[一季报]华东医药(000963):2026年第一季度报告（英文版）
原标题:华东医药:2026年第一季度报告（英文版） FirstQuarterlyReport2026 TheCompanyandallmembersoftheBoardofDirectorsherebyguaranteethattheinformationpresentedinthisreportis authentic,accurateandcompleteandfreeofanyfalserecords,misleadingstatementsormaterialomissions.ImportantDeclaration: 1.TheBoardofDirectors,directorsandseniormanagementofHuadongMedicineCo.,Ltd.(hereinafterreferredtoasthe "Company")herebyguaranteethattheinformationpresentedintheReportisauthentic,accurateandcompleteandfreeoffalse records,misleadingstatementsormaterialomissions,andshallundertakeindividualandjointlegalliabilities. 2.TheCompany'slegalrepresentative,theofficerinchargeofaccounting,andtheheadofAccountingDepartment(accounting manager)herebydeclarethatthefinancialinformationinthisquarterlyreportisauthentic,accurateandcomplete. 3.HastheFirstQuarterlyReportbeenaudited? □Yes?No Accordingto“StockListingRulesoftheShenzhenStockExchange”,iflistedcompanieshavebothChineseandotherlanguage versionofpublicnotice,theyshouldensurethecontentofbothversionsarethesame.Inthecaseofdiscrepancy,theoriginal versioninChineseshallprevail. I.KeyFinancialData (I)Keyaccountingdataandfinancialindicators WhethertheCompanyneedstoperformaretroactiveadjustmentorrestatementofpreviousaccountingdata
?Applicable□Notapplicable
Therearenootherprofitandlossitemsthatmeetthedefinitionofnon-recurringprofitsandlosses.Explanationforrecognizinganitemlistedasanon-recurringprofitandlossintheInterpretativeAnnouncementNo.1on InformationDisclosureCriteriaforPublicListedCompanies-Non-RecurringProfitsandLossesasanitemofrecurringprofitand loss □Applicable?Notapplicable TheCompanydidnotrecognizeanyitemofnon-recurringprofitandlossitemslistedintheInterpretativeAnnouncementNo.1on InformationDisclosureCriteriaforPublicListedCompanies-Non-RecurringProfitsandLossesasanitemofrecurringprofitand loss. (III)Detailsandreasonsforchangesinkeyaccountingdataandfinancialindicators?Applicable□Notapplicable Unit:RMB10,000
(I)Totalnumberofcommonshareholders,numberofpreferredshareholderswithrestoredvotingrightsandshareholdingsoftop10shareholders Unit:Shares
shareholdersandtop10shareholdersholdingtradableshareswithouttradingrestriction□Applicable?Notapplicable Changeintop10shareholdersandtop10shareholdersholdingtradableshareswithouttradingrestrictionduetolending/returning ofsharesthroughrefinancingascomparedtothepreviousperiod □Applicable?Notapplicable (II)Totalnumberofpreferredshareholdersandshareholdinglistoftop10preferredshareholdersoftheCompany □Applicable?Notapplicable Ⅲ.OtherImportantMatters ?Applicable□Notapplicable (I)OverviewoftheCompany'soveralloperationsduringthereportingperiodIn2026,externalcompetitionisexpectedtocontinueintensifying,andthepolicyenvironmenthasbecomeincreasinglycomplexandvolatile.Corporatedevelopmentfacesmountingpressures.Competitiondrivenbymarketsharewillenteranewstage.Duringthereportingperiod,inthefaceofthesechallenges,theCompanyhasremainedfirmlyalignedwithitsoverallstrategicroadmapandannualoperationalobjectives.Guidedbythebusinessprioritiesof"exploringnewmarkets,focusing on new products, strengthening organizational capabilities, and building newcompetencies",theCompanyhasupheldthemanagementphilosophyof"problem-solvingandvalue creation", and integrated the principles of "innovation-driven development, resourceintegration, and enterprise-wide collaboration" throughout all operational