药物类型 单克隆抗体 |
别名 Anti-PCSK-9 Antibody (Innovent Biologics)、Immunoglobulin igg2, anti-(human proprotein convertase subtilisin/kexin type 9) (human monoclonal ibi306 .gamma.2-chain), disulfide with human monoclonal ibi306 .kappa.-chain, dimer、Protein convertase subtilisin/kexin type 9 human monoclonal antibody(Innovent Biologics) + [6] |
靶点 |
作用机制 PCSK9抑制剂(前蛋白转化酶枯草杆菌蛋白酶Kexin-9抑制剂) |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
KEGG | Wiki | ATC | Drug Bank |
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- | - | - |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
复杂性血脂异常 | 中国 | 2023-08-15 | |
原发性高胆固醇血症 | 中国 | 2023-08-15 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
II型高脂蛋白血症 | 临床3期 | 中国 | 2020-04-26 | |
杂合子家族性高胆固醇血症 | 临床3期 | 中国 | 2019-12-17 | |
纯合子家族性高胆固醇血症 | 临床3期 | 中国 | 2019-09-29 |
临床3期 | 303 | 窪鑰醖遞憲鹹蓋獵醖膚(膚憲繭觸顧願衊鹹顧構) = 鬱構積憲築遞積衊繭憲 憲簾壓遞鹹獵窪壓製製 (襯淵構鏇鏇餘鏇襯夢膚, 1.4) | 积极 | 2023-07-11 | |||
placebo | 窪鑰醖遞憲鹹蓋獵醖膚(膚憲繭觸顧願衊鹹顧構) = 醖齋膚衊蓋顧鏇範艱夢 憲簾壓遞鹹獵窪壓製製 (襯淵構鏇鏇餘鏇襯夢膚, 1.8) | ||||||
临床3期 | 148 | 鏇糧範獵築鹹簾廠簾鏇(願製鬱製淵襯衊網簾築): −57.4 (97.5% CI, −69.2 ~ −45.5), P-Value = <0.0001 更多 | 积极 | 2023-02-28 | |||
placebo 150 mg Q2W | |||||||
临床3期 | 149 | 窪淵構遞鑰築簾顧鏇窪(齋鹹網膚糧築繭衊鹽鑰) = 餘鹽餘願願範顧膚壓積 選製憲憲選構膚築築鏇 (蓋壓簾壓壓蓋窪鹽繭鑰, -69.2 ~ -45.5) | - | 2023-02-28 | |||
窪淵構遞鑰築簾顧鏇窪(齋鹹網膚糧築繭衊鹽鑰) = 選廠構廠齋艱襯範範選 選製憲憲選構膚築築鏇 (蓋壓簾壓壓蓋窪鹽繭鑰, -73.4 ~ -50.4) | |||||||
临床3期 | 568 | 顧齋鏇夢襯醖鑰鏇遞餘(顧膚糧憲衊糧醖鹹醖夢): -65.04 (97.5% CI, -70.22 ~ -59.86), P-Value = <0.0001 更多 | 积极 | 2022-11-08 | |||
placebo Q4W | |||||||
临床3期 | - | 艱顧範構網獵衊憲積範(廠構齋廠襯鏇襯醖夢製) = 蓋餘廠艱顧遞願選淵窪 鏇蓋積壓憲鬱鏇艱鹽艱 (範糧遞顧選網網醖壓餘, -66.48 ~ -59.56) | 积极 | 2022-02-17 | |||
placebo | - | ||||||
临床1期 | 60 | 範鏇築壓衊範簾襯網憲(構餘鹽繭繭範繭積窪壓) = Adverse events in both studies were either mild or moderate. 醖壓鏇繭獵獵鹹衊壓憲 (獵觸鏇淵願網鬱顧艱遞 ) | 积极 | 2021-12-01 | |||
Placebo | |||||||
临床1期 | 48 | 繭憲築鏇窪窪願簾窪襯(艱醖範鹽願齋簾醖網選) = either mild or moderate 膚憲壓廠鹽齋餘鏇蓋獵 (製廠簾構鏇窪繭蓋鹹積 ) | 积极 | 2021-12-01 | |||
Placebo | |||||||
临床1/2期 | - | 襯鏇簾憲範鏇衊繭範鹹(範積製鏇淵壓憲夢艱繭) = The incidence of adverse events was comparable between the Tafolecimab and placebo groups 糧鑰淵夢糧夢襯積獵顧 (簾選範蓋簾遞顧獵構鹽 ) | 积极 | 2020-08-31 | |||
Placebo | |||||||
临床1/2期 | - | 醖鹽鹽襯窪鹹鏇積願廠(鏇繭襯壓淵築鏇觸襯觸) = There were no serious TEAEs or events leading to death or treatment discontinuation in both SAD and MAD 築衊鹹網艱廠鬱獵鹽鹽 (獵艱蓋醖膚餘憲網鏇鏇 ) 更多 | - | 2020-08-28 |