来凯医药-B2024年报

2105Laekna, Inc. 2024年 報 02 06 08 10 11 23 29 51 66 72 73 76 126 C3 MRCT PROC 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 518 333 183171712–1716 2105 www.laekna.com LAE102ActRIIAActivin-ActRIILAE10220246LAE102ISADILAE102202412LAE102ISADSAD6453LAE102SAD1LAE102ASADIMAD 20253IMADIMADLAE10260 NYSE:LLYLAE102IILAE102I2025 LAE102ActRIILAE103ActRIIBLAE123ActRIIA/IIB20241231IND2025LAE103LAE123INDActRIIActRII LAE002 (afuresertib)LAE001LAE002 (afuresertib)HR+HER2—IbIII20245PIK3CA/AKT1/PTENHR+/HER2–LA/mBCIIIAFFIRM–205LAE002afuresertibAKTIIIAFFIRM–20520252026(CDE)(NDA) PI3KLAE1182024INDUSP1LAE120IND20251(FDA)20252FDA(SMP, Study May Proceed)WRNLAE12220253(PCC) 2024112713.3617,636,000235.6230.4202411 21 2023230.515.46.7%2024215.120241231 202375.91.82.4%202474.1202362023 20241231LAE102LAE002(afuresertib)LAE001LAE005 20241231611432 Activin-ActRIILAE102LAE102ActRIILAE103ActRIIBLAE123ActRIIA/IIB LAE002 (afuresertib)LAE001LAE002 (afuresertib)AKTAKTAKT1AKT2AKT3AKTAKTLAE002(afuresertib)CapivasertibAKT202311FDAHR+/HER2-LAE002 (afuresertib) IbHR+/HER2-IIIIII20245HR+/HER2-LA/mBC 2030121— SOCHR+/HER2-HR+/HER2-mBCmCRPCPROC(TNBC)SOC 1231 LAE102I LAE102ActRIIAActivin-ActRIILAE1022024CDEFDALAE102IND202420246LAE102IILAE102 202411NYSE:LLYLAE102IILAE102I2025 202412LAE102ISAD SAD6453 LAE102SAD1LAE102A2025SADIMAD 20253IMADIMADLAE10260 LAE102ActRIILAE103ActRIIBLAE123ActRIIA/IIB2024IND2025LAE103LAE123IND LAE002 (afuresertib) LAE002 (afuresertib)(ATP)AKT2018LAE002 (afuresertib)LAE002 (afuresertib)11 LAE002 (afuresertib)+HR+/HER2-III 2021230.1233.632030266.6437.2460%HR+/HER2-CDK4/6HR+/HER2-15%20%30%40%CDK4/6HR+/HER2- LAE002 (afuresertib)SOCHR+/HER2-LA/mBCIbIb2023122023(SABCS)20249(ESMO)Ib 202482731PIK3CA/AKT1/PTENIbPIK3CA/AKT1/PTEN1833.3%66.7%PFS7.3 20245LAE002afuresertibAKTPIK3CA/AKT1/PTENHR+/HER2–LA/mBCIIIAFFIRM–205IIIAFFIRM–20520252026NDA LAE002 (afuresertib)+LAE001mCRPCII 2021145.1512.092030181.5119.93(ADT)ADT(CRPC) 2021620229LAE201SOCmCRPCIImCRPC20231121401–31ARIIrPFS8.1mCRPC24rPFS FDALAE201SOCmCRPCIII20245FDAIIILAE002 (afuresertib)LAE001 LAE002 (afuresertib) +PROCPROFECTA-IIII PROCPROCORR10%15%PFS3.5PROC202131.985.62203037.426.27 LAE002 (afuresertib)PROCPROFECTA-IILAE002 (afuresertib)150PROC20241afuresertibPFSHR0.74495%CI0.502–1.102AKTIHC>137%LAE002 (afuresertib)PFSPFS5.42.9HR0.35295% CI0.125–0.997 LAE002 (afuresertib)IPD-1/PD-L12024PD-1SOC202410IGCS2024LAE002 (afuresertib)++I LAE002 LAE001 LAE001CYP17A1CYP11B22017LAE001LAE001CYP17A1/CYP11B2CYP17A1/CYP11B2 LAE001ILAE001LAE002 (afuresertib)mCRPCIIFDA20245SOCmCRPCLAE201IIILAE001 LAE001 LAE005 LAE005PD-L1 IgG4LAE005PD-L1LAE002 (afuresertib)LAE005TNBCLAE005TNBC LAE002 (afuresertib)LAE005anti-PDL1mAb(TNBC)I20244(AACR)202422I14TNBC21141.50–35(ORR 35.7%)4(28.6%)(DCR)64.3%(DOR)9.26TNBC32732023928PFS16 202316.721.5128.7%202438.22024 20236.36.095.2%20240.3 202375.91.82.4%202474.1202362023 2023230.515.46.7%2024215.1(i)2023108.3202478.620241231(ii)2023202417.820245IIIAFFIRM-205 202371.22024 20241231813.4636.4163.613.420231231440.8195.644.4%20241231636.420231231338.1174.551.6%20241231163.620241231148.547.599.02.0 20241231800.035.3759.75.020231231778.92.7%202411 2024 2024123199.02023123149.43.20%4.10% 12315.48202312316.58 100%20241231 20241231 2024123120241231 20241231 20241231862024134.72023133.7 202369202461420242024——2024522 202362912.410.0000163,728,000724.4 (1)20248162024630 2024112713.3617,636,000235.6230.420241121 (1) LAE102ActRIIAActivin-ActRIILAE102LAE103ActRIIBLAE123ActRIIA/IIBActRIIActRII NK LAE002(afuresertib)CDK4/6HR+/HER2-LAE002(afuresertib)LAE001A/ARmCRPCmCRPC LAE102 612016720225 1998Ontogeny, Inc.20011120039(Wyeth Research)(Principal Scientist)2003920163NIBRCNIBR201211VIVA(Novartis Leading Scientist)NIBRCNIBR201620174 1985719886199581995 5320174201942018520225 20028200492008120173CNIBR2011320123—Myers-BriggsType Indicator (MBTI) 20037 592020120225 2001420081020081120194CNIBR20194201912 19851988199731997120008 632019720225 OrbiMed Advisors LLCOrbiMedAdvisors LLC201182017968850620251SVA20162178920171224072006420117WI Harper Group2020320242Gracell Biotechnologies Inc.GRCL 1986719956 362022420225 2013920221201711 20107201212 582023616 Clontech Laboratories Inc.Becton, Dickinson and CompanyBDXBoston Consulting (Shanghai) Co., Ltd.20004200422004220111AstraZeneca PlcAZNAZNAZN20111202112NovartisPharmaceuticals CorporationNovartis Group 19871995619986 622023616 2014120193GSKGSK201912020120201202022021220244Adagene Inc.ADAG ••(Helen Hay WhitneyFellow)199332013201111(American Association for the Advancement ofScience) 1984719915 462024115 20221120198202210 201692019220073