长春高新:子公司注射用伏欣奇拜单抗获批上市

格隆汇
Yesterday

长春高新公告,控股子公司金赛药业申报的注射用伏欣奇拜单抗(商品名:金蓓欣)已获国家药品监督管理局批准上市,适用于对非甾体类抗炎药和/或秋水仙碱禁忌、不耐受或缺乏疗效的,以及不适合反复使用类固醇激素的成人痛风性关节炎急性发作。注射用伏欣奇拜单抗是公司研发的新型全人源抗IL-1β单克隆抗体药物,可特异性结合人IL-1β,阻断IL-1β诱导的炎性介质产生,用于成人痛风性关节炎急性发作患者。该产品已完成的关键临床试验结果显示,伏欣奇拜单抗6小时即可快速起效,72小时镇痛效果与激素相当,6个月内首次复发风险降低近90%,且安全性良好。产品获批有利于丰富公司成人自免领域的产品布局,增强公司在医药市场的竞争力。

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