君实生物:昂戈瑞西单抗注射液新适应症上市申请获得批准

美港电讯
27 May

【君实生物:昂戈瑞西单抗注射液新适应症上市申请获得批准】金十数据5月27日讯,君实生物公告称,公司收到国家药监局核准签发的《药品注册证书》,昂戈瑞西单抗注射液(商品名:君适达®)用于杂合子型家族性高胆固醇血症(HeFH)的成人患者以及他汀类药物不耐受或禁忌使用的患者中,单独或与依折麦布联合用药用于非家族性高胆固醇血症和混合型血脂异常的成人患者的新适应症上市申请获得批准。昂戈瑞西单抗成为首个获批用于他汀不耐受人群的国产PCSK9靶点药物。

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