来凯医药-B2023年报

2105Laekna, Inc. 02 06 08 10 11 22 29 49 64 70 71 74 120 AfuresertibafuresertibAKTaHSCAKT3AKT1AKT2AKT3CDEC1CMC20167292024326ESOPLaekna Halley TrustLaekna Wonderland TrustEalex LLCThe Bryn Mawr Trust CompanyFDA HR+/HER2-HRHER2 IND(CTA) Laekna Limited2016826 2023629 2020128 20184112019103020214202022331 202422202422 202422202422 2023929 108 20241152024115 Davis Polk & WardwellA10 20241152024115 20241152024115 4th FloorHarbour Place103 South Church StreetP.O. Box 10240Grand CaymanKY1-1002Cayman Islands 350 53-2-467 8811 18346 Harneys Fiduciary(Cayman)Limited4th Floor,Harbour Place103 South Church StreetP.O. Box 10240Grand Cayman KY1-1002Cayman Islands 3 2105 www.laekna.com 183171712–1716 201620231231PD–1/PD-L1(MRCT)2024CDEFDAActRIIALAE102INDINDActivin-ActRIIActRIILAE103ActRIIBLAE123ActRIIA/IIBPCCLAE1032024LAE102 2023 Afuresertib+HR+/HER2 –Ib/III 1–2HR+/HER2 –afuresertib2023122023(SABCS)afuresertibHR+/HER2 –III Afuresertib+LAE001mCRPCII LAE001AfuresertibSOCmCRPCIImCRPC202310(ESMO)III Afuresertib (LAE002)+PROC (PROFECTOR-II)II 20241afuresertib(PROC)PROFECTA-IIafuresertibPFSHR0.74495%CI: 0.502–1.102AKTIHC>137%afuresertibPFSPFS5.42.9HR0.35295%CI:0.125–0.997 LAE102IND LAE1022024CDEFDAINDIND (PCC) 20231231PCCLAE103ActRIIBLAE105sHSCaHSC-NKLAE111LILRB1LILRB2LAE112FGFR2bLAE113TIGIT-PVRIGLAE119PARP1LAE120USP1LAE120IND(IND-enabling) 20232023629724.4202362820231231778.9 2022313.482.926.4%2023230.5(i)LAE1022023IND(ii)CMC 202280.24.35.4%202375.9 2022387.1315.981.6%202371.22022331 20231231Afuresertib (LAE002)LAE001LAE005(MRCT)LAE102ActRIIA2024CDEFDALAE102INDActivin-ActRIIActRIILAE103ActRIIBLAE123ActRIIA/IIB 20231231621730 2016 AfuresertibLAE001AfuresertibAKTAKTAKT1AKT2AKT3AKTAKTAfuresertibCapivasertibAKT202311FDAHR+/HER2-2023SABCSHR+/HER2-Afuresertib IbIIIPD–1/PD-L1Afuresertib 20235FDAActRIIALAE102IND202311CDEIND2024LAE1022024CDEFDAINDINDLAE102Activin-ActRIIActRIILAE103ActRIIBLAE123ActRIIA/IIB PCCLAE103ActRIIBLAE105sHSCaHSC-NKFGFR2b(LAE112)T/NKLILRB1–B2(LAE111)TIGIT-PVRIG(LAE113)PARP1(LAE119)USP1(LAE120) (SOC)/HR+/HER2-HR+/HER2–mBCmCRPCPROC(TNBC)SOC 203012*— 202362920231231 Afuresertib (LAE002) Afuresertib(ATP)AKT2018AfuresertibAfuresertib11 Afuresertib+HR+/HER2- 2021230.1233.632030266.6437.2460%HR+/HER2-CDK4/6HR+/HER2-15%20%30%40%CDK4/6HR+/HER2- AfuresertibSOCHR+/HER2-LA/mBCIb/III2023420Ib2023(SABCS)IbafuresertibLAE002AKTHR+/HER2-LA/mBC LAE205INT3101 (NCT04851613)Ib/IIIIbafuresertib (125mg