远大医药二零二五年中期报告

2 3 7 15 16 62 Conyers & Dill Pearman Conyers Corporate Services (Bermuda) LimitedClarendon House, 2 Church StreetHamilton HM11Bermuda 1831712-1716 Clarendon House, 2 Church StreetHamilton HM11, Bermuda 993302 www.grandpharm.com 12.1%51.0%14.9®LavaTM®®®®®®® ®[90Y]LavaTM®Q10®®®®®®GPN01768TP-030.25%(OC-01) mRNA First-In-ClassSTC3141 ®[90Y]LavaTMTLX591ITM-11GPN02006®[90Y]HCCFDAHCC686868Ge/68Ga STC3141GPN02006 OC-01 Go Global®STC3141 ARAPERTO® OTWARDSccRCCCOMPOSEITM-1123IIICOVID-19EMAFDA(United States Food andDrug Administration)GABA-ClGEP-NETsGPC-33Grand Pharma SphereGrand Pharma Sphere Pte LimitedGSP 301 NSRyaltrisHCCHPV-1616ICSIIT INDITM SEITM Isotope Technologies Munich SEIVUSLABA2LAMALEGFLOW® OTWLNPMRMRAmRNANDANMPANovasightNovasight Hybrid SystemNovasyncNovasync Hybrid SystemOC-01OCTRDCRESTORE DEB®SirtexSirtex Medical Pty LtdSSTR+ TelixTelix Pharmaceuticals Limited99.84% 381613324®[90Y]LavaTM®®®®®Q10 ITM-1123SSTR+GEP-NETsIIICOMPOSE GPN02006hepatocellularcarcinomaHCCIIT ®+ TLX591III TLX591-CDxIII ®[90Y]HCCII SIR-Spheres®[90Y]DOORwaY90FDA GPN00204ISTC3141II CBT-001IIIGPN00884IGPN01768 (TP-030.25%)OC-01GPN00646 13 3 30.64%59.91% 80% 100%14GMP 13020182602024 90050 SirtexTelix Pharmaceutical LimitedTelixITM Isotope TechnologiesMunich SERDC1568Ga177Lu131I90Y89Zr57RDC12 ®[90Y]HCCIIGPN00289SIR-Spheres®[90Y]HCCRDCIIITLX591-CDxTLX591TLX250-CDxGEP-NETsITM-11®[90Y] ®[90Y] ®[90Y]DOORwaY90FDAHCCFDAHCCSIRT5015(BCLC)NCCNESMO(EuropeanAssociation for the Study of the LiverEASL)NationalInstitute for Health and Care ExcellenceNICECSCO202420232021 ®[90Y]®70225092025(ASCO)[90Y]2025(APPLE 2025)15[90Y]10cm15cmTranscatheter Arterial ChemoembolizationTACEHepatic Artery InfusionChemotherapyHAICASCOAPPLE[90Y] ®FDA701,100®230®8910020® ®[90Y]50324100 LavaTM LavaTMLavaTM220LavaTM ® +1,000®92.5%95.8%+2024CSCO2024® RDC GPN00289 GPN00289 KonaTM KonaTMKonaTMFDA(PremarketApprovalPMA) AuroLase® AuroLase®AuroLase®FDAPMA RDC 9 TLX591/TLX591-CDx TLX591(PSMA)RDC(rPFS)8.8IIIIIITLX591-CDxPSMARDCTLX591TLX591-CDxPSMATLX591-CDxIII TLX250/TLX250-CDx TLX250TLX250-CDxTLX250-CDxFDA(CT)(MRI)ccRCCTLX250-CDx(PET)ccRCC86%87%FDA70%93%T1accRCC4cmTLX250-CDx85%89%TLX250-CDxccRCCccRCCTLX250-CDxFDATLX250-CDxCAIXIIITLX250II GEP-NETsITM-11/TOCscan® ITM-11TOCscan®ITM-11FDAEMAIIICOMPETESSTR+GEP-NETs I23SSTR+GEP-NETsIIICOMPOSE12SSTR+GEP-NETsIIIGEP-NETsTOCscan® TLX101 TLX101RDCL1LAT-1FDAI/IITLX101I ITM-41 ITM-41177LuRDC GPN02006 