荣昌生物2023 中期报告

: 9995 目 錄 202394 97927 131 118100020 公司資料 H 58 183171712–1716 H9995A688331 24840 www.remegen.com 77 161 •108 管理層討論及分析 2008(GMP)RC18愛®RC48愛® 2023630IND 管理層討論及分析 RC18愛® —(TACI)G(IgG)(Fc)BB(BLyS)(APRIL)B — o(SLE) •20197III20222022(ACR)CDE•20224(cSLE)(IND)(CDE)20236 30•FDA20198II(IND)20201FDAIIFDAIII2022III20229CDE o(LN) •20229IIINDCDE202320236 30 o(RA) III202120222023 oAIgA •IIIgA20229IgAIIICDE2023III2023630 •FDA202012IgAII30202211IgAFDAIII o(pSS) •20226pSSIIICDE202282023III2023630 管理層討論及分析 II20237RHEUMATOLOGYpSS421:1:1160 mg240mg12424160mg240mgESSDAI0.64.55[(S.D.)]–3.32.73–1.34.14MMRMESSDAI160mg24ESSDAI–4.3P0.002(SAE) pSS1224pSSESSDAI(Multidimensional Fatigue Inventory(MFI-20)) •202211pSSFDAIII o(MG) •2022II202211CDE2023III2023630•202210FDA(gMG)2023FDA(gMG)III o IgG4 —SLE —18A.08(3)RC18愛® RC48愛® —(ADC)INDADCADC2 (HER2)HER2(GC)(UC)HER2(BC) —HER2GCUCBCHER2 oUC •HER2IHC 2+IHC 3+UCIIIINMPAII202012NMPAUC20219NMPAUC20211220231 管理層討論及分析 •202363(ASCO)PD-1(la/mUC)Ib/IIla/mUC41la/mUC24%92.7%HER2IHC 1+32%PD-L12 mg/kg +3 mg/kg20221118(cORR)73.2%95%(CI): 57.1, 85.8(CR)9.8%ORR76.0%(DOR)8.2HER2 IHC 3+/2+IHC 1+ORR83.3%64.3%(DCR)90.2%95% CI, 76.9–97.3(PFS)9.295% CI:5.7–10.32(OS)63.2% •PD-1HER2UC®(MIBC)II(IND)20222NMPA •III®HER2452 oGC •PD-1PD-1HER220234CDE oBC —®HRHER2II20234CDE —Perjeta®®HER2II20234CDE —®HRHER2II20234CDE —Seagen Inc.Seagen20218Seagen2021102Seagen24 oUC Seagen2022IIHER2UC —18A.08(3)RC48愛® RC28 —RC28(VEGF)(FGF)RC28(wAMD)(DME)(DR)IwAMD2.0 mg RC28 owAMD IbRC28wAMD20211231372022938(WOC 2022)2023III oDME II20221231III 管理層討論及分析 oDR II —18A.08(3)RC28 —RC88ADCIRC88®I/II3CDE —RC108ADCc-Metc-Metc-Met202011NMPAc-MetI202212RC108FDAc-Met —RC118ADCClaudin18.2Claudin18.2E (Monomethyl Auristatin E,MMAE)(IC50)(Linker)— •20219RC118IClaudin18.2I •202212RC118FDA —RC14820237RC148ICDEIRC148(PK)IIRC148 —RC198RC198-15 (IL-15)IL-15(IL-15R)FcIL-15NKCD8+TT(NKT) •RC19820234 20237RC198ICDE —18A.08(3)RC88RC98RC108RC118RC148RC198RC218RC228 SLE20213NMPA12SLE2023630600 20216NMPA712HER2(GC)20231HER2(UC)2023630600 管理層討論及分析 —20237NMPARC48愛®®PD-1/PD-L1HER2II—20237RC148INMPA—20237RC198INMPA—20238RC28DMEIII 2023 SLEIIIIgAIISeagen 2022630348.82023630419.1 202263053.7202363055.0 2022630150.02023630350.2 2022630106.92023630168.6 管理層討論及分析 2022630449.72023630540.5 (i)53.6(ii)9.8(iii)27.3(iv)6.1(v)6.6(vi)1.6 