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中國生物製藥(01177.HK)治療哮喘藥物“孟魯司特鈉顆粒”獲藥品註冊批件
格隆匯 03-02 17:52

格隆匯3月2日丨中國生物製藥(01177.HK)發佈公告,公司附屬公司江蘇正大豐海製藥有限公司開發的預防和長期治療哮喘藥物“孟魯司特鈉顆粒”(商品名稱:辛泰),已獲國家藥品監督管理局頒發藥品註冊批件。該產品按照化藥新4類申報,視同通過仿製藥質量和療效一致性評價,國內二仿獲批。該產品獲批上市,進一步豐富和完善了集團呼吸領域的產品線佈局。

根據披露,孟魯司特鈉是一種口服的白三烯受體拮抗劑,能預防和減輕粘膜炎性細胞浸潤,舒張支氣管平滑肌;臨牀用於哮喘的預防和長期治療,可治療對阿司匹林敏感的哮喘患者以及預防運動誘發的支氣管收縮,亦適用於減輕過敏性鼻炎引起的症狀,常用於兒科、呼吸科、耳鼻咽喉科等科室。孟魯司特鈉顆粒適用於1歲以上兒童及成人哮喘的預防及治療,及適合2至5歲兒童及成人過敏性鼻炎使用,具有療效顯著、作用時間長、使用方便、服用順應性高的特點,市場潛力巨大。

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