再鼎医药2023 年度报告

2023年度報告 25737101103104124135175193197248255 510232301 John DiekmanRichard Gaynor頴William LisScott W. MorrisonLeon O. Moulder, Jr.Michel VounatsosPeter Wirth Harbour Place, 2nd Floor103 South Church StreetP.O. Box 472George TownGrand Cayman KY1-1106Cayman Islands 456014201210 International Corporation Services Ltd.Harbour Place, 2nd Floor103 South Church StreetP.O. Box 472George TownGrand Cayman KY1-1106Cayman Islands 314 Main Street4th Floor, Suite 100Cambridge, MA 02142USA 1831717121716 * 456014201210 Michel VounatsosLeon O. Moulder, Jr. F. Ty Edmondson314 Main Street4th Floor, Suite 100Cambridge, MA 02142USA 3485 3485 Scott W. MorrisonJohn DiekmanPeter Wirth Peter WirthJohn DiekmanLeon O. Moulder, Jr. KPMG LLP Leon O. Moulder, Jr.John DiekmanWilliam Lis Richard GaynorMichel Vounatsos 9688ZLAB *202317 Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 6943christine.chiou1@zailaboratory.com /lina.zhang@zailaboratory.comShaun Maccoun / Xiaoyu Chen+1 (415) 317-7255 / +86 185 0015 5011shaun.maccoun@zailaboratory.com /xiaoyu.chen@zailaboratory.com http://www.zailaboratory.com/ 1995 FCPA GMPFDAEMACOVID-19CFIUS 232025 (Trust for Life) ®OPTUNE®®® PARP 1/2PARPDNAPARPPARPDNADNABRCA1Tesaro Inc.GSKGSKGSKGSK 55,00037,000202020212022 20182021 OPTUNE OPTUNENovoCureNovoCureNovoCure OPTUNEGBM45,000GBM2020GBMGBMGBMGBM KITPDGFRαKITPDGFRαKITPDGFRαKITPDGFRαDecipheraDecipheraDeciphera GISTGISTGIST0.13%30,0002021GIST20231GIST ParatekGurnetPoint CapitalNovo Holdings A/SNovo Holdings CABPABSSSICABPABSSSIABSSSI2020CABP1,0002015ABSSSI280202112CABPABSSSI20231CABPABSSSI20241 CMO Efgartigimod alfa fcabIgG1FcRnFcRnIgGFcRnFcRnIgGIgGIgGgMGargenxargenxargenx gMG170,000gMG185%AChR20239αAChRgMG20241 2023odronextamabMacroGenicsRegeneron202451420241220Blueprint Medicines CorporationBLU-945 ZL-1218CCR8IgG1IZL-1102-17VHIICRO2023ZL-1310IDLL3 ADCDLL3Notch (TTFields) NovoCureGBM NSCLCNSCLC 2L NSCLCLUNAR IIINSCLCIIILUNARNSCLCOSOS3452020815,563NSCLC85%15%20241NovoCureFDAPMANSCLC2024 NSCLCMETIS IIINSCLC13,000 PANOVA-3 III2020125,0007.2% Tisotumab Vedotin Tisotumab vedotinADCGenmabSeagenADCMMAEMMAEtisotumab vedotinSeagentisotumab vedotin(Tisotumab Vedotin) tisotumab vedotinTisotumab vedotinIIIinnovaTV 301Tisotumabvedotin202310 SeagenGenmab A/SinnovaTV 301OSOSTisotumab vedotininnovaTV 301Tisotumab vedotininnovaTV 301110,000 Adagrasib AdagrasibKRASG12CKRASG12CNSCLCCRCMiratiBMSadagrasibBMSBMS (Adagrasib) adagrasibKRASG12CNSCLC