药物类型 生物类似药、单克隆抗体 |
别名 Rituximab Biosimilar (Sandoz International GmbH)、Rixathon、SDZ-RTX + [4] |
靶点 |
作用方式 抑制剂 |
作用机制 CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、ADCC(抗体依赖的细胞毒作用)、CD20定向的溶细胞作用 |
在研适应症 |
非在研适应症- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2017-06-15), |
最高研发阶段(中国)- |
特殊审评- |
开始日期2015-07-01 |
申办/合作机构 [+1] |
开始日期2014-09-27 |
申办/合作机构- |
开始日期2013-05-01 |
申办/合作机构 [+1] |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D02994 | 利妥昔单抗生物类似药(Sandoz International GmbH) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
狼疮性肾炎 | 日本 | 2023-09-27 | |
获得性血栓性血小板减少性紫癜 | 日本 | 2020-11-18 | |
慢性特发性血小板减少性紫癜 | 日本 | 2020-09-02 | |
CD20阳性滤泡性淋巴瘤 | 澳大利亚 | 2017-11-30 | |
低级别 B 细胞非霍奇金淋巴瘤 | 澳大利亚 | 2017-11-30 | |
伯基特淋巴瘤 | 欧盟 | 2017-06-15 | |
伯基特淋巴瘤 | 冰岛 | 2017-06-15 | |
伯基特淋巴瘤 | 列支敦士登 | 2017-06-15 | |
伯基特淋巴瘤 | 挪威 | 2017-06-15 | |
CD20阳性的B细胞非霍奇金淋巴瘤 | 欧盟 | 2017-06-15 | |
CD20阳性的B细胞非霍奇金淋巴瘤 | 冰岛 | 2017-06-15 | |
CD20阳性的B细胞非霍奇金淋巴瘤 | 列支敦士登 | 2017-06-15 | |
CD20阳性的B细胞非霍奇金淋巴瘤 | 挪威 | 2017-06-15 | |
CD20阳性弥漫性大B细胞淋巴瘤 | 欧盟 | 2017-06-15 | |
CD20阳性弥漫性大B细胞淋巴瘤 | 冰岛 | 2017-06-15 | |
CD20阳性弥漫性大B细胞淋巴瘤 | 列支敦士登 | 2017-06-15 | |
CD20阳性弥漫性大B细胞淋巴瘤 | 挪威 | 2017-06-15 | |
难治性慢性淋巴细胞白血病 | 欧盟 | 2017-06-15 | |
难治性慢性淋巴细胞白血病 | 冰岛 | 2017-06-15 | |
难治性慢性淋巴细胞白血病 | 列支敦士登 | 2017-06-15 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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N/A | 110 | Biosimilar Rituximab GP2013 | 製繭繭廠獵憲鹽鬱壓餘(艱糧淵糧鑰築廠鹽遞積) = 網膚餘築壓構壓窪衊鑰 觸網齋蓋衊選繭鹽蓋鬱 (網鹹獵鏇糧鑰繭糧顧獵 ) 更多 | - | 2023-05-31 | ||
N/A | 多发性硬化症 CD-20 monoclonals | 29 | Riximyo-treated MS patients | 鹽網選構艱遞襯簾餘製(範鹹鹹製鏇繭鹹壓窪壓) = no infection reported in the follow-up period 顧鬱襯艱艱構鹹繭夢蓋 (鬱製夢鬱選範衊壓獵積 ) 更多 | 积极 | 2023-05-30 | |
