研究报告全文：SWSResearchCoLtd99EastNanjingRoadShanghai862123297818wwwswsresearchcomBringingChinatotheWorldMedicaldevicesCompanyResearchLeadingcancerscreeningproductdeveloperinChina28March2023BUYNewHorizonHealth06606HKInitiationofcoverageMarketData20March2023NewHorizonHealthisthefirstbiotechcompanyinChinawithafocusondevelopingandcommercialisingClosingpriceHK3155cancerscreeningproductsAtpresentthecompanyhaslaunchedthreecommercialisedproductsincludingHSCEI6470ColoClearandPupuTubeforcolorectalcancerscreeningandUUtubeforHelicobacterpyloriHp52-weekhighLowHK38951270screeningInadditionthecompanyhasotherproductsandstudyunderdevelopmentincludingCerviClearMarketCapHKm14436forcervicalcancerscreeningLiverClearforlivercancerscreeningYibiqingfornasopharyngealcancerscreeningPANDAstudyforpan-cancerearlyscreeninganddiagnosingandotherearly-stageproductsSharesoutstandingm458underdevelopmentWiththesalesramp-upofthreekeycommercializedproductsweexpecttheExchangeRateRmb-HK088companysrevenuetoreachRmb143bnin23ERmb206bnin24EandRmb316bnin25EgrowingataPricePerformanceChartCagrof61in2022-25E80PromisingcancerscreeningmarketinChinaAccordingtotheglobalcancerstatisticsfromthe60InternationalAgencyforResearchonCancerIARCintermsofthenumberofnewcancercasesthetop40fivecancertypesarebreastcancerlungcancercolorectalcancerprostatecancerandgastriccancerwhich20accountedfor11711411073and56ofthetotalnewcancercasesrespectivelyBycountries0boththecancerincidence457mandmortality300mofChinarankedfirstintheworldin2020-20representing237and302ofthetotalAccordingtoFrostSullivantheChinesemarketsizeof-40screeningforcolorectalcancergastriccancerandcervicalcancerstoodatRmb46bnRmb37bnand-60Rmb31bnin2022respectivelyWiththeincreasingawarenessofcancerscreeningitexpectsthosemarketstogrowatCagrsof196202and197in2020-2030Erespectively22-0322-0422-0522-0622-0722-0822-0922-1022-1122-1223-0123-0223-03NHHealthHSCEIHIFastsalesramp-upofkeycommercialisedproductsColoClearandPupuTubeusedforcolorectalcancerscreeningwereapprovedbyNMPAasClassIIImedicaldeviceandClassIImedicaldeviceinNovember2020SourceBloombergandMarch2018respectivelywithColoClearbeingtheonlyapprovedscreeningproductinChinatargetingc120mpopulationwithhighriskofcolorectalcancerinChinaandPupuTubebeingthefirstandonlyAnalystapprovedself-examinedscreeningproductinChinaInJune2022ColoClearsuccessfullyenteredHongZhouWenyuanKongmarketthroughapartnershipwithPreneticsIn2022therevenueofColoClearandPupuTubeA0230518110003reachedRmb360m266YoYandRmb200m74Withthesalesramp-upinhospitalsweexpecttherevenueofColoCleartogrowataCagrof81in2022-2025EInadditionwiththegrowingawarenessofzhouwyswsresearchcomearlycancerscreeningandincreasingsalesinDTCchannelweexpecttherevenueofPupuTubetogrowataCagrof33in2022-2025EBesidesthecompanysthirdcommercializedproductUUTubewasSupportapprovedbytheNMPAasClassIIImedicaldeviceinJanuary2022AfterbeinglaunchedinthemarketUUHuMengtingTuberealisedfastsalesrampupwithsalesreachingRmb210min2022andweexpectittogrowataCagrA0230122050001of42in2022-2025EhumtswsresearchcomMulti-cancerscreeningproductsmatrixfocusingongastriccancercervicalcancerandlivercancerCurrentlythecompanyspipelineincludesCerviClearforcervicalcancerscreeningLiverClearforlivercancerscreeningNPClearfornasopharyngealcancerscreeningandapan-cancerearlydetectionprogramPANDAInNovember2022CerviClearhascompletedtheenrolmentoffirstpatientformallyenteringintoaregistrationaltrialwhichisalarge-scaleprospectivemulti-centreregistrationtrialfor3yearswithanestimatedtotalenrolmentofc20000peopleInadditionLiverClearisexpectedtoinitiateaprospectivemulti-centreclinicaltrialin1Q23InitiatewithBUYConsideringthesalesramp-upofthreekeycommercialisedproductsweforecastitsrevenuetoreachRmb143bnin23E87YoYRmb206bnin24E44YoYandRmb316bnin25E54YoYBasedonadiscountedcashflowDCFmodelwearriveatatargetpriceofHK551With75upsideweinitiatecoveragewithaBUYrecommendationRisksRisingcompetitioninthecancerscreeningmarketlower-than-expectedpenetrationratedelayofpipelineprogressFinancialsummaryandvaluation202120222023E2024E2025ERevenueRmbm213765143020583163GrowthYoY2015025954868843955371NetprofitRmbm30858043234556GrowthYoY----13797EPSRmb815019009051122ROE145083791557751558PEx341146212946254362284PBx494553457421356NoteEPSiscalculatedasthenetprofitattributabletoshareholdersdividedbyweightedaveragenumberofsharesJanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearch投资要点诺辉健康是国内首家专注于开发和商业化癌症筛查产品的生物科技公司目前公司共有三款商业化产品常卫清噗噗管和幽幽管以及其他在研产品项目其中三款商业化产品包括针对结直肠癌筛查的常卫清和噗噗管以及针对幽门螺旋杆菌筛查的幽幽管此外在研产品项目包括宫证清宫颈癌苷证清肝癌易必清鼻咽癌以及泛癌种早筛早诊队列PANDA研究项目等随着公司三款商业化产品销售放量我们预计2023-2025年公司收入分别为1430亿元2058亿元和3163亿元2022-2025年复合增速为61国内癌症早筛市场前景广阔根据国际癌症研究机构IARC的统计数据2020年全球新发病例数排名前五的癌种分别为乳腺癌肺癌结直肠癌前列腺癌和胃癌占比分别为11711411073和56按国家来看2020年中国癌症新发病例数和死亡病例数均位于全球第一分别为457万例和300万例占比分别为237和302根据弗若斯特沙利文的分析2022年中国结直肠癌胃癌宫颈癌筛查市场的规模分别为46亿元37亿元和31亿元随着癌症筛查意识的的逐步提升预计2020-2030年复合增速将分别为196202和197三款商业化产品快速放量公司结直肠癌筛查产品常卫清和噗噗管分别于2020年11月和2018年3月获得NMPA的三类和二类医疗器械注册证其中常卫清为国内唯一获批的针对中国约12亿结直肠癌高风险人群的早筛产品噗噗管为国内首款且唯一获批的自测早筛产品2022年6月常卫清通过Prenetics于香港成功上市2022年常卫清和噗噗管销售快速放量收入分别为36亿元和20亿元分别同比增长266和74随着临床医院渠道收入占比的提升我们预计2022-2025年常卫清收入复合增速为81此外考虑到癌症早筛意识和DTC渠道收入占比提升我们预计2022-2025年噗噗管收入复合增速为33此外公司第三款商业化产品幽幽管于2022年1月获得NMPA三类医疗器械注册证该产品上市后实现快速销售放量2022年幽幽管收入为21亿元预计2022-2025年幽幽管的收入复合增速为42多癌种布局聚焦胃癌宫颈癌和肝癌目前公司的在研产品项目包括宫证清宫颈癌苷证清肝癌易必清鼻咽癌以及泛癌种早筛早诊队列PANDA研究项目等2022年11月宫证清完成首例患者入组正式进入注册临床阶段该试验为大规模前瞻性多中心注册临床试验为期3年预计入组总规模近2万人苷证清预计于2023年第一季度启动前瞻性多中心临床试验首次覆盖给予买入评级考虑到三款商业化产品的销售贡献我们预计2023-2025年公司收入分别为1430亿元2058亿元和3163亿元分别同比增长8744和54基于DCF模型我们给予目标价为551港元对应75的上涨空间首次覆盖给予买入评级风险提示癌症早筛市场竞争加剧渗透率提升不及预期研发管线进展不及预期Pleaserefertothelastpageforimportantdisclosuresanddisclaimers1JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchInvestmentthesisEarningsforecastsandvaluationGivenNewHorizonHealthsleadingpositioninChinascancerscreeningmarketrisingmarketpenetrationrateandinsufficientsupplyorinconvenientuseofagoldstandardofscreeningmethodssuchascolonoscopyproceduresorureabreathtestsweexpectthecompanysproductstoseeafastsalesramp-upWeforecastrevenueofRmb143bnin23ERmb206bnin24EandRmb316bnin25EgrowingataCagrof61in2022-25EInadditionconsideringtheeconomyofscaleandchangesinthechannelmixweexpectblendedgrossmargintoreach860in23E864in24Eand870in25EMeanwhilewiththerisingrevenuecontributionfromhospitalsweexpectthegrossmarginofColoCleartoreach850in23E860in24Eand870in25EAsforthePupuTubeandUUTubeweexpectthegrossmargintoremainstableat821and907in2023-25EwitharelativelystablesaleschannelNewHorizonHealthistradingat9x23EPSand6x24EPSvs4x23EPSand4x24EPSforitsHongOverseaspeersand7x23EPSand6x24EPSforA-sharepeersonaverageWebelievethecompanydeservesavaluationpremiumtoitsHongKong-listedpeersthankstothescarcityofitsbusinessanditspromisinggrowthoutlookBasedonadiscountedcashflowDCFmodelwearriveatatargetpriceofHK551With75upsideweinitiatecoveragewithaBUYrecommendationKeyassumptionsBreakingdownbyproductsweexpecttherevenueofColoCleartoreachRmb750min23ERmb119bnin24EandRmb210bnin25EgrowingataCagrof81during2022-25Ewiththesalesramp-upinhospitalsInadditionwiththegrowingawarenessofearlycancerscreeningandincreasingsalesinDTCchannelweexpecttherevenueofPupuTubetogrowataCagrof33in2022-2025EreachingRmb288min23ERmb372min24EandRmb467min25EBesidesweforecastsalesofUUTubetoreachRmb392min23ERmb492min24EandRmb595min25EgrowingataCagrof42in2022-2025EGiventhatthepipelineproductsandprojectsareintheearlydevelopmentstageourearningsforecastof2023-25EhavenotincludedCerviClearcervicalcancerLiverClearlivercancerNPClearnasopharyngealcanceretcHowwedifferfromconsensusAtpresentcancerscreeningproductsarestillintheearlystageofdevelopmentGiventhesignificantshortsupplyofdomesticcolonoscopyequipmentandprofessionaldetectionpersonnelandthecompanysfirst-moveradvantageinChinascancerscreeningmarketwearepositiveonthelong-termgrowthpotentialofthecompanyWebelievethatthefastsalesramp-upofexistingproductsandcontinuedchanneloptimizationwillsupportrapidrevenuegrowthCatalysts1BusinessRisingcontributionfromhospitalsandDTChigher-than-expectedsalesrampup2PolicyCerviClearcompletedthepatientenrollmentin23ELiverCleartoinitiatetheprospectiveclinicaltrialsin23ERisks1BusinessRisingcompetitioninthecancerscreeningmarketlower-than-expectedpenetrationrate2PolicyDelayofpipelineprogressPleaserefertothelastpageforimportantdisclosuresanddisclaimers2JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearch1CompanyataglanceNewHorizonHealthNHHealthisthefirstbiotechcompanyfocusingondevelopingandcommercializingcancerscreeningproductsinChinaCurrentlythecompanyhasthreecommercializedproductsColoClearPupuTubeandUUTubeandotherproductsorstudiesunderdevelopmentThethreecommercializedproductsincludeColoClearandPupuTubeforcolorectalcancerscreeningaswellasUUTubeforHelicobacterPyloriHpscreeningBesidesotherproductsorstudiesunderdevelopmentincludeCerviClearforcervicalcancerCCLiverClearforlivercancerscreeningNPClearfornasopharyngealcancerandaPan-cancerEarlyDetectionPANDAstudyinChinaetcInNovember2015NewHorizonHealthwasestablishedinHangzhouChinaInAugustandOctober2016thecompanyenteredintopartnershipagreementsregardingmarketingandpromotionofColoClearwithiKangphysicalexaminationcenterandDoctorWorkonlinemedicalplatformrespectivelyInMarch2018thecompanyobtainedtheregistrationcertificateforClassIImedicaldeviceforPupuTubeInNovember2020thecompanyobtainedtheregistrationcertificateforClassIIImedicaldeviceforColorClearwhichwasNMPAsfirstregistrationcertificateforearlycancerscreeningproductsInFebruary2021thecompanywaslistedontheHongKongStockExchangebecomingthefirstHongKong-listedcompanyfocusingonearlycancerscreeningInMarch2021thecompanyandAstraZenecaenteredintoathree-yearexclusiveco-promotionagreementforthepromotionofColoClearinmainlandChinaBesidesthecompanyalsoenteredintostrategicpartnershipswithseveralonlinemedicalplatformsin2021includingJDHealthPAGooddoctorandPicahealthetcInAugust2021thecompanypurchasedabiobankfromEpigenomicsAGwithtotalconsiderationofUS67mInSeptember2021thecompanyinvestedintheNHHVentureFundInDecember2021thecompanysignedanexclusivelicensingagreementwithOrbitGenomicsregardingtheirtechnologyinGreaterChinaInJanuary2022thecompanyobtainedtheregistrationcertificateforClassIIImedicaldeviceforUUTubeInJune2022ColoClearwaslaunchedinHongKongthroughapartnershipwithPreneticsInNovember2022thecompanysurine-basedscreeningproductforcervicalcancerCerviClearenteredintotheregistrationaltrialInNovember2022thecompanylaunchedaPan-cancerEarlyDetectionPANDAstudywithPekingUniversityMedicalSchoolInJanuary2023UUTubewaslaunchedinHongKongthroughapartnershipwithPhaseScientificInFebruary2023thecompanysInternationalRDCenterwaslaunchedinHongKongFigure1Companyhistory2023UUTubelaunchedin2022ObtainedHongKongtheregistrationInternationalRD2021ListedincerfificateofClassCentercameHKEXEnteredIIImedicaldeviceintoplaceinHK2019CompletedintothestrategicforUUTubetheregistrationalpromotionColoClear2018ObtainedclinicaltrialforagreementwithAZlaunchedinHKregistrationColoClearIVDforColoClearthroughthe2016certificateof2020ReceivedtheStrategicpartnershipwithPartnershipClassIImedicalregistrationpartnershipswerePrenetics2015agreementsdeviceforPupucerfificateofClassenteredintowithCerviClearEstablishedinwithiKangandTubeIIImedicaldeviceseveralInternetenteredintotheHangzhouDoctorWorkObtainedtheforColoClearIVDmedicalplatformsregistrationaltrialChinaregardingthebreakthroughPurchasedbiobankLaunchedapan-marketingandapprovalchannelfromEpigenomicscancerearlypromotionofforColoClearIVDAGInvestedintoscreeningandColoClearfromNMPANHHVentureFunddiagnosisresearchprojectSourceProspectusNHsofficialwebsiteNHsannouncementsSWSResearchPleaserefertothelastpageforimportantdisclosuresanddisclaimers3JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchThecompanyscommercializedproductsColoClearPupuTubeforcolorectalcancerscreeningandUUTubeforHpscreeningreceivedtheNMPAsapprovalinNovember2020March2018andJanuary2022respectivelypricesatRmb1996Rmb99andRmb149inChinaIntermsoftheproductsunderdevelopmentCerviClearforcervicalcancerscreeninghascompletedthefirst-patient-ininNovember2022andenteredintotheregistrationaltrialofficiallyInadditionLiverClearforlivercancerscreeningisunderthelatestageofdevelopmentbeforetheregistrationaltrialanditisexpectedtoinitiateaprospectivemulti-centreclinicaltrialin1Q23EInadditionNPClearfornasopharyngealcancerscreeningisunderdevelopmentincollaborationwithSunYat-SenUniversityCancerCenterInNovember2022thecompanyandPekingUniversityMedicalSchooljointlylaunchedaPan-cancerEarlyDetectionPANDAstudyinChinawhichplanstocoverearlyscreeninganddiagnosisofover20typesofhigh-riskcancersinChinaincludinglungcancercolorectalcancergastriccancerlivercancercervicalcancerandbreastcanceretcthroughthecompanysSTAR-seqtechnologyplatformwithindependentintellectualpropertyrightsinthenextsixyearsFigure2NewHorizonHealthspipelineNMPADevelopmentstageProductNMPAPriceIndicationSampleTypeTechnologyApprovStudyApprovalTypeRmbEarlyLateRegistrationalNMPAalTimeDevelopmentDevelopmentTrialApprovalColorectalClassIIImedicalColoClearStoolFIT-DNANov-201996CancerdeviceColorectalClassIImedicalPupuTubeStoolFITcolloidalgoldMar-1899CancerdeviceImmuno-basedClassIIImedicalUUTubeGastricCancerStoolJan-22149emulsionprocessdeviceCervicalCerviClearUrineqPCR---CancerLiverClearLiverCancerBloodMulti-omics---NasopharyngeqPCRDNARNANPClearNasalSwab---alCancerproteinPANDAPanCancerBloodMulti-omics---OthersUndisclosedUndisclosedMulti-omicsSourceNHsannouncementsNHsofficialwebsiteNHsJDself-operatedflagshipstoreSWSResearchNewHorizonHealthhasanexperiencedandprofessionalmanagementteamwithaninternationalperspectiveTheCEOMrZhuYeqinghasover20yearsofmanagementexperienceandheldanumberofpositionsincludingmanagingdirectoratGEChinaCoLtdThechairmanoftheBoardandCSODrChenYiyouhasover20yearsofresearchanddevelopmentexperienceinthefieldofoncologyandistheinventorofsixpatentsintheUSandover20patentapplicationsgloballyTheCTODrLuNinghasover17yearsofexperienceinmoleculardiagnosticsandmedicaldevicesandhasover10yearsofIVDexperienceinmultipleglobalcompanieslikeRocheDiagnosticsandQuestDiagnosticsleadingthedevelopmentofeightIVDproductsInJune2020MrGaoYujoinedinthecompanyandservedasCFOMrGaohasover15yearsofhealthcareindustryinvestingexperienceFigure3ExperiencedmanagementteamYearofNamePositionMajorresponsibilityjoiningtheSummarycompanyMrZhuYeqinghasover20yearsofmanagementexperienceandcurrentlyservedasacouncilmemberoftheCancerCo-founderOverallstrategicplanningFoundationofChinaFrom1996to1999MrZhuworkedasasalesmanagerattheBeijingofficeofSamsungCorporationMrZhuCEOandthebusinessdirectionbusiness2015From2000to2013MrZhuheldanumberofpositionsincludingmanagingdirectoratGEChinaCoLtdMrZhuYeqingchairmanofthesustainabilityandoperationalobtainedtheBachelorsdegreeinBiochemistryatPekingUniversityinJuly1992andobtainedtheMastersdegreeinBoardmanagementBusinessAdministrationfromGuanghuaSchoolofManagementofPekingUniversityinJuly2001Pleaserefertothelastpageforimportantdisclosuresanddisclaimers4JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchDrChenYiyouhasover20yearsofresearchanddevelopmentexperienceinthefieldofoncologyandistheinventorofsixpatentsintheUSandover20patentapplicationsgloballyFrom1998to2003DrChenservedinvariouspositionsincludingdrugdiscoveryprojectleaderatGenencorInternationalIncFrom2003to2006DrChenco-foundedStarvaxIncCo-founderOverallresearchtechnologyandDrandservedasCSOIn2006DrChenco-foundedCrownBioscienceIncandservedasCSOfrom2012Since2013DrexecutiveclinicaldevelopmentChen2015ChenhasservedasaboardmemberofMedDataQuestIncandadirectoratBeijingPercansOncologyCoLtdIn2014directorandparticipatinginoverallstrategicYiyouDrChenco-foundedRejuvenDermaceuticalCoLtdwhereheservedasadirectorandasupervisoruntil2020SinceCSOplanningandbusinessdirection2018DrChenhasservedasadirectoratCotheraBioscienceIncDrChenobtainedtheBachelorsdegreeinBiochemistryfromPekingUniversityinJuly1992andtheDoctoraldegreeinExperimentalPathologyfromtheUniversityofUtahintheUSinJuly1997DrLuNinghasover17yearsofexperienceinmoleculardiagnosticsandmedicaldevicesandhasover10yearsofIVDexperienceinmultipleglobalcompaniesleadingthedevelopmentofeightIVDproductsFrom2004to2007DrLuDevelopmentofcancerscreeningworkedasaSeniorScientistintheRDdepartmentofQuestDiagnosticsFrom2007DrLuservedasamanageratRocheDrLuCo-founderandandtestingtechnologies2015DiagnosticsdevelopingIVDproductsforUSandEuropeanmarketsDrLuisoneoftheinventorsoftwopatentsnamelyNingCTOfocusingonclinicaldevelopmentbordetelladetectionassayandHAVdetectionDrLuobtainedtheBachelorsdegreeinBiochemistryinJuly1992fromandregulatoryapprovalPekingUniversityandtheDoctoraldegreeofPhilosophyinSeptember1999fromDukeUniversityintheUSSubsequentlyDrLuservedasapostdoctoralresearcherattheDepartmentofBiologicalSciencesStanfordUniversityAsaprivateequityinvestoraninvestmentbankerandamanagementconsultantMrGaoYuhasover15yearsofFinancialandstrategicplanninghealthcareindustryinvestingexperienceFrom2007and2014MrGaoservedasabusinessconsultantandvariousotherbusinessdevelopmentMrGaorolesatZSAssociatesinNewYorkFrom2014to2016MrGaowasaninvestmentbankingassociateatBankofAmericaCFOparticipatinginoperational2020YuMerrillLynchinNewYorkFrom2016MrGaowasavice-presidentatFountainVestPartnersMrGaoobtainedthemanagementandinvestorBachelorsdegreeinElectricalEngineeringfromShanghaiJiaoTongUniversityinJuly2005theMastersdegreeinSciencerelationsactivitiesfromPurdueUniversityintheUSinDecember2006andtheMBAfromColumbiaBusinessSchoolintheUSinMay2014SourceProspectusNHsofficialwebsiteNHsannouncementsSWSResearch2OverviewofthecancerscreeningmarketAccordingtotheglobalcancerstatisticsfromtheInternationalAgencyforResearchonCancerIARCthenumberofglobalnewcancercasesanddeathsstoodat1929mand996min2020respectivelyThetopfivecancerincidencebytypewerebreastcancerlungcancercolorectumcancerprostatecancerandgastriccancerwithnewcancercasesof226m221m193m141mand109maccountingfor11711410073and56respectivelyin2020Besidesthetopfivemortalitybycancertypewerelungcancercolorectalcancerlivercancergastriccancerandbreastcancerwithdeathsreaching180m094m083m077mand068mrepresenting180948377and69ofthetotalnumberrespectivelyFigure4DistributionofglobalcancerincidencebycancertypeFigure5Distributionofglobalcancermortalitybycancertype20202020Femalebreast117Lung180Others292Others369Lung114Colorectum94Colorectum100Liver83Leukemia31Bladder30CervixuteriProstate7334Thyroid30Prostate38Stomach56Pancreas47Stomach77CervixuteriEsophagus31Liver47Femalebreast31Esophagus5569SourceIARCSWSResearchSourceIARCSWSResearchIn2020boththenumberofnewcancercasesanddeathsinChinarankedfirstgloballyreaching457mand300mrespectivelyaccountingfor237and302muchhigherthanothercountriesIncomparisonthenumberofnewcancercasesanddeathsintheUSrankedsecondandthirdgloballystandingat228mand061mrespectivelyrepresenting118and61ofthetotalnumberPleaserefertothelastpageforimportantdisclosuresanddisclaimers5JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchFigure6Distributionofglobalcancerincidencebycountry2020Figure7Distributionofglobalcancermortalitybycountry2020China237China302Others426Others429US118India86India69US61Russia31Germany25Japan53Brazil31Brazil26Japan42Germany33Russia31SourceIARCSWSResearchSourceIARCSWSResearchAccordingtotheNationalCancerInstituteNCIallcancerscanbecategorizedintofivedevelopmentstageswhichareprecancerousstagelocalizedstageearlystageregionalstagedistantstageadvancedstageandunknownstageEarlydetectionofcancercaneffectivelyreducethetreatmentcostTakingthecolorectalcancertreatmentcostbystageinChinaasanexampleifthecancerisdetectedatprecancerousorearlystagethecostoftreatmentisonlyRmb8300andRmb82900IfthecancerisprogressedintoregionaloradvancedstagethecostoftreatmentwillbeincreasedtoRmb132000orRmb203800Figure8DifferentdevelopmentstagesofcancerFigure9ColorectalcancertreatmentcostbystageinChina2019StageSummary250thousandRmbAbnormalcellsarepresentbuthavenotspreadto2038Precancerousstagenearbytissuewhichareassociatedwithanincreasing200riskofdevelopingintocancer150Localizedstage1320ThecancerisfoundonlyincertainpartofthebodyEarlystage100829RegionalstageThecancerhasspreadtoregionallymphnodes50DistantstageThecancerismetastasizedAdvancedstage830PrecancerousstageLocalizedstageRegionalstageDistantstageUnknownstage-SourceProspectusNCISWSResearchSourceProspectusSWSResearchEarlydetectionofcancercanbeachievedthroughvarioustypesofscreeningmethodsCurrentlyearlycancerscreeningincludestraditionalscreeningmethodsandliquidbiopsyTraditionalscreeningmethodsaremainlydividedintothreetypeswhichareimagingproceduresendoscopicscreeningandtumormarkerscreeningHoweverthesemethodshavelimitationssuchasradioactivedamagelaginvasivenessandlackofsensitivityandspecificityInrecentyearsliquidbiopsyanon-invasivescreeningmethodcanprovidenewideasforearlycancerscreeningwithbloodurinecerebrospinalfluidandascitessamplingwithadvantagesofnon-invasivecomprehensivereal-timeandaccurateAmongwhichbloodbiopsyisthemainresearchdirectionfocusingontestingthecirculatingcell-freeDNAcfDNAcirculatingtumorDNActDNAcirculatingtumorcellsCTCsmicroRNAmiRNAandexosomesetcCurrentlyliquidbiopsyisstillunderearlydevelopmentstagePleaserefertothelastpageforimportantdisclosuresanddisclaimers6JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchFigure10SummaryoftraditionalscreeningmethodsFigure11BiomarkersinliquidbiopsyMethodsCharacteristicsLimitationsWiththehelpofvariousimagingtechniquesclearimagesarecreatedforinternalImagingstructuresandorganstodeterminethestatusRadioactiveandproceduresofphysiologicalfunctionsandpathologicallaggingchangesandtodeterminewhethercancerhasoccurredWiththehelpofadvancedopticalLimitedmedicalEndoscopicinstrumentsthebodyisaccessedfromresourcesstrongscreeningoutsidethebodythroughnaturalchannelstosenseofdiscomfortdetecttheoccurrenceofmutationslowcomplianceSpecificsubstancessuchasantigensenzymesreceptorshormonesspecificTumorproteinsandothercomponentsthatincreaseLackofsensitivityandmarkerwiththepresenceofatumorcanberapidlyspecificityscreeningdetectedbyimmunologicalandbiologicalmethodstofurtherdeterminewhetherthereexisttumormutationsSourceQianzhanSWSResearchSourceLiquidBiopsyisInstrumentalfor3PMDimensionalSolutionsinCancerManagementSWSResearchSensitivityandspecificityarethemainevaluationcriteriaforearlycancerscreeningproductsSpecificallysensitivityisalsocalledtruepositiveratewhichistheprobabilityofcancerinpatientswithpositivetestresultsThespecificityalsoknownasthetruenegativerateistheprobabilitythatpatientswithnegativetestresultsdonothavecancerInadditionothercriteriaincludepositivepredictiveratePPVandnegativepredictiverateNPVPPVreferstotheprobabilitythatauserwithapositivetestresultisactuallyacancerpatientwhichisameasureoftheabilityofearly-screeningproductstoavoidmisdiagnosisNPVreferstotheprobabilitythatauserwithanegativetestresultisnotacancerpatientwhichmeasurestheabilityofearlyscreeningproductstomissthetestAhigherNPVmeansthattheuserscanbemorecomfortablewiththenegativeresultFigure12EvaluationcriteriaforearlycancerscreeningproductsHighersensitivitymeansthehighertruepositiverateandlowerproabilityofmissthetestPositivePNegativeNHigherspecificitymeansthehighertruenegativeratereduceunnecessaryfollow-upTruePositiveFalseNegativeTrueTTPFNtestsforhealthypeoplewithpositivetestresultsFalsePositiveTrueNegativeMeasuretheabilityofearly-screeningproductstoavoidmisdiagnosisFalseFFPTNMeasuretheabilityofearlyscreeningproductstomissthetestPTPFPNFNTNSourceProspectusClassificationassessmentmethodsSWSResearchAtpresentExactSciencesandEpigenomicsAGarethemainoverseasearlycancerscreeningcompaniesamongwhichCologuardfromExactSciencesandEpiproColonfromEpigenomicsAGreceivedtheFDAsapprovalforcolorectalcancerscreeningin2014and2016usingFIT-DNAandliquidbiopsytechnologyforcolorectalcancerscreeningBesidesmultipleoverseasresearchonpan-cancerscreeningisongoingwithliquidbiopsyasthemaintechnologyFigure13PartofoverseasearlycancerscreeningproductsandclinicalstudiesCompanyProductIndicationRDprogressTechnologyCologuardcolorectalcancerFDAapproval2014FIT-DNAqPCRExactSciencesOncoguardlivercancerunderdevelopmentliquidbiopsyCancerSEEKpancancerunderdevelopmentliquidbiopsyqPCREpigenomicsAGEpiproColoncolorectalcancerFDAapproval2016liquidbiopsybloodtestqPCRPREEMPTCRCstudycolorectalcancerunderdevelopmentliquidbiopsyNGSFreenomeSandersonstudypancancerunderdevelopmentliquidbiopsyGRAILGalleripancancerunderdevelopmentliquidbiopsyNGSECLIPSEstudycolorectalcancerunderdevelopmentliquidbiopsyNGSGuardantHealthSHIELDstudylungcancerunderdevelopmentliquidbiopsyPleaserefertothelastpageforimportantdisclosuresanddisclaimers7JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchpancancerALMANACstudyunderdevelopmentliquidbiopsycolorectalcancerbreastcancerlungcancerCellMaxLifeFirstSightcolorectalcancerunderdevelopmentliquidbiopsySourceProspectuscompaniesofficialwebsitesSWSResearchForthedomesticmarketColoCearistheonlyproductinChinathatreceivedNMPAsapprovalforcolorectalcancerscreeningIntermsoftheHpscreeningUUTubefromNHHealthandKangjianyoufromCoWinBiosciencesobtainedNMPAsapprovalinJanuaryandDecember2022respectivelyDuetothelargeenrollmentretrospectiveclinicaltrialscombinedwithprospectiveclinicaltrialsandlongfollow-upperiodsofregistrationalclinicalsamplesforearlycancerscreeningproductscompanieswithearlierclinicaltrialshavefirst-moveradvantagesCurrentlyNHHealthGenetronBerryOncologyandBGIGenomicsareconductinganumberofclinicalstudiesfocusingonearlycancerscreeningforlivercancerFigure14PartofdomesticearlycancerscreeningproductsandclinicalstudiesCompanyProductIndicationRDprogressTechnologyColoClearcolorectalcancerNMPAapprovalNovember2020FIT-DNAPupuTubecolorectalcancerNMPAapprovalMarch2018FITcolloidalgoldUUTubegastriccancerNMPAapprovalJanuary2022immuno-basedNHHealthCerviClearcervicalcancerunderdevelopmentqPCRLiverClearlivercancerunderdevelopmentmulti-omicsNPClearnasopharyngealcancerunderdevelopmentqPCRPANDApancancerunderdevelopmentmulti-omicsCoWinBiosciencesKangjianyougastriccancerNMPAapprovalDecember2022qPCRBurningRockTHUNDERpancancerunderdevelopmentliquidbiopsyNGSGenetronHCCscreenlivercanerunderdevelopmentliquidbiopsyNGSQuansiningpancancerunderdevelopmentliquidbiopsyBerryOncologyLaisininglivercanerunderdevelopmentliquidbiopsySeqHPVcervicalcancerunderdevelopmentHPVDNABGIGenomicsHuachangkangcolorectalcancerunderdevelopmentFIT-DNAHuaganninglivercancerunderdevelopmentliquidbiopsySourceProspectuscompaniesofficialwebsitesSWSResearchIntermsofpoliciesrelatedtoearlyscreeningforcancerinChinatofurtherincreasetheoverallfive-yearsurvivalrateofcancerandexpandthecoverageofearlycancerdiagnosisandtreatmentinChinaauthoritieshaveintroducedanumberofpoliciessince2016InSeptember2019NHCreleasedtheHealthyChinaActionCancerPreventionandControlImplementationPlan2019-2022whichstatedthatby2022theoverallfive-yearsurvivalrateofcancerwillbeincreasedby3comparedto2015andthecoveragerateofkeyscreeningdistrictsandcountieswithhigh-riskswillreachover80BesidesinApril2022theStateCouncilreleasedHighlightsoftheProgramforHealthyChinain2022whichstatedtopromotetheconstructionofpilotcancerscreeningandearlydiagnosisandtreatmentcentresatdistrictandcountylevelsFigure15PoliciesonearlycancerscreeningDateRelatedauthorityPolicySummaryPromotetheconstructionofcancerscreeningandearlydiagnosisandtreatmentHighlightsofProgramforHealthyChinainApr-22StateCouncilcentersatdistrictandcountylevelsandsummarizeandpromotetheworkmechanism2022andmanagementmodelofopportunisticscreeningsuchasuppergastrointestinalcancerPleaserefertothelastpageforimportantdisclosuresanddisclaimers8JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchLocalhealthauthoritiesarerequiredtostrengthenthedesignofthesystemformulateActionPlanforQualityImprovementinandimprovescreeningguidelinesforsuitabletumorsspecifysafeeffectiveandOct-21NHCOncologyCareeconomicalscreeningmethodsandconductextensivetrainingandpopularizationofscienceAimtobuildahighlysensitivespecificandeconomicaltechnologysystemforearlyRDandApplicationofTechnologiesforEarlyMinistryofScienceanddetectionofmalignanttumorswithfullyindependentintellectualpropertyrightsforAug-20ScreeningandDiagnosisofHighlyPrevalentTechnologyscreeningearlydetectionkitstargetinglungandgastrointestinalcancersthatarehighlyMalignantTumorsprevalentinChina-By2022theoverall5-yearsurvivalrateofcancerwillincreaseby3comparedtoHealthyChinaActionCancerPreventionand2015thecoveragerateofkeyscreeningdistrictsandcountiesinhigh-incidenceareasSep-19NHCControlImplementationPlan2019-2022willreach80-Developguidelinesforearlydiagnosisandtreatmentofmaincancers-By2022and2030theoverall5-yearsurvivalrateofcancerwillbemorethan433and466Jun-19NHCProgramforHealthyChina20302019-2030-Theearlydiagnosisrateofkeycancerspeciesinhighincidenceareaswillreach55andaboveandcontinuetoimproveProgramforDeepeningtheReformandOpen-ExploretheconstructionofademonstrationcenterfortheapplicationofgeneticMay-18StateCouncilupofthePilotFreeTradeZoneinChinadiagnosistechnologytocarryoutapplicationsforthepreventionandtreatmentofmajorTianjindiseasessuchasbirthdefectsandtumorsTechnicalSpecificationforMicroarrayGeneIdentifygenemicroarraytechnologycandetecttumorgeneticmarkersmuchearlierandDec-17NHCChipsforIndividualizedMedicalTestingeasierIncreasethescreeningrateandearlydiagnosisandtreatmentofcommondiseasesthe13thFive-yearPlanforPromotingBasicMar-17StateCouncilamongwomenandexpandthecoverageofcervicalandbreastcancerscreeningPublicServicesprogramsforruralwomen-Implementearlydiagnosisandtreatmentofcancertoreducetheriskofhigh-riskChinasMedium-to-LongTermPlanforthegroupsJan-17StateCouncilPreventionandTreatmentofChronicDiseases-Proposetheoverall5-yearsurvivalrateofcancerasthemaintargetforprevention2017-2025andtreatmentwithabaselineoverall5-yearsurvivalrateof309anda5increaseby2020and10by2025-Strengthentumorfollow-upandregistration-ExpandthecoverageofcancerscreeningandearlydiagnosisandtreatmentandfullyDec-16StateCouncilthe13thFive-yearPlanforPovertyAlleviationimplementthefreescreeningprogramforruralwomenfortwocancersinpoorareasthe13thFive-yearPlanforHealthandAdvancetheuseofgenechipsandsequencingtechnologiesinthediagnosisofgeneticDec-16StateCouncilWellnessdiseasesearlycancerdiagnosisanddiseasepreventiondetectionMinistryofIndustryandITDevelopmentandReformSupportthedevelopmentofnewmedicaltechnologiessuchasgenesequencingGuidelineofProgramforthedevelopmentofNov-16CommissionMinistryoffocusingonthedevelopmentofhigh-throughputbiochemicalanalyzersandsingle-thePharmaceuticalIndustryScienceandTechnologyNHCmoleculegenesequencersNMPA-StrengthenthecancerscreeninganddiagnosisofchronicdiseasescarryoutearlyGeneralOfficesoftheCPCdiagnosisandearlytreatmentformajorcancersinhighincidenceareasandpromoteOct-16CentralCommitteeandTheOutlineofProgramforHealthyChina2030theopportunisticscreeningofchronicdiseasessuchascancersStateCouncil-By2030theoverall5-yearsurvivalrateofcancerwillbeincreasedby15SourceProspectusStateCouncilNHCSWSResearch21ColorectalcancerClearprecancerousstageColorectalcancerisacommonmalignanttumorinthegastrointestinaltractTheincidenceandmortalityratesofcolorectalcancerinChinarankinthesecondandfirsttiergloballyAccordingtotheglobalcancerPleaserefertothelastpageforimportantdisclosuresanddisclaimers9JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchstatisticsfromIARCtheage-standardisedincidenceandmortalityratesofcolorectalcancerinChinawere239and120permillionpeoplein2020respectivelyIncomparisontheincidenceandmortalityratesofcolorectalcancerintheUSrankinthesecondandthirdtiergloballywiththeage-standardisedincidenceandmortalityratesof256and80permillionpeoplein2020respectivelyIntermsofthemortalitytoincidencerateapopulation-basedindicatorofsurvivalratethenumberis050inChinaversus031intheUSFigure16Incidenceofcolorectalcancerintheglobalmarket2020Figure17Mortalityofcolorectalcancerintheglobalmarket2020SourceIARCSWSResearchSourceIARCSWSResearchIntermsofthenumberofnewcasescolorectalcanceristhethirdmostprevalentcancerinChinawithrisingdiagnosedcasesinrecentyearsAccordingtoFrostSullivananalysiscolorectalcancerincidenceinChinawas440000in2019withaCagrof32from2015to2019ItisexpectedtheincidenceofcolorectalcancerinChinatoreach480000in2022DuetotheincreasingawarenessofcolorectalcancerandthepopularityofearlycancerscreeningcolorectalcancerincidenceinChinaisexpectedtoreachc600000in2030withaCagrof28from2020to2030Figure18IncidenceofcolorectalcancerinChina2015-2019Figure19MortalityofcolorectalcancerinChina2020E-2030E500700thousandthousand44059945042758441460056940155453938852440051049548150046735045430040025030020015020010010050002020E2021E2022E2023E2024E2025E2026E2027E2028E2029E2030E20152016201720182019SourceFrostSullivananalysisSWSResearchSourceFrostSullivananalysisSWSResearchThedevelopmentofcolorectalcancerfollowsthesequencefromadenomatocancerTheprogressionfromtheprecancerousstagetocancergenerallytakesfivetotenyearswiththeadvancedadenomastageasthegoldenstageforearlydetectionIntermsoftheprecancerousandlocalisedstagesofcolorectalcancerthefive-yearsurvivalrateintheUSandChinaarebothc100andc90Thefive-yearsurvivalratedeclinessignificantlyasthediseaseprogressestoregionalanddistalstagesThustherisingawarenessofearlycancerscreeningwillincreasethefive-yearsurvivalrateofcolorectalcancereffectivelyPleaserefertothelastpageforimportantdisclosuresanddisclaimers10JