非在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)- |
特殊审评优先审评 (美国)、突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (韩国)、儿科研究计划 (欧盟) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11530 | Sutimlimab | - |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 溶血性贫血 | 欧盟 | 2022-11-15 | |
| 溶血性贫血 | 冰岛 | 2022-11-15 | |
| 溶血性贫血 | 列支敦士登 | 2022-11-15 | |
| 溶血性贫血 | 挪威 | 2022-11-15 | |
| 冷凝集素病 | 美国 | 2022-02-04 | |
| 溶血 | 美国 | 2022-02-04 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 免疫性血小板减少症 | 临床1期 | 美国 | 2017-08-14 | |
| 免疫性血小板减少症 | 临床1期 | 德国 | 2017-08-14 | |
| 免疫性血小板减少症 | 临床1期 | 英国 | 2017-08-14 | |
| 补体紊乱 | 临床1期 | 奥地利 | 2015-07-13 | |
| 终末期肾脏病 | 临床1期 | 奥地利 | 2015-07-13 | |
| 大疱性类天疱疮 | 临床1期 | 奥地利 | 2015-07-13 |
临床3期 | 25 | 鑰憲壓顧鹽顧衊蓋齋願(餘鹽夢醖衊憲鑰製夢餘) = At the last follow up only one patient had died due to progressive WM with sepsis 蓋艱築構構範鹽糧願選 (簾積鹽膚醖蓋壓淵鹽網 ) 更多 | 积极 | 2025-05-14 | |||
临床3期 | - | (Mild Anemia (≥10 g/dL)) | 餘餘醖襯製艱鹹衊壓壓(構蓋壓壓淵積鹹鏇蓋選) = 襯醖壓遞構壓觸鑰鏇網 繭範願膚鏇網築衊製鬱 (鬱襯淵淵顧鹹顧範獵觸, 1.55) 更多 | 积极 | 2024-05-14 | ||
(Moderate Anemia (≥8 - <10 g/dL)) | 餘餘醖襯製艱鹹衊壓壓(構蓋壓壓淵積鹹鏇蓋選) = 鏇膚窪鏇廠顧觸積繭壓 繭範願膚鏇網築衊製鬱 (鬱襯淵淵顧鹹顧範獵觸, 1.53) 更多 | ||||||
临床3期 | 22 | 夢壓蓋衊膚獵構艱積願(顧齋憲廠鬱餘窪夢窪鏇) = 製襯餘繭壓齋廠簾鏇築 壓積鏇選窪鬱窪獵構膚 (積壓餘廠廠網簾製憲鹽, 5.6) 更多 | 积极 | 2023-10-10 | |||
临床3期 | 7 | 鏇壓觸壓築壓糧鹹窪選 = 簾蓋築膚網網鬱鏇醖簾 糧糧獵繭衊遞艱膚壓構 (積蓋鹽範壓窪選餘築艱, 積繭鹽網選糧繭鑰夢網 ~ 餘淵鹹淵積廠壓憲遞鑰) 更多 | - | 2023-10-03 | |||
临床3期 | 66 | PRE-sutimlimab | 鑰夢鑰選構觸選觸鬱網(繭艱製構餘夢廠淵願餘) = 淵艱鹽鏇衊鹽廠蓋繭艱 構鏇襯構鹹夢鏇壓襯遞 (積餘膚憲憲遞蓋鏇廠觸 ) | - | 2023-06-24 | ||
ON-sutimlimab | 鑰夢鑰選構觸選觸鬱網(繭艱製構餘夢廠淵願餘) = 積艱獵夢範觸餘壓遞鏇 構鏇襯構鹹夢鏇壓襯遞 (積餘膚憲憲遞蓋鏇廠觸 ) | ||||||
临床3期 | 39 | 網鹹襯鹽蓋顧選顧壓衊(製網觸遞願艱衊網醖餘) = Thromboembolic events were observed in 2 (5.1%) pts (transient ischemic attack [n=1]; deep vein thrombosis [n=1]); both events occurred in pts with underlying risk factors for thromboembolism and were assessed as non-serious and unrelated to SUT by the Investigator. 觸糧鹽築鬱鹽襯築憲艱 (夢窪齋獵餘鏇鏇製獵壓 ) 更多 | - | 2023-06-08 | |||
Placebo | |||||||
临床3期 | 42 | 鏇壓鑰範構範鹽繭繭選(廠範範簾鏇壓餘網構網) = Raynaud¡¯s phenomenon (1 [2.6%] pts) 積製廠顧憲製蓋夢壓糧 (艱窪範鑰遞夢獵遞鏇蓋 ) 更多 | - | 2023-06-08 | |||
Placebo | |||||||
临床3期 | 22 | 築選網醖積齋遞襯廠願(醖鹹鹽淵繭範鏇獵窪簾) = After cessation of sutimlimab, most patients reported adverse events consistent with recurrence of CAD. 選襯簾艱觸繭積獵積選 (壓醖醖遞網齋願蓋顧顧 ) 更多 | - | 2023-05-29 | |||
临床3期 | 42 | (BIVV009/BIVV009) | 願艱願淵觸範繭壓餘窪(壓築築憲鹹衊蓋廠蓋膚) = 顧製選繭觸構積淵夢顧 鑰鏇壓繭鬱選艱廠觸獵 (鑰夢繭夢顧壓鏇夢夢鑰, 1.348) 更多 | - | 2022-12-23 | ||
placebo+sutimlimab (BIVV009) (Placebo/BIVV009) | 願艱願淵觸範繭壓餘窪(壓築築憲鹹衊蓋廠蓋膚) = 鹽衊鏇鑰憲鹽鹹壓窪積 鑰鏇壓繭鬱選艱廠觸獵 (鑰夢繭夢顧壓鏇夢夢鑰, 1.545) 更多 | ||||||
临床3期 | 24 | 齋觸繭膚壓鑰繭範網繭 = 獵壓鏇製範淵願憲壓鑰 糧願鹹鏇糧製鏇鹹襯壓 (鹽顧衊廠鬱糧餘築窪獵, 願顧衊遞積憲製壓憲構 ~ 積簾窪觸鏇範憲願窪積) 更多 | - | 2022-10-31 |






