全球医药、医疗行业：2026年创新药领域催化剂梳理

附录A：部分港股创新药公司催化剂日历图1：部分国内创新药企业主要催化剂时间表公司代码管线/药物作用机制适应症主要里程碑事件/催化剂时间百济神州ONEUSBrukinsaBTKsmallmolTNMCLPh3datareadout(MANGROVEtrial)2026百济神州ONEUSBGB-16673BTKCDAC(degrader)R/RCLLPh2readout26H1百济神州ONEUSBGB-43395CDK4i1LHR+/HER2-BCPh3initiation26H1百济神州ONEUSBG-C137FGFR2bADCPOCdataPh1Ph1datareadout26H1百济神州ONEUSBGB-53038Pan-KRASiPOCdataPh1Ph1datareadout26H1百济神州ONEUSBG-60366EGFRCDACPOCdataPh1Ph1datareadout26H1百济神州ONEUSBGB-68501CDK2i2-POCdataPh1Ph1datareadout26H1信达生物1801HKIBI363PD-1/IL-2alpha-bias2LIO/chemorefractorysqNSCLCGlobalPh3LPIandtoplinedata2026信达生物1801HKIBI363PD-1/IL-2alpha-bias2LIO/chemorefractorynsqNSCLCGlobalPh3FPI26H1信达生物1801HKIBI363PD-1/IL-2alpha-bias1LNSCLCGlobalPh3FPI26H1信达生物1801HKIBI363PD-1/IL-2alpha-bias1LMSSCRCGlobalPh3FPI2026信达生物1801HKIBI343CLDN18.2-TOPO1ADC1LCLDN18.2+PancreaticCancerGlobalPh3FPI2026信达生物1801HKIBI343CLDN18.2-TOPO1ADC3L+CLDN18.2+GastricCancerGlobalPh3FPI~26H2信达生物1801HKIBI3001EGFR/B7H3ADCBaskettrialPh1kickoff2026信达生物1801HKIBI3009DLL3ADCadvancedsmallcelllungcancerPh1datareadout2026H1和誉2256HK匹米替尼（ABSK021）CSF-1RTGCTUSPDUFA26Q2/Q3和誉2256HK依帕戈替尼（ABSK011）FGFR4抑制剂2L+肝癌中国关键注册性招募完成及初步数据2026和誉 2256HK 依帕戈替尼（ABSK011） FGFR4抑制剂 1L肝癌 FGFR4与多药联合用于1L肝癌的MRCT临床方 2026案及推进和誉2256HKABSK061FGFR2/3抑制剂1L胃癌初期临床安全性和初步疗效数据2026和誉2256HKABSK043口服PD-L1联合用药1LNSCLC联合3代EGFRTKI用药二期结果披露2026和誉2256HKABSK211Pan-KRASBaskettrialPh1kickoff2026康诺亚2162HKDLL3/SEZ6BsAbADCBsAbADCSCLCPh1FPI2026公司 代码管线/药物作用机制适应症主要里程碑事件/催化剂时间康诺亚 2162HKCM511siRNAhepaticdeliveryN/APh1kickoff2026康诺亚 2162HKCM512TSLP/IL-13BsAbPh1completionPh1satefyanddurabilitydata2026康诺亚 2162HKCM310IL-4Rα儿童ADChinasBLAapproval2026康诺亚 2162HKCM310IL-4Rα结节性瘙痒ChinasBLAapproval2026康诺亚/阿斯利康 2162HKCMG901CLDN18.2ADCGC/GEJPh3Initialdata2026基石药业 2616HKCS5001ROR1ADCSolid+hematumorPh1POCFULLdata2026基石药业 2616HKCS2009PD-1/VEGF/CTLA4SolidtumorPh1SADFULLdata2026基石药业 2616HKCS5007EGFR/HER3SolidtumorPh1kickoff2026料、EvaluatePharma附录B：大型制药企业及在小核酸领域的主要合作及临床资产布局图2：核酸药物研发平台型公司和大型药企在多疾病领域和多靶点的合作布局 香港）整理，ROreadout大型制药企业及部分生物技术企业临床催化剂日历-小核酸领域图3：小核酸领域主要靶点（及相关联竞争药物）全球临床项目催化剂大致时间表公司代码药物/管线代码作用机制适应症主要里程碑事件/催化剂时间Pelacarsen/TQJ230

first-in-classLp(a)ASO,QW HORIZON(a)CVOTOutcomestrialinpatientswithestablishedASCVD

