荣昌生物2025 中期报告

榮昌生物製藥(煙台)股份有限公司RemeGen Co., Ltd.* (於中華人民共和國註冊成立的股份有限公司)股份代號: 9995 2025中 期 報 告 2公司資料4財務概要5管理層討論及分析24其他資料46獨立審閱報告47中期簡明綜合損益表48中期簡明綜合全面收益表49中期簡明綜合財務狀況表51中期簡明綜合權益變動表53中期簡明綜合現金流量表55中期簡明綜合財務資料附註79釋義及詞彙 202526202542 2025110202552620251102025526 20251102025110202526202542 20251102025110 20257312025527202571520256262025731 97927 77 2One Island South10021207 118100020 161 •108 58 H 183171712-1716 24840 H9995A688331 www.remegen.com 2008(GMP)RC18愛®RC48愛® 2025630IND RC18愛® (TACI)G(IgG)(Fc)BBBLySAPRILB o(MG) 2023(gMG)III20248202410CDE202211CDE20255(NMPA) 20254(AAN)MGIII24MG-ADL5.740.91MG-ADL≥398.1%12%QMG8.662.27QMG≥587%16%MG-ADLQMG24AEAE(45.6% vs 59.6%) oAIgA 2023IgAIII20245III o(pSS) 20226pSSCDE202282023III20245 o II/III VorBiopharma Inc.VorBio20256VorBio(i)VorBio1.25VorBio4,50020257Vor Bio8,000(ii)VorBio41.05(iii)Vor BioVor Bio oMG VorBio(gMG)III202210FDA(gMG)2023FDA(gMG)FTD20248 18A.08(3)RC18愛® RC48愛® (ADC)ADCADC2(HER2)HER2(GC)(UC)HER2(BC) HER2GCUCBC o(UC) •HER2IHC 2+IHC3+UCIIIINMPAII202012NMPAUC20219NMPAUC202112202311Journal of ClinicalOncologyJCO202312023 •III®HER2(la/mUC)2024820255PFSOSHER2PFSOS20256CDEHER2HER2HER21+2+3+ •PD-1HER2UC®(MIBC)II(IND)20222NMPA20245CDE •20252(ASCOGU)HER2(MIBC)II4731(pCR)63.6%95% CI 45.1% – 79.6%(pPR)75.8%95% CI 57.7% – 88.9%12EFS92.5%18EFS85.9% o(GC) •HER2II/IIIIND20234NMPA2023 •20255(ASCO)HER2 1.HER2PD-1+PD-1++CAPOXORR66.7% vs 82.4% vs 68.8%mPFSvsvs14.154%HR=0.4641%HR=0.5912PFS66.3%67%53.6%3TRAE 2.HER2PD-1+CAPOX+ P D -1+CAPOXORR72.0%vs 47.8%mPFS9.9vs7.231%HR=0.693TRAE 3.HER2PD-1+CAPOX2.5 mg/kg2.0 mg/kg +PD-1 +CAPOXORR71.4% vs 66.7% vs 56.3%6PFS71.4%72.7%53.3% o(BC) •20246HER2III20255CDE•20255CDEHER2 SeagenInc.Seagen20218Seagen2021102Seagen24Pfizer Inc.PfizerSeagenPfizer/Seagen oUC•PfizerSeagen2022IIHER2UC2025630•PfizerSeagenPD-1UCIII2025630Pfizer 18A.08(3)RC48愛® RC28-E RC28-EVEGFFGFRC28-E(wAMD)(DME)(DR) o(wAMD) IbRC28-EwAMD2022938(WOC2022)2023III2025630 o(DME) 2023III2025630 20255RC28-E(DME)II(ARVO2025)RC28-EDMEBCVACST 63.5%36.5%VEGFBCVA73-24CST300μm4RC28-E2452BCVARC28-EDME521.0mgQ8W1.0mgPRN2.0mgQ8W2.0mgPRNBCVA8.45.59.59.29.7RC28-E II2025630 RC28-ERC28-ERC28-E2.55.25.25 18A.08(3)RC28-E RC88RC88ADCRC88PD-1II2025630 RC148RC148PD-1VEGFADCRC148I/II2025630 RC148Ib2025630 RC278RC278ADC20255RC278I/IIIND(NMPA)(CDE) RC288RC288ADC 18A.08(3)RC88RC148RC278RC288 SLE20213NMPA12SLE202320256301,000 20216NMPA72021HER2(GC)20231HER2(UC)20256301,000 20257HER2(CDE)–20257RC278I/IIINDCDE–20258RC148(FDA)(IND)II–20258(pSS)III–20258RC148CDERC148PD-1/PD-L1(NSCLC)–20258RC28-ERC28-ERC28-E2.55.25.25 2025 VorBioPfizer/SeagenRC28-E 2024630739.720256301,092.0 202463054.4202563020.3 2024630389.72025630525.8 2024630155.22025630154.4 2024630806.22025630647.2 (i)52.4(ii)71.6(iii)2.3(iv)16.6(v)2.6(vi)6.3(vii)11.8 20246303.820256302.1 (i)(ii)(iii)(iv)(v)202463018.5202563024.6 202463031.9202563041.8 20242025630 2024630780.52025630449.6 2025630245.720241231759.520256301,271.02025H 20256302,604.3 202563059.7%2024123163.9% 2025630 202412312025630210.8279.7(i)(ii) 2025630 20256303,0702025630525.72024630592.3 HA H 2025529H42.4419,000,000HHHH19806.36796731H41.892025521H46.90H2025529 2025630H77.25 (1)H(RC18)20271231 (2)H2025630 A A48.0054,426,301AAA20223312,612.4106.52,505.9A2022328A 630A2,437.9 (1)2025630 (2)2024426 (3)A20261231 2025630XV352 (1)L (2)2 0 2 563 05 6 3 , 6 0 8 , 2 4 32 0 8 , 5 8 1 , 2 3 9H355,027,004A (3)2025630102,381,89118,507,3889,190,20316,630,3372,163,655A2025630568,673A31.80%68.20% 2025630RongChang Holding Group LTD.RongChang Holding Group LTD.RongChang Holding Group LTD.RongChang Holding Group LTD. 2025630I-NOVA LimitedI-NOVA Limited 2020416RongChang Holding Group LTD.I-NOVA Limited (4)20256302022A2023AH (5)20256309,900A 2025630352 20256303365% (1)L(2)2 0 2 563 05 6 3 , 6 0 8 , 2 4 32 0 8 , 5 8 1 , 2 3 9H355,027,004A(3)(3) 2025630336 H 2021323HHH (a)H H i.ii.iii.(a)(b)(c) (b)H H (c) H1% (d)H H17HHHH7,347,550HH208,581,2393.52%563,608,2431.30%HHHHHHHH (e) HHH25%25%25%25%H (f) HHHHHHH (g)H H2021323H56HHH 2025630H (1)(2)(3)H(4)202526 H 2023714HHH (a)HH(i)(ii)(iii)(a)(b)(c) (b)H H (c) 1% (d)H H17HHHH27,213,150HH208,581,23913.05%563,608,2434.83%HHHHHHHH (e) HHH25%25%25%25%H (f) HHHHHHH (g)H H2023714H710HHH 2025630H –20246 3020246 3020289 307600,000600,00024.5022.36600,000600,000 (1)(2)H 2022A 202212282022A2022A172022A (a)2022A 2022A (b)2022A 2022A (c)2022A 2022A3,580,000563,608,2430.64%2022A2,082,690563,608,2430.37% (d)2022A 2022A1% (e)2022A A12B24 (f) 36.362022A202210162022A36.36 (1)2022AA57.5763.16%(2)2022A20A51.6170.45%(3)2022A60A53.3368.18%(4)2022A120A45.4580.00% (g)2022A 2022A20221228842022A43 (1)(2)2022A(i)2022202620232026(ii)20221229(3)2022A(i)2023202720242027(ii)2023113(4)202526(5)202542 20251120256302022A 2023A 202312282023A2023A172023A (a)2023A2023A 2023A (c)2023A2023A1,783,062563,608,2430.32%2023A1,382,450563,608,2430.25% (d)