialtrove,Wind,

L.E.K.analysis11

©2025L.E.K.Consulting6.08.5

Growthdrivers•ContinuedChinesegovernmentsupportingpolicytowardinnovativedrug

R&Dandcommercialization•Chinesebiopharmas’continuously

increasing

R&Dspending•Strongout-licensing

momentumto

provideChinesebiotechswithfundingto

reinvestininnovation•Continuous

MNC

pharmainvestment

in

ChinaHeadwinds•

RationalizationanduncertaintyofPE/VCfunding•Stricter

regulatory

requirementson

clinicaltrialsLookingforward,~80%ofsurveyrespondentsshowapositiveattitudetowardfuture

trial

number

growth

in

ChinaNote:*Surveyquestion:

Inthenextfiveyears(2025-30),

what’syour

viewonChina’sclinicaltrialgrowthratecomparedwithhistorical

growth

(2019-24)?您认为未来5年，即2025年至2030年，中国临床试验数量的增速相较于历史增长将会如何改变？**Includesninerespondentsfromfinancial

investors,employeesfrommedicaldevicecompanies,hospitals

andregulatoryagencies,

in

additionto

pharma

and

CRO

respondentsSource:

L.E.K.surveyandanalysisPerspectiveson2025-30growthoutlookofclinicaltrialvolumeinChina*Percentageofrespondents12%41%47%MNC

pharma(N=17)Unsure/cannotcommentLowerthanhistoricalgrowthSimilartohistoricalgrowthHigherthanhistoricalgrowth5%

8%51%36%Chinesebiopharma(N=39)7%12%42%39%Total**

(N=89)8%21%21%50%CRO

(N=24)12

©2025L.E.K.Consulting10080604020013

©2025L.E.K.ConsultingAgenda•

Contextofclinicaltrialdevelopment

in

China•

Futurestrategictrendsofclinicaltrialdevelopment

inChina

‒Developmentofmore

innovativeanddifferentiated

therapies

‒ContinuedglobalizationofChinese

innovation‒

Adoptionof

AIandsmarter

clinicaltrial

tools•

Nextstep

questions•

Resourcesand

references•

Abouttheauthors02Continued

globalization

of

Chineseinnovation03

ol

tion

of

AI

and

smarter

clinical

trial

spodtoA++Weanticipatethreestrategictrendsshaping

clinicaltrialdevelopmentasthe

sector

continues

its

shifttowardinnovationand

globalizationDevelopmentof

moreinnovative

and

differentiatedTherapies14

©2025L.E.K.Consulting01++15

©2025L.E.K.Consulting•

Contextofclinicaltrialdevelopment

in

China•

Futurestrategictrendsofclinicaltrialdevelopment

in

China‒Developmentofmore

innovativeanddifferentiated

therapies

‒ContinuedglobalizationofChinese

innovation‒

Adoptionof

AIandsmarter

clinicaltrial

tools•

Nextstep

questions•

Resourcesand

references•

AbouttheauthorsAgenda850200150100500838Non-listedListedcompanies19965271891-1011-2021-3031-4041-5051-6061-7071-8081-9091-100101+Numberofinnovative

drugassets*^

per

company10050053

50372019

20

21

22

23

241005008474452019

20

21

22

23

24Chinese

pharmasareactively

participatingininnovation,with

progress

made

inrecent

years

tosurpass

FDAannual

newdrugapprovalsandreachingarecord-high

numberofapprovals

in2024Note:*Innovativepharmasdefines

asinnovativedrugprogramsaccountfor50%+oftotaldrugprograms;

**ExcludingTCMs;

*^

Including

both

active

and

inactive

innovative

assets,

and

self-developed

and

licensed-inassets;^IncludesdrugsapprovedbyCenter

for

Drug

Evaluationand

Research(CDER),whilethe

biologics

approvedsolelybyCenter

for

Biologics

Evaluationand

Research

(CBER)are

not

included;

FDA:

Foodand

DrugAdministration;

NMPA:

NationalMedicalProductsAdministration;TCMs:traditionalChinesemedicinesSource:

NMPA,

FDA,

DXY,

Pharmcube,

L.E.K.analysisDistributionofChinese

innovative

pharmas

by

numberof

innovativedrugassets*

(2024)Numberofcompanieswith

innovativedrugassetsNMPA

newdrug

approvals

inChina**

(2019-24)NumberofdrugsFDA

newdrug

approvals

inU.S.^

(2019-24)Numberofdrugs16

©2025L.E.K.Consulting3

0

84548505550714283202

4•

FDAhasdevelopedfour

programstofacilitateandexpeditethe

developmentofnew

drugs•Around40%ofChinese

biopharmas’productswithFDAdesignationareglobalorChinafirst-in-classMany

innovativeassetsalsomanagedtoobtainFDAspecial

designation

throughfilling

unmet

needsforseriousconditionsorsignificant

improvementoneffectivenessNumberofChinese

biopharmas’productswithFDAspecialdesignation(notexhaustive*)