Ph3completion/readout 2026-Feb英克司兰 first-in-classPCSK9siRNA,英克司兰 first-in-classPCSK9siRNA,Q6MVICTORION-2PREVENT(V2P)(secondaryprevention)Ph3readout2027Novartis/ NVS Abelacimab HumanmAbtargetingFactorXI&XIastrokepreventioninAtrialFibrillation(SPAF)PDUFA2026Q4Anthoscancer-associatedthrombosisPDUFA2026Q4Novartis/ NVS Pacibekitug/ IL-6RmAbAtheroscleroticcardiovasculardisease(ASCVD)Ph3initiate2026

Inclisiran/

ORION-4CVRR-LDLCCVOTOutcomestrial Ph3readout 2026H2/2027Novartis/Regulus

TZLS-501NVS farabursen/RGLS

first-in-classmiR-17inhibitor autosomaldominantpolycystickidneydisease(ADPKD)

Ph3initiate 2026Novartis/Avidity

NVS AOC1001

AOC(Antibody-Oligoconjugate)DMPK myotonicdystrophytype1(DM1) Ph3completion/readout 2026Amgen AMGN AMG890

firstLp(a)targetingsiRNA,scQ3W OCEAN(a)-OutcomestrialinpatientswithestablishedASCVD

Ph3readout 2026-DecAmgen AMGN MariTide long-acting,peptide-antibodyconjugateQM Phase2studyinobesity Ph2partBreadout 2025YE/Regeneron/ Alnylam CemdisiranC5targetingsiRNARegeneron/ Alnylam CemdisiranC5targetingsiRNAGeographicAtrophyPhase3initialdata2026H2ParoxysmalNocturnalHemoglobinuriaCohortBstudyenrolling2026+Silence SLNZerlasiranLp(a)targetingsiRNAHighLp(a)potentialcollaborationeventSilence SLNDivesiranTMPRSS6targetingsiRNAPolycythemiaVeraPh2SANRECOtoplineresult2026Q3AstraZeneca AZNArrowhead ARWRLaroprovstat/AZD0780ARO-INHBELp(a)smallmoleculeINHBEtargetingsiRNAAZURE-LDLCVOTOutcometrialMonotreatmentorcombowithTirzepatidePh3readoutPhI/IIapart1(SAD/MAD)data2027-Mar2025YEArrowheadARWRARO-ALK7ALK7targetingsiRNAbodyweightleanmassreductioncombowithTirzepatidePhI/IIaSADdata2026AlnylamALNYMivelsiranAPPtargetingsiRNAAlzheimerdiseasePh2initiate2026H1AlnylamALNYAdiposetargetingACVR1CsiRNAINDfilingandPh1initiation2026H1AlnylamALNYmuscletargetingsiRNAGeneticmusclediseaseINDfilingandPh1initiation2026H1TherapeuticsTherapeutics大型制药企业及部分生物技术企业临床催化剂日历-减重领域图4：减重领域主要靶点（及相关联竞争药物）全球主要临床项目催化剂大致时间表公司代码药物/管线代码作用机制适应症主要里程碑事件/催化剂时间EliLilly/Chugai Orforglipron nonpeptideoralGLP-1receptoragonistObesity(ATTAIN-1)PDUFA2026-Mar4519JPT2D(ACHIEVE-4)PDUFA2026H2EliLilly Retatrutide GLP-1/GIP/GCGRtripleagonist ObesityorOverweightandOsteoarthritisoftheKnee

Ph3interimreadout 2026H2NovoNordisk NVO CagriSema dualamylinandcalcitoninreceptoragonist Obesity late2026NovoNordisk NVO Amycretin unimolecularagonistofGLP-1/Amylin Obesity Ph3initiateforbothoralandsubcu

2026Q1Arrowhead ARWR ARO-INHBE INHBEtargetingsiRNA MonotreatmentorcombowithTirzepatide PhI/IIapart1(SAD/MAD)data 2025YEArrowhead ARWR ARO-ALK7 ALK7targetingsiRNA bodyweightleanmassreductioncombowithTirzepatide

