LEKPharma)研发客Advancing Innovation and GlobalReach:The Next Chapter in China'sClinical Trial DevelopmentPharmaDJ x L.E.K.Clinical Development ReportNovember 2025Foreword:This report summarizes the key strategic trends of clinical development in China,and canbe referenced by pharmaceutical companies and CROs to support their R&D/service strategiesOver the past decade,China's clinical development landscape has undergone a remarkable transformation.The markethas expanded rapidly,fueled by favorable policy reforms and sustained R&D investment from pharmas.This evolution haslaid a strong foundation for the next phase of growth,one characterized by deeper innovation,greater global integration ofChinese biopharmas/biotechs and the increasing adoption of smarter tools such as artificial intelligence(Al).As the industrycontinues to mature,China is poised to emerge as a leading hub globally for innovation-driven clinical development.This report,produced in collaboration with PharmaDJ,provides a comprehensive overview of the strategic trends shapingChina's clinical trial ecosystem today.It highlights not only the progress made in innovation,globalization and Al/smarterclinical trial tools,but also the opportunities facing both multinational and Chinese companies.Supported by a comprehensive survey of pharmaceutical companies and contract research organizations(CROs),thisreport serves as a starting point for multinational corporation(MNC)pharmas,Chinese biopharmas and biotechs,andCROs to reassess how they can better prepare for the future of drug R&D,by driving greater innovation,efficiency andglobal collaboration2025 L.E.K.ConsultingLEKExecutive summary:Three strategic trends are shaping the future of China's clinical trial landscapeChina has established a strong foundation for clinical trial growth,underpinned by its large patient base,favorable policies and sustai ned R&Dinvestment from pharmas.Trial volume in China has risen rapidly from roughly one-third of the U.S.and one-half of the European levels in 2019to approximately 0.8x and 1.1x respectively by 2024,positioning China as a major global player in clinical development.As the sector entersits next phase of growth,three strategic trends are expected to shape the future of China's clinical trial landscape:Development of more innoyative and differentiated therapies:Chinese biopharmas and biotechs are increasing investment in first-in-class and best-in-dass assets,next-generation modalities,and new technology platforms,gai ning stronger global recognition.The surge inPhase ll and Ill trials highlights China's growing capability to advance innovations from early to late stages,creating rising opportunities forclinical development industry participants.While homogeneous competition persists,companies are driving differentiation through earlycombination planning,indication ex pansion and strategic asset prioritization.Continued globalization of Chinese innovation:Globalization remains a strategic imperative for Chinese biopharmas/biotechs,with risingChina-to-global trials and licensing deals reaching record highs.This creates expanding opportunities for MNCphamas to accessdifferentiated,early-stage Chinese assets that enhance global portfolios,and for CROs equipped with global-standard quality systems.regulatory expertise and multiregional execution capabilities to play a pivotal role in supporting cross-border dinical development.development,industry participants show growing interest in adopting A,with the highest near-temm potential in data analysis andmanagement.Pharmas and CROs need to proactively integrate Al into their clinical development capabilities to enhance efficiency andimprove trial quality.2025 L.E.K.ConsultingLEKAgendaContext of clinical trial development in ChinaFuture strategic trends of clinical trial development in China·Next step questionsResources and references·About the authorsChina has a strong foundation for healthcare market growth,based on the key economic andhealthcare indexes comparison of China,the US and European Union countriesKey economic and healthcare indexes of China,US and EUU.S.EUChinaPopulation (2024)340m4%450m6%No.1 total andaged populationI Aged population aged over 2024)60m7%100m1%29.220%19.417%2%1.3%4%Solid growingeconomyAverage GNI per capita (usp.2024)83.66044.09013.66018%10%7%800450250Third largestdrug market2530132025 L.E.K.ConsultingLEKChina has and will continue to have the largest patient pool with better affordability,though facingseveral challenges such as price pressure and lack of patient awarenessOpportunities and challenges of China healthcare marketChallengesHealthcare remains a strategic natio nal prioritySustained fundingMore healthcare front-tier R&DRegulatory upgradesStreamlined registration and accessPrice pressure caused by VBP,DRG/DIP,Reimbursement reformsWider healthcare coverageRegional economy disparities (flexibleSteady increase in health spending as acommercial tactics are required)Worid's second-largest economyshare of GDPRevaluation of healthcare capital marketin China raises hurdes for financial fundingLargest patient base for lung cancer,liverRising awareness on health QoL andLack of patient disease awarenessocietycancer,diabetes,hypertension,etc.