乐普生物-B2024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 2452328293032333459 (FCG, HKFCG) 2024131 (FCG, HKFCG) 2024131 22 1523 20241312024131 2023-31 H 183171712-1716 3485 02157 www.lepubiopharma.com 3800 68 365 651 ADCADCCMCGMP (i)(ii)(iii)MRG003NPCFDABTDODDFTDCDEBTDMRG002GC/GEJFDAODDCMG901GC/GEJFDAFTDODDCDEBTDMRG004APCFDAODDFTDMRG006AMRG007CTM012MRG006ACDEINDCTM012MRG007 1.*2.3.20227192022929®MSI-H/dMMRMSI-H/dMMRIV(M1c)III4.20232KYMAstraZenecaAstraZenecaCMG901202322320244155.IaCG0070MRCTCG OncologyCG0070 133.3®CDMO2024®94.8202344.020.7KYMAstraZeneca2023223CMG901CMG901CDMO17.8 ®20234MSI-H/dMMR2023CSCOCSGOKOL 20246302678 20246302024630 MRG003 MRG003EGFRMMAEvcADCEGFR 2024630NPCIIbNDAHNSCC IIIMRG003MRG003 oNPCNPCIIa20246BTDFDA20247R/M NPCBTD2024630NPC IIb2024NDAoHNSCC2024630HNSCCIII oMRG003 +®MRG003I/III2024ASCO2024130IORRDCR53.8%84.7%IINPCHNSCCORR77.8%60%DCR100%80%II2024ESMO 1 8 A . 0 8 ( 3 )MRG003 MRG002 MRG002HER2ADCHER2BCUCGC/GEJMRG002MRG002BCUCMRG002MRG002 oHER2BCHER2BCII2024630HER2BCIIIoUCIIIMRG002HER2UC2024630PD-1/PD-L1 oMRG002 +®MRG002HER2IIUC2024ESMO2024630 1 8 A . 0 8 ( 3 )MRG002 MRG004A MRG004ATFADCIPCTNBC CCI2024ASCO20231215PC2.0 mg/kgORRDCR33.3%83.3%TF≥50%3+5PCORRDCR80%100%mPFS5.520243MRG004AFDAFTDPCMRG004AIPCMRG004APC 1 8 A . 0 8 ( 3 )MRG004A MRG001 MRG001CD20ADCBNHLBNHLMRG001IbDLBCL 1 8 A . 0 8 ( 3 )MRG001 MRG006A MRG006AIGPC3 ADCHi-TOPiMRG006ACDXHCCPDXMRG006A20244AACR20247INDI20248 1 8 A . 0 8 ( 3 )MRG006A CMG901 CMG901CLDN18.2ADCCLDN18.2MMAEINDCLDN18.2ADCCLDN18.2GCPCKYMCMG901IaCMG90120245CMG901GC/GEJI2024ASCO20242242.2 mg/kgORR48%CMG901mPFS4.8mOS11.8AstraZenecaCMG90120243IIICMG901CLDN18.220244 1 8 A . 0 8 ( 3 )CMG901 ® ®PD-1IgG4PD-1PD-1PD-L1PD-L22022MSI-H/dMMR20234MSI-H/dMMR2023CSCOMSI-H/dMMR2023CSGO MSI-H/dMMR2024630MSI-H/dMMRIII 2024630IIIIV(M1c) GC/GEJIII2024630 CG0070 CG0070BCGCGOncologyMRCTIII202441CR75.2%92.4%2024(AUA)202312CG0070FDAFTDBTDCG OncologyCG00702024630IIaCG0070®BCGNMIBCIIND 1 8 A . 0 8 ( 3 )CG0070 vc-MMAEADCHi-TOPiADCTTOPAbodyADCMRG006AMRG007TCTM012MRG006AINDMRG007CTM012MRG006ATOPAbody20244AACR Hi-TOPiADCHi-TOPi(i)(ii)Pgp(iii)ADCPDX(iv) oMRG006AADC TTTOPAbody(i)TCRT(ii) oTCTM012TIND2024IND 2,000LGMPCDMOCDMO17.8 CMC12,000LADCADC MRG00320247MRG003FDABTD MRG006A20247INDI20248 ADC2024ADCMRG003MRG0022024MRG003NDAMRG004AMRG006ACTM012MRG007 ®ADCMRG003 ADCADC 2024630133.32023630153.6®94.8202344.0115.4%2024630CMG90120.7CDMO17.8 20246302023CMG901109.520.7®CDMO17.82023630 202463021.020236305.8 ®2023®202370%®2024630 202463043.8202363013.9® (i)(ii)(iii) 202363039.121.1%202463030.8 (i)(ii)(iii)(iv)(v)(vi)2024630216.620236.6%2023630231.9 (i)2024630CMC2023630 3.0 (iii)9.2NDAADCCMC (iv)12.8 (v)6.62023 (vi)202463020236301.23 202363017.720246300.140%PD-14.375% 20236305.520246302.6202363020246308.5 20246302023 2023630141.92024630197.0 2024630115.1202363075.639.52024630513.620231231426.087.6 2024630729.620231231694.3449.320231231394.0 2024630280.320231231300.320279 2024630798.9651.1 20245172024524H4.5851,170,000H2024524 2024524229.75209.18(i)70%160.83146.43ADC(ii)20%45.9541.84CG0070(iii)10%22.9820.92 6300.22 202463063.05%2023123162.73% 2024630 2024630452.820231231456.6 202463020231231 2024630 2024630491202463092.9202363089.2 2022317810.42657.61 2024630 CMG901®2025630 20245172024524 4.5851,170,000HH4.952024524H1.0051,570,00020245172024524 229.75209.182024630 20261231 2024630XV352 20246 30 20246301,710,614,8381,656,346,474H54,268,364 (2)433,239,436H100%100%225,352,113H433,239,436H225,352,113H (3)90,000,000HCereblue Limited100%Cereblue Limited100%90,000,000H 2024630XV78352 20246303365% (1)20246301,710,614,8381,656,346,474H54,268,364(2)136,355,106HMiracogenInc.100%MiracogenInc.100%Miracogen Inc.136,355,106H(3)(4)50%99.50%60%69.47%44.1%(5)(6)100%(7) 2024630336 18 2024630 2024630 202313.51B(1) 2024630 24102024630 20246302023630 2024924 295820246303434 2410 34 2024821 1 201811920201210 2024630 2024821 2 202452451,170,000HH4.58234,359,000213,379,0001,659,444,8381,710,614,838 3 20246303434 202312312023 20246301971152024630242514 7CDMO2023 (a) 117716 3 (b) 20231231 4 2023 5 5.1 2023 20231231 5.2 5.3 40% 202463020231231 5 5.3 (a)202420236303 (b)2024202363027 6 202463020,678,0002023630109,520,000KYM15.51%202363071.32%16,181,0002023630CDMO3012.14%202363010% 7 (a)CDMO 2024CDMOCDMOCDMO CDMO (a)(b)(c) 2 0 2 463 0C D M O17,769,0002023630 10 (a)202420236303.88%4.01% 20232025123115% 20232025123115% 20212023123115% 25% 14 (a) •• (b) 20242023630 (a)2024630614,682,000 17 18 (a)12 360202463020231231 23 (a)2202452451,170,000HH4.58234,359,000213,379,000 4,388,000 24 2020 2024630 (a) 20201271.0015145,149,702 (1/4) 25 (a)2 0 2 463 05 2 , 2 7 7 , 0 0 0657,598,0002023123154,133,000653,405,000280,267,00020231231300,321,0003.80%4.00%202312313.80%4.00%2022620202791 202463020231231 26 202463012,844,0002023123114,201,000 20242023630 28 29 (a) 2024630526,932