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泰格医药定期财报:泰格医药:2019年年度报告(英文版)

股票名称:泰格医药 股票代码:300347
研报类型:(PDF) 研报栏目:定期财报
研报大小:4399K 分享时间:2020-05-21 16:57:16
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【财报摘要】

1HANGZHOUTIGERMEDCONSULTINGCO.,LTD.2019AnnualReportApril20202Section1Important,ContentsandDefinitionTheBoardofDirectors,BoardofSupervisors,Directors,SupervisorsandseniormanagementoftheCompanywarrantthatthecontentsoftheannualreportaretrue,accurateandcompleteandthereisnofalserepresentation,misleadingstatementormaterialomission,andtakelegalresponsibilitiesjointlyandseverally.CaoXiaochun,headoftheCompany,JunGao,person-in-chargeofaccountingaffairsandYuGuoyun,headofaccountingdepartment(accountingsupervisor)warrantthetruthfulness,accuracyandcompletenessofthefinancialstatementscontainedinthisannualreport.AlldirectorshaveattendedtheBoardmeetingapprovingthisreport.NilThedividenddistributionplanconsideredandapprovedbytheCompanyattheBoardmeeting:assumingthetotalsharecapitalcomprises748,450,333shares,acashdividendofRMB2.78(taxinclusive)wastobepaidtoallshareholdersforevery10sharesheldwithnobonusshares(taxinclusive)andnosharescreatedbywayofcapitalisationofcapitalreserveforevery10sharesheldtoallshareholders.3CONTENTSSection1Important,ContentsandDefinition................................................................................2Section2CompanyProfileandMajorFinancialIndicators.......................................................10Section3BusinessOverview..........................................................................................................15Section4ManagementDiscussionandAnalysis..........................................................................24Section5ImportantNotice.............................................................................................................58Section6ChangesinShareCapitalandInformationonShareholders.....................................84Section7PreferenceShares............................................................................................................99Section8ConvertibleBonds.........................................................................................................100Section9InformationonDirectors,Supervisors,SeniorManagementandEmployees........101Section10CorporateGovernance................................................................................................108Section11CorporateBonds..........................................................................................................116Section12FinancialReport..........................................................................................................117Section13DocumentsavailableforInspection...........................................................................3044DefinitionTerm(s)definedDetailsofdefinition“Company”,“ourCompany”,“Tigermed”HangzhouTigermedConsultingCo.,Ltd.