(2019–1H25)NumberofproductsNote:*IncludingproductsdevelopedbyChinese

pharmas,globallyenteringclinicaltrial(Phase

I

and

beyond),

NDAorbeing

approved

after

2019,thatwere

granted

FDA

special

designation;

**Based

on

DXY

analysis,

FICis

determinedbasedonhighestdevelopmentstageand

pipelinetiming;

NDA:

New

DrugApplicationSource:

DXY,

L.E.K.analysis17

©2025L.E.K.ConsultingOthersChina

FIC**Global

FIC**AcceleratedPriorityreview

approvalFasttrackBreakthroughtherapy1008060402001,0066326

17

2124Chinese

pharmasareactively

investinginFICandfast-followerbeyond

me-too

development,venturinginto

nextgenerationmodalities

including

CGT,

ADCsandbi-/multispecificantibodiesOverviewofthe

investigationaldrugpipeline

inChinaofChinesecompaniesbyinnovationleveland

producttype(2021-24)Numberofinnovativeproducts

inthe

pipelinesNote:*IncludingCGT,bi-/multispecificantibodies,ADCs,nucleic-acid-baseddrugs,vaccines,

PROTACs

andoncolyticviruses;

CGT:cell

and

gene

therapies;ADCs:

antibody-drug

conjugates;

PROTACs:

proteolysis-targetingchimerasSource:

Nature

Reviews

Drug

Discovery,

L.E.K.analysis418836518

14321921

242,251613First-in-classFast-followerMe-tooClassificationnotavailable5,0004,0003,0002,0001,000018

©2025L.E.K.ConsultingCelltherapies

Bi-/multispecificantibodies1,0531,80335235929524AllNext-generation2073272104243419711612721ADCs

Genetherapies473923117473124367

23212513

7212021

248044215535254,3911,709

1643039677Inadditionto

newmodalities,companiesarealsoworkingto

discover

newtargets,

improve

drugfeaturesand

invest

incutting-edgetechnologyplatforms“

…Ratherthanreplacinghumans,AIwillextendour

reach,creatingmore

opportunities

andvalueinnewdrugdevelopmentand

igniting

the

next

phase

of

growth

for

Chinese

innovativedrugs.

The

future

of

biomedical

breakthroughs

will

be

forged

jointlybyhumaningenuity

andmachineintelligence

…

”-Partner,a

Chinesebiopharma,Jun.2025“

…

Todrivesustainedinnovationinthefuture,wemustleveragecutting-edgetechnologiestoexploreinnovations

indrugformulationanddelivery.

Thisincludesinvestigatinghowtoextendamolecule’shalf-life,reducedosingfrequency,or

developanoralformulationto

replaceaninjectableone

…”-SVP,aleadingMNCbiopharma,

Sep.

2024“…A

drug’s

differentiated

advantage

is

a

key

determinant

ofitsdevelopment

pace.Successinahighlycompetitivemarkethingesondrugsthatofferuniquetherapeutictarget,favorablesafety,andtrueinnovation

…”-

Chief

MedicalOfficer,aChinesebiopharma,Jul.2025Improvedrugfeatures(e.g.,dosageform,routeofadministration,safety,indicationexpansion)Investin

cutting-edgetechnologyplatformsDiscover

newdrugtargetsforTAswithunmetneedsLaunched

Erzofrianddifferentiatedamongexistingoralantipsychoticdrugs

byprovidingalong-actinginjectableoptiontoimprovepatientadherence

inschizophreniaLeveraging

AI-poweredantibodytechnologyplatform,Adagenehelpscreatenovelantibodiesthatovercomesafetyissues

andimproveefficacyforoncologydrugsIfupinostat(BEBT-908)for

lymphomaERZOFRI(paliperidonepalmitate)for

schizophreniaDynamicPrecision

Libraryincl.NEObody,

SAFEbody,

POWERbodyplatformsNote:TAs:therapeuticareas;

DLBCL:diffuselargeB-celllymphoma;

NMPA:

National

MedicalProducts

AdministrationSource:Companywebsites,

PubMed,press

release,

L.E.K.analysisTheworld’sfirstdualPI3K/HDAC

inhibitorforDLBCLwithNMPAapprovalinJul.2025ADA

GENEAplatform-driven,

clinical-

stagebiopharma19