荣昌生物2024 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 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81釋義及詞彙 97927 2One Island South121207 118100020 H 183171712-1716 58 H9995A688331 24840 www.remegen.com 77 161 •108 2008(GMP)RC18愛®RC48愛地希® 2024630IND RC18愛® (TACI)G(IgG)(Fc)BB(BLyS)(APRIL)B o(SLE) 202311NMPA2023 III o(LN) 20229IIINDCDE2023 o(RA) III202320238NMPABLA11(ACR)20247NMPA oAIgA 2023IgAIII20245III202211IgAFDAIII o(pSS) 20226pSSIIICDE202282023III20245 202312pSSIIIINDFDA20243FDAFTDpSS o(MG) 2023(gMG)III20248202211CDE202210FDA(gMG)2023FDA(gMG)IIIFTD20248oIgG420246IgG4(IgG4-RD)CDEo20247CDEo SLE 18A.08(3)RC18愛® RC48愛® (ADC)ADCADC2(HER2)HER2(GC)(UC)HER2(BC) HER2GCUCBCHER2 o(UC) HER2IHC 2+IHC 3+UCIIIINMPAII202012NMPAUC20219NMPAUC202112202311Journalof Clinical Oncology JCO202312023 PD-1HER2UC®(MIBC)II(IND)20222NMPA 20246(ASCO)PD-1HER2(MIBC)II4731(pCR)61.3%(19/31)(pPR)74.2%(23/31) III®HER220248 o(GC) HER2II/IIIIND20234NMPA 20246S-1HER2II2024ASCO53(ORR)94.3%(DCR)98.1%1(PFS)71.8%1(OS)97.6% o(BC) HER2III o ®HER2IIIND202310NMPA20243HER2II2024(European Society of Gynaecological Oncology, ESGO)52024HER22B SeagenInc.Seagen20218Seagen2021102Seagen24Pfizer Inc.PfizerSeagenPfizer/Seagen oUC Seagen2022IIHER2UC 18A.08(3)RC48愛® RC28-E RC28-E(VEGF)(FGF)RC28-E(wAMD)(DME)(DR)IwAMD2.0mg RC28-E o(wAMD) IbRC28-EwAMD20211231372022938(WOC2022)2023III 2024720RC28-E(wAMD)IbOphthalmologyand TherapyRC28-E0.5mg~2.0mgwAMD(AE)(16.2%)48RC28-E0.5mg1.0mg2.0mg(BCVA)(CST)146%(PCV)73%VEGFRC28-E o(DME)2023III2024630o(DR)II 18A.08(3)RC28-E RC88ADCRC88®I/IIIND20233NMPARC88(PROC)II202312CDE RC14820237RC148PD-1/VEGF)ICDEIRC148(PK)II20239 RC198RC198-15(IL-15)IL-15α(IL-15Rα)FcIL-15NKCD8+TT(NKT)20237RC198ICDE RC248RC248DR5ADCI2024630 RC278RC278ADC 18A.08(3)RC88RC148RC198 RC248RC278 SLE20213NMPA12SLE20232024630900 20216NMPA72021HER2(GC)20231HER2(UC)2024630700 20247NMPA(RA) 20247CDE20247RC28-E(wAMD)IbOphthalmology and Therapy 20248(gMG)III20248(gMG)III20248PD-1III 2024 SLEIIIIIIPfizer/Seagen 2023630419.12024630739.7 202363055.0202463054.4 2023630350.22024630389.7 2023630168.62024630155.2 2023630540.52024630806.2 (i)33.5(ii)62.2(iii)120.2(iv)13.6(v)10.6(vi)6.8(vii)18.87.0 20236304.120246303.8 (i)(ii)(iii)(iv)20236305.5202463018.5(i)6.5(ii)6.5 20236306.0202463031.9(i)(ii) 20232024630 2023630703.42024630780.5 2024630826.320231231726.62024630673.3 20246302,274.5 202463053.7%2023123137.8% 202312312024630201.9101.4(i)(ii) 2024630 20246303,4972024630592.32023630571.7 HA H H202011988,017,500HH4,444.23,784.5 2024630H (1)485.85H81.83 A A48.0054,426,301AAA20223312,612.4106.52,505.9A2022328A 630A2,405.66 (1)2024630 (2)2024426 (3)A20241231 2024630XV352 (1)L (2)2 0 2 463 05 4 4 , 3 3 2 , 0 8 31 8 9 , 5 8 1 , 2 3 9H354,750,844A (3)2024630102,381,89118,507,3889,190,20316,630,3372,163,655A2024630199,451A31.80%68.20% 2024630RongChang Holding Group LTD.RongChang Holding Group LTD.RongChang Holding Group LTD.RongChang Holding Group LTD. 2024630I-NOVA LimitedI-NOVA Limited 2020416RongChangHolding LTD.I-NOVALimited (4)20246302022AH (5)20246306,600A 2024630352 20246303365% (1)L(2)2 0 2 463 05 4 4 , 3 3 2 , 0 8 31 8 9 , 5 8 1 , 2 3 9H354,750,844A(3)(3) 2024630336 H 2021323HHH (a)H H i.ii.iii.(a)(b)(c) (b)H H (c) H (d)H H17HHHH7,347,550HH189,581,2393.88%544,332,0831.35%HHHHHHHH (e) HHH25%25%25%25%H (f) HHHHHHH (g)H H2021323HHH H (1)H(2)(3)H H 2023714HHH (a)HH(i)(ii)(iii)(a)(b)(c) (b)H H (c) 1% (d)H H17HHHH27,213,150HH189,581,23914.35%544,332,0835.00%HHHHHHHH (e) HHH25%25%25%25%H (f) HHHHHHH (g)H H2023714HHH H 2024112024630(1) –20246 3020246 3020289 3090750,000000750,000024.5022.360750,000000750,000 (1)(2)H 2022A 202212282022A2022A172022A (a)2022A 2022A (b)2022A 2022A (c)2022A 2022A3,580,000544,332,0830.66%2022A3,132,880544,332,0830.58% (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 2022A2022122884 (1)(2)2022A(i)2022202620232026(ii)20221229(3)2022A(i)2023202720242027(ii)2023113 20241120246302022A 2023A 202312282023A2023A172023A (a)2023A2023A 2023A (c)2023A2023A1,783,062544,332,0830.33%2023A1,773,062544,332,0830.33% (d)2023A2023A1% (e)2023A24 (f) 49.772023A202311172023A49.77 a.2023AA63.6778%b.2023A20A64.6577%c.2023A60A62.2080%d.2023A120A62.7979% (g)2023A 2023A2023122884 2023A 2024112024630(1) 20231228202312 28202912 2779,450000079,45049.7760.7472.73220231228202312 28202912 27100,0000000100,00049.7760.7472.732 20231228202312 28202912 271,253,0000010,00001,243,00049.7760.7472.732 (2)2023A(i)20242027(ii)20231229 20246302023A350,612350,612 0.85% HA202312312023 202463018 2024630 13.51B(1) 2024630 2024630 24102024630 2023 2024816 Ernst & Young27/F, One Taikoo Place979 King’s RoadQuarry Bay, Hong Kong
