来凯医药-B2024年中期报告

02 06 08 10 22 35 36 37 38 39 40 aHSC AKT CMC IND mCRPC PCC PD-11 PD-L11 PFS 202369 20184112019103020214202022331 PROC rPFS RP2D TNBCHER2 202422202422 202422202422 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 518 3 183171712–1716 2105 www.laekna.com 2024630 LAE102I LAE102ActRIIA2024CDEFDALAE102IND202420246LAE102II2024ISADActivin-ActRIILAE102ActRIILAE103ActRIIBLAE123ActRIIA/IIB LAE002 (afuresertib) +HR+/HER2 –III 20Ib2023122023(SABCS)Ib1120249(ESMO)Ib 20245LAE002afuresertibAKTPIK3CA/AKT1/PTENHR+/HER2 –LA/mBCIIIAFFIRM-205IIIAFFIRM-205IIIAFFIRM-205 LAE002 (afuresertib) + LAE001mCRPCII 2021620229LAE002afuresertibAKTLAE001CYP17A1/CYP11B2LAE201SOCmCRPCIImCRPC20231121401-31ARIIrPFS8.1mCRPC24rPFS FDALAE201SOCmCRPCIII20245FDAIIILAE002 (afuresertib)LAE001 LAE002 (afuresertib) +PROCPROFECTA-IIII LAE002 (afuresertib)150PROCIIPROFECTA-II20241IIPROFECTA-IILAE002 (afuresertib)PFS(HR)0.74495%CI:0.502-1.102AKTIHC>137%LAE002 (afuresertib)PFSPFS5.42.9HR0.35295%CI:0.125-0.997LAE002 (afuresertib)PROC (PCC) 2024630LAE103ActRIIBINDIND-enablingstudy2025LAE103IND2024LAE123ActRIIA/IIBPCC •2024LAE102I•2024LAE123PCC•2024LAE120USP1IND•20249ESMOLAE002 (afuresertib)Ib•202410IGCS2024LAE002(afuresertib)I 2023630102.323.823.3%2024630126.120245IIIAFFIRM–205 202363036.05.615.6%202463030.420236 2024630LAE102LAE002(afuresertib)LAE001LAE005 2024630641533 LAE102ActRIIA2024CDEFDAIND2024LAE102I202462024ISADLAE102 Activin-ActRIIActRIILAE103ActRIIBLAE123ActRIIA/IIB LAE002 (afuresertib)LAE001LAE002(afuresertib)AKTAKTAKT1AKT2AKT3AKTAKTLAE002(afuresertib)CapivasertibAKT202311FDAHR+/HER2-LAE002 (afuresertib) IbHR+/HER2-III20245HR+/HER2-LA/mBC PD-1/PD-L1LAE002 (afuresertib) 2030121— SOCHR+/HER2-HR+/HER2-mBCmCRPCPROC(TNBC)SOC 630 LAE102 LAE102ActRIIA2024CDEFDAIND2024LAE102I20246LAE102I2024ISAD Activin-ActRIIActRIILAE103ActRIIBLAE123ActRIIA/IIB LAE102 LAE002 (afuresertib) LAE002 (afuresertib)(ATP)AKT2018LAE002 (afuresertib)LAE002 (afuresertib)11 LAE002 (afuresertib) +HR+/HER2- 2021230.1233.632030266.6437.2460%HR+/HER2-CDK4/6HR+/HER2-15%20%30%40%CDK4/6HR+/HER2- LAE002 (afuresertib)SOCHR+/HER2-LA/mBCIb20Ib2023122023(SABCS)Ib1120249ESMOIb 20245LAE002afuresertibAKTPIK3CA/AKT1/PTENHR+/HER2-LA/mBCIIIAFFIRM-205IIIAFFIRM-205 LAE002 (afuresertib)+LAE001mCRPC 2021145.1512.092030181.5119.93(ADT)ADT(CRPC) 2021620229LAE201SOCmCRPCIImCRPC20231121401-31ARIIrPFS8.1rPFS24mCRPC FDALAE201SOCmCRPCIII20245FDAIIILAE002 (afuresertib)LAE001 LAE002 (afuresertib)+PROCPROFECTA-II PROCPROCORR10%15%PFS3.5PROC202131.985.62203037.426.27 LAE002 (afuresertib)PROCIIPROFECTA-IIIILAE002 (afuresertib)150PROC20241LAE002(afuresertib)PFSHR0.74495%CI:0.502-1.102AKTIHC>137%LAE002(afuresertib)PFSPFS5.42.9HR0.35295%CI:0.125-0.997LAE002 (afuresertib)PROC LAE002 (afuresertib)PD-1/PD-L1PD-1/202410IGCS 2024LAE002 (afuresertib)I LAE002LAE002 LAE001 LAE001CYP17A1CYP11B22017LAE001LAE001CYP17A1/CYP11B2LAE001CYP17A1/CYP11B2 LAE001ILAE001LAE002 (afuresertib)mCRPCIIFDASOCmCRPCLAE201III20245LAE001 LAE001LAE001 LAE005 LAE005PD-L1 IgG4LAE005PD-L1LAE002 (afuresertib)LAE005TNBCLAE005TNBC AKTLAE002 (afuresertib)LAE005anti-PDL1mAb(TNBC)I20244(AACR)202422I14TNBC21141.50-31421TNBC5(ORR35.7%)4(28.6%)(DCR)64.3%(DOR)9.26TNBC32732023928PFS16 20236303.210.9340.6%202463014.12024630 20236309.99.9100.0%20246304,000 202363036.05.615.6%202463030.420236 2023630102.323.823.3%2024630126.120245IIIAFFIRM–205 202363071.22024630 2024630666.8407.3249.010.520231231440.833.57.6%2024630407.320231231338.189.126.4%2024630249.02024630131.672.557.12.0 2024630656.322.8611.721.820231231778.915.7% 2024630 202463057.12023123149.43.30%4.10% 20246305.07202312316.58 100%2024630 2024630 20246302024630 2024630 202463092202463057.3202363057.5 20236920246142024 202362912.410.0000163,728,000724.4 (1) PIKOLCROSMOCDMOLAE102LAE002(afuresertib)LAE001LAE005LAE003 LAE002(afuresertib)LAE001A/ARmCRPCLAE002 (afuresertib)CDK4/6HR+/HER2 – NKLAE102ActRIIA2024CDEFDAIND2024FDACDEINDINDActivin-ActRIILAE103ActRIIBLAE123ActRIIA/IIB 2024630XV(a)XV78(b)352(c) (1)2024630390,100,350 (2)(i)(ii) (3)(i)Linbell Technology Holdings Limited(ii)ESOPESOPESOP(iii) (4) 2024630 2024630XV23XV336 (1)2024630390,100,350 (2)OrbiMed Asia Partners III, L.P.OrbiMedOrbiMedAsia PartnersIII, L.P.OrbiMed Asia GP III, L.P.OrbiMed Asia GP III, L.P.OrbiMed Advisors III LimitedOrbiMedAsia GP III, L.P.OrbiMed Advisors III LimitedOrbiMed Asia Partners III, L.P. (3)GP Healthcare Capital, Inc.25,000,880GPHealthcare Capital, Inc. 7,767,420GP HealthcareCapital, Inc. (4)38,021,00086.79% (5)Laekna Wonderland LimitedLaekna Wonderland Trust FIIF28,519,030FIIF (7)45%58.77%90%95.05%YanchuangFuture (BVI) LimitedYF BVIY