乐普生物-B2024年度报告

樂普生物科技股份有限公司LEPU BIOPHARMA CO., LTD. （於中華人民共和國註冊成立的股份有限公司） 年度報告 2 4 7 28 34 53 54 (ESG)76 128 136 137 139 140 222 (FCG, HKFCG) 2024131 (FCIS, HKFCG) 2024131 97927 1523 20241312024131 2023-31 H 183171712-1716 33191918 02157 www.lepubiopharma.com 3800 68 365 651 (ADC)ADC 2024202412312024 3.6863.2% ®32024®20241231®33CMG901 BD0.22CDMO0.46 ADC •NDAEGFRADCMRG003 MRG003NPCNDACDEHNSCCIII(NPC)(HNSCC)IIb2025ASCO(LBA) MRG003+®MRG003II2024ESMO •HER2ADCMRG002 MRG002HER2(BC)II2024SABCSHER2BCIII MRG002+®MRG002HER2IIUC2024ESMO •ITFADCMRG004A MRG004A(PC)TFADCMRG004AI/III2024ASCOPCIbPC •IGPC3ADCMRG006A MRG006AIGPC-3 ADCHi-TOPiI ADCMRG007 MRG007IND20251ArriVentArriVentMRG00712 I CG0070BCGCGOncologyIIICG OncologyCG0070I Hi-TOPi ADClinker-payloadMRG006AGPC3ADCMRG006ACDXHCCPDXMRG006A TTOPAbodyCTM012TIND2024Pre-IND MRG007BD 2025EGFRADCMRG003NDAMRG003EGFRADCMRG003MRG004AMRG006ACTM012MRG007 2025425 ADCADCCMCGMPADC (i)(ii)(iii)MRG003NPCFDABTDODDFTDCDEBTDMRG002GC/GEJFDAODDCMG901GC/GEJFDAFTDODDCDEBTDMRG004APCFDAODDFTDCG0070CDEBTDMRG006AMRG007CTM012MRG006ACDEINDCTM012MRG007 ®CMG901MRG007CMG901AstraZenecaMRG007ArriVentADC 1.*2.3.2022®MSI-H/dMMRMSI-H/dMMRIV(M1c)III4.20232KYMAstraZenecaAstraZenecaCMG901202322320244155.2025122ArriVentArriVentMRG00720251226.ICG0070MRCTCGOncologyCG0070 367.863.2%2024®300.32023101.422.0CMG901CDMO45.5 •®20234MSI-H/dMMR2023CSCOCSGOKOL 202412312781 •202422.0KYMAstraZeneca2023223CMG90120251ArriVentArriVentMRG00712 •CDMOGLP-1202445.5CDMO2025202517202536.0CDMO 2024123120241231 MRG003 MRG003EGFRMMAEvcADCEGFR MRG003R/M NPCNDACDEHNSCC IIIMRG003MRG003 NPC:MRG003NDA20253NDAMRG003CDEMRG00320246BTDFDA20247R/MNPCBTDIIb2025ASCO(LBA) HNSCC:20241231HNSCCIII MRG003+®MRG003I/III2024ASCOR/M NPCII2024ESMO ASIA2024630ORRDCR66.7%93.3%PFSDoR6PFS6DoR76.2%83.3% 1 8 A . 0 8 ( 3 )MRG003 MRG002 MRG002HER2ADCHER2BCUCGC/GEJMRG002MRG002BCMRG002MRG002 HER2BCHER2BCII2024SABCS20247IIORRDCR60.8%86.3%mPFS8.6mDoR9.420241231HER2BCIII MRG002 +®MRG002HER2IIUC2024ESMO20244ORRDCR64.0%89.0%MRG0021.8 mg/kgORRDCR70.0%90.0%HER2+ORRDCR70.6%94.1%PFS26.5 1 8 A . 0 8 ( 3 )MRG002 MRG004A MRG004ATFADCIPCTNBCCCI2024ASCO20231215PC2.0 mg/kgORRDCR33.3%83.3%TF≥50%3+5PCORRDCR80%100%mPFS5.520243MRG004AFDAFTDPCMRG004AIMRG004APC 1 8 A . 0 8 ( 3 )MRG004A MRG001 MRG001CD20ADCBNHLBNHLMRG001IbDLBCL 1 8 A . 0 8 ( 3 )MRG001 MRG006A MRG006AIGPC-3 ADCHi-TOPi20247INDIMRG006ACDXHCCPDXMRG006A20244AACR 1 8 A . 