QD)500mgQ28HR+/HER2-LA/mBC1–2CDK4/6≤1≤ 1 20231016201731915380%120%270%CDK4/611 •6(PR) (30%)10(SD) (50%)4(PD)(20%)•ORR30%95%CI, 11.9, 54.380%PFS7.395%CI, 3.7, NE•11PIK3CA/AKT1/PTENORR45.4%95%CI,16.7,76.682%PFS7.395%CI, 3.6, 8.2•17ORR29.4%95%CI, 10.3, 60.082.4%PFS7.395%CI,3.6, 8.2 •4173ALT/AST-GGT •1–2HR+/HER2- LA/mBCafuresertib CAPItello–291 III20236202311FDAIbCAPItello–2912023afuresertibHR+/HER2-III Afuresertib +LAE001/mCRPC 2021145.1512.092030181.5119.93(ADT)ADT(CRPC) 2021620229LAE001AfuresertibSOCmCRPCIImCRPC202310(ESMO)202391401–31ARIIrPFS7.995%CI5.7NErPFS24mCRPCRECIST 1.112PRPRIII Afuresertib+PROC (PROFECTA-II) PROCPROCORR10%15%PFS3.5PROC202131.985.62203037.426.27 AfuresertibPROCPROFECTA-IIafuresertibPROC150PFS20241 afuresertibPFSHR0.74495%CI0.502-1.102AKTIHC> 137%afuresertibPFSPFS5.42.9HR0.35295%CI0.125-0.997(OS)afuresertibPROC AfuresertibPD–1/PD-L1I2022620231231PD–1SOC LAE002LAE002 LAE001 LAE001CYP17A1CYP11B22017LAE001LAE001CYP17A1/CYP11B2LAE001CYP17A1/CYP11B2 I/IIIIImCRPCII(RP2D)LAE001 LAE001LAE001 LAE005 LAE005PD-L1 IgG4LAE005PD-L1AfuresertibLAE005TNBCLAE005TNBCRP2D2024 LAE102 LAE102ActRIIA2024CDEFDALAE102INDINDActivin-ActRIIActRIILAE103ActRIIBLAE123ActRIIA/IIB 20224.811.9247.9%202316.72023 20224.41.943.2%20236.320231231 202280.24.35.4%202375.9 2022313.482.926.4%2023230.5(i)LAE1022023IND202273.2202325.3(ii)2022153.62023108.3CMC 2022387.1315.981.6%202371.22022331 20231231788.0440.8338.19.120221231323.1117.736.4%20231231440.82022123120231231338.120231231119.868.549.41.9 20231231778.929.4653.596.020221231323.1141.1% 2023 2023123149.42022123119.83.40%4.35%202312310.62022123110.2 12316.58202212313.43 100%20231231 20231231 2023123120231231 20231231 2023123189 202369—— 202362912.410.0000163,728,00020231231724.4 (1) PIKOLCROSMOCDMOAfuresertibLAE001LAE005LAE003 AfuresertibLAE001A/ARmCRPCAfuresertibCDK4/6HR+/HER2 – NKLAE102ActRIIALAE1022024CDEFDAINDINDActivin-ActRIILAE103ActRIIBLAE123ActRIIA/IIB 602016720225 1998Ontogeny, Inc.20011120039(Wyeth Research)(Principal Scientist)2003920163NIBRCNIBR201211VIVA(Novartis Leading Scientist)NIBRCNIBR201620174 1985719886199581995 5220174201942018520225 20028200492008120173Novartis AGCNIBR2011320123–(Myers-BriggsType Indicator (MBTI)) 20037 582020120225 2001420081020081120194CNIBR20194201912 19851988199731997120008 622019720225 OrbiMed Advisors LLCOrbiMedAdvisors LLC2011820203Gracell Biotechnologies Inc.GRCL2017968850620162178920171224072006420117WI Harper Group2010320127300206201210