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國藥現代(600420.SH):國藥致君坪山的孟魯司特鈉咀嚼片獲得藥品註冊證書
格隆匯 12-08 17:02

格隆匯12月8日丨國藥現代(600420.SH)公佈,近日,上海現代製藥股份有限公司控股子公司國藥集團致君(深圳)坪山製藥有限公司(簡稱“國藥致君坪山”)收到國家藥品監督管理局核准簽發的孟魯司特鈉咀嚼片藥品註冊證書。

孟魯司特鈉咀嚼片是選擇性半胱氨酰白三烯受體拮抗劑,適用於哮喘的預防和長期治療,以及減輕過敏性鼻炎引起的症狀。該藥品最早由Merck Sharp&Dohme B.V.研究開發,於1998年獲FDA批准上市。

國藥致君坪山的孟魯司特鈉咀嚼片是以化學藥品4類申報註冊,視同通過一致性評價。根據CDE網站顯示,目前該藥品通過/視同通過一致性評價的企業還有杭州民生濱江製藥有限公司、石藥集團歐意藥業有限公司、齊魯製藥(海南)有限公司等。根據PDB數據庫顯示,2021年度,孟魯司特全球市場的銷售額為15.67億美元,國內樣本醫院的銷售額為人民幣2.15億元。

截至目前國藥致君坪山在該項目累計投入研發費用約人民幣1800餘萬元(未經審計)。

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