[三季报]华东医药(000963):2025年第三季度报告（英文版）
原标题:华东医药:2025年第三季度报告（英文版） ThirdQuarterlyReport2025 The Company and all members of the Board of Directors hereby guarantee that the informationpresentedinthisreportisauthentic,accurateandcompleteandfreeofanyfalse records,misleadingstatementsormaterialomissions.ImportantDeclaration: 1.TheBoardofDirectors,directorsandseniormanagersofHuadongMedicineCo.,Ltd.(hereinafterreferredtoasthe"Company")herebyguaranteethattheinformationpresentedintheReportisauthentic,accurateandcompleteandfreeoffalserecords,misleadingstatementsormaterialomissions,andshallundertakeindividualandjointlegalliabilities. 2. The Company's legal representative, the officer in charge of accounting, and the head of accounting department(accountingsupervisor)herebydeclarethatthefinancialinformationinthisquarterlyreportisauthentic,accurateandcomplete. 3.HastheThirdQuarterlyFinancialAccountingReportbeenaudited? □Yes?No Accordingto“StockListingRulesoftheShenzhenStockExchange”,iflistedcompanieshavebothChineseandotherlanguageversionofpublicnotice,theyshouldensurethecontentofbothversionsarethesame.Inthecaseofdiscrepancy,theoriginalversioninChineseshallprevail. I.KeyFinancialData (I)Keyaccountingdataandfinancialindicators DoestheCompanyneedtoretroactivelyadjustorrestatetheaccountingdataofpreviousyears?□Yes?No
?Applicable□Notapplicable
TheCompanyhasnootherspecificcircumstancesofprofitandlossitemsthatmeetthedefinitionofnon-recurringgainsand losses. Anexplanationofthefactthatthenon-recurringgainandlossitemslistedintheExplanatoryAnnouncementNo.1onInformation DisclosurebyCompaniesthatOfferSecuritiestothePublic-Non-recurringGainsandLossesaredefinedasrecurringprofitand lossitems □Applicable?Notapplicable TheCompanydidnotdefinethenon-recurringgainandlossitemslistedintheExplanatoryAnnouncementNo.1onInformation DisclosurebyCompaniesthatOfferSecuritiestothePublic-Non-recurringGainsandLossesasrecurringprofitandlossitems. (III)Detailsandreasonsforchangesinkeyaccountingdataandfinancialindicators?Applicable□Notapplicable Unit:RMB10,000
(I)Totalnumberofcommonshareholders,numberofpreferredshareholderswithrestoredvotingrightsandshareholdingsoftop10shareholders Unit:Shares
shareholdersandtop10shareholdersholdingtradableshareswithoutrestrictedsaleconditions□Applicable?Notapplicable Change in top 10 shareholders and top 10 shareholders holding tradable shares without restricted sale conditions due to lending/returningofsharesthroughrefinancingascomparedtothepreviousperiod□Applicable?Notapplicable (II)Totalnumberofpreferredshareholdersandshareholdinglistoftop10preferredshareholdersoftheCompany □Applicable?Notapplicable Ⅲ.OtherImportantMatters ?Applicable□Notapplicable (I)OverviewoftheCompany'soveralloperationsduringthereportingperiodGuided by the principles of "promoting entrepreneurial spirit, deepening reforms,strengtheningorganizationalsystems,andcapturingdevelopmentopportunities",theCompany,duringthereportingperiod,maintainedastrongfocusonoverallstrategicplanningandannualoperationalobjectives.Itsteadilyadvancedresearchanddevelopmentaswellasclinicaltrials,optimized production process efficiency and dynamic cost management, enhanced internalcoordinationandcollaboration,andimprovedorganizationaleffectiveness,therebyensuringtheeffectiveexecutionofvariousbusinessmanagementtasks. From January to September 2025, the Company achieved total operating revenue ofRMB32.664billion,ayear-on-yearincreaseof3.77%;netprofitattributabletoshareholdersofthelistedcompanywasRMB2.748billion,ayear-on-yearincreaseof7.24%;andnetprofitattributableRMB2.694billion,ayear-on-yearincreaseof8.53%. Specifically,inQ32025,theCompanyachievedtotaloperatingrevenueofRMB10.989billion,ayear-on-yearincreaseof4.53%;netprofitattributabletoshareholdersofthelistedcompanywasRMB933million,ayear-on-yearincreaseof7.71%;andnetprofitattributabletoshareholdersofthelistedcompanyafterdeductingnon-recurringgainsandlosseswasRMB932million,ayear-on-yearincreaseof8.77%. The Company maintained