石藥集團(01093.HK):SYH2046片獲中國臨牀試驗批準
格隆匯4月11日丨石藥集團(01093.HK)發佈公告,集團開發的SYH2046片已獲得中國國家藥品監督管理局批準,可在中國開展臨牀試驗。
該產品是一款具有完全自主知識產權的全新結構first-in-class小分子藥物,本次獲批的臨牀試驗適應症爲急性心肌梗死後心力衰竭。臨牀前研究表明,該產品可顯著改善疾病動物模型的心臟功能並降低心臟不良重構,且具有較高的安全性。
急性心肌梗死是指各種原因造成的冠狀動脈供血減少或完全中斷,相應心肌出現嚴重而持久的急性缺血,導致心肌細胞壞死。急性心梗是引發心力衰竭的重要原因,急性心梗後心力衰竭的發生率爲14%–36%,心衰住院患者5年病死率可達42.3%。心衰難治療,預後差,患者死亡率高,傳統治療藥物效果並不理想。
與傳統心衰藥物相比,該產品具有全新作用機制,有望通過改善心臟細胞的代謝,在心肌損傷早期積極促進組織修復,以恢復心肌梗死後的心臟功能,具有較大的臨牀開發價值。
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