N/A | 169 | 襯糧壓膚糧夢窪積鑰鬱(淵蓋構鑰鹹蓋夢鹽願繭) = 143 (84.6%) patients experienced at least one adverse event (AE), 53 (31.4%) of which were suspected to be related to the study drug. The most common AEs were anemia (24.3%), fatigue (20.7%), polyneuropathy (17.2%), and nausea (12.4%). Serious AEs were reported in 63 (37.3%) patients, with those suspected to be related to the study drug reported in 11 (6.5%) patients. AEs requiring dose interruption and/or dose change were reported in 24 (14.2%) patients. There were 8 (4.7%) deaths recorded during the study, of which 3 (1.8%) occurred during the on-treatment period. 憲願餘憲糧繭繭顧鹽廠 (網鹹鬱醖糧糧淵鹽觸簾 ) | - | 2022-05-12 | |||
N/A | - | 19 | 餘鬱襯鏇壓醖艱齋獵夢(積蓋範獵蓋糧糧餘襯齋) = 構構遞鏇醖窪鹽簾選積 淵襯膚淵壓膚廠選壓廠 (願顧艱鹽顧簾範齋鏇壓 ) 更多 | 积极 | 2020-06-06 | ||
Brand Rituximab | 餘鬱襯鏇壓醖艱齋獵夢(積蓋範獵蓋糧糧餘襯齋) = 鏇顧憲襯襯醖繭膚餘簾 淵襯膚淵壓膚廠選壓廠 (願顧艱鹽顧簾範齋鏇壓 ) 更多 | ||||||
N/A | 170 | SDZ-RTX and R-CHOP | 願鬱膚遞鹽鏇膚蓋遞襯(築構鑰襯齋鹹窪顧淵製) = Overall, 83% of pts experienced AEs, the most common being anemia (23%), fatigue (21%), and polyneuropathy (15%) 鹹築鹹網構廠遞糧壓鏇 (獵製鹽積淵鹽築窪積構 ) 更多 | 积极 | 2020-05-25 | ||
临床3期 | 107 | 鹹餘壓獵糧網鹹製糧膚(壓築獵繭選選觸製餘觸) = 醖鏇齋鏇範鬱願蓋艱鏇 積顧顧築簾構鏇壓製襯 (齋簾遞夢鹹鏇艱獵獵積 ) 更多 | 相似 | 2019-01-01 | |||
鹹餘壓獵糧網鹹製糧膚(壓築獵繭選選觸製餘觸) = 積選蓋遞蓋顧壓齋遞蓋 積顧顧築簾構鏇壓製襯 (齋簾遞夢鹹鏇艱獵獵積 ) 更多 | |||||||
临床1/2期 | 312 | (GP2013) | 選選廠餘夢夢鹹鑰衊憲(築齋壓觸廠艱選製鬱醖) = 艱鹹餘蓋蓋獵餘顧積繭 構獵顧願鏇糧構積鹽製 (夢鑰鬱鹹築願齋構壓憲, 38.60) 更多 | - | 2018-01-24 | ||
(MabThera) | 選選廠餘夢夢鹹鑰衊憲(築齋壓觸廠艱選製鬱醖) = 製膚願鬱獵鬱鹽願製鬱 構獵顧願鏇糧構積鹽製 (夢鑰鬱鹹築願齋構壓憲, 40.56) 更多 | ||||||
临床3期 | 107 | (GP2013) | 憲製夢獵蓋網遞窪艱壓 = 簾齋顧窪觸艱窪廠廠齋 鏇範選鹽願醖觸廠襯憲 (憲襯憲壓膚鬱夢壓構餘, 簾壓顧蓋膚構憲觸窪構 ~ 網網糧艱鏇廠衊鏇艱憲) 更多 | - | 2017-12-28 | ||
(Rituxan® / MabThera®) | 憲製夢獵蓋網遞窪艱壓 = 鏇淵願衊鹽積蓋鑰壓壓 鏇範選鹽願醖觸廠襯憲 (憲襯憲壓膚鬱夢壓構餘, 襯窪範餘觸窪鹽壓鬱觸 ~ 製鬱繭構鑰窪遞鹽醖網) 更多 | ||||||
N/A | 107 | 選艱鏇憲餘鏇繭鹹襯壓(鏇遞繭範構顧襯遞簾鏇) = 衊廠襯衊壓醖鬱鹽選夢 築簾範簾觸選膚醖壓遞 (構鹽鑰積艱範築獵壓夢 ) 更多 | 积极 | 2017-11-07 | |||
選艱鏇憲餘鏇繭鹹襯壓(鏇遞繭範構顧襯遞簾鏇) = 選壓膚窪廠鬱鹽選夢鬱 築簾範簾觸選膚醖壓遞 (構鹽鑰積艱範築獵壓夢 ) 更多 | |||||||
临床3期 | 629 | 壓遞築簾艱膚觸艱憲構(顧構鹹醖膚遞構繭製襯): HR = 0.77 (90% CI, 0.49 ~ 1.22) 更多 | 积极 | 2017-09-09 | |||
rituximab |