乐普生物-B2023中期报告

（於中華人民共和國註冊成立的股份有限公司）股份代號 : 2157 2023中期報告 4 (FCG, HKFCG) (FCG, HKFCG) 22 1523 2023-31 251908 651 3485 3800 68 365 H 183171712-1716 www.lepubiopharma.com ADCADCCMCGMP (i)(ii)(iii)MRG003FDANPCODDCDE BTD MRG002FDAGC/GEJ ODD CMG901FDAGC/GEJ ODDCDEBTD 1.*2.3.20227192022929®MSI-H/dMMR4.20232KYMAstraZeneca ABAstraZeneca ABCMG90120232235.IaCG0070MRCTCG OncologyCG0070 20222KYMAstraZeneca20232CMG901KYM109.5KYM1,188KYMAstraZeneca®44.0 2023630 MRG003 MRG003EGFRMMAEvcADCEGFR MRG003EGFRIIHNSCCNPCHNSCCNPCMRG003EGFR oNPCNPC IIa2023ESMO20231NPC IIbCDE2023630NPCIIb oHNSCCHNSCCII2023ESMO2023630HNSCCIII 1 8 A . 0 8 ( 3 )MRG003 MRG002 MRG002HER2ADCHER2BCUCGC/GEJMRG002MRG002BCUC oHER2BCNDA2023630HER2BCIII oUCIIIMRG002HER2UC2023630PD-1/PD-L1 1 8 A . 0 8 ( 3 )MRG002 ® ®PD-1IgG4PD-1PD-1PD-L1PD-L2202279®MSI-H/dMMR20234MSI-H/dMMR2023CSCOMSI-H/dMMR2023CSGO oMSI-H/dMMR2023630MSI-H/dMMRIII o2023630IIIIV(M1c)oGC/GEJIII2023630 18A.08(3)® MRG003+®MRG003I2023CSCOII MRG002+®MRG002HER2I2023630 CG0070+®INDCG0070BCGNMIBCICG0070BCGNMIBCI/II MRG004AMRG004ATFADCI/IIPCTNBCCCI2023CSCO MRG001MRG001CD20ADCBNHLBNHLMRG001Ib CMG901CMG901CLDN18.2ADCCLDN18.2MMAEINDCLDN18.2ADCCLDN18.2GCPCKYMCMG901IaCMG90120231Ia20232023ASCO GI202284CLDN18.2GC/GEJORRDCR75.0%100%2.6mg/kg3.0mg/kg3.4mg/kgORR100%(mPFS)(mOS) CG0070CG0070BCGCGOncologyMRCT IIICG OncologyCG00702023630I 1 8 A . 0 8 ( 3 )MRG004AMRG001 CMG901CG0070 T TTTOPAbody(i)TCRT(ii) oTCTM012TIND ADC(i)(ii)Pgp(iii)ADCPDX(iv) oMRG006AADCIND ADC2023630ADCMRG003NPCIIbMRG003HNSCCIIIMRG002UCIIIHER2BCNDAADC MRG004APC TNBC CCADCADCMRG003MRG002CMG901FDAODDNPCGC/GEJGC/GEJMRG003CDEBTDR/MNPCADCADC MRG002MRG003ADCLP002 MRG003NPCHNSCCMRG002HER2BCUC®MSI-H/dMMR 5 GMP2,000L200L 20221012,000L6,000L 2023223KYMAstraZenecaCMG901AstraZenecaCMG901CMG901KYM631,125KYMAstraZeneca2023630KYM109.5 2023223 ® ®20222023630®44.0 ®20234MSI-H/dMMR2023CSCOCSGOKOL 20236301050 A 202291414,861,209AAA202292320222022H2022414,861,209AAA 2023711AA2023825(i)A(ii)A122023711202389 20238120222023HH2023H2023224202381202381202381 20235242023524H2023615H202381 2023630 2023630 ADC2023ADCMRG003MRG002HER2BCMRG002NDAMRG003NDAMRG004A ADCADCADC 2023630153.62022630CMG901109.5®44.0 202363013.920226302022® (i)(ii)(iii)202263084.7202363039.133.5 (i)(ii)(iii)(iv)(v)2023630231.92022630230.7 (i)7.8 (ii)22.0 (iii)10.62022 (iv)6.5 (v)20236302022630 202263060.8202363017.740%PD-14.375% 202263036.820236305.520226302.820236307.9 