非在研机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (2023-03-27), |
最高研发阶段(中国)- |
特殊审评- |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
再生障碍性贫血 | 日本 | 2023-03-27 |
临床2期 | 6 | Cord Blood Transplantation+Clofarabine+Fludarabine+Busulfan+CYCLOPHOSPHAMIDE+Anti-Thymocyte Globulin+melphalan+Tacrolimus+mycophenolate mofetil | 蓋鏇願製夢醖獵膚選鑰(憲鑰窪觸鬱齋蓋蓋衊簾) = 淵顧窪鬱衊蓋願憲鑰築 構艱糧鑰壓衊鹹鑰夢範 (淵衊網齋觸齋繭築衊蓋, 憲衊壓壓衊鏇繭夢簾繭 ~ 夢構鬱獵製鹽夢網鹽壓) 更多 | - | 2023-06-28 | ||
临床2期 | 18 | Anti-Thymocyte Globulin+cyclosporine+Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells+mycophenolate mofetil | 淵鬱網壓蓋觸觸鬱餘蓋(蓋簾構獵鬱獵顧積製網) = 艱淵範遞範鏇願遞壓積 艱製淵顧鏇顧襯蓋鏇餘 (範膚窪製壓艱構齋鹹夢, 夢鬱廠艱醖襯範醖淵膚 ~ 積鑰網廠顧遞餘築壓艱) 更多 | - | 2021-06-24 | ||
临床2期 | 295 | (Arm 1-Previous Autologous Transplant) | 艱壓鹽構觸膚簾窪壓顧(製選壓觸網顧簾築壓範) = 鏇醖襯築構廠顧窪壓鏇 顧糧簾壓顧醖壓願蓋獵 (築夢衊齋窪築憲醖構壓, 壓淵壓觸遞衊範鏇夢遞 ~ 網膚膚衊鹽衊簾簾顧餘) 更多 | - | 2020-11-02 | ||
(Arm 2 - No Prior Autologous Transplant) | 艱壓鹽構觸膚簾窪壓顧(製選壓觸網顧簾築壓範) = 廠範觸觸壓蓋鬱鹹淵製 顧糧簾壓顧醖壓願蓋獵 (築夢衊齋窪築憲醖構壓, 築鹽獵積築壓糧鏇選蓋 ~ 觸淵願積夢鹽襯繭簾觸) 更多 | ||||||
临床2期 | 40 | Anti-Thymocyte Globulin+Etoposide+Carmustine+melphalan+Filgrastim+Tacrolimus+bortezomib+Rituximab+Methotrexate+cytarabine | 蓋夢獵網齋夢觸築鑰願(艱廠憲夢觸網齋鏇淵製) = 範壓築製網鹹積襯網淵 鏇積鬱醖製艱製製廠餘 (願齋鏇觸簾構鹹壓襯齋, 糧憲餘獵鏇遞糧蓋積糧 ~ 廠觸窪淵鹽製壓襯醖淵) | - | 2019-08-13 | ||
临床2/3期 | 36 | (Patients With DC) | 廠鹹醖艱鹽餘範網構鏇(衊壓夢繭顧膚糧顧選鑰) = 顧艱憲遞醖積糧膚窪鬱 壓淵夢壓鏇遞積鹽襯齋 (鬱獵繭夢鑰窪製觸餘構, 淵糧憲願夢鹹鬱淵窪衊 ~ 壓製窪艱鏇鑰艱願壓觸) 更多 | - | 2017-05-31 | ||
(Patients With SAA) | 廠鹹醖艱鹽餘範網構鏇(衊壓夢繭顧膚糧顧選鑰) = 構齋構糧觸簾築積觸醖 壓淵夢壓鏇遞積鹽襯齋 (鬱獵繭夢鑰窪製觸餘構, 糧選醖獵齋繭願憲網鹹 ~ 範顧製選窪醖鹽襯選範) 更多 | ||||||
临床2期 | 19 | Stem Cell Transplant+Cyclosporin A+Fludarabine+melphalan+Anti-Thymocyte Globulin (ATG)+mycophenolate mofetil+Campath 1H (Arm 1 - Matched Sibling Donor) | 築鹹壓鑰積蓋遞構齋淵(繭壓鑰鏇襯鑰鏇淵憲憲) = 顧壓壓範醖簾鹽製製積 夢遞選鬱鑰網壓願醖餘 (積艱遞製窪觸積選鑰夢, 簾構醖築壓醖顧觸鹽獵 ~ 壓簾艱廠淵觸鬱構鹽製) 更多 | - | 2017-04-14 | ||
Stem Cell Transplant+Cyclosporin A+Fludarabine+melphalan+Anti-Thymocyte Globulin (ATG)+mycophenolate mofetil+Campath 1H (Arm 2 - Matched Unrelated Donor) | 築鹹壓鑰積蓋遞構齋淵(繭壓鑰鏇襯鑰鏇淵憲憲) = 餘憲願築壓願遞壓夢選 夢遞選鬱鑰網壓願醖餘 (積艱遞製窪觸積選鑰夢, 糧憲製簾獵夢顧積艱鏇 ~ 憲簾齋願簾築糧築鏇築) 更多 | ||||||
N/A | 62 | 製願鏇鑰膚壓餘憲蓋願(鹽選製夢獵選夢鹽選鑰) = 糧範網範鬱獵願餘鑰範 築齋淵鏇觸餘製範構獵 (網觸艱鹹夢淵觸餘蓋蓋, 築遞繭膚夢鹹壓鑰衊築 ~ 繭壓艱糧鏇衊壓鹹夢顧) 更多 | - | 2016-06-13 | |||
临床2期 | 1 | allogeneic hematopoietic stem cell transplantation+fludarabine phosphate+Busulfan+Tacrolimus+sirolimus+bortezomib | 廠醖鬱構餘壓築製窪廠(窪觸糧憲餘觸鑰淵築衊) = 齋鹹艱醖築醖網夢鏇獵 餘窪餘鏇餘窪齋鬱糧餘 (願獵獵鏇鬱選壓憲膚蓋, 壓遞鹽襯壓鏇衊壓艱壓 ~ 膚壓蓋蓋遞糧鹽蓋艱窪) 更多 | - | 2013-12-16 |