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君實生物(688180.SH):JS401注射液的臨牀試驗申請獲得批准

格隆匯4月13日丨君實生物(688180.SH)公佈,近日,公司與控股子公司無錫潤民醫藥科技有限公司(簡稱“無錫潤民”)收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,JS401注射液(項目代號“JS401”)的臨牀試驗申請獲得批准。

公司與潤佳(上海)醫藥技術有限公司(簡稱“潤佳上海”)分別擁有無錫潤民50%的股權比例。JS401是公司與合作伙伴潤佳上海共同研發的一種靶向血管生成素樣蛋白3(簡稱“ANGPTL3”)信使RNA(簡稱“mRNA”)的小干擾RNA(簡稱“siRNA”)藥物,擬主要用於高脂血症等治療。ANGPTL3是由肝臟表達的血管生成素樣蛋白家族的成員,通過抑制脂蛋白脂肪酶(LPL)和內皮脂肪酶(EL)發揮調節脂質代謝的作用。ANGPTL3功能喪失或抑制可顯著降低甘油三酯及其他致動脈粥樣硬化性脂蛋白的水平。JS401經N-乙酰半乳糖胺(GalNac)被遞送至肝細胞內,在肝細胞內特異性降解ANGPTL3mRNA,並持續性抑制ANGPTL3蛋白的表達,從而發揮其降脂(甘油三酯及膽固醇)的作用。

截至公吿披露日,全球僅有一款靶向ANGPTL3的單克隆抗體類藥物Evkeeza®(Evinacumab-dgnb,再生元製藥公司產品)獲批上市,用於12歲及以上兒童或成人純合子型家族性高膽固醇血癥(HoFH)患者的治療,全球尚無同類靶點siRNA類藥物獲批上市。

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