processes; stayingcommittedtoitsinnovation,theCompanyhassystematicallyadvancedcomprehensiveupgradesacrossitsproductportfolio,managementsystems,andtalentdevelopment.ItconcentratedresourcesontacklingkeyR&Dandclinicalstudyprograms,deepenedcollaborationacrosssectorssuchaspharmaceuticals,medicalaesthetics,andcommercialoperations,continuouslyactivatedgrowthdrivers for innovative business, and realized steady improvements in operational quality andmanagementefficiency,ensuringtheorderlyexecutionofvarioustasks.Duringthereportingperiod,theCompanyachievedoperatingrevenueofRMB11.183billion,representingaYoYincreaseof4.17%andaquarter-on-quarterincreaseof2.15%comparedwithQ42025.NetprofitattributabletoshareholdersofthelistedcompanyreachedRMB1.002billion,up9.56%year-on-year.Netprofitattributabletoshareholdersexcludingnon-recurringprofitandlossitemswasRMB990million,markingaYoYincreaseof10.30%andreachingahistoricalhighforthesameperiod. Duringthereportingperiod,ZhongmeiHuadong,theCompany'scoresubsidiaryinthefieldofpharmaceuticalindustry,maintainedsteadygrowthinoveralloperations.Itachievedoperatingrevenue(includingCSObusiness)ofRMB4.048billion,representingan11.82%YoYincrease.TheconsolidatednetprofitattributabletotheparentcompanyreachedRMB931million,up10.44%year-on-year.Bothoperatingrevenueandnetprofitattributabletotheparentcompanyrecordedthegrowthexceeding10%. Duringthereportingperiod,therevenuecontributionofinnovativeproductscontinuedtoincrease.SalesandagencyservicerevenuegeneratedfrominnovativeproductsreachedRMB810million,representingayear-on-yeargrowthof61.8%andaccountingfor20.05%oftheoperatingrevenueofthepharmaceuticalindustrysegment(includingtheCSObusiness).TheoverallbusinessoftheCompanyhasenteredastronggrowthtrajectory,furtherdemonstratingtheeffectivenessoftheCompany’sR&Dachievementtransformationandtheprofessionalismofitscommercializationoperations.Bytheendofthefirstquarterof2026,medicalinstitutionsthatwerecertifiedandregisteredtoadministertheCAR-TtherapyZevorcabtageneAutoleucelInjection(zevor-cel)hadexpandedtomorethan20provincesandmunicipalitiesacrossthecountry.Zevor-celhasalsobeenincludedintheCommercialHealthInsuranceInnovativeDrugList.AsofthedateofthisReport,morethan100commercialandHuiminbao(acity-specificsupplementalmedicalinsuranceprogram)programs have incorporated zevor-cel into their reimbursement coverage. Since its launch,? Sailexin, the biosimilar of Ustekinumab Injection, has demonstrated outstanding marketperformance.Todate,ithasbeenprescribedinover2,000hospitals,anditssalesrevenueinthefirstquarterof2026increasedbynearly200%yearonyear. ? Inthediabetesfield,Huiyoujing,i.e.,GanagliflozinProlineTablets,whichistheClass1newdrug,hasnowbeenadoptedbyover1,900tieredhospitals.Itssalesrevenueinthefirstquarterof2026increasedbyover800%yearonyear(notingthatthefirstquarterof2025wasitsfirstsalesperiodafterinclusioninthenationalreimbursementdruglist). ? Bytheendofthefirstquarter,MirvetuximabSoravtansineInjection(tradename:ELAHERE)hadbeenlistedondrugprocurementplatformsin29provinces,prescribedinover200hospitals,andmadeavailableinmorethan400medicalinstitutionsandover200DTPpharmacies.Currently,? Elahere has also been successfully incorporated in multiple Huiminbao (a city-specificsupplementalmedicalinsuranceprogram)programsandcommercialinsuranceprograms,suchasBeijingInclusiveMedicalInsuranceProgram,JiangxiGanhuibao(inclusivecommercialhealthinsuranceprogram),LeshanHuijiabao(city-customizedinsuranceprogram),andShaanxiUniversal? HealthInsurance.From2025totheendofthereportingperiod,cumulativesalesofElahereexceeded