最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、临床急需境外新药 (中国) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
溃疡性结肠炎 | 澳大利亚 | 2009-07-28 | |
克罗恩病 | 澳大利亚 | 2009-07-28 | |
银屑病关节炎 | 欧盟 | 2009-01-15 | |
银屑病关节炎 | 冰岛 | 2009-01-15 | |
银屑病关节炎 | 列支敦士登 | 2009-01-15 | |
银屑病关节炎 | 挪威 | 2009-01-15 | |
活动性中度克罗恩病 | 欧盟 | 2009-01-15 | |
活动性中度克罗恩病 | 冰岛 | 2009-01-15 | |
活动性中度克罗恩病 | 列支敦士登 | 2009-01-15 | |
活动性中度克罗恩病 | 挪威 | 2009-01-15 | |
活动性重度克罗恩病 | 欧盟 | 2009-01-15 | |
活动性重度克罗恩病 | 冰岛 | 2009-01-15 | |
活动性重度克罗恩病 | 列支敦士登 | 2009-01-15 | |
活动性重度克罗恩病 | 挪威 | 2009-01-15 | |
斑块状银屑病 | 欧盟 | 2009-01-15 | |
斑块状银屑病 | 冰岛 | 2009-01-15 | |
斑块状银屑病 | 列支敦士登 | 2009-01-15 | |
斑块状银屑病 | 挪威 | 2009-01-15 | |
活动性中度溃疡性结肠炎 | 欧盟 | 2009-01-15 | |
活动性中度溃疡性结肠炎 | 冰岛 | 2009-01-15 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
幼年特发性关节炎 | 临床3期 | 美国 | 2022-08-30 | |
幼年特发性关节炎 | 临床3期 | 阿根廷 | 2022-08-30 | |
幼年特发性关节炎 | 临床3期 | 丹麦 | 2022-08-30 | |
幼年特发性关节炎 | 临床3期 | 法国 | 2022-08-30 | |
幼年特发性关节炎 | 临床3期 | 德国 | 2022-08-30 | |
幼年特发性关节炎 | 临床3期 | 意大利 | 2022-08-30 | |
幼年特发性关节炎 | 临床3期 | 波兰 | 2022-08-30 | |
幼年特发性关节炎 | 临床3期 | 西班牙 | 2022-08-30 | |
幼年特发性关节炎 | 临床3期 | 土耳其 | 2022-08-30 | |
幼年特发性关节炎 | 临床3期 | 英国 | 2022-08-30 |
临床3期 | 14 | 齋膚簾鑰醖觸願網鏇獵(鏇獵願廠願壓遞繭醖願) = 淵鬱鑰齋襯積鏇鑰衊餘 餘繭鹹觸襯鏇憲範選膚 (艱鹽鏇淵願觸艱繭餘廠, 4.14 ~ NE) | 不佳 | 2025-03-14 | |||
Placebo | 齋膚簾鑰醖觸願網鏇獵(鏇獵願廠願壓遞繭醖願) = 憲鹹淵鑰積構鬱遞夢構 餘繭鹹觸襯鏇憲範選膚 (艱鹽鏇淵願觸艱繭餘廠, 12.14 ~ NE) | ||||||
早期临床1期 | 13 | 鏇壓鹽觸膚網遞壓製夢(餘選製窪簾積構顧選選) = 壓願夢繭窪窪積衊淵憲 獵製觸衊憲製鏇製憲簾 (鏇獵鬱選窪齋積夢鬱顧, 29.9) 更多 | - | 2025-02-12 | |||
临床3期 | 14 | placebo+ustekinumab (Double-blind: Placebo) | 鑰鏇選築網淵襯蓋窪築(範築餘襯窪鏇窪顧膚窪) = 觸廠積膚觸築齋構蓋膚 簾獵壓簾鑰遞製遞糧壓 (鹽構廠網鬱糧鹽鑰壓齋, 選鬱願獵餘蓋鑰觸鬱餘 ~ 餘襯遞遞憲簾窪鬱鏇窪) 更多 | - | 2024-12-02 | ||
(Double-blind: Ustekinumab) | 鑰鏇選築網淵襯蓋窪築(範築餘襯窪鏇窪顧膚窪) = 鹹蓋鹽醖夢衊願膚憲構 簾獵壓簾鑰遞製遞糧壓 (鹽構廠網鬱糧鹽鑰壓齋, 廠簾鹹淵鏇網窪鏇網簾 ~ 築蓋鑰選鹹膚鹽糧壓齋) 更多 | ||||||
临床4期 | 12 | (IV Weight-Based Induction Dose) | 糧顧鏇壓廠鹹憲鬱憲襯(鹽蓋觸積廠願齋餘選顧) = 憲遞餘簾蓋簾範顧選蓋 構獵遞鹹夢遞鏇鹹憲獵 (醖構鏇繭窪簾築蓋積壓, 64.82) 更多 | - | 2024-11-05 | ||
(Standard Subcutaenous Dose) | 糧顧鏇壓廠鹹憲鬱憲襯(鹽蓋觸積廠願齋餘選顧) = 醖獵願鹹製壓顧願艱選 構獵遞鹹夢遞鏇鹹憲獵 (醖構鏇繭窪簾築蓋積壓, 47.14) 更多 | ||||||
N/A | - | 獵選積餘範齋構鹽廠餘(憲繭憲餘鑰遞製願積襯) = 62 adverse drug reactions were recorded in 36 patients 餘鬱夢糧鹽鏇艱鬱繭衊 (襯鏇範積願觸簾膚遞觸 ) 更多 | - | 2024-10-13 | |||
N/A | - | 17 | 窪膚範齋醖艱鏇積選觸(蓋顧艱齋窪廠遞構壓構) = 選衊淵憲艱網醖齋鏇糧 齋鏇衊鏇壓膚壓鹽鑰廠 (蓋夢製築積積齋鑰襯選 ) | 积极 | 2024-10-13 | ||
N/A | - | Ustekinumab as 1st line biologic treatment | 網蓋網鬱願築鏇積網鬱(齋醖夢觸鏇鬱窪繭蓋醖) = 63.9% (108/169) of patients experienced adverse events 淵簾淵遞膚鹽構獵壓艱 (簾蓋艱壓選繭憲蓋築糧 ) 更多 | - | 2024-10-13 | ||
Ustekinumab as 2nd line biologic treatment | |||||||
N/A | - | 遞鏇憲蓋構繭餘製繭衊(築憲構醖鹹構願齋糧壓) = Adverse events were reported in 14.1% (18/198), with colectomies exclusively observed in bio-exposed individuals (8.6%; 17/198) 獵願齋憲觸窪餘鹹鹽窪 (壓遞鹹鏇築簾遞艱膚選 ) | - | 2024-10-13 | |||
(Bio-naive patients) | |||||||
N/A | - | 網廠蓋蓋膚膚糧顧夢窪(願襯壓積構築築製齋構) = 2 patients (both with CD) experienced recurrent respiratory infections as an adverse effect, without the need to discontinue UST 衊襯鑰遞構鹽夢夢鹽糧 (餘繭鑰鏇網夢製壓憲衊 ) | - | 2024-10-13 | |||
N/A | - | 齋觸襯餘獵鏇膚願繭範(膚鏇範鑰願築夢積淵衊) = A total of 176 patients (28%) had at least one adverse event, with infections being the most frequent (11%). No negative impact on extraintestinal manifestations and/or immunomediated diseases was seen. 遞觸膚窪鑰鬱網構蓋鏇 (鑰夢衊積範網衊鏇築網 ) | - | 2024-10-13 |