宝济药业-B2025 年度报告

上海寶濟藥業股份有限公司Shanghai Bao Pharmaceuticals Co., Ltd. 股份代號 : 2659（於中華人民共和國成立的股份有限公司） 年 度 報 告2025 2357141537517194168173174175176177179252253 2019(i)(ii)(iii)(iv)12KJ017KJ103SJ02KJ101KJ015 BJ007 BJ009SJ04(BJ044BJ045 BJ047BJ008(i)SJ02(FSH-CTP)20258αN01®NDA(ii)KJ017NDA(iii)KJ103G(IgG)IgGIII Li Chen Li Chen 97927 2659 25831103-2 www.baopharma.com 20251210 1283 33191919 28 H 717710 18317M 2025 SJ02αN01®IgGKJ103GBMII/III100%KJ0172026 2026KJ101BJ044 •KJ017 KJ017KJ0172024KJ017(NDA)2026NDA 20251KJ017(GCP)20252KJ017(GMP)20253GCP20255FDAKJ017(DMF) (2269.HK)(2509.HK)(002252.SZ) 20251(2269.HK) 20261002252.SZ •KJ103IgG KJ103IgG(GBM)BTDKJ103IgGIgG 20258III202512III20263IIIGBM202510II20261III2026IIIGBS20254IND202511II 202510K J103G B MI IK J1033100.0%66.7%KJ1036.0100.0%75.0%KJ1033.081.2%30.6%KJ103 •SJ02® SJ02(FSH-CTP)(ART) 20258SJ02NDA20251120257300009SJ02(CSO)SJ02SJ02 •KJ101 KJ101KJ101KJ101 20252KJ101IND20257II 202512KJ101IND20263IND •KJ015HER2 KJ015HER2FabIgG1 202412KJ015IND20256I •BJ007 BJ007BJ007BJ007(DIVA) 20252IND20258BJ007I(CTR20253085)20261 •BJ009 BJ009BJ009BJ009 20255BJ009IND20259IND202512BJ009ICTR20255246 •SJ04 SJ04(hCG)SJ04SJ04SJ04 20245SJ04IND20248SJ04I20259I •BJ0442026IND•BJ045CD202026IND•BJ047CD1542026IND•BJ0082026IND (1)KJ017KJ017(2)KJ017DMF20255FDA(3)2.2(AUC)PK/PD(4)KJ103KJ103(5)SJ02SJ02(6)IgGIgG(7)20257CSOSJ0220249SJ02SJ022025411SJ022025728SJ022024(8)505(b)(2)(9)351(a) 2024250.72.51.0%2025248.2(i)36.4(ii)28.3(iii)6.7 2024107.63.02.8%2025104.6 2019(i)(ii)(iii)(iv)12KJ017KJ103SJ02®KJ101KJ015BJ007 BJ009SJ04BJ044BJ045BJ047BJ008(i) SJ02®(FSH-CTP)20258NDA(ii) KJ017NDA(iii)KJ103G(IgG)IIIIgGGBMGBS (1)KJ017KJ017(2)KJ017DMF20255FDA(3)2.2(AUC)PK/PD(4)KJ103KJ103(5)SJ02SJ02(6)IgGIgG(7)20257CSOSJ0220249SJ02SJ022025411SJ022025728SJ022024(8)505(b)(2)(9)351(a) •KJ017 KJ017KJ017 o2024KJ017NDA20251KJ017GCP20252KJ017GMP20253GCP2026NDA o(2269.HK)(2509.HK)(002252.SZ) 20261002252.SZ 20251(2269.HK) 20248 20223CD38 o20255FDAKJ017DMF(EMA)FDAKJ017INDEMAFDAIND2026INDKJ017 18A.08(3)KJ017 •KJ103IgG KJ103IgG(GBM)BTDKJ103IgGIgG o20258III202512III20263III2026NDA oGBM20261III2026III K J103G B MI IK J1033100.0%66.7%KJ1036.0100.0%75.0%KJ1033.081.2%30.6%KJ103 GBS202511II2026 oKJ103IgG2026FDAGBSIIIIND 18A.08(3)KJ103 •SJ02® SJ02(FSH-CTP)SJ02FSH-CTP SJ02SJ02FSHβCTPFSHβCFSHSJ02FSHSJ02 20258SJ02NDA202511 o20257SJ02CSOSJ02SJ02 o2026EMASJ02IND 18A.08(3)SJ02 •KJ101 KJ101KJ101KJ101 