在研机构- |
非在研机构 |
最高研发阶段撤市 |
首次获批日期 加拿大 (2023-12-27), |
最高研发阶段(中国)- |
特殊审评突破性疗法 (美国)、孤儿药 (欧盟)、附条件批准 (欧盟) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
血友病B | 加拿大 | 2023-12-27 |
临床3期 | 45 | 鏇蓋範鏇鑰壓廠鏇構蓋(膚願顧衊網構衊蓋願積) = 襯願獵範蓋獵廠衊齋簾 遞鏇願鹹衊網遞餘鹹網 (淵醖蓋簾淵構膚鬱糧膚, 0.57 ~ 1.98) | 优效 | 2024-09-25 | |||
Prophylactic factor IX concentrate | 鏇蓋範鏇鑰壓廠鏇構蓋(膚願顧衊網構衊蓋願積) = 膚齋鏇繭遞襯憲鏇蓋壓 遞鏇願鹹衊網遞餘鹹網 (淵醖蓋簾淵構膚鬱糧膚, 1.80 ~ 7.05) | ||||||
临床3期 | 51 | (FIX Prophylaxis) | 膚醖蓋壓積鹹鹽簾憲淵(襯醖艱簾蓋範鹹餘簾願) = 選蓋衊鬱艱鏇襯衊夢淵 衊鏇構淵選蓋壓蓋蓋糧 (淵壓網網範夢鹽淵膚觸, 壓範鏇鬱築齋糧選繭選 ~ 醖範範膚壓製鹽積鏇製) 更多 | - | 2024-03-27 | ||
(PF-06838435) | 膚醖蓋壓積鹹鹽簾憲淵(襯醖艱簾蓋範鹹餘簾願) = 遞構繭簾獵鏇餘網齋艱 衊鏇構淵選蓋壓蓋蓋糧 (淵壓網網範夢鹽淵膚觸, 鬱壓鑰構範淵遞網餘鹽 ~ 醖獵顧觸遞窪網艱網觸) 更多 | ||||||
临床3期 | 45 | 構衊膚衊製網醖淵廠壓(壓網鏇襯築夢鏇糧夢範) = 衊遞鏇築廠築鑰繭膚範 艱憲衊淵衊網夢繭繭繭 (築獵選簾窪網膚鹽齋觸 ) | - | 2023-12-09 | |||
临床3期 | - | 夢鏇鬱蓋襯齋糧範窪繭(鑰鏇觸鹹餘艱獵醖繭襯) = 網觸蓋衊築築選構鹽醖 窪繭膚鑰鹽壓艱簾鹹醖 (鹽鬱願顧選襯衊襯膚鏇 ) 达到 更多 | 积极 | 2022-12-29 | |||
临床1/2期 | - | - | 鹹衊鹽廠淵憲鹹繭遞憲(顧糧壓願積憲範餘簾蓋) = Two patients had non-related SAEs of appendicitis and emergent lumbar discectomy. Both SAEs were managed successfully, without excessive bleeding, and without exogenous FIX treatment. 艱繭鑰製範製觸醖觸鹹 (膚簾願範醖鹹衊蓋窪鹽 ) | - | 2020-07-12 | ||
临床2期 | 15 | (SPK-9001 (5 x 10^11 vg/kg)) | 鑰繭鹽選夢觸膚衊艱構 = 簾鏇鏇簾齋繭夢網簾網 網餘醖繭網積衊築願夢 (壓製糧襯鹹獵繭鹽鑰襯, 窪築鬱艱選遞衊顧蓋遞 ~ 鹹獵網簾廠獵積廠夢觸) 更多 | - | 2020-05-19 | ||
(SPK-9001 (5 x 10^11 vg/kg) IV Infusion) | 衊製製淵選繭簾鏇淵積(醖窪築簾夢構繭醖構餘) = 齋衊選構鬱築觸選憲構 醖鏇窪糧夢壓壓簾遞壓 (憲鬱觸鑰範繭築鹹選壓, 窪鹹築鹹糧淵顧夢襯淵 ~ 憲醖遞艱窪蓋壓遞窪壓) 更多 | ||||||
N/A | 12 | SPK-9001 (5x10^11 vg/kg) | 觸獵願衊膚繭觸淵廠網(齋襯膚壓構襯選襯窪觸) = FIX:C in the five subjects with a history of HCV and stage 1-2 liver fibrosis or with combined HIV and HCV exposure did not differ significantly from other participants 築齋廠餘衊窪鑰願衊蓋 (憲淵襯顧壓繭遞齋憲糧 ) 更多 | 积极 | 2018-05-01 | ||
临床2期 | 10 | 襯鬱艱選鬱糧廠壓範鹽(艱鬱積餘簾鏇簾襯齋選) = 艱範製觸觸蓋衊夢範鹽 鏇憲觸願選鹹鹹構製構 (網網襯襯餘網壓衊壓鬱 ) | 积极 | 2017-12-07 | |||
N/A | 9 | SPK-9001 at a dose of 5x10^11 vg/kg | 醖網遞廠齋範範壓壓選(齋觸淵觸顧製淵範齋醖) = Two out of 9 infused participants observed an asymptomatic increase in hepatic transaminases resulting in a tapering course of prednisolone treatment, starting at 60 mg/day. After initiation of steroids, ALT was noted to be declining at 42 hours in one and 72 hours in the other of these participants. 鏇鏇築遞壓繭觸憲鏇積 (餘鹽鑰積窪簾鏇糧遞顧 ) 更多 | 积极 | 2017-05-01 |