海正药业(600267.SH):海泽麦布片(10mg)已被正式纳入优先审评品种名单
格隆汇 12 月 21日丨海正药业(600267.SH)公布,2020年12月11日,公司的化学1类新药海泽麦布片(10mg)被国家药品监督管理局药品审评中心(“国家药品审评中心”)纳入拟优先审评品种公示名单,公示截止日期为12月18日;2020年12月21日,根据国家药品审评中心官网信息显示,海泽麦布片(10mg)已被正式纳入优先审评品种名单。
本品作用机制与已上市的依折麦布相同,作用于肠道和肝细胞表面的尼曼匹克C1类1(Niemann-Pick C1-like1, NPC1L1)蛋白受体,选择性地抑制胆固醇的吸收,从而降低小肠中的胆固醇向肝脏中的转运,使得肝脏胆固醇贮量降低,增加血液中胆固醇的清除。这种作用机制恰可与HMG-CoA还原酶抑制剂的作用互补,联合使用与任何一种单药治疗相比,能更有效改善血清中的TC、LDL-C、ApoB、甘油三酯(TG)及高密度脂蛋白-胆固醇(HDL-C)水平。适应症为单独或联合他汀类药物应用于治疗原发性(杂合子家族性或非家族性)高胆固醇血症;高胆固醇血症患者经常规剂量他汀治疗后胆固醇水平仍不能达标者,可与本品联合应用。
截至目前,公司在海泽麦布研发项目上已投入约2.80亿元人民币。
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