stable and favorable overall operations. In Q4 2025, it willcontinue to rigorously execute the annual operational plan, efficiently advancing research,production,andbusinessactivities,withaviewtoachievingthefull-yearperformancetargets.FromJanuarytoSeptember2025,theCompany'scorepharmaceuticalsubsidiary,ZhongmeiHuadong,sustainedastablegrowthtrendinoveralloperations,achievingoperatingrevenue(includingCSObusiness)ofRMB11.045billion,representingayear-on-yearincreaseof11.10%;and achieved consolidated net profit attributable to the parent company in the amount ofRMB2.475billion,withayear-on-yearincreaseof15.62%.Inthethirdquarter,itrecordedoperatingrevenueofRMB3.728billion(includingCSObusiness),representingayear-on-yearincreaseof14.95%,andanetprofitattributabletotheparentcompanyofRMB894million,up18.43%year-on-year. During the reporting period, the Company concentrated on the strategic priority ofcommercializinginnovativeproductsandactivelypursuedtheexpansionofitsmarketpresence.These initiatives have begun to yield tangible results, with innovative products making anincreasinglysignificantcontributiontorevenue.Specifically,fromJanuarytoSeptember2025,theCompany'srevenuefrominnovativeproductssalesandagencyservicestotaledRMB1.675billion,representingasignificantyear-on-yearincreaseof62%.Amongthese,Mirvetuximab? Soravtansine Injection (trade name: ELAHERE) utilized the "Hong Kong-Macao MedicalDevices and PharmaceuticalsAccess Scheme" to pioneer its market entry, generating salesrevenueofoverRMB45millionfromJanuarytoSeptember2025,anditsdomesticmarketlaunchisprogressingsmoothlyandisscheduledforanofficialrolloutinNovember2025.? Zevorcabtagene Autoleucel Injection (trade name: Saikaize), the CAR-T productexclusivelycommercializedbyZhongmeiHuadong,continuestobeincludedinanincreasingnumberoflocalgovernment-subsidizedinsuranceprogramsandcommercialinsuranceplans,thereby improving patient accessibility. Meanwhile, the number of certified and registeredmedicalinstitutionsforthisproducthassteadilyincreased,furtheracceleratingmarketpenetration.Inthereportingperiod,ademandof thisproductcommercializationhasincreasedsignificantly.partner,CARsgenTherapeutics,exceedingthetotalnumberofordersfortheentirepreviousyear.? Furthermore,thefirstdomesticallyproducedUstekinumabInjection(tradename:SAILEXIN)intheautoimmunefield,alongwiththeClass1newdruginthediabetesfield,GanagliflozinProline? Tablets(tradename:Huiyoujing),havesustainedrapidquarterlysalesgrowth,drivenbytheirclinicalvalueandmarketpromotionefforts. Inaddition,theCompany'sexclusivepromotionofthenew1.5-generationPARPinhibitor? SenaparibCapsules(tradename:Paishuning)hasdeliveredstrongmarketperformance,withsales doubling month-on-month in the third quarter. Concurrently, the Company is activelypreparingfornationalmedicalinsuranceandcommercialinsurancenegotiationsforitsthree? ? ? innovativeproducts—Paishuning,ELAHERE andSaikaize inthefourthquarterof2025,aimingtoenhancepatientaccessibility,expandsaleschannels,andacceleratemarketpenetration.HuadongMedicine(Guizhou)PharmaceuticalCo.,Ltd.(hereinafterreferredtoas"GuizhouCorporation") focuses on achieving breakthroughs in its core products. By establishing aprofessional,self-operatedpromotionteam,itisfullycommittedtofacilitatingthemarketaccess? of Shang Ke Ling in large and medium-sized hospitals as well as its coverage in retailpharmacies. Therefore, Guizhou Corporation's overall operations continue to grow rapidly.Specifically,fromJanuarytoSeptember2025,GuizhouCorporationachievedoperatingrevenueofRMB172million,representingayear-on-yearincreaseof194%,andanetprofitofRMB53million,up489%year-on-year,withitsprofitabilitycontinuingtostrengthen.In the reporting period, the Company actively expanded its medical device sales andpromotion team. In October 2025, the domestic marketing authorization application for theworld's first-in-class innovative drug, Relmapirazin Injection (R&D code: MB-102), wasofficially approved. Its companion Transdermal