20236302022 2022630348.42023630141.9 202363075.62022630192.8117.22023630581.520221231669.487.9 2023630749.420221231650.0434.1 2023630315.320221231320.420279 2023630783.7516.3 202363068.24%2022123164.39% 2023630 2023630466.220221231482.0 202363020221231 2023630 2023630436202363089.2202263085.6® 2022317899,000H810.42657.61 2023630 CMG901®2025630 2023630XV352 20236 30 (1)20236301,659,444,8381,605,176,474H54,268,364 (2)433,239,436H100%100%225,352,113H433,239,436H225,352,113H (3)138,328,106HMiracogenInc.100%MiracogenI n c .1 0 0 %138,328,106H (4)90,000,000HCereblue Limited100%Cereblue Limited100%90,000,000H (5)King Star Med LP20,900,000HKing Star Med LPKing StarMed Management LimitedKing Star Consulting LimitedAce Treasure TrustSuperb Outcome Trust40%30%King Star Med LPH 20236 30 (6)20.68%XV4.83%50% 2023630352 2023630XV233365% (1)20236301,659,444,8381,605,176,474H54,268,364(2)H(3)(4)50%99.50%60%69.47%44.1%(5)(6)100%(7) 2023630336 18 2023630 202363013.51B(1) 2023630 24102023630 20236302022630 2023922 285220236303434 2410 34 2023825 1 201811920201210 2023630 2023825 2 2023222KYM Biosciences Inc.KYMAstraZeneca ABAstraZenecaKYMCMG901KYMCMG901KYM 70%30% AstraZenecaCMG901CMG901 KYM63.01,125.0KYMAstraZenecaKYMAstraZenecaCMG901 KYMKYMCMG901KYMAstraZeneca30% 3 20236303434 202212312022 2023630141.975.62023630155.3581.5 72022 (a) 1712812 3 (b) 20231231 4 2022 5 5.1 2022 20221231 5.2 5.3 40% 202363020221231 5 5.3 (a)202320226303 (b)2023202263024 6 2023630109,520,0002022630KYM71.32%202263010% (a) • • 7 (a) 22023630KYMAstraZenecaKYM109,520,000109,520,000 8 (a)202320226304.01%4.18% 13 202011182020202215% 202110252021202315% 25% 14 (a) • 14 (b) 20232022630 15 18 19 (a)2022223126,876,0001.00HH7.13 (b)2022322H7.13899,000H 33,287,000 21 2020 2023630 (a) 20201271.0015145,149,702 (1/4) 22 (a)2 0 2 363 05 5 , 9 9 0 , 0 0 0596,160,00044,727,0002022123157,846,000585,260,00045,345,000315,315,00020221231320,414,0003.90%4.15%202212314.00%4.20%20231220202791 202363020221231 23 202363020,075,0002022123122,335,000 24 20232022630 25 26 (a) 2023630533,516,00020221231516,146,000 26 (b) 27 CG Oncology, Inc. 27 202363020221231 27 27.3 28 20232022630 29 2023630 IC50IgGGIHCIND201691KOLKYMKYM Biosciences Inc.1999611300003H20222232022223 PD-11TBPD-L1PD-11TPD-1TPD-L2PD-12TTPDXPgpIIIIIIPRRECIST30%100% 2022210RECIST20002(EORTC)RECIST2000220092023630R/MSDRECIST30%20%2L5711.00HSMO