AI智能总结
2024 246935548789117123125127128130212213 20241210 108 215 15323203-3207 329 16 293-10 H 1617 2920 90711310 2509 www.qyuns.net 33191912 2024202420243 20202410®QX001S® ®QX001SPs20241020253PsQX005N(PN)20241(BTD)20253IIIQX002N(AS)III20252c-kitQX013N20245IND9Ia 20241QX008N(COPD)II20244QX004N20247QX005NBD GMPCDMO23.0CDMOBD2024BD130.0 20232024158.847.6%38.1% 20241231158.8(i)QX008NQX004N100.9(ii)QX008NQX004NCDMO55.7(iii)QX001S2.1CDMO20242023CDMO202312.111.7202423.8CDMO 2024123166.6(i)QX004NQX008N(ii)CDMOCDMO2024 2023364.48.3%2024334.3(i)QX004NQX008N26.3(ii)15.519.1 (1) 2015QX002NQX005NQX002NIL-17A20252QX002N(AS)IIIQX005NIL-4RmAbQX005N(AD)III2025319QX005N(PN)IIIIL-12/IL-23p40QX001SPs202410® 20241231 •QX008N 20241QX008N •QX004N 20244QX004N75.01,032.0 •QX005N 20247QX005NIII50/50 (1)QX002NASIII20252(2)QX005NPNIIIQX005NADIII20245FPI2025319QX005NPNIII2025320(3)QX005NADIb/IIa20246FPI(4)20208QX001SQX001SQX001S20241029®202533QX001S202533(5)20248II20253(AAD)QX004NIIhttp://www.chinadrugtrials.org.cn/QX004NIIICTR20250602(6)QX004NCDIa(7)QX006NSLEIb(8)20244QX004NQX004N(9)20241QX008NBLAQX008NMAHQX008NCOPDII(10)QX013NCSUIa20249LPICSR(11)20247QX005N20247212024927 QX005N QX005NIL-4IL-4RIL-4RIL-4RIL-4IL-13IL-4IL-132QX005NAD12-17ADPN CRSwNP CSUCOPD7IND 2024510QX005NADIIIQX005NADIb/IIa20246 QX005NPNIIQX005N20241(BTD)QX005NBTD20245 29QX005NPNIIIPNIII2025319QX005NPNIII409202452920246142025320 20252QX005NCRSwNPII 20247QX005NIII50/50 QX002N QX002NIL-17AIL-17AIL-17AASTNFTNFIL-17AIL-17ATNF-TNF- QX002NASIII20249641QX002N3223192025224160mg QX002NQ4W16ASAS4040.4%18.9%P0.0001QX002NASAS2065.2%41.3%P0.00012025224 18A.08(3) QX001S QX001S®2024102009FDAIL-23IL-12Ps20242024Stelara®103.61752.2120232024®13.227.39 QX001S20237BLA2023820241029QX001S20241222025212202533QX001S202533QX001SPs QX004N PsCDIL-23p19QX004NIL-23p19Ps 20248(IDMC)28II20248202412QX004NIJAMA Dermatology20253(AAD)QX004NIIIIQX004NHS-20137281676.9%(PASI)≥90%2489.7% 20232QX004NCDIa20245Ia 20244QX004NQX004N75.01,032.0 QX008N QX008NTSLPIgG1COPDTSLP2 20251QX008NIb20241QX008NQX008NBLAQX008NMAHQX008NQX008NCOPDIIJKN24011 QX013N QX013Nc-kitIIIIgG1CSUC-kitCSUQX013Nc-kitCSU 202459QX013NCSUQX013Nc-kitQX013NCSUCSUQX013NCSUIa20249LPI CSR QX006N QX006NIFNAR1SLESLEIFNAR1SAPHNELO®2021FDA2011SLE QX006NSLEIb202410Ib QX007N QX007NIL-33IL-1IgG1QX007NCOPD20242QX007NCOPDIND (i)mAb(ii)(iii)(iv)(v)(vi)20241231920IND19FDA 1CRO2024123112559% 20241231334.3 cGMP202411QX001SGMP57,97742,000L300kg2ml10ml30ml18,0001ml2ml9,000cGMP 202412315040101047QX002NQX005N20241231932120241231 20241231339 20241231168.820231231222.4 20241231 ••CMC••• 20241231 20241231158.8(i)QX008NQX004N100.9(ii)QX008NQX004NCDMO55.7(iii)QX001S2.1CDMO20242023CDMO202312.111.7202423.8CDMO 2024123166.6(i)QX004NQX008N(ii)CDMOCDMO2024 202324.915.63%202428.83.13.31.5 20243.73.9 2023164.62024115.940.4 2023364.48.3%2024334.3(i)QX004NQX008N26.3(ii)15.519.1 202316.839.3%202423.4 (1) 20231231376.747.6%20241231556.1196.5QX005NQX008NQX004N162.0 20231231166.620241231186.6196.5QX005NQX008NQX004N162.0 20231231242.937.0%20241231332.723 202412318.8QX001SCDMO 2023123126.595.8%2024123151.8QX004NQX008N22.5 20231231129.920241231208.8(i)37.9QX005N2024III(ii)48.945.0 QX001SQX008NQX004NQX005N 2024123123114.9202350.0 20241231161.7 2024123120231231300.7114.6186.1(i)QX008NQX004NQX008NQX004N117.0(ii)45.0 2024123125.220231231243.12024 202412312023123161.2290.6351.8196.5 202320241231344.1525.720241231200.0202359.6202412313.0%3.8%20233.3%4.2%60.0 12100% 202312311.7202412311.4QX002NQX005NIII 2023123142.5%2024123174.7% 202472024 2024123199.5% 20241231 202412315% 20241122 20241231 20241231 542015652023323201562024102021920222 (i)20181202132018820233(ii)20187 301993720041(i)11hIL-1111(ii)2004220056(i)(ii) 20051220151(i)2005720151(ii)2007820151(iii)2008720151(i)2(ii)(iii)B(RANKL)(iv)20096 1993720056200520062 442019410202332320156202412 15201562015620191QX001SCMC2019220232QX002NQX005N QX004N QX006NQX008N2019320232QX001S2000L20233202412 2007720153(i)2008720105(ii)2010520155500L 2003720069201312 432022316202332320218202182021920219 15200410200562005112009122010(i)2010520125Arkema S.A.AKE(ii)20131220156Imerys S.A.NK(iii)20162201610(iv)20161120183(v)2018920193(vi)2019620201202142 200472016620132 5220208142023323 JNJSanofi S.A.SANSYN20189201912202011000963 19977 (i)B+QX001S202058202011B+QX001S (ii) (iii) (iv) 4420219172023323 152007122010660137720115201711(i)2012120125201511201612(ii)2013520187(iii)2015112016122019920148202122024520246 20046 61202414 3319847198791990819927199271995919987200522005220211120059202111 198471990819987200920132 57202414 241994819999200420112011420231 198871994720043202012 56202414 301992819999•199910200782008120108391820111202212(i)20111201472098(ii)20147201740295(iii)201752022123718 20174(i)2017420238GEM8452(ii)201762021101695(iii)2020103913(iv)2021110672(v)202392576(vi)2023102473(vii)2023102419 199210200110(ACCA)20059 532021917 20