乐普生物-B2025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 2025中 期 報 告 (FCG, HKFCG) 20256272025627 (FCIS, HKFCG) 97927 1523 2023-31 20256272025627 H 183171712-1716 33191918 3800 68 365 651 02157 www.lepubiopharma.com ADCADCCMCGMPADC (i)(ii)(iii)TMRG003NPCFDABTDODDFTDCDEBTDMRG002GC/GEJFDAODDCMG901GC/GEJFDAFTDODDCDEBTDMRG004APCFDAODDFTDCG0070CDEFDABTDMRG003MRG006AFDAIND ®CMG901MRG007CMG901AstraZenecaMRG007ArriVentADC 1.*2.3.2022®MSI-H/dMMRMSI-H/dMMRIV(M1c)III4.20232KYMAstraZenecaAstraZenecaCMG901202322320244155.2025122ArriVentArriVentMRG00720251226.202581ExcalipointCTM012ExcalipointExcalipoint 10%202581 465.92024133.33.5309.0MRG0072025®150.6202458.8%202463094.8CDMO6.3202463017.8 •2025630309.0MRG00720251ArriVentArriVentMRG007CMG90112 •®20234MSI-H/dMMR2023CSCOCSGOKOL 202563028118 •CDMOGLP-120256306.3CDMO 20252025 MRG003 MRG003EGFRMMAEvcADCEGFR MRG003CDENDAR/M NPCHNSCC IIIMRG003MRG003 NPCMRG003R/MNPCNDACDEMRG003R/MNPCIIb2025ASCO(LBA)2024630MRG003PFSPFS5.822.8337%MRG003ORR30.2%11.5%20241231MRG003OSOS17.08vs11.99mOS MRG003R/M NPCIIIR/M NPCII2025ESMO HNSCC2025630HNSCCIII MRG003HNSCCIIII2025ESMO20256LA-SCCHNII(CTA)(EMA)2025 1 8 A . 0 8 ( 3 )MRG003 MRG004A MRG004ATFADCIPCIb2025ESMOCDEMRG004A20258III 1 8 A . 0 8 ( 3 )MRG004A MRG002 MRG002HER2ADCHER2BCUCGC/GEJMRG002MRG002BCMRG002MRG002 HER2BCHER2BCII2025630HER2BCIII MRG002+®2025630MRG002HER2IIIIIUC 1 8 A . 0 8 ( 3 )MRG002 MRG001 MRG001CD20ADCBNHLBNHLMRG001IbDLBCLMRG001BTKDLBCL67 1 8 A . 0 8 ( 3 )MRG001 MRG006A MRG006AIGPC-3 ADCHi-TOPiADCI20251FDAINDMRG006ACDXHCCPDXMRG006A 1 8 A . 0 8 ( 3 )MRG006A MRG007 MRG007CDH17ADCIND20256INDIaMRG00720254AACR 2025122ArriVentMRG007ArriVentMRG0074,70011.62025630 1 8 A . 0 8 ( 3 )MRG007 CMG901 CMG901CLDN18.2ADCCLDN18.2MMAEINDCLDN18.2ADCCLDN18.2GCPCKYMAstraZeneca20232CMG901 (AZD0901)AZCMG901 (AZD0901) AstraZeneca2025IIAZD0901Claudin 18.2PKAZIIIAZD0901Claudin 18.2 1 8 A . 0 8 ( 3 )CMG901 CG0070 CG0070BCGCGOncologyCG0070MRCT III20254120CG007075.5%CR2025314DOR28 CGOncologyCG00702025630ICDECG0070®BCGNMIBCIIND 20251CG0070CDEBTDBCGCG0070 1 8 A . 0 8 ( 3 )CG0070 ® ®PD-1IgG4PD-1PD-1PD-L1PD-L22022MSI-H/dMMR20234MSI-H/dMMR2023CSCOMSI-H/dMMR2023CSGOIIMSI-H/dMMR2025ASCO oMSI-H/dMMR2025630MSI-H/dMMRIII o2025630IIIIV(M1c) ADCHi-TOPi ADCADCADCMRG006AMRG007INDMRG00720254AACR Hi-TOPi ADCADCHi-TOPi ADC(i)(ii)Pgp(iii)ADCPDX(iv) MRG006AADCI ADCADCAB bsAb ADC PD-1PD-1×PD-1PD-1+(ORR)(OS)ADC TTTOPAbody(i)TCRT(ii) 