健康元(600380.SH):吸入用布地奈德混懸液獲得藥品註冊證書
格隆匯 12 月 10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《藥品註冊證書》,該藥品通用名稱為吸入用布地奈德混懸液。
該品為公司自主研發產品。布地奈德是一種糖皮質激素,通過局部抗炎作用治療哮喘。而吸入療法是防治哮喘等呼吸道疾病的首選療法,吸入的藥物可直接到達呼吸道和肺部,因此具有起效快,使用劑量小、毒副作用小等優點。
截至公告日,吸入用布地奈德混懸液(2ml:1mg)公司累計直接投入的研發費用約人民幣3067.28萬元。
布地奈德吸入混懸液最早由AstraZeneca公司研製生產,1991年在英國首次上市,2001年進入中國市場。根據IQVIA抽樣統計估測數據,國內布地奈德吸入混懸液2019年度終端銷售金額約為人民幣56.32億元。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,已批准上市的該藥品國內生產企業有2家(含公司),國內另有3家廠家申報。
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