基石药业-B2024年年报

(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 96 497 699 10100 12102 29172 39 72 92 Kenneth Walton Hitchner III Kenneth Walton Hitchner III 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 218C1 Paul Herbert Chew 24840 Paul Herbert Chew Walkers Corporate LimitedCayman Corporate Centre27 Hospital RoadGeorge TownGrand Cayman KY1-9008Cayman Islands 2616 •8835 183171712-1716 826 717710 •407.2175.1204.028.1108.3113.1%56.612.2% •527.8393.1134.7 •182.7104.977.8 •199.365.5133.8 •367.2276.075.2%91.2 •672.9 •534.7410.0124.7•338.2113.8224.4•330.2236.271.5%94.0 •®PD-L1 ®NDAGC/GEJCIVNSCLCEMAIIINSCLC ▪EwopharmaAGEwopharma▪Pharmalink Store – L.L.C – O.P.CPharmalinkMENA▪SteinCaresSteinCares▪ ▪GEMSTONE-304ESCCPFSOSNature Medicine▪G E M S T O N E - 3 0 2I VN S C L CO SESMO▪GEMSTONE-303GC/GEJCCPS≥5PFSOS▪ESMO®ESMO(Non-Oncogene-Addicted Metastatic NSCLC Living Guidelines)NSCLC •®KIT/PDGFRA ®300 mg100 mg ®NRDLPDGFRA18PDGFRA D842VGIST® •®RET CDEBE •CS5001 (ROR1 ADC) Ib C S5001I IC S 5 0 0 1R - C H O P++++BD L B C LC S 5 0 0 1S O CD L B C LCS5001DLBCLCS5001PD-L1CS5001 ASCO & ASH A S C OA S HCS5001IaCS50011ROR1ADCCS5001IIRP2D(125μg/kg)CS5001NHLHLORR70%100%CS5001 •CS2009 (PD-1/VEGF/CTLA-4 I FIH I/O 39SITCFICBICPD-1/CTLA-4PD-1/VEGFPD-1/CTLA-4CS2009 INDADC ADCRDC2.0 A D C2 . 0A D CC S 5 0 0 7E G F R3HER3CS50052SSTR2CS5008δ3DLL3SSTR2CS5006ITGB4 • CS5001(ROR1ADC)CS2009PD-1/VEGF/CTLA-4CS2011CS5007 CS5005 CS5008 CS5006 • ®® • ADCAACRESMOASH 18A.08(3) ®IVNSCLCPD-L1EMAIIINSCLCPD-(L)1GC/GEJCEwopharmaPharmalinkSteinCares ®®1.0 2.0CS5001(ROR1 ADC)ASCOASHIaIbCS2009PD-1/VEGF/CTLA-4IADCSSTR2 ADCITGB4 ADCEGFR/HER3SSTR2/DLL3B7H3/PD-L1 ® 26164916NDAADC16 •® PD-L1OmniRat®G4(IgG4) ▪IVNSCLC(EGFR)(ALK)NSCLCNSCLC▪IIINSCLCIIINSCLC▪NK/TNK/T▪ESCC▪GC/GEJCPD-L1CPS≥5(G/GEJ) ECMHRA®EGFRALK1ROS1RETNSCLCEMAIIINSCLCIIIIVNSCLC EwopharmaEwopharma1851.3EwopharmaEwopharma PharmalinkPharmalinkPharmalinkPharmalink SteinCares10SteinCaresSteinCares ® ▪®HER2CPS≥5CSCO1AESCCCSCO1AHER2CSCO1A®R/RNK/TENKTLCSCO®ESMONSCLC[I,A] ▪G E M S T O N E - 3 0 4E S C CP F SO SN a t u r e M e d i c i n eGEMSTONE-302IVNSCLCOSESMOGEMSTONE-303CPS≥5GC/GEJCPFSOS •® ®RETRETNSCLCRETNSCLCRETMTCRETTCRETNSCLCTFDARETNSCLCRETTC BECDE ®®® ®11NSCLCTC®CSCONSCLCRET®RETNSCLC®IVRETNSCLCCSCO RETMTCI/IIARROWEndocrine-RelatedCancerRETMTC •® ®KIT/PDGFRAPDGFRA18PDGFRA