乐普生物-B2023年度报告

（於中華人民共和國註冊成立的股份有限公司） 股份代號 : 2157 公司資料2 董事長報告4 管理層討論及分析8 董事、監事及高級管理人員履歷25 董事會報告32 監事會報告50 企業管治報告51 環境、社會及管治報告73 獨立核數師報告116 綜合全面虧損表126 綜合資產負債表127 綜合權益變動表129 綜合現金流量表130 綜合財務報表附註131 財務概要213 釋義及技術詞彙214 (FCG, HKFCG) 20241 31 (FCIS, HKFCG) 2024131 22 1523 20241312024131 2023-31 188262602 H 183171712-1716 3485 02157 www.lepubiopharma.com 3800 68 365 651 (ADC)ADC 2023ADC202312312023 2.25 CMG901BD1.2420232KYMAstraZenecaCMG901AstraZenecaCMG901KYM6,30011.2520231231KYMAstraZeneca1.24 ®1.012023®20231231®1.01 20239281.0420.03%11.84%1.16202312312.2 20230.3096%2.5 ADC EGFRADCMRG0032024(NPC)(HNSCC)NPCIIa2023ESMO20231011FDAIND(FTD)MRG003NPCIIbHNSCCII2023ESMOMRG003HNSCCIII HER2ADCMRG002NDAMRG002HER2IINDAIIIMRG002(UC)III TFADCMRG004A(PC)TFADCMRG004AI/III2024ASCOPCIbPC202312MRG004APCFDA CG0070BCGCGOncologyIII20237MRCT IIICG OncologyCG0070I ADC+IO MRG003+®MRG003I2024ASCOIINPCHNSCC MRG002+®MRG002HER2IIUC2024ESMO Hi-TOPi ADClinker-payloadMRG006AADCIND2024IND TTOPAbodyCTM012TIND2024IND MRG006ATOPAbody20244(AACR) 2023ADC 2024ADCMRG003MRG002MRG003NDA2024NDAHER2BCMRG002NDAMRG004AMRG006ACTM012IND ®®ADC ADCADC 2024425 ADCADCCMCGMP (i)(ii)(iii)MRG003FDANPCODDFTDCDEBTD MRG002FDAGC/GEJ ODD CMG901FDAGC/GEJ FTD ODDCDEBTDMRG004AFDAODDFTDPCMRG006ACTM012 1.* 2.3.20227192022929®MSI-H/dMMRMSI-H/dMMRIV(M1c)III4.20232KYMAstraZenecaAstraZenecaCMG90120232235.IaCG0070MRCTCG OncologyCG0070 20231231 225.4®124.0KYMAstraZeneca2023223CMG901KYM109.5AstraZeneca®101.4 202312312023928103.920.03%11.84%116.420231231220.3 2022123195.7% 2023123120231231 MRG003 MRG003EGFRMMAEvcADCEGFR 20231231NPC IIbHNSCCIIIMRG003EGFR oNPCNPC IIa2023ESMO2023315PD-1 (L1)NPCORR47.4%DCR79.0%2.0mg/kgORR39.3%DCR71.4%mPFS7.32.3mg/kgORR55.2%DCR86.2%2.3mg/kgmPFSMRG003202310202311FDAINDFTDR/M NPCNPCIIb202312312024NDA oHNSCCHNSCC II2023ESMO2023315PD-1(L1)2.3mg/kgORRDCR43%86%mOS11.320231231HNSCCIII 1 8 A . 0 8 ( 3 )MRG003 MRG002 MRG002HER2ADCHER2BCUCGC/GEJMRG002MRG002BCUC oHER2BCHER2BCIINDA20231231HER2BCIII oUCIIIMRG002HER2UC20231231PD-1/PD-L1 1 8 A . 0 8 ( 3 )MRG002 MRG004A MRG004ATFADCIPCTNBCCCI2024ASCOIPCMRG004APC202312MRG004AFDAODDPC 1 8 A . 0 8 ( 3 )MRG004A MRG001 MRG001CD20ADCBNHLBNHLMRG001IbB(DLBCL)652023728CD20DLBCLCD-20CRORR17.6%38.2%T(CAR-T)CRORR22.2%44.4%mPFS6.3 1 8 A . 0 8 ( 3 )MRG001 CMG901 CMG901CLDN18.2ADCCLDN18.2MMAEINDCLDN18.2ADCCLDN18.2GCPCKYMCMG901IaCMG901202311CMG901GC/GEJICMG90120237242.2mg/kg2.6mg/kg3.0mg/kg113GC/GEJ4450 19274%PD-1/PD-L1≥354%31%8%89CLDN18.2GC/GEJORR33%DCR70%2.2mg/kgORR42%mPFS4.8(mOS)CMG901CMG901CLDN18.2GC/GEJ2024326AstraZenecaCMG901 1 8 A . 