2,000LGMPCDMOCDMO6.3 CMC12,000LADCADC 20257420257115.0293,825,0002025711 462.94(i)20%92.59MRG003(EGFR-ADC)(ii)60%277.76(iii)20%92.59 H 202572154,268,364HH20257222025721 202581202581ExcalipointTTOPAbody Excalipoint(i)10ExcalipointInnocubeExcalipoint10%(ii)847.5(iii)Excalipoint MRG004ABTD 20258MRG004ACDEBTD ADC ADCMRG003MRG004A20258IIICDECG0070MRG006AMRG007 ®®MRG003ADC ADCCMG901AstraZenecaMRG007ArriVentADCADC 2025630465.92024630133.320243.5(i)MRG007309.0202463020.7(ii)®150.6202458.8%202463094.8(iii)CDMO6.3202463017.8 202563027.4202463021.0 202563097.9202463043.8® (i)(ii)(iii) 202463030.8202563055.4(i)2024(ii) (i)(ii)(iii)(iv)(v)(vi)2025630202.22024630216.6 (i)20256305.8 (ii)7.5 (iii)4.7NDAADCCMC (iv)10.1 (v)9.22024 202563020246301.5 20246300.1202563017.040%PD-1 20246302.620256307.520246308.5202563014.92024 20256302024630 29.32024630197.0® 202563046.72024630115.1161.82025630472.720241231401.371.4 (i)(ii)(iii) 2025630877.120241231794.4647.020241231534.1566.6 2025630230.120241231260.320279 2025630998.5651.5 202563069.9%2024123170.1% 2025630 2025630448.720241231456.8 2025630 2025630 20256305462025630110.3202463092.9 2022317810.42657.61 2025630 ®20251231 2024 20245172024524 20224.5851,170,000H2024H4.952024524H1.0051,570,00020245172024524 229.75209.182025630 2025630XV352 2025630 (1)20256301,710,614,8381,656,346,474H54,268,364 (2)433,239,436H100%100%225,352,113H433,239,436H225,352,113H (3)90,000,000HCereblue Limited100%Cereblue Limited100%90,000,000H 2025630XV78352 20256303365% (1)20256301,710,614,8381,656,346,474H54,268,364(2)131,496,106HMiracogenInc.100%MiracogenInc.100%Miracogen Inc.131,496,106H(3)(4)50%99.50%60%69.47%44.1%(5)(6)100%(7) 2025630336 18 2025630 2025630 202566202562720242024 2025662025662024 202413.51B(1) 2025630 24102025630 20256302024630 2025919 30542025630343434 2410 34 2025820 1. 201811920201210 2025820 2. 202563034 20241231 20256304074732025630 3. 20241231 21 21 4. 2024 5. 5.1 2024 20241231 5.2 5. 5.3 40% 202563020241231 (a)202520246303 (b)2025202463024 6. 7. 2025630295,033,000ArriVent BioPharma INC.63.32% 202463020,678,000KYMBiosciences Inc.KYM15.51%16,181,00027CDMO12.14% 10% 8. 9. 10. 11. 12. 20256302024630 202315% 202415% 2023121215% 25% 13. (a) •• (b) 20252024630 14. 2025630680,790,00020241231648,229,000230,173,00020241231260,261,00022 202563048,565,0002024123150,421,000230,173,00020241231260,261,00022 16. 2 0 2 563 0P D - 139,097,00020246306,644,000 17. (a)1212 19. 3