“CRO”ContractResearchOrganization“NMPA”ChinaNationalMedicalProductsAdministration“FDA”theU.S.Food&DrugAdministration“GCP”theGoodClinicalPracticepromulgatedbythePRCgovernment“ICH-GCP”theGuidelinesonGoodClinicalPracticeoftheUnitedStates,EuropeanUnionandJapancoordinatedbyInternationalConferenceonHarmonization“SOP”StandardOperationProcess“CRA”ClinicalResearchAssociate,mainlyresponsiblefororganizingclinicalresearchofrelatedprojectsandformulatingimplementationplansforclinicalresearchofrelatedprojects.Clinicalinspectorsaregenerallyrequiredtopossessprofessionalknowledgeinclinicalmedicineandhealthstatistics,GCPcertificate,extensiveworkexperienceinclinicaltrials,aswellasstrongexternalcommunicationandcoordinationskillsandlanguageexpressionabilities“BD”BusinessDevelopmentDepartment,mainlyresponsibleforformulatingandimplementingdevelopmentplansbasedontheCompany’sstrategy,establishingsmoothcooperationchannelswithupstreamanddownstreamandparallelpartners,andcommunicatingwithrelevantgovernmentauthorities,associationsandotherorganizationstoseeksupportandobtainresources.“CRC”ClinicalResearchCoordinator“SMO”SiteManagementOrganization,aprofessionalmanagementorganizationwithintegratedclinicalresourcesoperation,awell-managedprofessionalcommercialorganizationthatassistsclinicaltrialinstitutionstoconductspecificoperationsofclinicaltrialsandaverificationagencyforsitemanagement“GSP”GoodSupplyPractice,asetofmanagementproceduresthatmanageallthefactorsthatmayresultinqualityissuesintheprocessofdistributionofdrugproductstoavoidqualityissues5“GMP”GoodManufacturingPractice,thebasicprincipleofdrugmanufacturingandqualitymanagement,whichisapplicabletothewholeprocessofdrugformulationmanufacturingandthekeyprocessthataffectsthequalityoffinishedproductsinthemanufacturingofAPI“ARO”AcademicResearchOrganization,whichdiffersfromCROwiththefollowingkeyfeatures:ithasacademicexpertteamsinscientificinstitutions,hospitaldepartments,diseasepreventionandcontrolcentersandotherinstitutionsandisresponsiblefortheopenpublicationofclinicaltrialsinacademicjournalsandmeetstheindependentacademicsupervisionrequirementsofclinicaltrialsmeetingtheexpectationsofregulatoryauthorities“innovativedrug(s)”Class1chemicaldrugsclassifiedaccordingtotheNMPAregistrationofchemicaldrugsandClass1biologicalproductsclassifiedaccordingtotheNMPAregistrationofbiologicalproducts“clinicalresearch(es)”apartofmedicalresearchandhealthresearchwiththepurposeofestablishingthebasictheoriesabouthumandiseasemechanism,diseasepreventionandhealthpromotion.Clinicalresearchinvolvesthestudyofdoctor-patientinteractionanddiagnosticclinicalinformation,data,orpatientpopulationdata“clinicaltrial(s)”anysystematicresearchofdrugsinthehumanbody(patientsorhealthyvolunteers)toconfirmorrevealtheeffects,adversereactions,and/orabsorption,distribution,metabolism,andexcretionofthetestdrugwiththepurposeofdeterminingtheefficacyandsafetyofthetestdrug“ShanghaiTigermed”ShanghaiTigermedCoLtd,awholly-ownedsubsidiaryoftheCompany“MacroStat”MacroStat(China)ClinicalResearchCo.,Ltd.,awholly-ownedsubsidiaryoftheCompany“JiaxingTigermed”JiaxingTigermedDataManagementCo.,Ltd.,awholly-ownedsubsidiaryoftheCompany“HangzhouSimo”HangzhouSimoCo.,Ltd.,awholly-ownedsubsidiaryoftheCompany“TigermedHK”HongkongTigermedCo.,Limited,awholly-ownedsubsidiaryoftheCompany“TaizhouKanglihua”TaizhouKanglihuaPharmaceuticalTechnologyCo.,Ltd,awholly-ownedsubsidiaryoftheCompany“GuangzhouTigermed”TigermedResearchInstituteCo.,Ltd.,awholly-ownedsubsidiaryoftheCompany“TigermedMacroStat”TigermedMacroStat,LLC,awholly-ownedsubsidiaryoftheCompany“BrightSky”BrightSkyResourcesInvestmentLtd,awholly-ownedsubsidiaryoftheCompany“BeijingBMD”BeijingMedicalDevelopmentCo.,Ltd,awholly-ownedsubsidiaryoftheCompany6“SuzhouBMD”BeijingMedicalDevelopment(Suzhou)Co.,Ltd,awholly-ownedsubsidiaryoftheCompany“TigermedEquity”HangzhouTigermedEquityInvestmentPartnership,awholly-ownedsubsidiaryoftheCompany“Tigermed-Jyton”TaizhouTigermed-JytonMedicalTech.Co.,Ltd.,awholly-ownedsubsidiaryoftheCompany“BeijingEjyton”BeijingEjytonTech.Co.,Ltd.,awholly-ownedsubsidiaryoftheCompany“JytonEmergo”JytonEmergo(Beijing)MedicalTechnologyCo.,Ltd.,awholly-ownedsubsidiaryoftheCompany“JytonKangxin”JYTON-GOWINMEDICALTECHNOLOGYCO.,LTD,awholly-ownedsubsidiaryoftheCompany“JytonKannel”BeijingJytonandKannelMedicalTech.Co.,Ltd.,awholly-ownedsubsidiaryoftheCompany“BlueSky”BlueSkyResourcesInvestmentLtd.,awholly-ownedsubsidiaryoftheCompany“TGSKY”TGSkyInvestmentLtd.,awholly-ownedsubsidiaryoftheCompany“ChengduXinsheng”ChengduXinshengTigermedTechnologyCompanyLimited,awholly-ownedsubsidiaryoftheCompany“Tigermed-BDM”Tigermed-BDMInc.,awholly-ownedsubsidiaryoftheCompany“TigermedClinical”TigermedClinicalResearchCo.Ltd.,awholly-ownedsubsidiaryoftheCompany“TigermedAustralia”TigermedAustraliaPtyLimited,awholly-ownedsubsidiaryoftheCompany“TigermedSingapore”SingaporeTigermedPTE.Ltd.,awholly-ownedsubsidiaryoftheCompany“Tiger-Xinze”Tiger-XinzeMedicalTechnology(Jiaxing)Co.,Ltd.,awholly-ownedsubsidiaryoftheCompany“TGMountain”TGMountainInvestmentCO.,(GP),awholly-ownedsubsidiaryoftheCompany“TGSkyGrowth”TGSkyGrowth(LP),awholly-ownedsubsidiaryoftheCompany“TigermedSwiss”TigermedSwissAG.,awholly-ownedsubsidiaryoftheCompany“TigermedUSA”TigermedUSAINC.,awholly-ownedsubsidiaryoftheCompany“HKHealthcare”HongKongTigermedHealthcareTechnologyCo.,Limited,awholly-ownedsubsidiaryoftheCompany“Tigermed-IntelliPV”HangzhouTigermed-IntelliPVCo.,Ltd.,awholly-ownedsubsidiaryoftheCompany“TigermedAmerica”TigermedAmericaLLC,awholly-ownedsubsidiaryoftheCompany7“WuxiTigermed”WuxiTigermedConsultingCo.,Ltd.,awholly-ownedsubsidiaryoftheCompany“JiaxingClinflash”JiaxingClinflashComputerTechnologyCo.,Ltd.,acontrollingsubsidiaryoftheCompany“BeijingCanny”BeijingCannyConsultingInc.,acontrollingsubsidiaryoftheCompany“HangzhouTaiyu”HangzhouTaiyuInvestmentConsultingCo.,Ltd.,acontrollingsubsidiaryoftheCompany“HangzhouYuding”HangzhouYudingEquityInvestmentManagementPartnership(LimitedPartnership),acontrollingsubsidiaryoftheCompany“FantasticBioimaging”FantasticBioimagingCo.,Ltd.,acontrollingsubsidiaryoftheCompany“FrontageHoldings”FrontageHoldingsCorporation,acontrollingsubsidiaryoftheCompany“FrontageLaboratories”FrontageLaboratories,Inc.,acontrollingsubsidiaryoftheCompany“FrontageShanghai”FrontageLaboratories(Shanghai)Co.,Ltd.,acontrollingsubsidiaryoftheCompany“Croley”CroleyMartellHoldings,Inc,acontrollingsubsidiaryoftheCompany“ConcordBiosciences”ConcordBiosciencesLLC,acontrollingsubsidiaryoftheCompany“ConcordHoldings”ConcordHoldings,LLC,acontrollingsubsidiaryoftheCompany“FrontageCanada”11736655Canada,Ltd,acontrollingsubsidiaryoftheCompany“RMI”RMILaboratories,LLC,acontrollingsubsidiaryoftheCompany“BRI”BRIBiopharmaceuticalResearch,Inc“FrontageSuzhou”FrontageLaboratories(Suzhou)Co,Ltd.,acontrollingsubsidiaryoftheCompany“FrontageLuohe”FrontageLaboratories(Luohe)Co,Ltd.,acontrollingsubsidiaryoftheCompany“DreamCIS”DreamCISInc.,acontrollingsubsidiaryoftheCompany“TigermedIndia”TigermedIndiaDateSolutionPrivateLimited,acontrollingsubsidiaryoftheCompany“Opera”OperaContractResearchOrganizationS.R.L.,acontrollingsubsidiaryoftheCompany“JiaxingYixin”EPSTigermed(Jiaxing)Co.,Ltd.,acontrollingsubsidiaryoftheCompany“TigermedMalaysia”TigermedMalaysiaSDNBHD.,acontrollingsubsidiaryoftheCompany“TigermedXingrong”BeijingTigermedXingrongInvestmentManagementCo.,Ltd.,acontrollingsubsidiaryoftheCompany“BeijingYaxincheng”BeijingYaxinchengMedicalInfoTechCo.,Ltd.,acontrollingsubsidiaryoftheCompany“YaxinchengBusiness”BeijingYaxinchengBusinessServiceCo.,Ltd.,acontrollingsubsidiaryoftheCompany8“KhorgasYaxincheng”KhorgasYaxinchengInformationTechnologyCo.,Ltd.,acontrollingsubsidiaryoftheCompany“Xi’anLaisai”Xi’anLaisaiTranslationCo.,Ltd.,acontrollingsubsidiaryoftheCompany“TalentMedConsulting”HangzhouTalentMedConsultingCo.,Ltd.,acontrollingsubsidiaryoftheCompany“TaiwanTigermed”TaiwanTigermedConsultingCo.Ltd,acontrollingsubsidiaryoftheCompany“TiayuPhaseII”HangzhouTaiyuPhaseIIEquityInvestmentPartnership,aninvesteeoftheCompany“JietongInspection”HangzhouTigermedJietongInspectionTechnologyCo.,Ltd.,aninvesteeoftheCompany“ShanghaiShengtong”ShanghaiShengtongInternationalLogisticsCo.,Ltd,aninvesteeoftheCompany“ShengtongSupplyChain”ShanghaiShengtongPharmaceuticalSupplyChainManagementCo.,Ltd.,aninvesteeoftheCompany“LuoheTaiyuAnkang”LuoheTaiyuAnkangInvestmentManagementCenter(LimitedPartnership),aninvesteeoftheCompany“LuoheYukang”LuoheYukangInvestmentCenterPartnership,aninvesteeoftheCompany“ShihezishiTaiyu”ShihezishiTaiyuEquityInvestmentPartnership,aninvesteeoftheCompany“ShiheziTai’er”ShiheziTai’erEquityInvestmentPartnership,aninvesteeoftheCompany“ShanghaiTeddy”TeddyClinicalResearchLaboratory(Shanghai)Limited,aninvesteeoftheCompany“HangzhouWangji”HangzhouWangjiHealthTechnologyCo.,Ltd.,aninvesteeoftheCompany“HangzhouYibai”HangzhouYibaiHealthManagementCo.,Ltd.,aninvesteeoftheCompany“CombakHospital”HangzhouCombakHospitalCo.,Ltd.,awholly-ownedsubsidiaryofHangzhouYibai,whichisaninvesteeoftheCompany“Mosim”MosimCo.,Ltd.,aninvesteeoftheCompany“YuzhouYixin”(Suzhou)TigermedCo.,Ltd.,aninvesteeoftheCompany“EPSTigermed”EPSTigermed(Nantong)Co.,Ltd.,aninvesteeoftheCompany“FrontageFJPharma”FJPharmaLLC,aninvesteeoftheCompany“FrontageClinical”FrontageClinicalServices,Inc.,aninvesteeoftheCompany“AntengeneInvestment”AntengeneInvestmentLimited“TigermedCloud”HangzhouTigermedCloudHospitalManagementCo.,Ltd.9“Non-publicoffering”theproposedofferingofRMB-denominatedordinaryshares(Ashares)totargetsubscribersbytheCompanybywayofnon-publicoffering“CSRC”ChinaSecuritiesRegulatoryCommission“ShenzhenStockExchange”or“SSE”theShenzhenStockExchange“CompanyLaw”theCompanyLawofthePeople’sRepublicofChina“SecuritiesLaw”theSecuritiesLawofthePeople’sRepublicofChina“BDOCPA”BDOChinaShuLunPanCertifiedPublicAccountantsLLP“Sponsor”CitiOrientSecuritiesCo.,Ltd.“CitiOrient”CitiOrientSecuritiesCo.,Ltd.10Section2CompanyProfileandMajorFinancialIndicatorsI.CompanyinformationStockshortname泰格医药Stockcode300347CompanynameinChinese杭州泰格医药科技股份有限公司CompanyshortnameinChinese泰格医药CompanynameinEnglish(ifany)HangzhouTigermedConsultingCo.,LtdCompanyshortnameinEnglish(ifany)TigermedLegalrepresentativeCaoXiaochunRegisteredaddress1502-1,DongguanPlaza,No.618JiangnanAvenue,BinjiangDistrict,HangzhouPostalcodeofregisteredaddress310053Officeaddress15thfloor,No.618JiangnanAvenue,BinjiangDistrict,HangzhouPostalcodeofofficeaddress310053CompanywebsiteEmailir@tigermedgrp.comII.ContactpersonandcontactmethodSecretarytotheBoardRepresentativeofsecuritiesaffairsNameGaoJunLiXiaoriContactaddress15thfloor,No.618JiangnanAvenue,BinjiangDistrict,Hangzhou15thfloor,No.618JiangnanAvenue,BinjiangDistrict,HangzhouTelephone0571