君實生物(01877.HK):昂戈瑞西單抗的兩項III期臨牀研究達到主要研究終點
格隆匯2月27日丨君實生物(01877.HK)發佈公吿,近日,公司產品昂戈瑞西單抗(重組人源化抗PCSK9單克隆抗體,產品代號:JS002)治療原發性高膽固醇血癥和混合型高脂血症的兩項隨機、雙盲、安慰劑對照、多中心III期臨牀研究(研究編號:JS002-003和JS002-006)均達到主要研究終點。
昂戈瑞西單抗是由公司自主研發的重組人源化抗PCSK9單克隆抗體,用於治療原發性高膽固醇血癥和混合型高脂血症。公司是國內首個獲得該靶點藥物臨牀試驗批件的中國企業。公司已完成在原發性高膽固醇血癥和混合型高脂血症患者人羣中的III期臨牀研究,以及在純合子型家族性高膽固醇血癥患者中的II期臨牀研究。在雜合子型家族性高膽固醇血癥患者中的III期臨牀研究已完成入組。
PCSK9抑制劑作為強效降低LDL-C水平的新型降脂藥物,已得到國內外血脂異常管理指南的推薦,並得到臨牀醫生的廣泛認可。截至本公吿日期,國內已有兩款進口抗PCSK9單抗獲批上市,尚無國產抗PCSK9單抗獲批上市。
截至本公吿日期,昂戈瑞西單抗兩項主要關鍵註冊臨牀研究(研究編號:JS002-003和JS002-006)均已順利完成,並且均達到主要研究終點。其中JS002-003研究是在原發性高膽固醇血癥和混合型高脂血症患者中評價皮下注射昂戈瑞西單抗的有效性和安全性,JS002-006研究是在原發性高膽固醇血癥和混合型高脂血症患者中評價使用兩種給藥裝置(預充式注射器和預充式自動注射器)皮下注射昂戈瑞西單抗的有效性和安全性。昂戈瑞西單抗在兩項研究中均表現出顯着的降脂療效,並且安全性良好。
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