GFR Measurement System (TGFR) hadpreviouslyreceivedapprovalinFebruary2025,markingtheoverallauthorizationoftheworld's? firstbedsiderenalfunctionassessmentproduct,MediBeacon TGFR,suitableforpatientswith? bothnormalandimpairedrenalfunctionintheChinesemarket.BecauseMediBeacon TGFRpossessessignificantpotentialforclinicalapplication,inordertodeliveritsearlybenefitstopatientsinChina,theCompanywillfullyleverageitscommercialcapabilitiestofacilitaterapidandefficientmarketpenetrationfollowinglaunch.Simultaneously,itwillcollaboratecloselywithitspartner,MediBeacon,tojointlyexploreapplicationsolutionsacrossvariousclinicalsettingsandfurtherrealizetheproduct'sclinicalvalue. FromJanuarytoSeptember2025,theCompany'spharmaceuticalbusinesssegmentachievedanoveralloperatingrevenueofRMB21.253billion,representingayear-on-yearincreaseofImpactedbythedualeffectsoftheglobaleconomy'scyclicaladjustmentsandintensifiedindustrycompetition,growthintheCompany'smedicalaestheticssegmentremainedunderpressure.FromJanuarytoSeptember2025,thesegmentachievedtotaloperatingrevenueofRMB1.568billion(excludinginternaloffsets),representingayear-on-yeardeclineof17.90%.Indetail,fromJanuary to September 2025, the Company's wholly-owned subsidiary, Sinclair UK, achievedconsolidatedoperatingrevenueofapproximatelyRMB719million,representingayear-on-yeardecreaseof7.34%.Withthegoalof"buildingagloballyleadingmedicalaestheticsenterprise",theCompany actively aligns with the global trend of flat structure of management adopted bymultinationalcorporationsandisimplementingstrategicadjustmentstoitsorganizationalstructureandhumanresources.Itiscommittedtoestablishingarefined,efficient,andinnovativeoperatingsystem, promoting innovation in management models, optimizing and upgrading resourceallocation,focusingoncorebusinesses,andcontinuouslyachievingbreakthroughs,therebylayingasolidfoundationforthesustainedimprovementofoperationalqualityandlong-termgrowth.Ontheotherhand,thedomesticmedicalaestheticsmarketisalsoundergoingaperiodofstructuraladjustment.FromJanuarytoSeptember2025,theCompany'swholly-ownedsubsidiary,Sinclair,recordedoperatingrevenueofRMB745million,representingayear-on-yeardecreaseof18.03%.TheCompanyismakingacomprehensiveprogressinregistrationactivitiesacrossitscoremedicalaestheticsmarkets bothdomestically andinternationally. InOctober2025, theChinesemarketregistrationapplicationforMaiLiPrecise—aClass3medicaldevice"Lidocaine-containing Cross-linked SodiumHyaluronate Gel forInjection"—was officially accepted. InSeptember 2025, Sinclair's newly patented Carboxymethyl Chitosan Solution, KIO021,completedthefirstsubjectinjectioninitsclinicalstudyinChina.Meanwhile,theU.S.clinical? trialofEllansé Shascompletedenrollmentofallsubjects.Withthecontinuedadvancementofregistrationforcoreproductpipelinesandtheprogressivelaunchofnewproductsinthedomesticmarket, the brand influence and core competitiveness of the Company's medical aestheticsbusinessareexpectedtobefurtherstrengthened. Intermsofthesegmentofindustrialmicrobiology,fromJanuarytoSeptember2025,theoverall revenue sustained rapid growth, representing a year-on-year increase of 28.48%.Subsequently,withtheproactiveexpansionintooverseasmarkets,thissegmentisexpectedtosustainitspositivegrowthmomentum. (II)Researchanddevelopmentstatus 1.R&Doverview During the reporting period, adhering to the "Scientific Research-based and Patient-centered" corporate philosophy, the Company has deepened its expertise in the fields ofendocrinology,autoimmunityandoncology.ThroughsustainedincreaseintheR&Dinvestmentand expansion of innovative drug R&D pipelines, it has strengthened the innovative R&Decosystemandtechnologicalplatforms,whileacceleratingclinicaltrials,withmultiplesignificantmilestoneachievementsmade.AsofthedateoftheReport,theCompany'sinnovativedrugR&Dcenterisadvancingover90innovativedrugpipelineprojects.FromJanuarytoSeptember2025,the Company's R&D investment in pharmaceutical industry (excluding equity investment)reachedRMB2.186billion,ayear-on-yearincreaseof35.99%,ofwhichdirectR&Dexpenditurewas RMB1.767 billion, a year-on-year increase of 53.76%, accounting for 16.21% ofpharmaceuticalindustrialrevenue. 