-899867950571-89986795Facsimile0571-899867950571-89986795Emailir@tigermedgrp.comir@tigermedgrp.comIII.InformationdisclosureandplaceofinspectionNameofmediadesignatedbytheCompanyforinformationdisclosureSecuritiesTimes11WebsitedesignatedbyCSRCforpublicationofannualreportPlaceofinspectingtheannualreportoftheCompanySecuritiesaffairsdepartmentoftheCompanyIV.OtherrelevantinformationAccountingfirmengagedbytheCompanyNameofaccountingfirmBDOChinaShuLunPanCertifiedPublicAccountantsLLPOfficeaddressofaccountingfirm4thfloor,No.61NanjingEastRoad,ShanghaiNameofsigningaccountantsZhangSongbai,WangFaliangSponsorengagedbytheCompanythatperformsthedutiesofcontinuoussupervisionduringthereportingperiod√Applicable□NotapplicableNameofsponsorOfficeaddressofsponsorNameofsponsorrepresentativesPeriodofcontinuoussupervisionCitiOrientSecuritiesCo.,Ltd.24thfloor,BuildingNo.2,No.318ZhongShanSouthRoad,ShanghaiGeShaozheng,BianJiazhenFebruary2015toDecember2019FinancialadvisorengagedbytheCompanythatperformsthedutiesofcontinuoussupervisionduringthereportingperiod□Applicable√NotapplicableV.MajoraccountingdataandfinancialindicatorsWhetherretrospectiveadjustmentsorrestatementswouldbemadebytheCompanytotheaccountingdataforprioryears□Yes√No20192018Change2017Revenue(RMB)2,803,309,287.652,300,659,706.6221.85%1,687,033,455.82Netprofitattributabletoshareholdersofthelistedcompany(RMB)841,634,823.38472,183,931.6578.24%301,013,932.80Netprofitattributabletoshareholdersofthelistedcompanyafterdeductingextraordinarygainorloss(RMB)558,119,891.62357,055,961.1556.31%239,901,292.95Netcashflowfromoperatingactivities(RMB)527,557,935.51522,242,718.651.02%314,970,861.81Basicearningspershare(RMB/share)1.130.6379.37%0.41Dilutedearningspershare(RMB/share)1.130.6379.37%0.4112Weightedaveragereturnonnetassets23.65%17.52%6.13%13.74%December31,2019December31,2018ChangeDecember31,2017Totalassets(RMB)7,532,651,176.524,279,788,506.4876.01%3,583,167,950.81Netassetsattributabletoshareholdersofthelistedcompany(RMB)4,225,457,956.552,668,584,135.2758.34%2,491,046,293.20VI.QuarterlymajorfinancialindicatorsUnit:RMBFirstquarterSecondquarterThirdquarterFourthquarterRevenue608,888,953.83728,405,635.50693,703,343.54772,311,354.78Netprofitattributabletoshareholdersofthelistedcompany145,507,918.52206,610,332.04176,005,998.02313,510,574.80Netprofitattributabletoshareholdersofthelistedcompanyafterdeductingextraordinarygainorloss111,544,220.08176,185,239.19150,387,116.25120,003,316.10Netcashflowfromoperatingactivities51,154,595.7574,907,541.11214,234,583.53187,261,215.12Whethertheabovefinancialindicatorsoraggregateismateriallydifferentfromtherelevantfinancialindicatorsdisclosedinquarterlyreportsorsemi-annualreportsoftheCompany□Yes√NoVII.Differencesinaccountingdataunderdomesticandforeignaccountingstandards1.DifferencesinnetprofitandnetassetsdisclosedinthefinancialstatementsunderInternationalAccountingStandardandChinaAccountingStandard□Applicable√NotapplicableThereisnodifferenceinnetprofitandnetassetsdisclosedinthefinancialstatementsduringthereportingperiodunderInternationalAccountingStandardandChinaAccountingStandard.2.DifferencesinnetprofitandnetassetsdisclosedinfinancialstatementsunderforeignaccountingstandardsandChinaAccountingStandard□Applicable√NotapplicableThereisnodifferenceinnetprofitandnetassetsdisclosedinthefinancialstatementsduringthereportingperiodunderforeignaccountingstandardsandChinaAccountingStandard.13VIII.Itemsandamountsofextraordinarygainorloss√Applicable□NotapplicableUnit:RMBItemAmountsin2019Amountsin2018Amountsin2017RemarksGainorlossfromdisposalofnon-currentassets(includingthosealreadywrittenoffintheprovisionforimpairmentofassets)43,737,385.02-151,707.39-107,618.59Mainlyduetothedisposaloflong-termassetsincludingthelong-termequityinvestmentsandfixedassetsduringthereportingperiod.Governmentgrants(exceptforgovernmentgrantswhicharecloselyrelatedtotheordinarybusinessoftheCompanyandentitledinstandardamountsorquantitiesinconformitywiththeuniformstandardsoftheState)includedintheprofitorlossfortheperiod16,216,189.6310,570,098.1012,845,384.29MainlyduetothegovernmentgrantsreceivedbytheCompanyduringthereportingperiod.Capitaloccupationfeereceivedfromnon-financialentitiesincludedinprofitorlossfortheperiod1,818,429.16GainfromtheexcessofthefairvalueoftheidentifiablenetassetsofinvesteesonacquisitionoftheinvestmentovertheinvestmentcostintheCompany’ssubsidiaries,associatesandjointventures41,488,162.45MainlyduetotheinvestmentincomearisingfromadditionandconsolidationofsubsidiarybytheCompanyduringthereportingperiod.Gainorlossfrominvestmentsontrustorassetmanagement1,371,800.461,544,444.664,277,695.56MainlyduetotheincomefromwealthmanagementproductsoftheCompanyduringthereportingperiod.14Profitorlossarisingfromchangesinfairvalueofheld-for-tradingfinancialassets,derivativefinancialassets,held-for-tradingfinancialliabilitiesandderivativefinancialliabilitiesandinvestmentgainsreceivedfromdisposalofheld-for-tradingfinancialassets,derivativefinancialassets,held-for-tradingfinancialliabilities,derivativefinancialliabilitiesandotherdebtinvestments(exceptforthoserelatedtoeffectivehedgingbusinessesunderordinarybusinessscopeoftheCompany)277,841,928.30126,926,483.9948,906,000.13Mainlyduetotheinvestmentincomederivedduringtheholdingofothernon-currentfinancialassetsandrecognizedupondisposalandthegainonchangesinfairvaluearisingfromothernon-currentassets;andthegainarisingfromtheremainingequityinterestatfairvalue(restated)aftercontrolislost.Othernon-operatingincomeandexpensesapartfromtheaboveitems-470,286.854,218,015.4910,069,412.04Less:Effectofincometax23,682,926.6218,326,757.5713,992,846.38Effectofminorityinterests(aftertax)72,987,320.6311,471,035.94885,387.20Total283,514,931.76115,127,970.5061,112,639.85--ForitemsofextraordinarygainorlossofdefinedintheNoticeonExplanationofInformationDisclosureofCompaniesPubliclyIssuingSecuritiesNo.1–ExtraordinaryGainorLoss,anditemsofextraordinarygainorlossillustratedintheNoticeonExplanationofInformationDisclosureofCompaniesPubliclyIssuingSecuritiesNo.1–ExtraordinaryGainorLossdefinedasitemsofextraordinarygainorloss,theCompanyshallprovidethereasons□Applicable√NotapplicableDuringthereportingperiod,therewasnoitemofextraordinarygainorlossdefinedandillustratedintheNoticeonExplanationofInformationDisclosureofCompaniesPubliclyIssuingSecuritiesNo.1–ExtraordinaryGainorLossdefinedasitemofextraordinarygainorloss.15Section3BusinessOverviewI.PrincipalBusinessConductedbytheCompanyDuringtheReportingPeriod(I)BusinessPrimarilyConductedbytheCompanyTheCompanyisacontractresearchorganisation(CRO)focusedonprovidingprofessionalservicesfortheR&Dofnewdrugsthroughouttheclinicaltrialprocess.Itprovidescomprehensiveandintegratedclinicalresearchsolutionstoglobalpharmaceuticalandmedicaldeviceinnovationcompaniestoensureresearchquality,reduceR&Drisks,shortentheR&Dcycle,andsaveR&Dexpenditure,promotingtheprocessofproductmarketisationsothatpatientscanusenewerandbettermedicinesandmedicalproductssoon.