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信立泰(002294.SZ):“S086片”獲批開展臨牀試驗
格隆匯 12-16 18:48

格隆匯12月16日丨信立泰(002294.SZ)公佈,近日,公司申報的“S086獲得國家藥品監督管理局臨牀試驗默示許可。

適應症1原發性高血壓患者;2慢性心力衰竭成人患者,降低心血管死亡和心力衰竭住院的風險。(已申報臨牀並獲得批件)

S086為公司自主創新研發,是一種血管緊張素II受體-腦啡肽酶雙重抑制劑。此次為新增適應症“原發性高血壓”獲批開展臨牀試驗目前公司完成S086I期臨牀相關研究“原發性高血壓”適應症準備進入II期臨牀階段。

公司將按照國家藥品註冊的相關規定要求開展臨牀試驗,臨牀試驗成功後按程序申報相關產品的生產。獲批上市進一步豐富公司心腦血管領域的創新產品線為患者提供新的用藥選擇

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