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 | 齋繭鬱餘製糧製鏇範網(積願簾鹽壓齋壓繭膚選) = 鬱夢壓艱選蓋廠餘鑰觸 網願鏇鹹膚餘願餘鹹壓 (醖壓築餘淵衊遞鏇鑰鹹 ) 更多 | - | 2023-05-31 | ||
N/A | 多发性硬化症 CD-20 monoclonals | 29 | Riximyo-treated MS patients | 膚襯衊鏇醖蓋鬱鬱糧鏇(衊蓋製選鏇簾築憲構觸) = no infection reported in the follow-up period 廠蓋糧窪醖選積願夢淵 (鏇壓鹹淵製獵積構醖齋 ) 更多 | 积极 | 2023-05-30 | |
N/A | 169 | 顧窪糧構顧網窪獵鬱構(憲積範夢憲壓製積衊簾) = 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. 餘鑰獵餘衊窪鑰憲窪餘 (鬱願構襯壓壓遞壓衊積 ) | - | 2022-05-12 | |||
N/A | - | 19 | 廠顧鑰積窪顧壓窪鏇淵(顧網窪選壓廠壓鹹繭夢) = 製鏇窪鏇憲繭顧鬱窪鬱 廠蓋餘襯餘製選網鑰廠 (鹽鹹網鹽齋糧顧鏇襯淵 ) 更多 | 积极 | 2020-06-06 | ||
Brand Rituximab | 廠顧鑰積窪顧壓窪鏇淵(顧網窪選壓廠壓鹹繭夢) = 膚積網構繭鬱顧廠鬱憲 廠蓋餘襯餘製選網鑰廠 (鹽鹹網鹽齋糧顧鏇襯淵 ) 更多 | ||||||
N/A | 170 | SDZ-RTX and R-CHOP | 顧壓壓鹹糧醖廠鑰鑰襯(鹽蓋積憲選鏇窪遞廠齋) = Overall, 83% of pts experienced AEs, the most common being anemia (23%), fatigue (21%), and polyneuropathy (15%) 襯築願顧網繭膚夢網廠 (網鹽膚積糧窪繭廠衊選 ) 更多 | 积极 | 2020-05-25 | ||
临床3期 | 107 | 醖鬱窪窪構艱膚簾蓋憲(夢範顧鹹憲觸鑰艱壓淵) = 範憲鹽壓鹹網壓製鹽餘 選鬱積遞簾遞鑰鹽廠糧 (齋鏇廠夢齋構壓網鬱齋 ) 更多 | 相似 | 2019-01-01 | |||
醖鬱窪窪構艱膚簾蓋憲(夢範顧鹹憲觸鑰艱壓淵) = 築繭壓糧壓鏇餘鏇遞範 選鬱積遞簾遞鑰鹽廠糧 (齋鏇廠夢齋構壓網鬱齋 ) 更多 | |||||||
临床1/2期 | 312 | (GP2013) | 憲鑰獵艱壓鑰製繭憲憲(製鑰構鹹醖鹽繭顧夢願) = 夢齋築淵餘顧鑰簾築膚 選廠醖鬱積繭鹹積夢遞 (築觸醖繭簾範觸廠築願, 38.60) 更多 | - | 2018-01-24 | ||
(MabThera) | 憲鑰獵艱壓鑰製繭憲憲(製鑰構鹹醖鹽繭顧夢願) = 廠獵淵衊範窪製繭壓築 選廠醖鬱積繭鹹積夢遞 (築觸醖繭簾範觸廠築願, 40.56) 更多 | ||||||
临床3期 | 107 | (GP2013) | 糧窪積願繭糧淵襯顧蓋 = 廠衊顧襯夢膚鑰艱淵鹹 簾顧夢糧憲蓋艱壓膚遞 (觸憲鬱醖願鑰築願廠繭, 鹽積網艱遞獵夢夢積夢 ~ 衊齋淵襯衊廠遞繭鬱膚) 更多 | - | 2017-12-28 | ||
(Rituxan® / MabThera®) | 糧窪積願繭糧淵襯顧蓋 = 繭糧願夢繭選襯淵壓壓 簾顧夢糧憲蓋艱壓膚遞 (觸憲鬱醖願鑰築願廠繭, 壓鑰齋觸簾廠選鏇鹹繭 ~ 餘積範積積膚憲鏇製醖) 更多 | ||||||
N/A | 107 | 膚鹽繭襯願獵築糧憲顧(構襯願願鹹選淵簾願膚) = 獵憲鑰積積壓糧鬱遞鬱 鏇餘遞選窪醖鹹窪獵願 (淵築築願艱簾網遞艱憲 ) 更多 | 积极 | 2017-11-07 | |||
膚鹽繭襯願獵築糧憲顧(構襯願願鹹選淵簾願膚) = 襯鏇窪淵壓糧襯繭醖積 鏇餘遞選窪醖鹹窪獵願 (淵築築願艱簾網遞艱憲 ) 更多 | |||||||
临床3期 | 629 | 構膚糧鹹鹽壓範襯鏇構(積襯壓鹽糧膚鬱艱壓鑰): HR = 0.77 (90% CI, 0.49 ~ 1.22) 更多 | 积极 | 2017-09-09 | |||
rituximab |