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人福醫藥(600079.SH):米非司酮片通過仿製藥一致性評價
格隆匯 12-09 16:17

格隆匯12月9日丨人福醫藥(600079.SH)公佈,近日,公司控股子公司武漢九瓏人福藥業有限責任公司(“九瓏人福”,公司控股子公司湖北葛店人福藥業有限責任公司(持股比例為81.07%)持有其100%的股權)國家藥品監督管理局(“國家藥監局”)關於米非司酮片《藥品補充申請批准通知書》(通知書編號:2020B05143)該藥品通過仿製藥質量和療效一致性評價

米非司酮片是目前廣泛應用的終止妊娠藥,本次批准增加一項適應症,為用於成年生育年齡女性中重度症狀的子宮肌瘤的術前治療九瓏人福2019向國家藥監局遞交一致性評價申請並獲受理,累計研發投入約為人民幣2000元。

根據國家藥品監督管理局網站顯示,國內共有7家企業持有米非司酮片生產批文

根據米內網數據統計2019年度米非司酮全劑型在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為2.4元人民幣,主要生產廠商包括湖北葛店人福藥業有限責任公(含九瓏人福)華潤紫竹藥業有限公司浙江仙琚製藥股份有限公司等。

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