来凯医药-B2023年中期报告

02 05 07 09 10 18 30 31 32 33 34 35 AKT 3AKT1AKT2AKT3 CMC 2023824 ESOP FDA HR+HER2-HRHER2 IND(CTA) 2023629 PROC RP2D 571 0.00001 0.0001100.00001 SOC TNBCHER2 頴 頴 108 Davis Polk & WardwellA10 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 2023 Afuresertib (LAE002)PROC (PROFECTOR-II)II 2023NDAFDANDA AfuresertibHR+HER2-Ib/III Ib202342023III AfuresertibLAE001mCRPC, II 20233mCRPC2023(ESMO) AfuresertibLAE005TNBC, I RP2DTNBC2023(CSCO) AfuresertibECCC, I PD–1SOC LAE102IND LAE10220235FDAINDLAE102LAE102 (PCC) PCCLAE111LILRB1LILRB2LAE113TIGIT-PVRIGLAE112FGFR2b 2023CSCOAfuresertibLAE005I 2023ESMOAfuresertibLAE001 I/II 202311(SITC)38LAE111/LILRB1-2 202311SITC38LAE113/TIGIT/PVRIG 2023AfuresertibIb 21.4(i)LAE1022023IND(ii)CMC 7.5 2022331 2023630Afuresertib(LAE002)LAE001LAE005(MRCT) 20236 30661734 2016 AfuresertibLAE001AfuresertibAKTAKTAKT1AKT2AKT3AKTAKTAfuresertibPROCHR+/HER2-mCRPCTNBCPD-1Afuresertib 20235FDAActRIIALAE102INDLAE102LAE102PCCFGFR2b(LAE112)T/NKLILRB1-B2(LAE111)TIGIT-PVRIG(LAE113)LMWPARP1(LAE119)USP1(LAE120) aHSCTGFßLAE104LAE105aHSCaHSC-NKLAE106TGFß SOC(PROC)(mCRPC)HR+/HER2-HR+/HER2-mBC(TNBC)SOC 20236292023 Afuresertib (LAE002) •Afuresertib(ATP)AKT2018AfuresertibAfuresertib11AfuresertibPROC •Afuresertib +PROCPROFECTOR-II PROCPROCORR10%15%PFS3.5PROC202131.985.62203037.426.27 AfuresertibPROCMRCT IIPROFECTOR-II20236302023NDAFDANDAIIFDAIII •Afuresertib +HR+/HER2- 2021230.1233.632030266.6437.2460%HR+/HER2-CDK4/6HR+/HER2-15%20%30%40%CDK4/6HR+/HER2- AfuresertibSOCHR+/HER2-Ib/III20234IbIIIAstraZeneca Plc.CAPItello-291 IIIcapivasertibAKTPFS7.23.6capivasertib+HR0.60AstraZenecaPlc.FDANDA20236IbCAPItello-2912023Ib •Afuresertib + LAE001mCRPC 2021145.1512.092030181.5119.93(ADT)ADT(CRPC) 2021620229LAE001AfuresertibAfuresertibSOCmCRPCMRCTII20233mCRPC2023ESMOFDA2023 •AfuresertibPD-1/PD-L1I20226 LAE001 •LAE001CYP17A1CYP11B22017LAE001LAE001CYP17A1/CYP11B2LAE001CYP17A1/CYP11B2 •I/IIIIImCRPCII(RP2D)LAE001 LAE005 •LAE005PD-L1 IgG4LAE005PD-L1AfuresertibLAE005TNBCLAE005TNBCRP2D2023CSCO 20226300.32.920236303.22023630 20226301.78.220236309.9 202263043.57.5202363036.0 2022630123.721.42023630102.3(i)LAE1022023IND202263022.5202363011.2(ii)202263063.9202363049.0CMC 2022630132.6202363071.22022331 2023630916.8837.179.720221231323.1514.02023630837.1202363091.950.239.81.9 2023630837.134.189.0714.020221231323.1159% 2023630 202363039.82022123119.82.75%4.35%202363010.220221231 6309.98202212313.43 100%2023630 2023630 202363093202363057.5202263051.5 PIKOLCROSMOCDMOAfuresertibLAE001LAE005LAE003 AfuresertibLAE001A/ARmCRPCAfuresertibCDK4/6HR+/HER2- NK 2023630XV(a)XV78(b)352(c) (1)2023630390,100,350 (2)(i)(ii) (3)(i)Linbell Technology Holdings Limited(ii)ESOPESOPESOP(iii) (4) 2023630XV23XV336 (1)2023630390,100,350 (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.33,039,880GPHealthcare Capital, Inc. 7,869,920GP Healthcare Capital, Inc. (4)38,021,00085% (5)Laekna Wonderland LimitedLaekna Wonderland Trust FIIF28,519,030FIIF (7)45%58.77%90%95%Yanchuang Future (BVI) LimitedYF BVIYF BVIYanchung Future Cayman Corp.YFCaymanYF CaymanYanchuang Biotech Investment L.P. (8)16,913,6705,621,37060% (9)Ealex LLCThe Bryn Mawr Trust Company XVXV23336 18 20184112019103020214202022331 34,019,770 1. (a) (b) (c) 56,999,430 (d) (10%) (e) (f) 60(40%)(24)(12) (g) 10 (h) (i) 2. (1)202362920231 1(2)(i)40%(ii)5%(3)(i)20%(ii)5%(4)252,50050,000(i)40%(ii)5%202,500(i)20%(ii)5%(5)15,248,00012,012,000(i)40%(ii)5%3,236,000(i)20%(ii)5%(6)(7)(8)548,000(9)(10)1%(11)16 202369 39,010,035 1. (a) (b) (a)(b) (c) 10%39,010,03510% 1%3,901,003 17.03C (d) 121% (e) (f) (g) 10 (h) (i)(ii)(iii) (i) 11 —— 13.51(B) 7292023629 13.51(B)(1) 20236142170 13.51B(1) C.2.1 C.2.12018520174 2410 202362912.410.0000163,728,000726.5 (1) 314820236303434 2410 202363034 108 2023824 2023630— 2023630— 2023630— 1 2016729 2023629 2 342023824 202220233 34 2022 241030 3 •17•8•12•12— 4 5 (a) (b) (c) 6 (i) (ii) 16.5%20232022630 (iii) 21%0.75%9.99%20232022630 (iv) 25% 20233202311100% 7 2023630216,985,0002022630301,925,00082,489,000202263073,982,000 2023202263020232022630 8 (a) (i)LAE001 2017630Novartis Pharma AGLAE001 16.6776,4377,764,3701.812.2 (ii)LAE002LAE003 201859LAE002LAE003 531.9165,2001,652,0005.233.5 (iii)LAE005 202024LAE005 1069.4 (iv) 20236301231362023630 18 2023630610,191,000202263,180,000 13 202363039,650,0003.40%4.35% 2.75%178,0002022132,000 (a) 20232