2.SignificantR&Dprogress Oncology In March 2025, the supplemental application to convert the conditional approval of? MirvetuximabSoravtansineInjection(Elahere,R&Dcode: IMGN853,HDM2002)to regularapprovalwasacceptedandpassedtheclinicalinspectioninAugust2025.TheNDAforCompany'sClass1newdrug,MifanertinibMaleateTablets(formername:MefatinibTablets),wasapprovedinOctober2025forfirst-linetreatmentofadultpatientswithlocallyadvancedormetastaticnon-smallcelllungcancer(NSCLC)harboringepidermalgrowthfactorreceptor(EGFR)exon21(L858R)substitutionmutations. TheCompany'sself-developeddifferentiatedinnovativeADCdrugpipelinetargetingnoveltargets has established a gradient layout. Current key advancing projects include HDM2005,HDM2020,HDM2012,HDM2017,andHDM2024.Amongthese,theROR1-targetedADCproject,HDM2005,isattheforefrontofglobalclinicaldevelopmentforROR1ADCsandiscurrentlyconductingthreeclinicaltrialsinChina:aPhaseItrialofHDM2005monotherapyforadvancedhematologic malignancies (MCL, DLBCL, classical Hodgkin lymphoma (cHL)), which hascompletedfivedose-escalationcohorts,withtwodoselevelsnowintheexpansionphase;aPhaseItrialofHDM2005monotherapyforadvancedsolidtumors,withthefirstsubjectdosedinMay2025,sevensubjectsenrolledtodate,anddoseescalationongoingat2.5mg/kg;andaPhaseIb/IItrialofHDM2005combinationtherapyforDLBCLpatients,whichenrolleditsfirstsubjectinSeptember2025. Additionally, the FGFR2b-targeting HDM2020 and MUC17-targeting HDM2012 havereceivedINDapprovalsinChinaandtheU.S.InAugust2025,thePhaseItrialofHDM2012foradvancedsolidtumorsdoseditsfirstsubject,makingittheworld'sfirstMUC17ADCtoenterclinicaldevelopment.Patientenrollmentinthefirstdosecohorthasbeencompleted.Furthermore,Currently,patientenrollmentfordoseescalationatthefirstdoselevelisunderway.TheCDH17-targetingHDM2017hasreceivedINDapprovalsinboththeU.S.andChinainSeptember2025.Inaddition,HDM2024isprogressingthroughpreclinicaldevelopmentandisaimingtosubmititsINDapplicationintheQ42025. InOctober2025,theCompany'sassociate,HeidelbergPharmaAGinGermany,announcedthatitsAmanitin-basedADCcandidate,HDP-101(HDM2027),wasgrantedFastTrackdesignationbytheU.S.FoodandDrugAdministration(FDA).Additionally,theINDapplicationforHDP-101(HDM2027)inChinahasbeenapproved.TheCompanyiscurrentlyconductingclinicalpreparationactivitiesandanticipatesinitiatingtheclinicaltrialbylate2025orearly2026.Thesmall-moleculeanti-tumordrugHPK-1PROTAC(hematopoieticprogenitorkinase1proteolysis-targetingchimera),HDM2006tablets,iscurrentlyundergoingaPhaseIclinicaltrialinChina forthe treatment of advanced solid tumors, with enrollment forthe third dose cohortunderway. ForDR30206Injection,aproprietaryPD-L1/VEGF/TGF-βtri-specificantibodyfusionproteindevelopedbytheCompany'ssubsidiaryDoerBiologics,iscurrentlyleadingglobalR&Dprogressforthesametarget.InApril2025,thePhaseIbclinicaltrialofDR30206forfirst-linetreatmentofNSCLCsuccessfullydoseditsfirstsubject.TheclinicaltrialapplicationforcombinationtherapywithstandardchemotherapyinpatientswithadvancedormetastaticgastrointestinaltumorswasapprovedinApril2025,andthePhaseIb/IIaclinicalstudyofthiscombinationregimeniscurrentlyunderway. Endocrinology The oral small-molecule GLP-1 receptor agonist HDM1002 (conveglipron) has nowcompleted enrollment of all subjects for its Phase III clinical trial in China for the weightmanagementindication.Thestudyiscurrentlyinthetreatmentfollow-upanddatacollectionphase.Furthermore,bothPhaseIIIclinicalstudiesofthisproductforthetreatmentoftype2diabeteshavecommenced,withthefirstsubjectenrolledinAugust2025. TheHDM1005(poterepatide)injection,aGLP-1R/GIPRlong-actingpolypeptidedual-targetagonist,enrolleditsfirstsubjectinthePhaseIIIclinicaltrialfortheweightmanagementindicationinOctober2025.ThePhaseIIclinicaltrialforthediabetesindicationcompletedfullsubjectenrollmentinJuly2025,andtheapplicationforPre-PhaseIIIconsultationforthisindicationiscurrentlybeingprepared. DR10624,afirst-in-classtriple-targetagonist(FGF21R/GCGR/GLP-1R)developedbythecontrollingsubsidiaryofDoerBiologics,hassuccessfullycompletedaPhaseIIclinicaltrialforthe2025AmericanHeartAssociationScientificSessions(AHAScientificSessions2025)andwillbefeaturedastheopeningpresentationonthemainstageoftheAHA2025mainvenue,scheduledforNovemberthisyear.PreparationsarecurrentlyunderwayforthePhaseIIIclinicaltrialtargetingthe