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健康元(600380.SH):鹽酸左沙丁胺醇異丙託吸入溶液獲批臨牀試驗
格隆匯 09-09 18:20

格隆匯 9 月 9日丨健康元(600380.SH)公佈,近日,公司全資子公司健康元海濱藥業有限公司及控股子公司上海方予健康醫藥科技有限公司(以下簡稱:上海方予)收到國家藥品監督管理局簽發的《藥物臨牀試驗批准通知書》,藥品通用名稱為鹽酸左沙丁胺醇異丙託吸入溶液。

批准內容同意本品開展用於氣道阻塞性相關可逆性支氣管痙攣的臨牀試驗

上海方予首次提交鹽酸左沙丁胺醇異丙託吸入溶液(以下簡稱:本品)註冊獲得受理時間為20200625日,受理號為CYHL2000324

本品適用於需要多種支氣管擴張劑聯合應用的患者,用於治療氣道阻塞性疾病有關的可逆性支氣管痙攣。本品為新複方製劑,由上海方予自主研發。本品活性成分包括鹽酸左沙丁胺和異丙託溴銨。其中鹽酸左沙丁胺醇為短效β2受體激動劑,與硫酸沙丁胺醇相比,保留了主要活性成分左沙丁胺醇,去除了產生副作用的右沙丁胺醇異丙託溴銨為抗膽鹼能藥物,為臨牀常用的支氣管擴張劑

截止公告日,公司累計直接投入鹽酸左沙丁胺醇異丙託吸入溶液的研發費用約人民幣1092.47萬元。

本品為2.3改良型新藥,根據國家藥品監督管理局藥品審評中心網站及鹹達數據庫顯示,截至目前,國內僅上海方予申報本品並獲批臨牀

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