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君實生物(01877.HK):昂戈瑞西單抗注射液新適應症上市申請獲得批準

格隆匯5月27日丨君實生物(01877.HK)公告,近日,公司收到國家藥品監督管理局覈準簽發的《藥品註冊證書》,昂戈瑞西單抗注射液(重組人源化抗 PCSK9 單克隆抗體注射液,商品名:君適達)用於:1)雜合子型家族性高膽固醇血癥(以下簡稱“HeFH”)的成人患者;2)在他汀類藥物不耐受或禁忌使用的患者中,單獨或與依折麥布聯合用藥用於非家族性高膽固醇血癥和混合型血脂異常的成人患者的兩項新適應症上市申請獲得批準。昂戈瑞西單抗成爲首個獲批用於他汀不耐受人羣的國產PCSK9靶點藥物。

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