0 8 ( 3 )MRG006A CMG901 CMG901CLDN18.2ADCCLDN18.2MMAEINDCLDN18.2ADCCLDN18.2GCPCKYMCMG901I20246CMG901GC/GEJI2024ASCO202516IThe Lancet Oncology20242242.2 mg/kgORR48%CMG901mPFS4.8mOS11.8AstraZenecaCMG90120243IIICMG901CLDN18.220244 1 8 A . 0 8 ( 3 )CMG901 MRG007 MRG007ADCIND20253INDMRG00720254AACR 1 8 A . 0 8 ( 3 )MRG007 ® ®PD-1IgG4PD-1PD-1PD-L1PD-L22022MSI-H/dMMR20234MSI-H/dMMR2023CSCOMSI-H/dMMR2023CSGOIIMSI-H/dMMR2025ASCO MSI-H/dMMR20241231MSI-H/dMMRIII 20241231IIIIV(M1c) GC/GEJIII20241231 CG0070 CG0070BCGCGOncologyCG0070MRCTIII202425(SUO)2024930CG007074.5%CRDOR27CG OncologyCG007020241231IICG0070®BCGNMIBCIIND 1 8 A . 0 8 ( 3 )CG0070 vc-MMAEADCHi-TOPiADCTTOPAbodyADCMRG006AMRG007TCTM012MRG006AINDMRG007CTM012MRG006ATOPAbody20244AACR Hi-TOPiADCHi-TOPi(i)(ii)Pgp(iii)ADCPDX(iv) MRG006AADC TTTOPAbody(i)TCRT(ii) TCTM012TIND2024CTM012pre-IND 2,000LGMPCDMOCDMO45.5 CMC12,000LADCADC MRG007ArriVent 2025122ArriVentADCMRG007ArriVentMRG0074,70011.6 MRG007IND2025INDMRG00720254AACR MRG0072025122 CG0070CDEBTD 20251CG0070CDEBTDBCGCG0070 20241126CDMOGLP-120251231CDMO36.020251720252025CDMO 2024112620241217202517 2024112024112620242025172025 2024112620241217202517 ADC2025 ADCMRG003MRG004AMRG006ACTM012MRG007 2024®®MRG003ADC ADCCMG901AstraZenecaMRG007ArriVentADCADC 20241231367.82023225.463.2%(i)®300.32023101.4(ii)CMG90122.02023124.0(iii)CDMO45.52023 2024123174.8202328.3164.6% 20241231146.0202343.320241231® (i)(ii)(iii) 2024123191.9202386.72024 (i)(ii)(iii)(iv)(v)(vi)2023458.12024437.74.4% (i)2023123111.2NDACMC 7.2 8.2 (iii) (iv)25.0 (v)20.92023 (vi)202412311.1 2023175.020245.140%PD-1 20238.320246.0202316.0202423.02024 202320241231 202330.32024424.2 (i)(ii)(iii)20241231429.320231231425.5 202320241231 (1)20.03%11.84% 20241231401.32023426.020241231196.420231231250.854.420241231 20241231794.420231231694.3534.120231231394.0478.2 20241231260.320231231300.320279 20241231883.6666.4 20245172024524H4.5851,170,000H2024524 2024524229.75209.2(i)70%160.83146.4ADC(ii)20%45.9541.8CG0070(iii)10%22.9820.9 2024123124.6ADC19.9 2024123170.1%2023123162.7% 1231 20241231 202320241231456.6456.8 20241231 20241231 202412314982024211.92023198.9 2022317810.42657.61 20241231 ®20251231 20245172024524 4.5851,170,000HH4.952024524H1.0051,170,00020245172024524 229.75209.1820241231 62 19996199911 20131120145201732019620201200272119981119996U.S.WP MedicalTechnologies, Inc. 1983198519907 4520203202395.51%2018620228StarCombo PharmaLimitedS66 20074202012012320155ComedBV201542