药物类型 单克隆抗体 |
别名 |
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) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评特殊审批 (中国) |
开始日期2022-05-25 |
申办/合作机构 |
开始日期2022-05-25 |
申办/合作机构 江苏恒瑞医药股份有限公司 [+2] |
开始日期2021-07-30 |
申办/合作机构 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
高胆固醇血症 | 申请上市 | 中国 | 2023-06-21 | |
高胆固醇血症 | 申请上市 | 中国 | 2023-06-21 | |
家族性混合型高脂血症 | 临床3期 | 中国 | 2021-04-23 | |
II型高脂蛋白血症 | 临床3期 | 中国 | 2021-04-23 | |
III型高脂蛋白血症 | 临床3期 | 中国 | 2021-04-23 | |
V型高脂蛋白血症 | 临床3期 | 中国 | 2021-04-23 | |
常染色体显性遗传性高胆固醇血症3型 | 临床3期 | 中国 | 2021-04-14 | |
原发性高胆固醇血症 | 临床3期 | 中国 | 2021-04-14 | |
纯合子家族性高胆固醇血症 | 临床2期 | - | 2020-09-01 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
---|
临床3期 | 689 | recaticimab 150 mg (injection every 4 weeks) | (築願餘餘鬱衊簾夢憲衊) = At every dosage/interval, participants who received recaticimab had lower bad cholesterol levels at 24 weeks than those receiving a placebo.
In the 4-week injection group, bad cholesterol was reduced 62% among those taking recaticimab vs. 0% among those in the placebo group; in the 8-week injection group, bad cholesterol was reduced 59% vs. +0.4% respectively; and in the 12-week injection group bad cholesterol was reduced 51% vs. +2% respectively.
At every dosage/interval, recaticimab lowered their bad cholesterol to the target by 24 weeks compared to the placebo and these levels were maintained at 48 weeks. 襯積鑰糧窪鏇網願構壓 (淵淵積遞積簾獵憲積蓋 ) 更多 | 积极 | 2023-11-13 | ||
Placebo (injection every 4 weeks) | |||||||
临床1/2期 | 110 | (築窪夢範淵獵觸鑰窪艱) = No serious treatment-emergent adverse events (TEAEs) occurred. 觸範醖廠鏇窪衊醖淵構 (淵築顧糧膚網窪網遞選 ) 更多 | 积极 | 2022-01-18 | |||
Placebo |