PhI/IIaSADdata 2026WaveSciences

WVE WVE-007 INHBEtargetingsiRNA weightloss(fatlosswithmusclepreservation) Ph1POCdata 2025YE/2026Q1Amgen AMGN MariTide long-acting,peptide-antibodyconjugateQM Phase2studyinobesity Ph2partBreadout 2025YE/2026Q1Pfizer/Metsera PFE MET-097i fullybiasedmonthlyGLP-1RAinj,QM obesity Ph2completionandreadout 2026H1Pfizer/Metsera PFE MET-233i amylinanaloginj obesity Ph1completionandreadout 2026H1Pfizer/Metsera PFE MET-097iMET-233i

abovetwomonthlyinjcombo obesity Ph2completionandreadout 2026H1Zealand ZEAL Petrelintide amylinanaloguedosedonceweekly resultsfromPh2ZUPREME-1trialinobesity

Ph2completionandPh3initiate 2026H1/H2Zealand ZEALPetrelintide+CT-388monthlyamylin+GLP-1comboobesityInitiationofPh22026H1Zealand ZEALsurvodutideAmylinsubcuQWoverweightorobesitywithoutT2DPhase3readout2026H1Kailera/ 600276HengruiPharmaHRS9531DualGLP-1/GIPRAinj,QM8mg/10mgandlongertreatmentdurationsonobesityPh3trialinitiate2026Q1Innovent 1801 mazdutide GLP-1/glucagondualagonist,long-acting T2D/obesity Phase3data 2026H1Biologics/EliLilly Ascletis1672HKASC30GLP-1receptoragonist,subcuobesityPhase2adata2026Q1RegeneronREGNgaretosmabActivinAfibrodysplasiaossificansprogressiva(musclegeneticdisorder)Phase3data2026Q1BiomeaFusion BMEA BMF-650 GLP-1receptoragonist obesity Phase1data 2026H1公司 代码 药物/管线代码 作用机制 适应症 主要里程碑事件/公司 代码 药物/管线代码 作用机制 适应症 主要里程碑事件/催化剂 时间atirmociclib CDK4inhibitor breastcancer Ph3data 2025/2026Pfizer PFEsigvotatugvedotinPfizer PFEsigvotatugvedotinintergrinbeta-6lungcancerPh3data2026/2027InstilBio/ImmuneOnco TIL/1541HKSYN-2501PD-L1andVEGFbi-specificlungcancerPh2data2025H2/2026H1Merck MRKpembrolizumabPD-1ovariancancerPh3data20254Q/2026H1Immutep IMMAUeftilagimodalphasolubleLAG-3fusionproteinlungcancerPh3dataLate2025/Early2026Amgen/Zailab bemarituzumabFGFR2bgastriccancer/gastroesophagealPh3dataLate2025/Early2026junctioncancerRoche/BioNTech ROF/BNTX autogenecevumeran mRNA-basedpersonalizedcancervaccine

colorectalcancer Ph2data Late2025/Early2026RelmadaTherapeutics/TrigonePharma

RLMD NDV-01 gemcitabineanddocetaxel bladdercancer Ph2data 2026Q1CGoncology CGON

oncolyticimmunotherapy bladdercancer Ph2data 2026H1endometrialcancerPh2dataEarly2026lungcancerPh2data2026kidneycancerPh3data2026H1headandneckcancerPh3data2026endometrialcancerPh2dataEarly2026lungcancerPh2data2026kidneycancerPh3data2026H1headandneckcancerPh3data2026IovanceBiotherapeutics IOVA Amtagvi tumor-infiltratinglymphocyte(TIL),autologousMerck/PelotonTherapeutics MRK/PLTX Welireg HIF2alphainhibitor+VEGF-R/FGF-R/RETinhibitorMerusNV MRUS petosemtamab EGFRandLGR5bi-specificArrVentBioPharma/ShanghaiAlistPharma

AVBP/688578CH firmonetinib EGFRinhibitor lungcancer Ph3data Early2026REVOLUTIONMedicines RVMD daraxonrasib KRASG12D/G12V/G12R(ON)

