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健友股份(603707.SH):注射用伏立康唑獲批臨牀試驗
格隆匯 10-13 16:58

格隆匯10月13日丨健友股份(603707.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》。

根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年06月10日受理的注射用伏立康唑符合藥品註冊的有關要求,同意該品開展臨牀試驗。

伏立康唑由輝瑞公司開發,於 2002年03月獲歐洲藥物管理局(EMA)批准上市,於2002年05月獲美國食品藥品監督管理局(FDA)批准上市,商品名為VFEND®

注射用伏立康唑是一種廣譜的三唑類抗真菌藥,適用於治療成人和2歲及2歲以上兒童患者的下列真菌感染:(1)侵襲性麴黴病;(2)非中性粒細胞減少患者中的念珠菌血症;(3)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);(4)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,注射用伏立康唑於2004年10月21日首次在國內批准上市,上市許可持有人為Pfizer Limited,商品名為威凡(Vfend®),規格為200mg,目前國內已獲批的企業有麗珠集團麗珠製藥廠、晉城海斯製藥有限公司、珠海億邦製藥有限責任公司和四川美大康華康藥業有限公司。

截至目前,該產品項目已投入研發費用約為1921.92萬元人民幣。

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