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchFigure20Colorectalcancerdevelopmentperiodandthefive-yearFigure21Five-yearsurvivalrateofcolorectalcancerintheUSandChinasurvivalratec100c100902901718631143104PrecancerousstageLocalizedstageRegionalstageDistantstagetheUSChinaSourceProspectusSWSResearchSourceProspectusSWSResearchGuidelinesforColorectalCancerScreeningandEarlyDiagnosisandTreatmentinChina2020BeijingreleasedbytheNationalCancerCenterrecommendscolorectalcancerscreeningforpeopleagedbetween40and75consideringthedietaryhabitsandthedecreasingaverageageofcolorectalcancercasesinChinaAccordingtotheFrostandSullivananalysisthepopulationrecommendedforregularcolorectalcancerscreeninginChinawas633min2019inwhichthehigh-riskpopulationwas120maccountingforc20ofthetotalnumberItisexpectedthatthepopulationrecommendedforregularcolorectalcancerscreeninginChinawillreachc130min2022Ewiththehigh-riskpopulationof130mConsideringtheincreasingincidenceofcolorectalcancerinChinathepopulationrecommendedforregularcolorectalcancerscreeninginChinaisforecastedtoreachc760min2030Ewithhigh-riskpopulationtoreachc160mFigure22PopulationrecommendedforregularcolorectalcancerFigure23PopulationrecommendedforregularcolorectalcancerscreeninginChina2015-2019screeninginChina2020E-2030E700million800758million73574762263371272460260868870059266567760070064365450060050040040030030020012010811111311720015415816213413814214615010012412713110002015201620172018201902020E2021E2022E2023E2024E2025E2026E2027E2028E2029E2030EPopulationrecommendedforregularcolorectalcancerscreeningHigh-riskpopulationofcolorectalcancerPopulationrecommendedforregularcolorectalcancerscreeningHigh-riskpopulationofcolorectalcancerSourceNationalBureauofStatisticsFrostSullivananalysisSWSSourceNationalBureauofStatisticsFrostSullivananalysisSWSResearchResearchNowearlycancerscreeningisstillintheearlystageinChinaAccordingtotheanalysisofFrostandSullivanthepenetrationrateamongthepopulationrecommendedforcolorectalcancerscreeninginChinawasonly164inChinacomparedto601intheUSWithrisingcancerscreeningawarenessinChinaandthesupportofrelevantpoliciesthepenetrationrateinChinaisexpectedtoreach398in2030EPleaserefertothelastpageforimportantdisclosuresanddisclaimers11JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchFigure24ColorectalcancerscreeningpenetrationrateofFigure25ColorectalcancerscreeningpenetrationrateofrecommendedrecommendedpopulationinChina2015-2019populationinChina2020E-2030E1845164398155161474036814113534014353132883012264242102522220418882017561541025002020E2021E2022E2023E2024E2025E2026E2027E2028E2029E2030E20152016201720182019SourceFrostSullivananalysisSWSResearchSourceFrostSullivananalysisSWSResearchCurrentlycolorectalcancerscreeningtechnologiesincludecolonoscopyandstool-basedtestsColonoscopyisthegoldstandardforcolorectalcancerdiagnosisbutduetotheinvasivenessandinconvenienceaswellasthelackofprofessionaltestingequipmentandanesthetistsinChinapatientcomplianceforcolonoscopyisrelativelylowBesidesasbloodinstoolisthemainsymptomofcolorectalcancerstool-basedtestsarecommonlyusedforcancerscreeningStool-basedtestsaremainlydividedintoFOBTFITandFIT-DNAAsanon-invasiveandwidely-usedtechnologypatientcomplianceisrelativelyhigherbutthesensitivityandspecificitystillneedtobeimprovedAccordingtothelatestGuidelinefortheTreatmentofColorectalCancer2022releasedbyCSCOintermsofcolorectalcancerscreeninginasymptomatichealthypeoplecolonoscopyandFITarerecommendedasClassIandFIT-DNAisrecommendedasClassIIIforgeneralriskgroupsInadditioninJanuary2021theGuidelinesforColorectalCancerScreeningandEarlyDiagnosisandTreatmentinChinarecommendedFIT-DNAtestsforcolorectalcancerscreeningFigure26ComparsionofcolorectalcancerscreeningtechnologiesImagingStool-basedtestMulti-targetstool-basedDNAtestingColonoscopygoldstandardFecaloccultbloodtestFOBTFecalimmunochemicaltestFITFIT-DNAUseacolonoscopetoexaminetherectumandDetecthemoglobinalongwithcertainIntroductionUseachemicaltodetecthemeUseantibodiestodetecthemoglobintheentirecolonDNAbiomarkers-Non-invasive-Visualization-Non-invasive-Nodietaryrestrictions-AbletoapplyresectionandbiopsyAdvantage-Lowprice-Superiorclinicalperformanceeg-Highsensitivityandspecificity-BettercompliancethancolonoscopysensitivityspecificityandPPVthan-RequireslessfrequentscreeningFOBTFIT-Invasiveandinconvenient-Lackofprofessionalandanesthetiststo-Lowsensitivity-HigherpricethanFOBTFITDisadvantageoperateinChina-FOBTmayrequiredietaryrestrictions-5daysturnaroundtime-Notsuitableforthespecificpopulationwith-Mayrequiremultipletestsotherunderlyingdiseases-Hospital-HospitalApplicationscenario-Hospital-Clinic-Clinic-At-home-At-homeChineseGuidelinesforScreeningandEarlyDiagnosisandTreatmentofColorectalCancerExpertConsensusonearlyDiagnosisandScreeningStrategiesforcolorectalChineseSocietyofClinicalOncologyChineseSocietyofClinicalOncologyCSCOTumorsinChinaCSCOColorectalCancerDiagnosisGuidelinesColorectalCancerDiagnosisandTreatment-andTreatmentGuidelines2022ClassGuidelines2022ClassIrecommendationExpertConsensusonEarlyDiagnosisandIrecommendationTreatmentofColorectalCancerinChinaChineseSocietyofClinicalOncologyCSCOColorectalCancerDiagnosisandTreatmentGuidelines2022ClassIIIrecommendationSourceProspectusNCISWSResearchPleaserefertothelastpageforimportantdisclosuresanddisclaimers12JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchColorectalcancerscreeninginChinahaslargemarketpotentialinthefutureForthe633mofthetargetedcolorectalcancerpopulationinChinain2019thepenetrationrateofcolonoscopyFITFOBTandFIT-DNAisonlyc16Thepercentageofunscreenedpopulationreached84Incontrastamongthe93mofthetargetedpopulationintheUSthepenetrationrateofdifferentscreeningtechnologymethodsisc60Figure27PenetrationrateofdifferentcolorectalcancerscreeningFigure28PenetrationrateofdifferentcolorectalcancerscreeningtechnologyinChina2019technologyintheUS2019FIT-DNA001FIT-DNA183FITFOBTFITFOBT1492925Colonoscopy150Unscreened3989633m93maddressableaddressablepopulationpopulationColonoscopyUnscreened49038356SourceFrostSullivananalysisSWSResearchSourceFrostSullivananalysisSWSResearchAccordingtotheFrostandSullivananalysisthecolorectalcancerscreeningmarketinChinawasRmb30bnin2019andRmb46bnin2022EWithincreasingpublicawarenessgovernmentsupportandtheimprovementofearlycolorectalcancerscreeningtechnologythecolorectalcancerscreeningmarketinChinaisexpectedtoreachRmb198bnin2030EwithaCagrof196from2020Eto2030EFigure29MarketsizeofthecolorectalcancerscreeningmarketinFigure30MarketsizeofthecolorectalcancerscreeningmarketinChinaChina2015-20192020E-2030E19820RmbbnRmbbn17630183282726161532514130212108108887015764639433202015201620172018201902020E2021E2022E2023E2024