D842VGIST®TFDAPDGFRA D842VGIST ®®® ®®PDGFRA18PDGFRAD842VGIST ®CSCO CS5001 (LCB71, ROR1 ADC)1b •C S5001R O R1A D CC S5001pyrrolobenzodiazepinePBD(Payload)(linker)CS5001PBDPBDPBDCS5001CS5001CS5001(DAR)CS5001ROR1ADC •CS5001IIIb CS5001R-CHOPDLBCLCS5001DLBCLCS5001ROR1CS5001 •ASCO 1a7156 μg/kgDLTDLT12NCI-CTCAE v5.0CS5001PKCS5001ADCCS5001 ADCRECISTv1.1Lugano2014▪5(50μg/kg)5-991CR4PRORR55.6%▪DLBCL7(100μg/kg)7-961CR2PRORR50.0%▪7(100μg/kg)PRSDNSCLC1PR3SD1PR1SD1SD ASH 10(195μ g / k g )DLTCS5001B 33B17(DLBCL)11HL2FL1MCL1MZL1BHGBCL84.8%81.8%38TCAR-T20% C S 5 0 0 1BO R R48.4%DL8(125 μg/kg)13ORR76.9% ▪HLDL5(50μg/kg)DL5-9103CR3PRORR60.0%DL8(125 μg/kg)32CR1PR ▪NHLDL7(100μg/kg)DL7-9163CR2DLBCL1MCL6PR3DLBCL1MZL1HGBCL1FLORR56.3%DL8(125μg/kg)10ORR70.0% CS2009 (PD-1/VEGF/CTLA-4)I •CS20092.0PD-1VEGFACTLA-4CS20093TILVEGFVEGF •CS2009PD-1VEGFACTLA-4CS2009PD-1CTLA-4TILsPD-1CTLA-4TCTLA-4CS2009TILsPD-1CTLA-4CS2009VEGFACS2009VEGFAVEGFAPD-1CTLA-4 •39SITCCS2009CS2009PD-1/CTLA-4PD-1/VEGFPD-1/CTLA-4PD-1/VEGF •CS2009(PD-1/VEGF/CTLA-4FIH 18A.08(3) NofazinlimabCS1003 PD-1 •nofazinlimabLENVIMA®(lenvatinib)HCCIIIiDMCOS•I(TargetedOncology) CS1002CTLA-4 •CS1002/SHR-8068NSCLCIND•CS1002nofazinlimabICancer•CS1002/SHR-8068adebrelimabbevacizumabHCCIII IND ADCRDC •ADCADCβADCTMEβADCADC2.0ADCCS5005SSTR2CS5006ITGB4CS5007EGFR&HER3CS5008DLL3&SSTR2 •CS5007EGFR/HER3ADCCS2011EGFR/HER3CS5007EGFRHER3ADCNSCLCSCCHNCRC •CS5005 (SSTR2 ADC)CS5008 (SSTR2/DLL3 ADC)CS5005SSTR2ADCSSTR2CS5008DLL3/SSTR2ADCADCSCLC •CS5006(ITGB4 ADC)CS5006(ADC)β4(ITGB4)ITGB4α6(ITGA6)(α6β4)NSCLCSCCHN CRC •CS2013BSLEIgAIgANBCS2015Th2CS2015ADSSHS 18A.08(3) EwopharmaPharmalinkSteinCares ®®35® ® PD-L1(®)Ewopharma18PharmalinkSteinCares 407.2175.1204.028.1108.3113.1%56.612.2% 50.623.527.1 199.5196.53.0179.5 527.8393.1134.7361.7351.310.4 182.7104.977.8111.480.930.5 199.365.5133.8109.553.2113.2 11.83.415.2 9412209 12.00186,396,0000.0001146,294.762,090.16H.10 13.37115,928,803200.01,355.9 84,800,0004.6336.61%389.07338.12 672.91,026.7 100%73.9%72.5% 101,936,000 318,200,0001005050 M.D.,Ph.D.61 25BGNE6160688235PD-1BTKPARP CovanceInc.Tularik Inc.Amgen Inc. 6015 MichaelS.BrownJosephL.GoldsteinStuartL.Schreiber Ph.D.53 20CreacionVentures6Dimensions Capital,L.P.WuXiHealthcareVenturesII,L.P.1477 MBA KennethWalton Hitchner III65Hitchner Hitchner30 HitchnerProvidentAcquisition Corp.PAQCValianceAssetManagementHitchne