RMB 100 million. The novel PARP inhibitor, Senaparib Capsules (trade name:? Paishuning), exclusively promoted by the Company, has delivered outstanding marketperformance.Currently,itisavailableinover300DTPpharmaciesandmorethan900medicalinstitutions,supportedbyamulti-tierdistributionnetwork;atthesametime,theCompanyactivelypromotedtheinclusionofitsproductinreimbursementcoverageofinsuranceprograms.Theproduct has been incorporated into multiple regional Huiminbao programs (e.g., West LakeYilianbao,Huhuibao,Chonghuibao,JiaxingHuiminbao,andCPIC-Huxiangbao),aswellasothercommercialinsuranceprograms,effectivelyreducingthefinancialburdenofpatients.patientswithnormalorimpairedrenalfunction,hasofficiallycommencedcommercialsalesinthe? Chinesemarket.Todate,consumablesofMediBeacon TGFRhavebeenlistedin25provinces,whileRelmapirazinInjectionhasbeenlistedin21provinces. During the reporting period, the pharmaceutical distribution segment of the Companysustainedstableoperations,yieldinganaggregateoperatingrevenueofRMB7.181billion,markingayear-on-year(YoY)uptickof3.57%,andanetprofitofRMB119million,representinga3.16%YoYincrease.Overall,itdemonstratedarobustdevelopmentaltrajectory.Affectedbymultiplefactorssuchasthecyclicalfluctuationsintheglobaleconomy,intensifiedindustry competition, and slower-than-expected recovery in domestic aesthetic medicineconsumption,theCompany'saestheticmedicinesegmentcontinuedtoconfrontgrowthheadwinds.Throughout the reporting period, it achieved a total operating revenue of RMB 361 million(excludinginternaloffsets),reflectingaYoYdeclineof30.38%. OnMarch25,2026,theCompany'sexclusivelydistributedproduct,RecombinantBotulinum? Toxin TypeAfor Injection (R&D code: YY001; trade name: Retoxin), received marketingapprovalfromtheNationalMedicalProductsAdministration(NMPA).Thisproductisindicatedforthetemporaryameliorationofmoderate-to-severeglabellarlinesinadultsaged65andunder,resultingfromtheactivityofthecorrugatorsuperciliiand/orprocerusmuscles.Thisproductispoisedtoinitiateformalcommercialsalesinthenearfuture. Duringthereportingperiod,theCompany'sindustrialmicrobiologysegmentcontinuedtoexperiencerelativelyrapidrevenuegrowth,withaYoYincreaseof21.82%.Giventheproactiveexpansionintooverseasmarketsandaconsistentuptickinorders,thissegmentisanticipatedtoupholditsfavorabledevelopmentalmomentum. (II)ImportantR&DprogressoftheCompanyduringthereportingperiod1.Majorprogressininnovation-drivenR&DduringthereportingperiodOncology HDM2005,anantibody-drugconjugate(ADC)targetingROR1,hasmaintaineditsleadingpositionwithintheglobalfirstechelonofclinicaldevelopmentforROR1ADCs.Presently,threeclinicalstudiesarebeingconductedinChina:aPhaseIclinicalstudyevaluatingmonotherapyforadvancedhematologicmalignancies,includingmantlecelllymphoma(MCL),diffuselargeB-celllymphoma(DLBCL),andclassicalHodgkinlymphoma(cHL).ThisstudyhascompletedPhaseIamonotherapydoseescalationandiscurrentlyperformingdoseexpansionstudiesforMCLandcHL.AnotherPhaseIstudy,assessingmonotherapyforadvancedsolidtumors,hasenrolled17patientsstudyinvestigatingcombinationtherapyforDLBCLpatientsiscurrentlyundergoingcombinationtherapydoseescalation.Inaddition,theCompanyhassubmittedcommunicationandmeetingrequeststotheCDE,respectively,forcombinationtherapyinMCLandcHL.TheclinicalstudyfordoseescalationofmonotherapyinvolvingHDM2020,anADCtargetingFGFR2b,hasadvancedtothefourthdosecohort.Furthermore,aPhaseIastudyforlungsquamouscellcarcinomahasofficiallycommenced,withsubjectscreeningcurrentlyinprogress.InFebruary2026,HDM2020wasgrantedorphandrugdesignation(ODD)bytheU.S.FDAforgastriccancer(includinggastroesophagealjunctioncancer). HDM2012,anADCtargetingMUC17,hasreachedthefourthdosecohortinitsPhaseIclinicalstudyaimedattreatingadvancedsolidtumors. HDM2017, targeting