0 8 ( 3 )CMG901 ® ®PD-1IgG4PD-1PD-1PD-L1PD-L22022MSI-H/dMMR20234MSI-H/dMMR2023CSCOMSI-H/dMMR2023CSGO oMSI-H/dMMR20231231MSI-H/dMMRIII o20231231IIIIV(M1c) oGC/GEJIII20231231 CG0070 CG0070BCGCGOncologyMRCTIII20237MRCT III2023105BCGNMIBCCR75.7%36CR68.2%63.6%202312CG0070FDAFTDBTDCGOncologyCG007020231231I 1 8 A . 0 8 ( 3 )CG0070 MRG003+®MRG003I2024IINPCHNSCC MRG002 +®MRG002HER2IIUC2024ESMO CG0070 +®INDCG0070BCGNMIBCICG0070BCGNMIBCI/II ADCHi-TOPiTTOPAbodyADCMRG006ATCTM01220244MRG006ATOPAbody Hi-TOPiADCHi-TOPi(i)(ii)Pgp(iii)ADCPDX(iv) oMRG006AADCIND2024IND TTTOPAbody(i)TCRT(ii) oTCTM012TIND2024IND GMP2,000LCDMO 12,000LADCADC 20231231124.02023223KYMAstraZenecaCMG901AstraZenecaCMG901CMG901KYM631,125KYMAstraZenecaKYM109.5AstraZenecaAstraZeneca 2023223 ® 2022®20231231®100 ®20234MSI-H/dMMR2023CSCOCSGOKOL 202312312176 我們候選藥物於報告期後的開發進度 •MRG004A20243MRG004AFDAFTDMRG004A 20231113CDMOGLP-120231222202413120242024CDMO 202311132023122220241162024131 ADC2024ADCMRG003MRG002MRG003NDA2024NDAHER2BCMRG002NDAMRG004AMRG006ACTM012IND 2024®ADC ADCADC 20231231225.4202215.61,347.2%AstraZenecaCMG901124.02022®20231231101.420221231551.1% 2023123128.320222.01,310.3% 2023123143.320221.72022® (i)(ii)(iii)(iv) 2022138.8202386.72022234.3 (i)(ii)(iii)(iv)(v)(vi)2022524.32023458.1 (i)31.6 (ii)36.7 (v)15.72022 2023123120221231 202262.82023175.040%PD-14.375% 202245.920238.320228.6202316.0 202220231231 2022699.4202330.3 經調整報告期淨虧損（非國際財務報告準則計量） (i)(ii)20231231250.620221231699.4 202220231231 (1)20.03%11.84% (2) 20231231250.820221231480.9230.1®20231231426.020221231669.4243.4 20231231694.320221231650.0394.020221231329.6 20231231300.320221231320.420279 20231231743.6706.4 2023123162.73%2022123164.39% 出售皓陽生物15%的股權 202392815%1255.68% 2023929 20231231 20231231 202320221231456.6482.0 20231231 20231231 202312314292023198.92022188.3 2022317810.42657.61 20231231 CMG901®2025630 執行董事 61 19996199911 2013112014520173201732019620201200272119981119996U.S. WP Medical Technologies, Inc. 1983198519907 4420203202395.68%2018620228Star Combo PharmaLimitedS66 20074202012012320155ComedBV201542019122017102020120156202012016920207 2001720073 非執行董事 552017122018102020320206(a) 20049201712002437(b) 2001520048 PD-18.10 19917201110 3520154Viralytics Limited20182 201810RgenixInc.20193CG OncologyRgenix Inc.CG Oncology8.10 2012520136