NSCLCIIIKRYSTAL-12adagrasibKRASG12CNSCLCAdagrasibKRASG12CNSCLCFDAPKKRYSTAL-12NDA NSCLCIIKRYSTAL-7adagrasibKRASG12CNSCLC202310MiratiadagrasibNSCLC 2LIIIKRYSTAL-10adagrasibKRASG12C20242MiratiFDAadagrasibKRASG12CsNDAPDUFA2024621 42,000NSCLC Bemarituzumab BemarituzumabFGFR2bIgG1FGFR2bGEJFive PrimeAmgenbemarituzumabAmgenAmgen(Bemarituzumab) bemarituzumabGEJIIIFORTITUDE-101bemarituzumabFGFR2bIIIFORTITUDE-102bemarituzumabGEJ126,000HER2- FGFR2b+76,000FGFR2b10% ROS1TKITurning Point TherapeuticsBMSBMSBMS ROS1 + NSCLCNTRK+I/IITRIDENT-ITKITKIROS1NSCLCNTRK ROS1+ NSCLC20238BMSI/IITRIDENT-1ROS1NSCLC202311TRIDENT-1FDAROS1NSCLC2023814,00021,000ROS1NSCLC NTRK+20238BTDNTRKTRK TKI0.5%NTRK + BTDBTDROS1TKIROS1NSCLC1ROS1 TKI1ROS1NSCLC1ROS1 TKIROS1NSCLCBTDTRIDENT-1 20242BMSTRIDENT-1FDANTRK12sNDAPDUFA2024615 argenxαgMGgMGCIDP gMG20237gMGsBLA20236argenxFDAVYVGART Hytruloα-qvfcgMG CIDP20239BTDCIDPBTDADHEREADHERE(p = 0.000039)61% (HR0.39 95% CI 0.25 0.61)A67%IgGCIDP50,000CIDP20242argenxFDACIDPsBLAPDUFA2024621sBLA SUL-DUR--InnovivaEntasisSUL-DURInnovivaInnoviva (SUL-DUR) SUL-DURMDRCRABCARSS20222022300,00053%70% IIIATTACKSUL-DURATTACKCRABSUL-DURSUL-DUR20235InnovivaFDAXACDUROMDRCRABNDA20232ATTACKLacent Infectious Diseases[Kaye et al] Xanomeline-Trospium Xanomeline-trospiumKarXTM1/M4Xanomeline-trospiumxanomeline-trospiumKarunaxanomeline-trospiumKaruna (Xanomeline-Trospium) KarXTADP 202311KarunaEMERGENTFDAKarunaKarXTNDAPDUFA20249268 ADPKaruna2023ADPIII ADEPTIIIADEPT-2ADEPT-3845% 18 (i)(ii)(iii) GSK 20169Tesaro, Inc.GSKGSKMerck & Co., Inc.AstraZeneca UK LimitedGSKPARPGSKGSK20182GSKGSKGSKGSK NovoCure 20189NovoCureNovoCureOPTUNENovoCure Deciphera 20196DecipheraDecipheraDeciphera Novo Holdings 20174ParatekParatek Bermuda Ltd.Gurnet Point CapitalNovo Holdings A/SParatek Bermuda Ltd.Paratek Bermuda Ltd.ParatekBermuda Ltd.Paratek Bermuda Ltd.Paratek Bermuda Ltd. Paratek Bermuda Ltd.Paratek Bermuda Ltd. argenx 20211argenxargenxargenxargenx (Tisotumab Vedotin) 20229Seagentisotumab vedotin BMS (Adagrasib) 20215MiratiBMSMRTX849 (adagrasib)adagrasibBMSadagrasibBMS Amgen (Bemarituzumab) 201712Five PrimeAmgenFive PrimeFive PrimeFGFR2bbemarituzumab(FPA144)Amgen (i)(ii)bemarituzumabFPA144-004bemarituzumabFPA144-004 BMS 20207Turning PointBMSBMS Innoviva 20184InnovivaEntasisEntasisEntasisSUL-DURFDAInnoviva (i)(ii)EntasisCROSUL-DURIIIATTACKSUL-DURIIIATTACK Karuna (Xanomeline-Trospium) 202111Karunaxanomeline-trospium (KarXT)xanomeline-trospium 20 ZAI LAB 2001 CTA