CDH17, has progressed to the fourth dose cohort in its Phase IamonotherapytrialinChina,withconcurrentdoseexpansionatadosageof3.2mg/kg.ThefirstAustraliansitewasactivatedinFebruary2026,andsubjectscreeningisongoing.Inaddition,inMarch2026,HDM2017receivedODDfromtheU.S.FDAforthreeindications:biliarytractcancer,gastriccancer,andpancreaticcancer. HDM2024,anEGFR/HER3-targetingbispecificADC,receivedINDapprovalsintheUnitedStatesandChinainMarch2026forthetreatmentofadvancedsolidtumors.ThefirstsubjectadministrationinaPhaseIclinicalstudyinChinawascompletedinApril2026.HDP-101(HDM2027),aBCMA-targetingamanitinADC,enrolleditsfirstpatientinChinainMarch2026forthetreatmentofplasma-celldisorders,includingmultiplemyeloma.Thesmall-moleculeantineoplasticagentHPK-1PROTAC(hematopoieticprogenitorkinase1proteolysis-targetingchimera),HDM2006tablets,iscurrentlyundergoingaPhaseIclinicalstudyinChina forthe treatment of advanced solid tumors, with enrollment forthe third dose cohortunderway. DR30206forinjection,aproprietaryPD-L1/VEGF/TGF-βtri-specificantibodyfusionprotein,developedbyDoerBiologics,acontrolledsubsidiaryoftheCompany,isnearingthecompletionofdoseexpansionstudiesinitsPhaseIbtrialforthefirst-linetreatmentofnon-smallcelllungcancer,demonstratingpromisingoverallefficacy.Theprogramisadvancingitscombinationtherapystudy.Phase Ib/IIa clinical studies evaluating combination therapy with standard chemotherapy foradvancedormetastaticgastrointestinaltumors,aswellasPhaseIbmonotherapyexpansionstudiesforheadandnecksquamouscellcarcinomacohorts,arecurrentlyunderway.InJanuary2026,theDR30206wasadministeredtothefirstsubjectinthemonotherapyexpansioncohortforplatinum-resistantovariancancerduringitsPhaseIbtrial.InMarch2026,DR30206receivedINDapprovalmetastaticnon-smallcelllungcancer. Endocrinology HDM1002(conveglipron),theoralsmall-moleculeGLP-1receptoragonist,hascompletedenrollmentofallsubjectsforitsPhaseIIIclinicalstudyinChinafortheweightmanagementindication.Thestudyiscurrentlyinthestageoftreatmentfollow-upanddatacollection.TheNDAapplicationisexpectedtobesubmittedinQ42026.BothPhaseIIIclinicalstudiesforthetype2diabetes mellitus indication of this product have completed full enrollment. Pre-NDAcommunicationapplicationisexpectedtobesubmittedinQ42026. HDM1005 (poterepatide) Injection, a GLP-1R/GIPR long-acting polypeptide dual-targetagonist,enrolledallsubjectsinthePhaseIIIclinicalstudyfortheweightmanagementindication.Top-lineresultsforthePhaseIIclinicalstudyfordiabeteswereobtainedinFebruary2026.ThefirstsubjectshavebeenenrolledinbothPhaseIIIstudiesfordiabetes.TwoPhaseIIIstudiesfortheobstructivesleepapneahypopneasyndrome(OSAS)indicationarecurrentlyinpreparation.DR10624, a first-in-class therapeutic candidate targeting FGF21R/GCGR/GLP-1R anddevelopedbyDoerBiologics,acontrolledsubsidiaryoftheCompany,iscurrentlyprogressingwithpreparationsforitsPhaseIIIclinicalstudyaimedattreatingseverehypertriglyceridemia.InJanuary2026,DR10624wasincludedintheBreakthroughTherapyDesignationbytheCDEforseverehypertriglyceridemia.ThePhaseIIclinicalstudytargetingpatientswithmetabolicdysfunction-associatedsteatoticliverdiseasewithhighriskofliverfibrosis