PFSdatafromPh3 2026inhibitorOSdatafromPh3inhibitorOSdatafromPh32026/2027BicycleTherapeuticsBCYCzelenectidepevedotinNectin-4bladdercancerPh2/3data2026Q1ShanghaiHenliusBiotech2696HKHetroniflyPD-1lungcancerPh3data2026H1Pfizer/RemegenPFE/9995HKdisitamabvedotinHER2bladdercancerPh3data2026DaiichiSankyo/AstraZeneca4568JP/AZNLNDatrowayanti-Trop-2+PD-1lungcancerbreastcancerPh3dataPh3data2026H12026livercancerPh3data2026AstraZeneca AZNlivercancerPh3data2026

tremelimumab/durvalumab

bladdercancer Ph3data 2026H1CTLA-4+PD-L1livercancer Ph3data 2026durvalumab

lungcancer Ph3data 2026Roche ROGSW divarasib KRASG12Cinhibitor lungcancer Ph3data 2026AstraZeneca/HUTCHMEDChina

AZNLN/13HK Tagrisso/savolitiniv EGFRinhibitor+cMETinhibitor lungcancer Ph3data 2026Merck/Pfizer/AstellasPharma

MRK/PFE/4503JP

pembrolizumab/padcev Pd-1+Nectin-4 bladdercancer Ph3data 2026Celcuity CELC gedatolisib pan-PI3KandmTORC1/2inhibitor breastcancer Ph3data Late1Q/2QCompassTherapeutics CMPX tovecimig DLL4/VEGF-Abi-specific biliarytractcancer Ph2/3data Late1Q2026Karyopharm KPTI selinexor XPO1(orCRM1)inhibitor endometrialcancer Ph3data MidUroGen URGN UGN-103 mitomycinC bladdercancer Ph3data 2026H2

FGEN1445471D FG-3246(FOR46) CD46 prostatecancer Ph2data 2026H2SummitTherapeutics/Akeso SMMT/9926HK ivonescimab PD-1/VEGFbi-specific lungcancer Ph3data 2026H2美国FDA针对新药申请的主要PrescriptionDrugUserFeeAct(PDUFA)日期时间表公司 代码 药物公司 代码 药物/管线代码 作用机制 适应症 主要里程碑事件/催化剂 时间AquestiveTherapeutics AQST Anaphylm orallydeliveredepinephrine

TreatmentofIallergicreactions(SAR),including

2026/01/31anaphylaxisPharmingGroupPHARLeniolisibPI3KδinhibitorActivatedPhosphoinositide3-kinasedeltaPDUFA2026/01/31syndrome(APDS)Pharmaceuticals VNDA Bysanti

activemetaboliteofiloperidone,targetsHTR2andDRD2receptors

acutebipolarIdisorderand schizophreniaEtonPharmaceuticalsETONSyntheticanalogueofhormone diabetesinsipidus 2026/02/25vasopressinOtsukaHoldingsOTSKFnucleosidemetabolicINQOVI inhibitor/cytidine newlydiagnosedacutemyeloid deaminase leukemiainhibitorBiomarinPharmaceuticalBMRNphenylalanine-metabolizing phenylketonuria 2026/02/28enzymeRocketPharmaceuticalsRCKTKRESLADI ITGB2gene severeLeukocyteAdhesion 2026/03/28Deficiency-IArcutisARQTZORYVE Phosphodiesterase-4inhibitor plaquepsoriasisinchildrenages2 2026/07/03to5CingulateIncLantheusCINGLNTHCTx-1301LNTH-2501(Ga68)DexmethlphenidateSSTR+NETsADHDinchildrenandadultsdiagnostickitforGa-68edotreotideInjection2026/05/312026/05/29NuvalentZidesamtinibROS1-selectiveinhibitorROS1-positiveNSCLCPDUFA2026/09/18XsprayXS003inhibitskinaseactivityofBCR-ABLchronicmyeloidleukemiaPDUFA2026/06/18RegenxbioIncRGNXClemidsolanparvovecGenetherapyMucopolysaccharidosistypeIIPDUFA2026/02/08LantheusHoldingsLNTHPYLARIFYactivediagnosticagentPETimagingforprostatecancerPDUFA2026/03/06RhythmPharmaceuticalsRYTMIMCIVREEMC4RagonistObesityduetoBBS,POMC,PCSK1orLEPRPDUFA2026/03/30GSKGSKArexvypre-FrespiratorysyncytialvirusPDUFA2026/03/12unresectableormetastaticHER2-DaiichiSankyo/AstraZeneca4568JP/AZNENHERTUHER2-directedantibodypositivebreastcancerPDUFA2026/01/23DenaliTherapeuticsDNLITividenofuspalfaIduronate2-sulfataseenzymeHuntersyndromePDUFA2026/04/05AtaraBiotherapeutics AllogeneicEVC-specificcytotoxicTlymphocytesJohnson&Johnson JNJ intravesicalgemcitabinereleasingsystem

