信立泰(002294.SZ):“S086片”獲批開展臨牀試驗
格隆匯12月16日丨信立泰(002294.SZ)公佈,近日,公司申報的“S086片”獲得國家藥品監督管理局的臨牀試驗默示許可。
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,公司已完成S086片I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和要求開展臨牀試驗,待臨牀試驗成功後按程序申報相關產品的生產。若獲批上市,將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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