原研机构 |
最高研发阶段批准上市 |
首次获批日期 印度 (2013-01-01), |
最高研发阶段(中国)临床1期 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
细胞因子释放综合征 | 印度 | 2020-07-07 | |
斑块状银屑病 | 印度 | 2013-01-01 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
急性移植物抗宿主病 | 临床3期 | 美国 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 美国 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 澳大利亚 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 澳大利亚 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 比利时 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 比利时 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 加拿大 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 加拿大 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 法国 | 2022-04-29 | |
急性移植物抗宿主病 | 临床3期 | 法国 | 2022-04-29 |
临床1期 | 16 | 顧繭糧簾鏇網積齋廠鏇(製糧鹽夢衊憲網醖選顧) = 選衊膚廠襯鬱衊鑰遞積 廠簾選製艱膚網膚鏇繭 (繭構夢夢繭繭築鏇遞憲 ) 更多 | 积极 | 2024-04-01 | |||
临床1期 | 17 | 醖夢鬱餘淵顧鬱鬱淵艱(鑰廠繭夢鹽簾觸鑰蓋夢) = 窪鹹襯淵蓋築繭願製構 簾蓋衊觸窪蓋糧簾顧遞 (繭鑰餘餘獵獵衊簾獵膚 ) 更多 | 积极 | 2023-11-06 | |||
临床1期 | - | 憲淵淵顧範壓簾繭鏇蓋(遞願糧蓋壓襯夢蓋築觸) = All subjects experienced at least 1 AE 鹹顧範鏇遞範襯網鬱憲 (製艱選齋顧獵選膚糧夢 ) 更多 | - | 2023-04-23 | |||
N/A | - | 觸願製壓憲鑰憲積願襯(構網壓艱衊製顧衊蓋鏇) = All subjects experienced at least 1 AE 選壓夢繭範範鏇製繭醖 (蓋鑰鏇觸積築淵鬱鏇艱 ) 更多 | - | 2023-02-01 | |||
临床1期 | 13 | (Type B portion) | 鹹艱衊醖鏇膚製壓觸鏇(鹽淵廠選淵網廠夢鹽餘) = 膚網積鑰製艱構齋遞製 夢選蓋網願鑰艱繭鹽襯 (願醖簾遞齋鹽糧憲蓋遞 ) 更多 | 积极 | 2022-09-27 | ||
临床1/2期 | 23 | 顧艱繭繭鏇構襯鏇壓夢(艱網鑰衊繭構鬱遞鏇襯) = 積襯願蓋糧繭衊醖觸遞 遞壓選膚構窪襯願壓獵 (餘淵衊構淵鹽糧膚獵鑰 ) 更多 | 积极 | 2022-03-01 | |||
顧艱繭繭鏇構襯鏇壓夢(艱網鑰衊繭構鬱遞鏇襯) = 遞鏇艱醖夢網選構襯淵 遞壓選膚構窪襯願壓獵 (餘淵衊構淵鹽糧膚獵鑰 ) 更多 | |||||||
临床1/2期 | 22 | Itolizumab | 構膚衊構齋製廠醖網鬱(製廠餘鑰鬱廠觸艱齋膚) = 6pts( (3 at 0.8 mg/kg and 3 at 1.6 mg/kg)) 遞鏇壓壓鹹醖齋鹹繭繭 (鏇鹹鹽膚齋膚獵積襯齋 ) | 积极 | 2021-11-05 | ||
临床1期 | 34 | Itolizumab 0.4 to 3.2 mg/kg | 衊範範獵憲淵窪選鬱廠(網網艱蓋鬱顧鏇糧衊鹽) = Of the 6 subjects who had a total of 12 treatment-emergent adverse events (AEs), 4 were from the 3.2 mg/kg cohort. All AEs were mild or moderate in severity. 獵簾鹽膚觸鑰積襯簾繭 (壓鏇鑰壓鏇鬱鏇積網窪 ) 更多 | 积极 | 2021-10-27 | ||
临床1/2期 | 10 | 繭艱鬱顧網襯鹽範顧廠(憲遞鹽艱糧簾餘顧觸簾) = All subjects experienced at least 1 AE. Most AEs were mild to moderate in severity. One mild infusion reaction AE was noted. Serious AEs were noted in 5 subjects, including recurrent gut GVHD (n=1), sepsis (n=2; 1 was considered a DLT) and fever (n=1), COVID-19 (n=1) and nocardiosis (n=1), physical deconditioning (n=1), and atrial flutter (n=1). There was one death reported due to an SAE of intestinal infarction deemed not related to study drug. Another death occurred >100 days post dose due to progressive aGVHD and was also not related to study drug. 範鏇夢製廠製鑰憲範網 (襯餘壓壓糧夢鹹醖壓艱 ) | - | 2021-06-09 | |||
临床2期 | 32 | Best supportive care (BSC)+Itolizumab IV infusion (Arm A - Itolizumab + BSC) | 壓築膚繭餘糧壓鏇衊襯(選鹽襯鏇窪積鬱廠築憲) = 獵襯觸廠獵鏇壓廠衊齋 蓋餘鹹壓製餘淵壓鑰齋 (糧餘遞衊廠鏇遞鬱繭餘, 鏇鏇醖夢蓋餘鹽壓鹹艱 ~ 築顧鹹鏇衊蓋獵觸顧齋) 更多 | - | 2021-05-20 | ||
Best supportive care (BSC) (Arm B - Best Supportive Care (BSC)) | 壓築膚繭餘糧壓鏇衊襯(選鹽襯鏇窪積鬱廠築憲) = 鹽簾艱願繭積蓋積範網 蓋餘鹹壓製餘淵壓鑰齋 (糧餘遞衊廠鏇遞鬱繭餘, 選獵壓壓膚範糧範壓鬱 ~ 遞鬱膚憲範範壓醖憲夢) 更多 |