GPN020063GPC-3GPC-3HCCGPC3GPN02006IIT2025XDCGPN020063012HCC31HCC23HCCGPN02006HCCHCC 30221IberisTMNeoNova®DEEPQUAKE-CTM +3407065% RESTORE DEB® RESTORE DEB®JACCJournal of the AmericanCollege of CardiologyCardiovascular InterventionsSAFEPAX APERTO®OTW APERTO®OTWAPERTO®OTWAmerican Journal of KidneyDiseases NOVASIGHTNOVASYNC NOVASIGHTNOVASYNCIVUSOCTNOVASIGHTFDANOVASYNCNOVASIGHTNOVASIGHT ® ® IberisTM IberisTMCirculation35.5CERDN DEEPQUAKE-CTM DEEPQUAKETM DEEPQUAKE-CTM≥50%DEEPQUAKETM≥50%DEEPQUAKE-CTMDEEPQUAKETMDEEPQUAKE-CTMDEEPQUAKETM NeoNova® aXess aXessESRDAVGaXessAPERTO®OTW Saturn Saturn CoRISMA CoRISMA mRNA ®®®® ARDS ®®®®® ® 2022-20232023-20242024202120212020 2020 ®®II®®IIIII ®®2LABAICS(1)ICSLABALAMAICS-LABAICS– LABALAMA®®(2)(3)®IIIARGON®®2443%®®ICSLABA12®®III®®26%22%19% 2023202420242025 202420222022 202420222022 ARDS RyaltrisGSP 301 NS GSP 301 NS12IIIGSP 301 NSPatanase®NS®NSGSP 301 NSNewDrug ApplicationNDA STC3141: STC3141STC3141Nature CommunicationsCriticalCareARDSCOVID-19COVID-19ARDSIbARDSIbCOVID-19IIaSTC3141ICUII7SOFASTC3141STC3141 OTC 30220242022 ® 14 ® 2021202020192017 2024 2022 OC-01 OC-01IIIOC-01Schirmer1020242023 GPN00833: FDAIIINew Drug ApplicationNDA GPN00153CBT-001: IICBT-001IIIIII GPN00884: GPN00884II GPN01768TP-03 GABA-ClGABA-ClFDAFDAIINDA 301416®20 Q10 ®® 202420242024ST20242024 ®Q10 20252025202420242024202420212018 ® 2022202020202020120172016 ® MRAmineralocorticoid receptorMRMR202420242022MRAMRAMRMRA2024 Jext® 2110 ® A220242022 ESC/ERS2021®2022 mRNA mRNAmRNAmRNALNP16HPV-16ARC01 (A002)IHPVmRNALNPHPV-16E6 E7mRNATriMix®LNPTriMix® 902006050 20 EU GMPREACHW CF D AK F D AI S OFSSC22000FAMI-QSIPHALALKOSHER 5026FDA 14040%500 6,107,320,0006,047,240,0001.0%12.0%113.0%251.0%36.1%14.91,169,020,0001,557,950,00025.0%124.2%Telix151,730,000476,630,000324,910,000telix31,017,290,0005.9%5.0% 577,740,0001342,750,00070.2%421,780,0001207,240,000105.5%155,960,000 3,845,190,00013,772,940,0002.9%1,047,350,0001962,550,0009.9%®®®®1,494,710,00011,230,820,00022.6%904,410,0001,167,410,00021.8%164.3% 1,684,390,00011,931,540,00011.9%1,346,620,00011,502,070,0009.5% 1 2 3TelixTelix3,5001.69Telix2,0957.251,000Telix7,2503,750228.90495Telix14,2596.89Telix24.42Telix60014,6527.55 1,916,290,000691,750,0001,611,950,000606,200,000304,340,00085,550,000 80,350,00086,120,000 10.22 4,750,240,0001,295,650,0001,348,790,000 3,591,890,000663,800,000398,540,000263,410,000 5%(i) Grand Pharma Sphere Pte LimitedGrand Pharma Spher