(pharmas are required to invest in patientDigital health innovation onInfrastructure,data privacy and paymentUpsurge of life scienceechnology(e.g.,CRO,CMO)model for new technologies are yet to bethe risetalentsimproved2025 L.E.K.ConsultingLEKChina clinical trial volume has returned to growth after a dip in 2022,with Chinese pharmas'in-Chinatrials accounting for ~75%of total new trial startsChina newly started clinical trials by sponsor type*(2019-24)CAGR%19-2121-2222-2323-2419-243,000Total27%14%12%13%13%2,6942.5002,412258China to global37%2%8%2,29827T%3232,1242532.0002981,6921,5001,4342411722,051China for China25%7%)25%13%16%1,548180814421.0001,142985500277309427384351385MNC in China24%10%7%201920212223242025 L.E.K.ConsultingLEKIn-China trial volume has risen rapidly compared to U.S.and Europe,positioning China as a majorglobal player in clinical developmentNumber of newly started clinical trials in ChinaNum ber of newly started clinical trials in U.S.Num ber of newly started clinical trials in EUR2019-24(2019-24(2019-24Number of clinical trialsChinaNumber of clinical trialsU.S.EUR5,0005,000CAGR=(3%)5,0004.0004,0003,5433,6183,8374,000CAGR=(4%)3.000CAGR=14%3,3103,1463,0313,0003,0002,8492,97723742,5392.4462.0001,9141775227220872,0001.2341,4121.0001,0001,00000201920212223242019202122232420192021222324Key drivers of China's clinical trial volume growthFavorable policyAccelerated innovationContinuous R&D investment2025 L.E.K.ConsultingLEKFavorab/e policy:Healthcare industry has benefited from stronger government policy support and aprogressively maturing regulatory environment,most notably in pharmaKey regulatory initiatives impacting China's healthcare market(2017-24)R&DRWE forregistrationDRG/DIPAlternativeDig ital-izationpaymentaccelerationTwo batchesOpening upof rareVolume basedprotectionof e-disease listprocure-mentcommerceClinical dataneededMedTechdugi做protection(GBA,Bo'Ao)localizationNRDLChina NMPAAcceleratedupdates (incl.Anti-Innovativejoining ICHregistrationpathssimplemedicine fullGenericrenewal*)chain supportStreamlinedqualitySu pport high-MarketCTA reviewqualityinnovativeAuth or iza-timelineevaluationdrug dev.tion HolderPositive for innovative drugs2025 L.E.K.ConsultingLEKAccelerated innovative drug development:China has built a strong foundation in early-phase clinicaldevelopment and is now rapidly expanding its late-phase development capabilitiesNumber of newly started clinical trials in China by phase"Newly started Phase lll clinical trials in China*(2019,24)CAGR%CAGR%Number of dinical trials(2019-24Number of clnical trials(2019-24800Total156682,374Total1433%MNC sponsored84003342,00028%Phase lll1545%67%CN companysponsored2055%020191,50024123428%Phase ll20Newly started Phase ll clinical trials in China*(2019,2024)CAGR%(2019-241.00027%Total2067622%11%MNC sponsored1250043%Phase I1140027651%14%89%CN compary sponsored2186%0201924201924The rapid growth of Phase ll and lll trials in China demonstrates Chinese pharmas'strong willingness and capability to advance innovations from early-to late-stage clinical developmentPhase ll and Ill now account forover 50%of total trials,indicating rising opportunities for the dinical development ecosystem particpants102025 LE.K.ConsultingLEKContinuous R&D investment:Robust pharma R&D expenditure among Chinese pharmas has alsosustained the underlying growth of China clinical trials in the pastTotal R&D spending of Chinese top 50 biopharma bypharmaceutical revenue (2018-24)Billions of USD10CAGR=12%8.5Under encouraging policy,Chinese pharmas are devotingmore efforts to drug development,supported by rising top6.97.3biopharma R&D spending with a 12%CAGR from 2021 toCAGR=25%6.0202464.73.9Continuous R&D investment has driven steady patent3.1growth for Chinese pharmas,with their share of publis hedpharma PCT (Patent Cooperation Treaty)applications rising2018192021222324R&Dpercentage3.7%4.1%4.7%54%5.7%6.0%7.1%of revenue112025 L.E.K.ConsultingLEKLooking forward,~80%of survey respondents show a positive attitude toward future trial numbergrowth in ChinaPers pectives on 2025-30 growth outlook of clinical trialvolume in China*Percentage of respondentsGrowth drivers7%12%5%8%8%Continued Chinese government supporting policy toward12%innovative drug R&D and commercialization8021%Chinese biopharmas'continuously increasing R&D spending41%6042%51%21%Strong out-licensing momentum to provide Chinese biotechswith funding to reinvest in innovation40Continuous MNC pharma investment in China2050%39%47%36%HeadwindsMNC pharmaChineseCRORationalization and uncertainty of PEVC fundingN=17)N=39Stricter regulatory requirements on clinical trialsUnsure/cannot commentSimilar to historical growthLower than historical growthHigher than historical growth122025 L.E.K.ConsultingLEKAgendaContext of clinical trial development in ChinaFuture strategic trends of clinical trial development in ChinaDevelopment of more innovative and differentiated therapiesContinued globalization of Chinese innovationAdoption of Al and smarter clinical trial tools·Next step questionsResources and referencesAbout the authors13We anticipate three strategic trends shaping clinical trial development as the sector continues its shifttoward innovation and globalization01Development of more innovative anddifferentiated Therapies02Continued globalization of Chineseinnovation03Adoption of Al and smarter clinical trialtools142025 L.E.K.ConsultingLEKAgendaContext of clinical trial development in ChinaFuture strategic trends of clinical trial development in ChinaDevelopment of more innovative and differentiated therapies-Continued globalization of Chinese innovationAdoption of Al and smarter clinical trial tools·Next step questionsResources and referencesAbout the authors15