indication of severe hypertriglyceridemia. Furthermore, the IND application for severehypertriglyceridemiaintheU.S.receivedapprovalinOctober2025.ThePhaseIIclinicaltrialtargetingpatientswithmetabolic-associatedsteatoticliverdiseasewithhighriskoffibrosisandthose with metabolic-alcohol-related steatotic liver disease is currently being conductedconcurrently. TheINDapplicationforHDM1010tablets(afixed-doseoralcombinationformulationofHDM1002)forthetreatmentoftype2diabeteswasapprovedbytheU.S.FDAinJune2025,andclinicaltrialpreparationsarecurrentlyunderway. ThemarketingauthorizationapplicationforSemaglutideInjectionforthediabetesindicationwassubmittedandacceptedinMarch2025,andsuccessfullypassedclinicalreview.Fortheweightmanagementindication,allsubjectsinthePhaseIIIclinicaltrialwereenrolledinFebruary2025,andthestudyiscurrentlyinthetreatmentfollow-upanddatacollectionphase.ThemarketingauthorizationapplicationforInsulinDegludecInjectionwassubmittedandacceptedinFebruary2025;theon-siteinspectionhasbeencompleted,andtheapplicationiscurrentlyundertechnicalreview. ThePhaseIIIclinicaltrialofInsulinDegludecandInsulinAspartInjectionachievedtop-lineresultsinSeptember2025. Autoimmunity The supplemental application of HDM3001 (QX001S), a biosimilar of UstekinumabdevelopedincollaborationbetweentheCompanyandQyunsTherapeutics,forthenewpediatricplaquepsoriasisindication,wasapprovedinMarch2025.Additionally,themarketingauthorizationapplicationandsupplementalapplicationforCrohn'sdiseasewereacceptedforreviewinFebruary2025. TheinnovativedrugHDM3016(QX005N),jointlydevelopedwithQyunsTherapeutics,iscurrentlyinPhaseIIIclinicaltrialsinChinafortwoindications:prurigonodularisandatopicdermatitis.EnrollmentforthePhaseIIIstudyinatopicdermatitishasbeencompleted,andaPre-BLAcommunicationfortheprurigonodularisindicationisanticipatedtobesubmittedintheQ42025. HDM3014(RoflumilastCream),developedincollaborationbetweentheCompanyandArcutis,hasachievedpositivetop-lineresultsinPhaseIIIclinicaltrialsinChinaforbothplaquepsoriasisTheCompany'sindependentlydevelopedmodifiednewdrug,RuxolitinibGel(HDM3010),forthetreatmentofprurigonodularis,hasachievedtop-lineresultsfromitsPhaseI/IIclinicalstudy.APre-PhaseIIIcommunicationapplicationwassubmittedinSeptember2025.Inaddition,aPhaseIIIclinicaltrialinvitiligoiscurrentlyongoing. TheMC2-01Cream,developedincollaborationbetweentheCompanyandMC2Therapeutics,receivedapprovalinJuly2025toinitiateaPhaseIIIclinicaltrialinChinaforplaquepsoriasis.ThePhaseIIIclinicaltrialpreparationsarecurrentlyunderway. The Company's independently developed first-in-class bispecific antibody candidates,HDM3018InjectionandHDM4002Injection,arecurrentlyunderIND-enablingdevelopment,withINDapplicationsinChinaandtheU.S.targetedfor2026. Othersegments The Transdermal GFR Measurement System, a Class 3 innovative medical device, wasapproved by the NMPA in February 2025. The marketing authorization application forRelmapirazinInjectionusedcooperativelywiththedevicewasapprovedinOctober2025.The marketing authorization application for Ranibizumab Injection was submitted andacceptedinMay2025. 3. Major regulatory milestones in pharmaceutical innovation since 2025 (innovativedrugs,medicaldevicesandbiosimilars) From2025tothedateoftheReport,theCompany'sproductshavereceivedfivemarketingapprovals, six marketing authorization applications have been accepted, and eighteen INDapprovalshavebeengrantedinChinaortheU.S.,asdetailedinthetablebelow:
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