普利製藥(300630.SZ):注射用阿奇黴素獲得英國藥品註冊批件
格隆匯12月19日丨普利製藥(300630.SZ)公佈,公司於近日收到英國藥品和健康產品管理局(MHRA)簽發的注射用阿奇黴素批准通知。
注射用阿奇黴素適應症:適用於敏感病原菌所致的下列感染,1、社區獲得性肺炎;2、盆腔炎性疾病。
化合物阿奇黴素(Azithromycin)最初由Pliva研發團隊發現和研製。1986年,Pliva與Pfizer(輝瑞)簽署授權協議,Pfizer獲得西歐和美國的獨家市場銷售權,1997年輝瑞注射用阿奇黴素(商品名為ZITHROMAX)在美國獲准上市,2007年進口原研(商品名:希舒美)在國內獲准上市。注射用阿奇黴素目前已經在全球廣泛上市銷售。
公司注射用阿奇黴素完成技術研發後,逐步向國內外多個市場提交了產品的上市申請,目前獲得的批准情況如下:於2017年7月獲得國家食品藥品監督管理總局簽發的註冊批件,並於2018年5月通過中國化學仿製藥質量與療效一致性評價。2018年10月以來逐步獲得了美國、荷蘭、奧地利、德國、加拿大、澳大利亞、馬來西亞、泰國、新西蘭、白俄羅斯等多個國家的批准。
注射用阿奇黴素註冊申請獲得英國MHRA批准標誌着普利製藥的注射用阿奇黴素具備了在英國銷售的資格,將對公司拓展英國市場帶來積極影響。
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