再鼎医药2024年度报告

2024年度報告 25736102104105125136182199203257 510232301 John Diekman*20241231Richard 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 LtdHarbour 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 33191922 33191922 Scott W. MorrisonJohn DiekmanPeter Wirth Peter WirthJohn DiekmanLeon O. Moulder, Jr. KPMG LLP Leon O. Moulder, Jr.John Diekman頴*2025416William Lis 9688ZLAB Richard Gaynor*20241231Michel Vounatsos Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 6943christine.chiou1@zailaboratory.com /lina.zhang@zailaboratory.com Shaun Maccoun / Xiaoyu Chen+1 (415) 317-7255 / +86 185 0015 5011shaun.maccoun@zailaboratory.com /xiaoyu.chen@zailaboratory.com http://www.zailaboratory.com/ 1995 FCPA GMPFDAEMACMOCRO ®PARP 1/2PARPDNAPARPPARPDNADNABRCA1TesaroGSK 61,10032,600202020212022 20182021 IgG1FcRnFcRnIgGFcRnFcRnIgGIgGIgGgMGCIDPargenx gMG200,000MG85%MGgMG85%AChR20239®AChRgMG2024120247®BLAAChRgMG2024 202411sBLACIDP202450,000CIDP ®ParatekGurnetPoint CapitalNovo Holdings CABPABSSSICABPABSSSIABSSSI2020CABP1,0002015ABSSSI2802021CABPABSSSI20231CABPABSSSI20241CABPABSSSI20251 CMO OPTUNE OPTUNEOPTUNENovoCure OPTUNEGBM45,000GBM2020GBMGBMGBM ®KITPDGFRαKITPDGFRα KITPDGFRαKITPDGFRαDeciphera GISTGIST0.13%30,0002021GISTGIST2023120251GIST SUL-DUR ®--InnovivaEntasisSUL-DUR ABCHABPVABPCARSS20222022300,00053%70%20251ABCHABPVABP 202411 ®ROS1TKITurning PointBMS ROS1 +NSCLC2022110NSCLC85%NSCLC70%NSCLC2%ROS1202412ROS1 +NSCLC20251 CRO 2023odronextamabMacroGenicsRegeneron202451420241220 ZL-1310DLL3ADCSCLCSCLCIIZL-1102IL-17VHIIZL-1503IL-13/IL-31RZL-6201ADCLRRC15IND ZL-1310 (DLL3 ADC) ZL-1310DLL3ADCDLL3SCLCZL-1310DLL31ADCTMALIN®ADCZL-1310 ZL-1310SCLCZL-1310Ia/IbSCLC 20251FDAZL-1310SCLCZL-1310FDA7SCLC25015%SCLCES-SCLC510% FGFR2bIgG1FGFR2bGEJFive PrimeAmgen GEJIIIFORTITUDE-101FGFR2bGEJIIIFORTITUDE-102FGFR2bGEJ95,000FGFR2b TIVDAK TIVDAKADCGenmabSeagenADCMMAEMMAETIVDAKSeagen TIVDAKIIIinnovaTV 301TIVDAK20244OSTIVDAKinnovaTV 301TIVDAK20251innovaTV 3012025NDA150,000 OPTUNE NovoCureGBM2L+ NSCLC1L 2L+ NSCLCLUNAR IIINSCLCIIILUNARNSCLCOSOS3452022110NSCLC85%SCLC15%202410NovoCureFDAOPTUNE LUAPD-1/PD-L1docetaxelNSCLC2025 1LPANOVA-3 III1L202412NovoCurePANOVA-3mOS2020134,0007.2%2025 Turning PointBMSROS1 + NSCLC NTRK +I/IITRIDENT-ITKITKINTRK20238NTRKTRK TKI0.5%NTRK + 20246BMSTRIDENT-1FDANTRK122025NTRK +sNDA argenxgMGgMGCIDPTEDsn-gMGMGLN TEDTEDIIIUplighTED100TED II/IIIALKIVIA17 sn-gMGsn-gMGIIIADAPT-SERON25,000sn-gMG MGMGIIIADAPT-OCULUS44,000MG LNLNII POC32LN KarXT KarXTM1/M4ADPKarXTKarXTADPKarunaBMS KarXTADP 20251KarXTNDANDAIPKIIIIIIEMERGENT-2 EMERGENT-3FDA20249KarXTCOBENFYCOBENFY8 ADPADPIIIADEPT-2 ADEPT-3845% 16 (i)(ii)(iii) GSK 20169TesaroGSKGSKMerck & Co., Inc.AstraZeneca UK LimitedGSKPARPGSKGSK20182GSKGSKGSKGSK argenx 20211argenxargenxargenxargenx Novo Holdings 20174ParatekGurnet Point CapitalNovo Holdings A/SParatekParatekParatekParatekParatekParatekParatek NovoCure 20189NovoCureNovoCure(OPTUNE)NovoCure Deciphera 20196DecipheraDecipheraDeciphera Innoviva 20184EntasisInnovivaEntasis EntasisSUL-DURInnoviva (i)(ii)EntasisCROSUL-DURIIIATTACKSUL-DURIIIATTACK BMS 20207Turning PointBMSBMS Amgen 201712Five PrimeAmgenFive PrimeFive PrimeFGFR2b(FPA144)Amgen (i)(ii)FPA144-004FPA144-004 20229Seagen(TIVDAK) BMS 202111KarunaBMS(KarXT) (DLL3 ADC) 20234MediLinkDLL3ADC 20 ZAI LAB 2001 CTA IMCCTIMCCTIMCCTIMCCT IMCCT 20231213.395% gMGCABPABSSSI(GIST)ROS1 +NSCLC GBMOPTUNE 2016202411763%202312161.7% FDA CRO 10% (i)(ii)(iii)10 FCPAFCPA2023 2024202332.4%35.0% cGMP5,000 1222200L1000L PIC/S CMO CMOCMO CMOCMOCMOCMOCMO (i)(ii)(iii)CRO argenxOPTUNENovoCureDecipheraInnovivaBMSAmgen CROCRO CMO D&O 2014202424466.520191.020152019166.520201.02017201815.0 10%50% 10-K10-Q8-K www.zailaboratory.com CMO cGMPFDAEMAFDAEMAcGMP FCPA PCAOBPCAOBPCAOBHFCAA20225KPMG LLPPCAOBKPMG LLPHFCAA KPMG LLPPCAOB 2023PCAOBKPMG LLPKPMG LLPKPMGLLP 202411 FCPA FCPA 2014202424466.520191.02015201910166.520201.02017201815.0 10%50% (i)(ii)(iii)(iv) FDAEMA FDAEMACMOGMPGMP 202420238.22.4 25% 25%25% 10%10%20%20% 10%50%300% CFIUS CFIUSCFIUSCFIUSCFIUSCFIUSCFIUSCFIUS 20229CFIUSCFIUS 2024112024257.1 202411 2024123112 240.21,721.7217.71,561.7 202411 CROargenxNovoCureOPTUNEDecipheraInnovivaBMS CROICHGCP NDAPMA CRO CMOCMO CMO TMZGBMOPTUNEGEJ FDA FDAFDANDA CROCRO FDAFDAFDA FDA FDAFDA PARP (REMS) 1 11111 cGMPGCP IVOPTUNE FCPA 20211argenx (i)(ii)(iii) 53%63% 2024 CROCMO CMO argenxNovoCureOPTUNEDecipheraInnovivaBMSCMO cG