E2025E2026E2027E2028E2029E2030ESourceFrostSullivananalysisSWSResearchSourceFrostSullivananalysisSWSResearch22GastriccancerHpisclassifiedasClassIcarcinogenGastriccanceroriginatesinthemostsuperficialmucosalepithelialcellsofthestomachwallDuetodietaryhabitsandotherreasonsgastriccanceriscommonlyseeninAsiancountrieslikeMongoliaJapanSouthKoreaandChinaAccordingtotheglobalcancerstatisticsfromIARCboththeincidenceandmortalityratesofgastriccancerinChinarankinthetoptiergloballywithanage-standardisedincidenceandmortalityrateof206and159permillionpeopleTheage-standardisedincidenceofgastriccancerinJapanandSouthPleaserefertothelastpageforimportantdisclosuresanddisclaimers13JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchKoreaare316and279permillionpeoplewhichishigherthanthatofChinawhilethemortalityratesare82and61permillionpeoplerespectivelywhichislowerthanthatofChinaThisismainlyduetothemoresufficientsupplyofgastroscopyinJapanandSouthKoreathaninChinawhichreducesthemortalityrateeffectivelybydetectinggastriccancerearlierFigure31Globalcancerincidenceofgastriccancer2020Figure32Globalcancermortalityofgastriccancer2020SourceIARCSWSResearchSourceIARCSWSResearchAccordingtothe2022VersionofGuidelinesforScreeningandEarlyDiagnosisandTreatmentofGastricCancerinChinagastriccanceristhefourthmostprevalentcancerinChinaAccordingtotheIARCgastriccancerincidenceinChinawasc480000in2020andthenumberisexpectedtoreachc770000in2040EwiththeproportionofgastriccancercasesinChinaremainingstableatc44EarlysymptomsofgastriccancerarenotobviouswithmanypatientsatthemiddleorlatestagewhendiagnosedIfthepatientisintheprecancerousandearlystagesearlyscreeningforgastriccancercanincreasethefive-yearsurvivalrateeffectivelyAccordingtotheFrostandSullivananalysisthefive-yearsurvivalratesofgastriccancerintheprecancerousandlocalisedstagesarec100and785whilethefive-yearsurvivalratesofgastriccancerintheregionalanddistantstagesareonly290and48Figure33ForecastofgastriccancerincidenceinChina2020-2040EFigure34Five-yearsurvivalrateofgastriccancerinChina100900thousand80076870778570063460055650047940029030020048100PrecancerousstageLocalizedstageRegionalstageDistantstage020202025E2030E2035E2040ESourceIARCSWSResearchSourceFrostSullivananalysisSWSResearchGuidelinesforGastricCancerScreeningandEarlyDiagnosisandTreatmentinChina2022BeijingreleasedbyNCCrecommends45asthestartingageforgastriccancerscreeningwithscreeningendingattheageof75lifeexpectancyoffewerthan5yearsAccordingtotheFrostandSullivananalysistherecommendedpopulationforgastriccancerscreeningwas690min2019andthenumberisexpectedtoreach730minPleaserefertothelastpageforimportantdisclosuresanddisclaimers14JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearch2022Eand810min2030ENowthepenetrationrateofrecommendedpopulationforgastriccancerscreeninginChinahasincreasedfrom145in2015to216in2019whichisexpectedtoreach282in2022EWiththeupdateofcancerscreeningguidelinesandtheincreasingpublicawarenesstowardsearlyscreeningthepenetrationrateisexpectedtoreach565in2030EFigure35ForecastofpopulationrecommendedforgastriccancerFigure36ForecastofgastriccancerscreeningpenetrationrateofscreeninginChina2015-2030ErecommendedpopulationinChina2015-2030E900million60800507006004050030400300202001010000SourceFrostSullivananalysisSWSResearchSourceFrostSullivananalysisSWSResearchIn1994HpisclassifiedastheClassIcarcinogenofgastriccancerbyWHOandithasnowbeenproventobestronglyassociatedwiththeprogressionofatrophicgastritisgastriculcersgastriccancerandotherrelateddiseasesIn2019ExpertConsensusOpinionsonHelicobacterpyloriPreventionandControlofGastricCancerinChinapointedoutthatHpinfectionisthemaincauseofgastriccancerinChinaAccordingtotheReportonNutritionandChronicDiseasesinChina2020theoverallHpinfectionrateforresidentsagedfrom18to64yearsoldis415inChinaSpecificallytherateis420inbigcitiesandruralareasandtherateis389insmalltomid-sizedcitiesDifferentiatedbygendertherateis416formalesand414forfemalesFigure37Hpinfectionrateforresidentsagedfrom18to64yearsFigure38Hpinfectionrateforresidentsagedfrom18to64yearsoldinoldinChinabyregionChinabygender10010090908080707060605050420420416414389404030302020101000big-sizedcitiessmalltomid-sizedcitiesruralareasmalesfemalesSourceReportonNutritionandChronicDiseasesinChina2020SWSSourceReportonNutritionandChronicDiseasesinChina2020SWSResearchResearchTherearethreemainnon-invasiveHpscreeningtestsavailableinthemarketincludingstoolantigentestSATserologicaltestandureabreathtestUBTUBTisthegoldstandardforHpscreeningbutisexposedtoradiationInadditionasallHpinfectionsareantibodypositiveantibody-basedtestscannotdistinguishPleaserefertothelastpageforimportantdisclosuresanddisclaimers15JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchbetweenthecurrentandpreviousinfectionsConsideringthecostandequipmentSATismoresuitableforlarge-scalescreeningthanUBTandserologicaltestsFigure39HptestsforgastriccancerscreeningUreabreathtestUBTgoldstandardStooltestSerologicaltest14C13CStoolantigentestSATAntibody-basedtestWhenureaseinHelicobacterpyloridecomposesureacarbondioxidewithAccordingtodifferentdetectionprinciplesfecalantigenTwoanti-HPantibodiescancarbon13orcarbon14isotopelabelisproducedMeasuringitscontentcarbontestscanbedividedintoenzyme-linkedimmunoassayandappearinthebloodPrinciple13orcountingtheflowratecarbon14canreflectthenumberofbacteriaofimmunochromatographyandmonoclonalmethodandcirculationofpatientsHpyloriinthebodyIfitexceedsacertainrangethepositiveresultwillbepolyclonalmethodaccordingtodifferentantibodiesusedinfectedwithHpindicated-Non-invasive-Accuracyisnotaffectedby-Non-invasive-Non-invasive-Non-invasiveulcerbleedinggastric-Highlyaccurateand-MorereliablethanimmunochromatographyassayAdvantage-Highlyaccurateandreproducibleatrophyaswellastheuseofreproducible-Lowprice-Lessexpensivethan13Cprotonpumpinhibitorsor-Freeofradiation-FewerneedsforequipmentthanUBTantibiotics-Lessfalse-negativeresults-HigherpricethanSATor-InfluencedbymanyfactorsUBT-Influencedbymanyfactors-Exposuretoradiationthoughtheradiation-Longerdurationtogivetest-Higherpricethan14C-InfluencedbymanyfactorsDisadvantageisrelativelylowresults-Moreneedsforequipment-Influencedbypreservationofthespecimen-Notsuitableforwomenwhoarepregnant-Cannotdistinguishbetweenthan14CorbreastbreedingcurrentandpreviousinfectionsSourceProspectusGuidelinesforGastricCancerScreeningandEarlyDiagnosisandTreatmentinChina2022BeijingSWSResearchAccordingtotheFrostandSullivananalysisthemarketsizeofthegastriccancerscreeningmarketinChinawascRmb21bnin2019withaCagrof204from2015to2019whichisexpectedtoreachRmb37bnin2022EWithgovernmentsupportandincreasingpublicawarenesstowardsHpthegastriccancerscreeningmarketinChinaisexpectedtoreachRmb157bnin2030EwithaCagrofc202from2020Eto2030EFigure40GastriccancerscreeningmarketinChina2015-2019Figure41GastriccancerscreeningmarketinChina2020E-2030E2518RmbbnRmbbn157211613620141612114151095137811810651065444374302505202020E2021E2022E2023E2024E2025E2026E2027E2028E2029E2030E0020152016201720182019SourceFrostSullivananalysisSWSResearchSourceFrostSullivananalysisSWSResearch23CervicalcancersecondlargestfemalecancerCervicalcancerisoneofthemostcommonfemalecancersAccordingtotheglobalcancerstatisticsfromIARCcervicalcancerwasthefourthmostprevalentfemalecancergloballyin2020accountingfor65oftotalincidencefollowingbreastcancer245colorectalcancer94andlungcancer84Atthesametimecervicalcancerwasthefourthmaincauseoffemalecancerdeathsrepresenting77oftotaldeathsfollowingbreastcancer155colorectalcancer137andlungcancer95Pleaserefertothelastpageforimportantdisclosuresanddisclaimers16JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchFigure42DistributionofglobalcancerincidencebycancertypeFigure43Distributionofglobalcancermortalitybycancertypefemalefemale20202020Breast155Breast245Others289Others254Lung137ColorectumLeukemia30Non-Hodgkin94lymphoma26EsophagusColorectum3895Liver30Lung84Ovary47Ovary34Stomach40CervixuteriPancreas49CervixuteriCorpusuteri657745Thyroid49Liver57Stomach60SourceIARCSWSResearchSourceIARCSWSResearchAccordingtotheNationalCancerCenterAnnualWorkReportin2022releasedbytheNCCcervicalcanceristhesixthmostprevalentfemalecancerinChinaAccordingtotheIARCcervicalcancerincidenceinChinawasc110000in2020Eaccountingforc18ofthetotalcervicalcancercasesgloballySince2009ChinahaslaunchedascreeningprogramfortwocancersbreastcancerandcervicalcanceramongruralwomenwhichhasbeenincludedinamajornationalpublichealthserviceprogramWiththefurthersupportandimplementationofpoliciesaswellastherisinguseofHPVvaccinesitisexpectedthatthenumberofcervicalcancercasesinChinawilldecreasetoc85000in2040EIfthereexistsaprecancerouscervicallesioncervicalintraepithelialneoplasiaCINincervixuteriithaspotentialtodevelopintosquamouscellcarcinomaoradenocarcinomawithin10to15yearsifuntreatedwhichprovidesthetimewindowforearlycancerscreeningAccordingtodatafromFrostandSullivandetectionofcervicalcancerattheprecancerousandearlystagecanincreasethefive-yearsurvivalrateeffectivelyFigure44ForecastofcervicalcancerincidenceinChina2020-Figure45Five-yearsurvivalrateofcervicalcancerintheUSandChina2040E100100120thousand1001109181069084610010093808670576806050401604030401682012910200PrecancerousstageLocalizedstageRegionalstageDistantstage0theUSChina20202025E2030E2035E2040ESourceIARCSWSResearchSourceFrostSullivananalysisSWSResearchTheChinesePreventiveMedicineAssociationCPMArecommendswomenagedbetween25to65yearsoldtotakecervicalcancerscreeningAccordingtoFrostandSullivananalysisthepopulationrecommendedforcervicalcancerscreeninginChinawas420min2022Eandisexpectedtoincreaseto430min2030EThemainproblemforcervicalcancerscreeninginChinaisthelackofcoveragewiththecervicalcancerscreeningpenetrationrateofrecommendedpopulationinChinaofonly51in2022WiththefurtherPleaserefertothelastpageforimportantdisclosuresanddisclaimers17JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchpromotionoftwocancersscreeningandthestandardisationofscreeningandtreatmentitisexpectedthatthecervicalcancerscreeningpenetrationrateofrecommendedpopulationinChinawillincreasesignificantlyto79in2030EFigure46PopulationrecommendedforcervicalcancerscreeninginFigure47CervicalcancerscreeningpenerationrateofrecommendedChina2015-2030EpopulationinChina2015-2030E450million9040080350703006025050200401503010020501000SourceFrostSullivananalysisSWSResearchSourceFrostSullivananalysisSWSResearchAtpresentcervicalcancerscreeningtechnologiescanbedividedintomoleculartestingcytologyandvisualinspectioninwhichpapsmearisthegoldstandardbutwithdisadvantagesofinvasivenessandlackofprivacyThenewversionoftheWHOguidelineclearlysuggestsusingHPVDNAastheprimarycancerscreeningmethodinwhichHPV16andHPV18canscreenoutthemosthigh-riskgroupandhavehighersensitivityandNPVcomparedtootherscreeningmethodsBesidesmoleculartestinglikeDNAmethylationandproteinbiomarkersarestillinthedevelopmentstageFigure48SummaryofcervicalcancerscreeningtechnologiesScreeningmethodMoleculartestingCytologyVisualinspectionPapsmeargoldstandardNucleicacidamplificationtestsAvailable-hrHPVDNALiquid-basedcytologyVisualinspectionwithaceticacidorwithLugolsiodine-HPVmRNADualstainingtoidentifyp16andKi-67DNAmethylationUnderdevelopmentProteinbiomarkers-AI-HPVantibodies-OncoproteinsSourceWHOSWSResearchWiththeincreasingpenetrationrateoftwocancersscreeningespeciallythegovernmentsupportforwomeninruralareasandtheincreasingpublicawarenessofHPVthecervicalcancerscreeningmarketinChinastillhaslargepotentialAccordingtoFrostandSullivananalysisthemarketsizeofthecervicalcancerscreeningmarketinChinawasRmb19bnin2019withaCagrof122from2015to2019ThemarketisexpectedtoreachRmb31bnin2022EandRmb133bnin2030EwithaCagrof197from2020Eto2030EPleaserefertothelastpageforimportantdisclosuresanddisclaimers18JanuaryOctober122015122010BuildingFoodMaterialsBeverageCompanyCompanyTobaccoResearchResearchCompanyResearchFigure49CervicalcancerscreeningmarketinChina2015-2019Figure50CervicalcancerscreeningmarketinChina2020E-2030E201915RmbbnRmbbn133161191215141041212909751060647383105263220002020E2021E2022E2023E2024E2025E2026E2027E2028E2029E2030E20152016201720182019SourceFrostSullivananalysisSWSResearchSourceFrostSullivananalysisSWSResearch24LivercancercancerscreeningproductsinearlydevelopmentstageLivercancercanbedividedintoprimaryandsecondarylivercancersandprimarylivercancerishighlyprevalentinChinaAccordingtotheglobalcancerstatisticsfromIARCboththeage-standardisedincidenceandmortalityrateoflivercancerinChinarankedinthetoptiergloballywhichwas182and172permillionpeoplein2020respectivelyRiskfactorsforlivercancermainlyincludehepatitisBvirusHBVhepatitisCvirusHCValcoholandaflatoxinetcandlivercancercausedbyalcoholincreasesatthehighestrateFigure51Incidenceoflivercancerintheglobalmarket2020Figure52Mortalityoflivercancerintheglobalmarket2020SourceIARCSWSResearchSourceIARCSWSResearchAccordingtotheIARCtheincidenceoflivercancerinChinawasc410000in2020accountingfor45ofthetotallivercancercasesgloballyTheincidenceisexpectedtoreach460000in2025Eand510000in2030ETheearlysymptomsofprimarylivercancerarenon-specificwhiletherearemoresymptomsinthemiddleandadvancedstagesAtpresenttheeffectivenessoflivercancerscreeninginreducingmortalityrateisstilldebatableandthecoveragerateoflivercancerscreeninginChinaisrelativelylowPleaserefertothelastpageforimportantdisclosuresanddisclaimers19