(II)BusinessModelTheCompanyiscommittedtoprovidingcomprehensiveandintegratedservicesupportforcustomersinthedevelopmentofnewdrugs/medicaldevicesinthebestway,providingcomprehensivetechnicalservicesandsolutionsfromthestagesofpre-clinical,clinicaltopost-launchtohelpcustomersenhanceclinicalresearchefficiencyandensureresearchquality,savingtimeandcost.TheCompany’sprincipalbusinessincludesclinicaltrialsolutionsandclinical-relatedservicesandlaboratoryservices.1.ClinicalTrialSolutionsTheCompanyprovidesclinicaltrialoperationservicesforinnovativedrugs,genericdrugsandmedicaldevices,aswellascomplementaryservicesdirectlyassociatedwithclinicaltrialoperationssuchasmedicalwriting,translationandregistrationservicesandpharmacovigilanceservices.(1)ClinicalDrugResearchRelyingonasoundqualitymanagementsystem,astandardoperatingprocedure,amatureprojectmanagementsystem,andahighly-qualifiedandexperiencedclinicalteam,weareabletoensureefficientprojectadvancement,patientsafety,anddataqualitythroughouttheprocessofaprojectfromstarttofinish.Wecanprovidemedicalliaison,early-,middle-andlate-stageclinicaldevelopment,medicalmonitoring,projectmanagement,qualitymanagementandotherservices.Havingalong-termcooperationwithexcellentclinicaltrialorganisationsinChinaandotherpartsoftheworld,wehaveestablishedaclosecooperativerelationshipwithpartiesincludingresearchinstitutes,hospitals,laboratories,andauthoritativeexpertsintheclinicalfield,toensurethatallclinicalstudiesweservecomplywithcGCPandrelevantICH-GCPguidelines,thusguaranteeingglobalconsistencyandhighstandards.Asofthedisclosuredateofthisreport,theCompanyhasestablished123serviceoutletsinmajormainlandChinacities,HongKongandTaiwanthatefficientlyinteractwithclinicalresearchers,coveringresearchhospitalresourcesin28provinces,fourautonomousregions,andfourmunicipalities16nationwide,tofullyshareinformationofresearchhospitals.TheCompanyhasmatureandcompleteSOPandrichinternationalprojectmanagementexperience.Projectmanagementissystematicandefficient,andwhole-processdynamicmonitoringandmanagementofresearchprogressisimplemented.TheCompany’squalityassurancedepartment,whichisindependentoftheclinicaltrialoperationdepartments,evaluatesthequalityandriskthroughouttheprocess,includingclinicaltrialoperationsandsuppliers,fromanindependentthird-partyperspective,providingstrongassuranceforcustomers’projectsonitsefficientclinicalinspection,comprehensivetrainingsystem,andperfectSOPmanagement.(2)ClinicalMedicalDeviceResearchAsChina’sleadingmedicaldeviceregulatoryliaisonandclinicalresearchserviceprovider,ourteamhasestablishedlong-termcooperativerelationswithover1,400medicaldeviceR&Dandproductioncompaniesinmorethan30countries.Weprovideassistanceinallaspectsinvolvedinthedevelopmentandproductionofmedicaldevicesandinvitrodiagnosticproductsinordertorespondtochangesincomplexinternationalregulatoryrequirements.ThebusinessismainlyundertakenbyoursubsidiaryTigermed-Jyton,anddetailsofthebusinesscanbefoundonitswebsite.