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上海醫藥(02607.HK)糠酸莫米鬆富馬酸福莫特羅吸入氣霧劑獲得臨牀試驗批准
格隆匯 08-19 19:10

格隆匯8月19日丨上海醫藥(02607.HK)公告,近日,公司及其全資子公司上海上藥信誼藥廠有限公司開發的“糠酸莫米鬆富馬酸福莫特羅吸入氣霧劑”收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》。

該藥品由上海上藥信誼藥廠有限公司自主研發,於2020年1月19日提交註冊申請並獲受理,受理號為CYHS2000086。該藥品為皮質類固醇(糠酸莫米鬆)和長效β2-激動劑(富馬酸福莫特羅)聯用,主要用於12歲以上哮喘患者的治療。截至目前,該藥品已累計直接投入的研發費用約725.89萬元人民幣。

該藥品原研為默克公司的糠酸莫米鬆富馬酸福莫特羅氣霧劑(商品名為Dulera),目前國內尚未上市。根據PDB全球暢銷藥500強數據,該藥品2019年的全球市場銷售金額為3.49億元。

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