20252KJ101IND20257II2026II 202512KJ101IND20263IND2026II •BJ044 BJ044BJ044-α- 2026IND •KJ015HER2 KJ015HER2FabIgG1 202412KJ015IND20256I2026I 2026FDAKJ015IND •BJ045CD20 BJ045KJ103CD20KJ103KJ103IgGIgGBJ045 2026IND •BJ047CD154 BJ047KJ103CD154BJ047KJ103BJ047 2026IND •BJ007 BJ007BJ007BJ007DIVA 20252IND20258BJ007I(CTR20253085)202612026 •BJ008 BJ008β-BJ008 2026IND •BJ009 BJ009BJ009BJ009 20255BJ009IND20259IND202512BJ009I(CTR20255246)2026I •SJ04 SJ04(hCG)SJ04SJ04SJ04 20245SJ04IND20248SJ04I2025820259I 18A.08(3)KJ101BJ044 KJ015BJ045BJ047 BJ007 BJ008 BJ009SJ04 •AIKJ103 •(CHO) CHO CHO • (i)(ii)(iii)(iv) 20252026 (i)(ii)(iii)(iv) 2026KJ017 •KJ0172026NDAHER2KJ0152026I2026FDAIND •KJ1032026NDA2026GBMIIIGBSII2026GBSFDAIIIINDBJ045BJ047KJ103 •ARTFSH20258SJ02®SJ02FSH-CTPFSHSJ02® •2026KJ101IIKJ101IIBJ044IND GMP63,00037,0002026SJ02KJ017KJ103KJ101IIBJ044IND SJ0220258KJ0172026 (i)(ii)(iii) 2026 18A.08(3) 202412316.22025123149.2(i)40.0(ii)3.6 202412311.1202512315.4 202412317.6123.3%2025123117.0(i)5.4(ii)3.2(iii)1.5 20241231107.620251231104.6 20241231250.720251231248.2(i)36.4(ii)28.3(iii)6.7 2024123178,0002025123165.155.17.5 202420250.60.2 *10,000 202420251231 202512311,241.620241231524.2202512312024123120251231 202512311,363.220241231665.61,241.687.627.66.20.1 20251231330.720241231196.2210.5114.04.61.68,000 2025123120251210 2025123128.19%2024123126.95% 20251231312.420241231201.9114.0198.4 20251231202512312.75%3.45%202412313.10%3.75% 202512312.6202412313.4 20251231174.52024123182.0 20251231 20251231539.82024470.450.8202451.9 20251231354 1.KJ017 2026331K J017®KJ017202648 2.BJ044IND 20263BJ044IND20264 2025930603.5 0.5 61 20209202512021120215 351989719919199871999819998200112001120122134920136201962607601607 198971994719986305020054 SidneyKimmel (i)201312(ii)20212(iii)20212(iv)20217(v)20221 49 2020920251201182014720222 202001920107134920118 199862001620141220211220231202312 201312 5920212202512017720227 3519888199871993121998820098134920118201472014820208 19887 392021122023720251 20087201011201011201772017720171020171020188201882020122020122021126998) 200872024620179 4120251 2018620231020247TWO653520245TWO412320166202312023120119201111201111Lead Trend Limited202112 20086 552022820251 20081 199612199812261160121119998200211200212200712 665720201202012011620116835033 1995720119 (i)202010(ii)20207(iii)20207(iv)201012(v)200411(vi)200812(vii)20249(viii)20209 LiChen442024720251 2010620159Li6000306030Li2016220