Epstein-Barrviruspositivepost-transplantediseasehigh-risknon-muscleinvasivebladdercancer

2026/01/102026/01/17Bayer Kerendia mineralocorticoidreceptor

chronickidneydisease

2026CapricorTherapeutics CAPR deramiocel allogeneiccardiosphere-derivedcells

Duchennemusculardystrophy 2026H1/MidAdaptimmune ADAPY letetresgeneautoleucel sarcoma 2026AmpjastarPharmaceuticals AMPH biosimilartoNovolog insulin diabetes 2026Q1Moderna MRNA mRNA-1083 mRNAvaccine influenzaprophylaxis/Covid-19 2026fixed-dosecombinationofD-NRXPharmaceuticals NRXP NRX-101

CycloserineandLurasidone

psychiatricdisease 2026Q1Pfizer/Remegen PFE/9995HK disitamabvedotin HER2 bladdercancer 2026大型制药企业及部分生物技术企业临床催化剂日历-免疫与炎症领域图5：免疫与炎症领域主要靶点（及相关联竞争药物）全球主要临床项目催化剂大致时间表公司代码药物/管线代码作用机制适应症主要里程碑事件/催化剂时间Apogee Therapeutics

APG777 IL-13 atopicdermatitis Ph2datapartAPh2datapart

2026Q12026Q2APG279 IL-13+OX40L atopicdermatitis Ph1bdata 2026H2zasocitinib(TAK-279,

TYK2inhibitor ulcerativecolitis Ph2bdata 20264502

NDI-034858) NektarTherapeuticsNKTRrezpegaldesleukin(NKTR-358)PEG-conjugatedIL-2T-regstimulatoratopicdermatitisNektarTherapeuticsNKTRrezpegaldesleukin(NKTR-358)PEG-conjugatedIL-2T-regstimulatoratopicdermatitisPh2data2026Q1IncyteINCYpovorcitinib(INCB54707,JAK1inhibitorvitiligoPh2datapartB2026Q2INCB054707)AclarisACRSAPG279IL-13+OX40LatopicdermatitisPh1bdata2026H2ArcutisBiotherapeutics

ARQT roflumilastcream PDE4inhibitor atopicdermatitis Ph2data 2026Q1Corvus CRVSsoquelitinib ITKinhibitor atopicdermatitis Ph1data 2026,AbbVie ABBVRinvoq JAK1inhibitor vitiligo Ph3data 2026H1Sanofi SAN amlitelimab OX40L atopicdermatitis Ph3data 2026ForteBiosciences FBRXFB102 IL-2(CD122) vitiligo Ph1bdata 2026ZealandPharma ZEAL ZP9830 Kv1.3ionchannelblocker autoimmunediseases Ph1data 2026H1ulcerativecolitis MaintenancedataPh3data 2026Q2AbivaxSA ABVX obefazimod miR-124 Crohn'sdisease Ph2bdata 2026H2Norvartis/XOMA A

iscalimab(CFZ533) CD40 Sjogren'ssyndrome Ph3data 2026Bristol-Myers

BMY

Sotyktu(deucravacitinib)

TYK2inhibitor Sjogren'ssyndrome Ph3data 2026Squibb

Zeposia(ozanimod) S1P1receptormodulator Crohn'sdisease MaintenancedataPh3 Early2026大型制药企业及部分生物技术企业临床催化剂日历-肺部/血栓及凝血领域图6：肺部疾病领域主要靶点（及相关联竞争药物）全球主要临床项目催化剂大致时间表公司代码药物/管线代码作用机制适应症主要里程碑事件/催化剂时间GossamerBio