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中恆集團(600252.SH):伏立康唑片獲得藥品註冊證書
格隆匯 11-08 18:17

格隆匯11月8日丨中恆集團(600252.SH)公佈,公司的控股子公司萊美藥業近日收到國家藥品監督管理局核准簽發的伏立康唑片《藥品註冊證書》,藥品通用名稱:伏立康唑片;規格:50mg、0.2g;主要成份:伏立康唑。

伏立康唑片最早由輝瑞製藥有限公司研製,2002年5月在美國獲得FDA批准上市,2004年10月獲國家藥品監督管理局批准上市。目前國內已上市主要劑型包括注射劑、片劑、膠囊劑、混懸劑。伏立康唑片是一種廣譜的三唑類抗真菌藥,治療侵襲性麴黴病,非中性粒細胞減少患者中的念珠菌血症,對氟康唑耐藥的念珠菌引起的嚴重侵襲性感染(包括克柔念珠菌),由足放線病菌屬和鐮刀菌屬引起的嚴重感染。主要用於進展性、可能威脅生命的真菌感染患者的治療。預防接受異基因造血幹細胞移植(HSCT)的高危患者中的侵襲性真菌感染。

經查詢,截止目前國內約有7家企業取得了伏立康唑片藥品註冊證書。根據米內網數據顯示,伏立康唑片2018年、2019年、2020年在中國城市公立醫院終端市場銷售額分別為20億元、21.52億元、18.2億元。

截至目前,萊美藥業在伏立康唑片研發項目上已投入研發費用3203.98萬元。

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