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天士力(600535.SH):開展T89預防及治療急性高原反應Ⅲ期臨牀試驗
格隆匯 07-22 16:58

格隆匯7月22日丨天士力(600535.SH)公佈,公司T89(複方丹蔘滴丸,美國FDA臨牀研究申報代碼為T89)預防及治療急性高原反應(Acute mountain sickness,簡稱“AMS”)申請美國FDA(美國食品藥品監督管理局)新藥上市項目(“該項目”)Ⅲ期臨牀試驗已於近日完成臨牀試驗準備工作,開始受試者入組,進入Ⅲ期臨牀試驗。

公司於近日已完成預防及治療急性高原反應(AMS)相關Ⅲ期臨牀試驗準備工作,開始受試者入組,正式開展Ⅲ期臨牀試驗。截至2021年6月30日,公司關於T89預防及治療急性高原反應(AMS)國際臨牀研究項目的累計研發投入為3905.39萬元人民幣。

急性高原反應(AMS)是一種高原特有的缺氧性常見疾病,在人體急進高原暴露低氧環境後產生的病理生理學變化和機能紊亂並出現相應的頭暈、頭痛、噁心、嘔吐等臨牀症狀,其發病急、進程快。隨着登山運動、高原旅遊業及經濟建設的迅速發展,其用藥羣體不斷增大。針對急性高原反應的不良症狀,若未採取預防或治療措施,可引起高原肺水腫(HAPE)和高原腦水腫(HACE)。

根據公開文獻顯示,在海拔1850米到2750米時,急性高原反應的發生率為25%,在3000米時的發生率為42%。目前,美國FDA批准的針對這一適應症的藥物只有乙酰唑胺(利尿降壓藥),國內外尚未有適應症明確是急性高原反應的天然藥物上市。

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