石藥集團(01093.HK):SYH2068注射液(雙鏈小幹擾RNA藥物)獲臨牀試驗批準
格隆匯4月25日丨石藥集團(01093.HK)公告,集團自主研發的化學1類新藥SYH2068注射液(雙鏈小幹擾RNA (si RNA)藥物 )已獲得中國國家藥品監督管理局批準,可以在中國開展臨牀試驗。
該產品是一款通過偶聯乙醯半乳糖胺(Gal NAc)實現肝臟靶向遞送的si RNA 藥物,以皮下給藥的方式靶向脂蛋白(a) [ Lp (a) ],能有效降低Lp (a)水平。該產品適用於治療高脂蛋白(a)血癥,通過優化序列和化學修飾的策略來實現更持久的基因沉默效果,有望成爲超長效降低Lp (a)的si RNA藥物,具有預防動脈粥樣硬化性心血管疾病(ASCVD)的潛力。臨牀前研究顯示,該產品在藥物活性和藥效持續性方面優於同類型si RNA產品,展現出藥物作用效果持久、安全性好、患者依從性高等差異化優勢,具有較高的臨牀開發價值。
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