基石药业-B2024年中期报告

CStone Pharmaceuticals基石藥業(Incorporated in the Cayman Islands with limited liability)( 於開曼群島註冊成立的有限公司 )Stock Code股份代號 :2616 2 4 5 9 25 33 54 55 56 58 59 60 77 Paul Herbert Chew Kenneth Walton Hitchner III Kenneth Walton Hitchner III Paul Herbert Chew Paul Herbert Chew www.cstonepharma.com Paul Herbert Chew Vistra (Cayman) LimitedP.O. Box 31119, Grand PavilionHibiscus Way802 West Bay RoadGrand Cayman KY1-1205Cayman Islands Paul Herbert Chew 717710 218C1 24840 2616 •8835 Walkers Corporate LimitedCayman Corporate Centre27 Hospital RoadGeorge TownGrand Cayman KY1-9008Cayman Islands 183171712-1716 826 •254.2118.3122.613.3122.6128.67.32.8% •186.8120.666.2 •89.242.546.7 •131.468.662.8 •209.215.7 •198.1127.171.0•183.173.5109.6•183.010.8 •(PD-L1) •ECCEJEMLY®EGFRALKc-rosoncogene 1ROS1RETNSCLCPD-L1IVNSCLCMAAMHRA •EwopharmaAGEwopharmaEwopharma185,130 •1PD-L1CPS≥5GC/GEJC •GEMSTONE-304PFSOSNature Medicine •GEMSTONE – 302IVNSCLCOSESMO •®1ACSCOCSCOCSCO •Nofazinlimab (PD-1) •IIInofazinlimabLENVIMA®(lenvatinib)HCCIIIiDMCOS 2.0 •CS50011(ROR1)ADC •FIH10DLTMTD •CS5001CS5001ROR1ADC•ASCOASCOFIHASH•1bIb•ROR1ROR1IHC1bROR1 •CS2009PD-1/CTLA4/VEGF •CS2009FICBICPD-(L)1NSCLC •INDINDIND •(FIC)ADC •C S 5 0 0 6C S 5 0 0 5 ( S S T R 2A D C )A D CPCCADCCS5006INDSSTR2ADCCS5005IND •CS5007EGFRxHER3ADCCS2011CS5007(CS2011)EGFR3HER3IND • •CS2013B•CS2013SLEIgAIgANB •® •®CDE•® •® •®300mg100mg•®3,500®•®2023PDGFRA18PDGFRAD842VGIST •®®1 5NSCLCTC(GIST)SM •IVNSCLCMAA •CS5001ASH1bBD•CS2009IND•CS5006IND•CS5005IND•CS2011/CS5007IND•®•NofazinlimabOS 26164915NDAADC16 •® ®RETRETNSCLCRETNSCLCRETMTCRETTCRETNSCLCTFDARETNSCLCRETTC ®®® ®11NSCLCTC®CSCONSCLCRET®RETNSCLC®IVRETNSCLCCSCO •® ®KIT/PDGFRAPDGFRA18PDGFRA D842VGIST®TFDAPDGFRA D842VGIST ®BlueprintMedicines®®97%3220,000 ®®PDGFRA18PDGFRAD842VGIST ®®CSCO •® E w o p h a r m aEwopharma185,130EwopharmaEwopharma GC/GEJC ® ®HER2CPS≥5CSCO1AESCCCSCO1AHER2CSCO1A®R/RENKTLCSCO1A CS5001(LCB71, ROR1 ADC) •ROR1 ADC1aII •ASCO 1a7156μg/kgDLTDLTMTD 12NCI-CTCAEv5.0CS5001PKCS5001ADCCS5001 ADC RECISTv1.1Lugano2014 §5(50μg/kg)5-991CR4PRORR55.6%§DLBCL7(100μg/kg)7-961CR2PRORR50.0%§7(100 μg/kg)PRSDNSCLC1PR3SD1PRTNBC1SD1SD •CS5001ROR1 ADC •10DLTMTDCS5001RP2DIbASH1a •CS5001MMAEROR1 ADCCS5001MCLTNBCBICCS5001ROR1/ •ROR1ROR1IHC1bROR1 CS1001PD-L1 •P D - L 1I VN S C L CI I INSCLCR/RENKTL ESCCGC/GEJCPD-L1GIgG4 •IVNSCLC: NSCLCMAAEMAMHRA EMACROGCPEMACHMPNSCLCEC NSCLCMAAMHRA GEMSTONE-302OSESMO •GC/GEJC: GC/GEJC(CPS≥5)NDA •ESCC: GEMSTONE-304PFSOSNature Medicine 18A.08(3) NofazinlimabCS1003 PD-1 •nofazinlimabLENVIMA®(lenvatinib)HCCIIIiDMCOS ALK/ROS-1 •ROS1NSCLCROS1NSCLCpre-NDA/NDA•ROS1NSCLCWCLC CS3009RET •R E TM T CI / I IA R R O WE n d o c r i n e - R e l a t e dCancerRETMTC CS3010IDH1 •R/R AMLGCP•IDH1R/R AMLIBlood ScienceIDH1R/R AML ADC •CS2009PD-1CTLA4VEGFaINDIND/PD-(L)1NSCLCHCC •/ADCADCADCCS5006INDSSTR2ADC CS5005INDCS5007ADCCS2011CS5007(CS2011)EGFRHER3IND •CS2013BSLEIgANB /Ewopharma •Ewopharma EwopharmaEwopharma185,130EwopharmaEwopharma • BlueprintMedicines®3,500 CTLA-4(CS1002)2CS1002CS1002CS1002Ib/IIINDHCCNSCLCCS1002(SHR-8068)NSCLCIND • n o f a z i n l i m a b40GMP61nofazinlimabnofazinlimabCMCnofazinlimab • • 544 • IVNSCLCIIINSCLCIIINSCLCPFSPD-1/PD-L1R/R ENKTLESCCPD-L1(CPS≥5)G/GEJ ROS1NSCLCROS1NSCLC •Blueprint Medicines BlueprintMedicinesRigelPharmaceuticals,Inc.BlueprintMedicines • 254.2118.3122.613.3122.6128.67.32.8% 25.811.014.8 24.811.912.9 186.8120.666.2(i)122.0106.615.4(ii)46.512.334.2 89.242.546.761.737.823.9 131.468.662.868.158.89.3 5.92.48.3 104192021 12.00186,396,0000.0001146,294.762,090.16H.10 13.37115,928,803200.01,355.9 84,800,0004.6336.61%389.07338.12 813.91,026.7 100%69.5%72.5% 63,321,000101,936,000 306,422,00045 M.D.,Ph.D.60 25BGNE6160688235PD-1BTKPARP CovanceInc.Tularik Inc.Amgen Inc. 60 MichaelS.BrownJosephL.GoldsteinStuartL.Schreiber Ph.D.52 20CreacionVentures6Dimensions Capital,L.P.WuXiHealthcareVenturesII,L.P.1477 MBA KennethWalton Hitchner III64Hitchner Hitchner30 HitchnerProvidentAcquisition Corp.PAQCValianceAssetManagementHitchner Hitchner2269HitchnerElementsAdvisors SPVAntler6032592359HitchnerHH&LAcquisitionCo.HHLAHitchnerCydar MedicalSphere Fluidics Hitchner 54 2157 61 1228 •AmbrxBiopharma Inc.AMAM•2269•Viela Bio Inc.VIE•WuXiPharmaTech(Cayman)Inc.•TanoxInc.TNOXGenentech Inc.•BiogenInc.BIIB• (Carnegie Mellon University) PaulHerbert ChewM.D.72Chew ChewPhesiChewCorMedix,IncChewArisGlobalFDA140 ChewChewOmadaHealthChewChew GBS,JP70 870011406110515150006096625001477 SincereWatch(Hong Kong)Limited044412880270 (Teesside Polytechnic) •••• 49 2015181860225608532252 M.D.,Ph.D.60 Michael J.ChoiMBA50 Choi25ChoiSun Pharma Advanced Research Corporation (SPARC)SPARCChoiChoi40ChoiLifeTechnologiesChoiEnvisionConsulting GroupIQVIAFrankel GroupOliver Wyman Choi M.D., Ph.D., 48INDNDA 2 0CovancePharmaceutical Research andDevelopment (Shanghai) Co., Ltd. PAREXEL