20226305.620236304.1 (i)(ii)(iii)(iv)20226309.820236305.54.60.3 20226302.220236306.0(i)(ii) 20222023630 2022630489.12023630703.4 2023630724.1202212312,069.220236301,119.7 2023630542.8530.9530.420303 21B-415811.912 管理層討論及分析 202363026.3%2022123117.3% 630 202212312023630467.0233.3(i)(ii) 2023630 20236303,5912023630571.72022630335.3 HA H H202011988,017,500HH4,444.23,784.5 2023630H3,715.5 (1)485.85H81.83 (2)20231231 管理層討論及分析 A A48.0054,426,301AAA20223312,612.4106.52,505.9A2022328A 2023630A1,952.8 A20241231 2023630XV352 其他資料 (3)2023630102,381,89118,507,3889,190,20316,630,3372,163,655A 2023630RongChang Holding Group LTD.RongChang HoldingGroup LTD.RongChang Holding Group LTD.RongChang Holding Group LTD. 2023630I-NOVA LimitedI-NOVA Limited 2020416RongChang Holding LTD.I-NOVA Limited (4)20236302022AH 2023630352 20236 303365% 其他資料 2023630336 其他資料 H 2021323H2023714HH H H (a)H H i.ii.iii.(a)(b)(c) (b)H H (c) H (d)H H17HHHH7,347,550HH189,581,2393.88%544,263,0031.35%HHHHHHHH (e) HHH25%25%25%25%H (f) HHHHHHH (g)H H2021323HHH 其他資料 H HHH20236152023628 A 20221228AA17A (a)A A 其他資料 (b)A A (c)A A3,580,000544,263,0030.6578%A3,580,000 (d)A A1% (e)A A12B24 (f) 36.36A20221016A36.36 (1)AA57.5763.16%(2)A20A51.6170.45%(3)A60A53.3368.18%(4)A120A45.4580.00% (g)A A2022122884 A 2023112023630710,550710,5500.66% HA202212312022 202363018 其他資料 2023630 13.51B(1) 2023630 2023630 24102023630 2022 2023821 獨立審閱報告 27/F, One Taikoo Place979 King’s RoadQuarry Bay, Hong Kong Tel : +852 2846 9888Fax : +852 2868 4432www.ey.com :+852 2846 9888:+852 2868 4432 35632023630343434 2410 2023821 2023630 1. 200874202051258 中期簡明綜合財務資料附註 2023630 2. 20236303420221231 3. 20221231 171717179—1 281212— (a)12202311 3. (b)8202311 (c)1212202211202211 1220232022630 (d)12—20231120231231 中期簡明綜合財務資料附註 2023630 4. (a) 5. 中期簡明綜合財務資料附註2023630 6. 7. 20081125% 202215% 20% 202363021%8.84% 202363016.5%2023630 5025%5030%2023630 20236302022630 8. 20236302022630 中期簡明綜合財務資料附註 2023630 9. 10. 11. 中期簡明綜合財務資料附註2023630 12. 13. 14. 15. 5% 中期簡明綜合財務資料附註2023630 9 17. 18. 19. 中期簡明綜合財務資料附註2023630 20. 2023630 (a) (i)(i)(i)(i)(i)(ii)(iii) (i) (ii)201912 201912 RongChang Holding Group Ltd.I-NOVA Limited202041620171140.06% (iii) 20. (b) 中期簡明綜合財務資料附註2023630 20. 20. (d) 21. 中期簡明綜合財務資料附註 2023630 21. 21. 中期簡明綜合財務資料附註2023630 21. 22. 2023630 23. 2023821 釋義及詞彙 20201028 2023630 AA H2023714H 1.00AH %