iscurrentlybeingconductedconcurrently.Top-lineresultsareexpectedtobeobtainedinQ32026.HDM1014injection,whichistheGalNAc-siRNAweight-lossdrugself-developedbytheCompany,isundergoingINDdevelopmentwork.ItisexpectedtosubmitINDapplicationinChinainQ42026. TheINDapplicationforHDM1010tablets(afixed-doseoralcombinationformulationofHDM1002)intendedforthetreatmentoftype2diabetesmellitushasreceivedapprovalfromtheU.S.FDA.Clinicalstudypreparationsarecurrentlyinfullswing. TheNDAforthediabetesindicationofSemaglutideInjectionwassubmittedandacceptedinMarch2025andsuccessfullypassedclinicalinspection;theNDAfortheweightmanagementindicationwasacceptedinApril2026. TheNDAforInsulinDegludecInjectionwassubmittedandacceptedinFebruary2025;theon-siteinspectionhasbeencompleted,andtheapplicationiscurrentlyundertechnicalreview.Thetop-lineresultsfromthePhaseIIIclinicalstudyofInsulinDegludecandInsulinAspartInjectionhavebeenobtained.ItisexpectedtosubmitNDAintheQ2of2026.TheMarketingAuthorizationApplication(MAA)andsupplementalapplicationforHDM3001(QX001S),austekinumabbiosimilardevelopedincollaborationwithQyunsTherapeuticsforthetreatmentofCrohn'sdisease,areexpectedtoreceiveapprovalintheQ2of2026.The Phase III clinical studies for the innovative drug Oturkibart (R&D code:HDM3016/QX005N), which was developed by the Company in collaboration with QyunsTherapeuticsforthetreatmentofprurigonodularis(PN)andatopicdermatitis(AD)havereachedtheirprimaryendpoints.TheNDAsforthePNandADindicationsareexpectedtobesubmittedinthefirstandsecondhalvesof2026,respectively. The Chinese NDA applications for HDM3014 (Roflumilast Cream), developed incollaborationwithArcutisintheUnitedStatesfortwoindications—plaquepsoriasisinpatientsaged6andabove,andatopicdermatitisinpatientsaged6andabove—havesuccessfullypassedtheclinicalon-siteinspectionconductedbytheNationalMedicalProductsAdministration.Inaddition,theChineseNDAapplicationforRoflumilastCreamforatopicdermatitisindicationinpatientsaged2to5wasacceptedinFebruary2026. ThePhaseI/IIclinicalstudyevaluatingRuxolitinibGel(HDM3010),amodifiednewdrugdevelopedbytheCompany,forthetreatmentofprurigonodularishasyieldedtop-lineresults.TheCompanyhasreceivedfeedbackfromtheCenterforDrugEvaluation(CDE)andarecurrentlymakingpreparationsforsubsequentstudiesbasedonthisfeedback.Inaddition,aPhaseIIIclinicalstudyinvitiligoiscurrentlyongoing. ThePhaseIIIclinicalstudyofMC2-01Cream,developedthroughacollaborationbetweentheCompanyandMC2Therapeuticsforthetreatmentofplaquepsoriasis,hasenrolledmorethan120subjectsinChinatodate. HDM4002Injection,thefirst-in-classbispecificantibodycandidateindependentlydevelopedbytheCompany,iscurrentlyundergoingIND-enablingdevelopment.ItisanticipatedthatINDapplicationswillbesubmittedinbothChinaandtheUnitedStatesin2026.Othersegments TheNDAforRanibizumabInjectionwassubmittedandacceptedinMay2025.Subsequently,the on-site inspection has been completed for the production. Ranibizumab Injection hassuccessfullypassedtheclinicalon-siteinspectionconductedbytheNationalMedicalProductsAdministration. 2.Registrationmilestonesforkeyinnovativeproductssince2026
bytheCompanyintheChinesemainland. 3.TheCompany'spharmaceuticalinnovationachievementspresentedatinternationalacademicconferencessince2026
(I)Financialstatements 1.Consolidatedbalancesheet Preparedby:HuadongMedicineCo.,Ltd. March31,2026
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