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健康元(600380.SH):鹽酸左沙丁胺醇霧化吸入溶液獲藥品補充申請批准通知書
格隆匯 08-19 18:17

格隆匯 8 月 19日丨健康元(600380.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,藥品通用名稱為鹽酸左沙丁胺醇霧化吸入溶液。

本產品活性成分鹽酸左沙丁胺醇為短效β2受體激動劑,其能產生舒張支氣管平滑肌的作用,主要用於預防和治療6-11歲兒童可逆性氣道阻塞性疾病引起的支氣管痙攣,如支氣管哮喘等。

本產品是在公司已獲批的鹽酸左沙丁胺醇霧化吸入溶液(規格:3ml:0.63mg批准文號:國藥準字H20193279)基礎上,申請新增3ml:0.31mg規格3ml:0.63mg規格相比,3ml:0.31mg規格更適合於6歲以上兒童哮喘患者的症狀緩解及長期控制。首次提交本品註冊申請的受理時間為20200416日(受理號:CYHB2002557)。

截至公告日,鹽酸左沙丁胺醇霧化吸入溶液累計直接投入的研發費用約人民幣3578.50萬元。

鹽酸左沙丁胺醇霧吸入溶液原研品種為Sepracor公司(後Sunovion)Xopenex®,該藥3ml:0.63mg規格199904月在美國上市,3ml:0.31mg規格200202月上市

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,截至公告日,國內只有公司取得該品種註冊批件另有1家企業審評審批

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