(3)MedicalRegistrationTheCompanycanprovideprofessionalregistration-relatedservicesforchemicaldrugs,biologicalproductsandmedicaldeviceproducts,includingmarketingauthorisationandproductregistration,andmedicaltranslation.Theregistrationteamhasawealthofpracticalexperience.Duringtheproductregistrationprocess,theycanaccuratelygraspthekeypointsinproductregistrationwithfullunderstandingofthespecificrequirementsofNMPA,FDA,EMAandotherregulatoryauthoritiesaroundtheworldonthematerialsforproductdeclaration,maintainingeffectivetwo-waycommunicationwithcustomersandgovernmentregulatorsatmultiplelevelsandinmanyrespects,includingproceduralregulations,regulatoryrequirements,technicalcomplianceandotherperspectives,toensurespeedyprojectprogress,boostdrugdevelopment,andshortenthetimetomarket.(4)BioequivalenceServicesTheCompanyhasaprofessionalBEteamwithstrongtechnicalstrengthsandrichprojectexperience,capableofregulatingthescientificityandjustifiabilityofsolutionsdesignaccordingtodomesticandforeignresearchprogress.Theteamisexperiencedindevelopinganalyticalmethodsforcompoundsandhastheabilitytodevelopchallenginganalyticalmethods.Inaddition,theCompanyhascooperatedwithanumberofclinicalorganisationsonthebuildingofclinicalcentresthatprovidemorereliablequalityassuranceincompliancewiththeverificationstandardsofNMPA,FDAandtheEU.ProvidingcustomerswithaunifiedqualitysysteminChinaandtheUS,andoperatinginfullcompliancewiththeUSFDAandtheEUGLP/GMP/GCPstandards,theCompanysuccessfully17underwentmultipleUSFDAon-siteinspectionsandChineseNMPAon-siteinspections.ThebusinessismainlyundertakenbyoursubsidiaryFrontageHoldings.Fordetails,pleaserefertoFrontageHoldings’announcementonthe2019annualresults,thelinkofwhichis.2.Clinical-relatedServicesandLaboratoryServicesTheCompanyprovidesotherimportantservicesinthedrugdevelopmentprocess,includingdatamanagementandstatisticalanalysis,sitemanagementandpatientrecruitment,medicalimagingaswellaslaboratoryservicesprovidedbyoursubsidiaryFrontageHoldings.(1)ProvisionofComprehensiveInternationalDataManagementandStatisticalAnalysisServicesTheCompany’sdatamanagementandstatisticalanalysisteam,mainlydistributedinmainlandChina,Taiwan,theUS,SouthKorea,andIndia,iscommittedtoprovidingtimelyandhigh-qualitydatamanagement,biostatistics,andstatisticalprogrammingservicesforclinicaldevelopmentandregistrationsubmission.Theteamhastheabilitytomanagethesubmissionofdatathatmeetsinternationalstandards,boastingtheprovisionofflexibleandaccuratesolutionsforthewholeresearchprocessfromstarttofinish,athoroughunderstandingofvariousdiseaseareas,suchastumour,immunity,endocrine,neurology,andinfectiousdiseases,anindustryreputationforhighcredibilityandtrustworthiness,anexcellenttrackrecordonhighqualityandon-timedelivery,andthepermissionforsponsorstoaccessreal-timedataprocesses,whichisinlinewithWHO-DDMedDRA,SASandotherinternationalstandardsandcertifications.Thedatamanagementandstatisticalanalysisteamhasawealthofprojects.Asofthedisclosuredateofthisreport,itparticipatedinmorethan2,200clinicalresearchprojectsandmorethan300CDISCstandardprojects,andsubmittedapplicationof16drugsorindicationsfortheFDAnewdrugapplicationandbiologiclicenseapplication(NDA/BLA)approvals.(2)SiteManagementandPatientRecruitmentTheCompanyhasasitemanagementorganisation(SMO)teamcoveringallmajorcitiesinChina.Theteamiscommittedtoassistingresearchersandresearchcentrestocompleteliaisonworkinvolvingnon-medicaljudgmentinclinicaltrialsbyprovidingprofessionalservicesforsitemanagementandspecificoperationstoensurethequalityofclinicaltrialsandtheprogressofresearch,promotingthestandardisationofclinicaltrials.Sincethecommencemen……

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