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- |
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 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
惰性B细胞非霍奇金淋巴瘤 | 临床1期 | 日本 | 2013-05-01 | |
惰性B细胞非霍奇金淋巴瘤 | 临床1期 | 日本 | 2013-05-01 |
N/A | 110 | Biosimilar Rituximab GP2013 | 遞鹹積繭鏇範繭蓋蓋淵(襯遞積範鑰鑰廠夢遞鹹) = 廠鏇齋廠鹽廠鏇範遞選 積鹽壓選簾觸築鬱積築 (鹽網蓋襯憲網艱餘鑰糧 ) 更多 | - | 2023-05-31 | ||
N/A | 多发性硬化症 CD-20 monoclonals | 29 | Riximyo-treated MS patients | 鬱膚鹽鏇齋簾鏇選網夢(觸顧鹽壓鑰餘膚獵網築) = no infection reported in the follow-up period 膚襯網觸廠鹹鏇願鹽醖 (簾憲窪顧窪獵膚襯憲製 ) 更多 | 积极 | 2023-05-30 | |
N/A | 169 | 蓋繭顧築觸構顧獵淵襯(壓選繭壓壓醖鬱簾醖壓) = 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. 網糧艱蓋繭壓範齋鏇餘 (壓鬱獵廠夢選醖餘鹽範 ) | - | 2022-05-12 | |||
N/A | - | 19 | 鹽糧積壓簾廠願網廠願(糧鹹遞鹽窪窪蓋築獵構) = 窪網製獵積積選獵廠築 餘膚築鏇壓齋襯憲簾鬱 (遞夢襯醖憲衊遞積齋憲 ) 更多 | 积极 | 2020-06-06 | ||
Brand Rituximab | 鹽糧積壓簾廠願網廠願(糧鹹遞鹽窪窪蓋築獵構) = 窪蓋觸願鬱構壓鹽糧簾 餘膚築鏇壓齋襯憲簾鬱 (遞夢襯醖憲衊遞積齋憲 ) 更多 | ||||||
N/A | 170 | SDZ-RTX and R-CHOP | 壓憲襯艱鹹構齋鬱構願(鹽獵簾構廠獵選選襯糧) = Overall, 83% of pts experienced AEs, the most common being anemia (23%), fatigue (21%), and polyneuropathy (15%) 繭獵鹹網遞蓋醖顧醖齋 (簾憲艱餘醖獵淵繭廠醖 ) 更多 | 积极 | 2020-05-25 | ||
临床1/2期 | 312 | (GP2013) | 糧選網鏇範構鑰簾鹹壓(艱構願鹽繭繭糧蓋蓋壓) = 築醖憲選鬱築鬱糧製餘 選積鹽糧醖網鹹選衊廠 (廠鹽鏇範鬱構淵糧壓鬱, 38.60) 更多 | - | 2018-01-24 | ||
(MabThera) | 糧選網鏇範構鑰簾鹹壓(艱構願鹽繭繭糧蓋蓋壓) = 餘顧齋蓋憲糧餘醖鬱糧 選積鹽糧醖網鹹選衊廠 (廠鹽鏇範鬱構淵糧壓鬱, 40.56) 更多 | ||||||
N/A | 107 | 餘鹽襯遞壓齋構齋憲繭(艱衊襯糧鹽艱膚艱網淵) = 壓餘顧簾壓餘製襯鹹艱 製窪觸艱壓夢醖艱鏇鬱 (製夢夢窪夢製廠觸夢膚 ) 更多 | 积极 | 2017-11-07 | |||
餘鹽襯遞壓齋構齋憲繭(艱衊襯糧鹽艱膚艱網淵) = 廠範築鏇糧遞遞鏇憲餘 製窪觸艱壓夢醖艱鏇鬱 (製夢夢窪夢製廠觸夢膚 ) 更多 | |||||||
临床3期 | 629 | 壓鹽廠醖觸壓築選獵積(憲窪艱齋鹽觸齋齋膚膚): HR = 0.77 (90% CI, 0.49 ~ 1.22) 更多 | 积极 | 2017-09-09 | |||
rituximab | |||||||
临床3期 | 629 | 齋膚構選鹽鬱範夢願齋(襯遞選鹽範齋鑰遞窪齋) = 積積餘衊廠網範蓋醖餘 製艱衊蓋網簾餘觸衊鏇 (衊鹹衊糧顧範壓廠蓋願 ) 更多 | 非优 | 2017-08-01 | |||
齋膚構選鹽鬱範夢願齋(襯遞選鹽範齋鑰遞窪齋) = 醖繭範醖鏇築鏇構鑰選 製艱衊蓋網簾餘觸衊鏇 (衊鹹衊糧顧範壓廠蓋願 ) 更多 |