荣昌生物2023 年度报告

(於中華人民共和國註冊成立的股份有限公司)股份代號: 9995 24621284581878889919395186187 2023928202394 97927 131 118100020 H 58 183171712-1716 H9995A688331 24840 www.remegen.com 77 161 •108 20231231 2008 2023 202112(SLE)2023202312317002,30020232024 2023IgAIII2023III 202112(GC)2022HER2(UC)2023202312316002,00020232024 HER2IIIHER2IIHER2IIHER2II2024Pfizer/Seagen ADCRC88ADC 20232024 2024327 2008(GMP)(RC18愛®)(RC48愛®) 20231231 20231231 (RC18愛®) (TACI)G(IgG)(Fc)BB(BLyS)(APRIL)B o(SLE) •20197III20222022(ACR)2023NMPA202311NMPA202212023202312IIbAnnals of The RheumaticDiseases, ARD) •2022III20229CDE o(RA) III202320238NMPABLA11ACR 160mg(MTX)RA47924ACR20ACR50ACR70ACRDAS28-ESR24mTSS IIIMTX 24ACR2060.0%vs 26.9%P0.00124ACR5021.4%vs 5.9%P0.001DAS28-ESRACR24mTSS≤090.2%vs 66.4%P0.001mTSS24 (TEAEs)(SAEs)TEAEs oAIgA •II20229IgAIIICDE2023III •202211IgAFDAIII o(pSS) •20226pSSIIICDE202282023III pSSII20237RHEUMATOLOGY 202312pSSIIIINDFDA o(MG) •2022II202211CDE2023III20231231 •202210FDA(gMG)2023FDA(gMG)IIIFTD o 18A.08(3)(RC18愛®) (RC48愛®) (ADC)ADCADC2(HER2)HER2(GC)(UC)HER2(BC) o(UC) •HER2IHC 2+IHC3+UCIIIINMPAII202012NMPAUC20219NMPAUC202112202311Journal of Clinical OncologyJCO202312023 •PD-1HER2UC®(MIBC)IIIND20222NMPA•III®HER2 o(GC) •PD-1PD-1HER2IND20234NMPA•®HER2IIIND202310NMPA•開®HER2II/IIIIND202312NMPA o(BC) •®HRHER2IIIND20234CDE•Perjeta®®HER2IIIND20234CDE•®HRHER2IIIND20234CDE o •®HER2IIIND202310NMPA SeagenInc.Seagen20218Seagen2021102Seagen24Pfizer Inc.PfizerSeagenPfizer/Seagen 18A.08(3)(RC48愛®) RC28–E RC28–E(VEGF)(FGF)RC28-E(wAMD)(DME)(DR)IwAMD2.0mg RC28-E o(wAMD) IbRC28-EwAMD20211231372022938(WOC 2022)2023III o(DME) 2023III II 18A.08(3)RC28-E RC88ADCIRC88®I/IIIND20233NMPA202312RC88IIINDFDA RC118Claudin18.2ADCClaudin18.2Claudin18.2E(Monomethyl Auristatin E, MMAE)(Linker) •2 0 2 19R C 1 1 8IClaudin18.2I •202212RC118FDA RC14820237RC148PD-1/VEGF)ICDEIRC148(PK)II20239 RC198RC198-15 (IL-15)IL-15α(IL-15Rα)FcIL-15NKCD8+TT(NKT) •RC19820234 •20237RC198IINDCDE RC248RC248DR5ADCI20231231 18A.08(3)RC88RC118RC148 RC198RC248 SLE20213NMPA12SLE202320231231800 20216NMPA72021HER2(GC)20231HER2(UC)202320231231650 20241RC88FDAFTD 20241HER2(GC/GEJ)I(TheLancet)eClinicalMedicine 20243HER2II2024European Society of Gynaecological Oncology, ESGO 20243FDAFTDpSS 2024 SLEIIIIIIPfizer/Seagen 2022767.820231,076.1 2022232.52023110.675.633.410.42.5 2022440.72023775.2 2022272.52023313.7 2022982.120231,306.3 (v)14.3 2022123111.12023123111.3 (i)(ii)(iii)(iv)202216.0202315.2 20226.8202323.1(i)(ii)(iii) 202220231231 2022998.820231,511.2 202312311,501.8202212312,069.220231231726.6 202312311,126.9 2023123137.8%2022123117.3% 1231 202220231231467.0201.9 20231231 202312313,61520231,152.32022810.7 HA H H202011988,017,500HH4,444.23,784.5 20231231H3,741.30 (1)485.85H81.83 (2)2024630 A A48.0054,426,301AAA20223312,612.4106.52,505.9A2022328A 1231A2,368.16 120231231 (2)A20241231 6420131030202052220196211993327 19827 202312019720202201920202 61200810162020522CMC20RemeGen Biosciences, Inc. 19985DalhousieUniversity19972000 20103201212conbercept40 6220205112020522202051133FDA2020181020167201810199920161996619996Howard University Hospital and Affiliated Hospitals19883199661986719883 198381986719976HowardUniversity1999201520192688266 20129Serotonin(5-HT)ReceptorAgainstClass-AC2013710FDA20149(leveraging collaboration award)2015525 682008742020522352008720196RemeGen Biosciences, Inc. 19821 5320205112020522262012122012112014122020220191020198 201911UnitedBusiness Institute201962019570•2018220172015112015 372020511202052262015920171115 20087201452014620153(Hospital for Special Surgery) 382022552009620101220103201210202162020820159201572016122520141201569832012420141201210201412010820124Gibson Dunn & Crutcher 582020511202052219200910 201992020700250920085201442018620216000977300074 198971996719956200012 652021611990199119931993199520031120087201911 50202051123201952520176201942014220175 19966 4120205119201612 2006720117 492020511152011720195 1997720061220116 13.51(2)13.51B(1) 13.51(2)13.51B(1) 5720205111620042201952019111990619955 532023928 212019620221299696884282013720195UBS AG2008520135Bank of America MerrillLynch2001620084Mehta Partners 199371996820015 20205112018 20142017 20231231 20231231 202312313.10(1)(2)3.10A C.2.1 2023692022 3.133.13 40406060 22%56%2023 1291338912913389 20231231 20231231 20231231 (1) (2) C.5.1C.5.314 20231231 •••••• 20231231 E.1.520231231 10%50%(i)(ii) •••••C1 20231231 3.21C1D.33.10(2)3.21(i)(ii)(iii)(iv)(v)(vi)(vii)(viii) 202312317 •20221231•2023630•• 3.25E.1(i)(ii)(iii)(iv)(v)(vi)(vii)E.1.2(c) 202312316 • ••• 3.27AB.3(i)(ii)(iii)(iv)(v)(vi) 3033 202312314 ••• (i)(ii)(iii)(iv)(v)(vi) 20231231 20231231 •(i)(ii)(iii)(iv)(v) •(i)(ii)(iii)(iv)(v) •(i)(ii)(iii)(iv)(v)(vi) 571 20231231818620231231 2023 20233.291527 10%10 5 1010% 5 9010% 3%10 58 www.remegen.com (ir@remegen.com) 202312720231212 20231