健友股份(603707.SH):健進製藥的注射用嗎替麥考酚酯獲批上市
格隆匯5月27日丨健友股份(603707.SH)公佈,公司子公司健進製藥有限公司(簡稱“健進製藥”)產品於近日收到國家藥品監督管理局關於核准簽發注射用嗎替麥考酚酯(規格:500mg)藥品註冊證書的通知(藥品批准文號:國藥準字H20223317)。
嗎替麥考酚酯是麥考酚酸的2-乙基酯類衍生物,是一種抗代謝免疫抑制劑。注射用嗎替麥考酚酯與環孢黴素和皮質類固醇聯合,用於預防接受同種異體腎移植或肝移植患者的急性器官排斥反應。
經查詢,注射用嗎替麥考酚酯,500mg/瓶原研產品是ROCHE持有,商品名為驍悉®(CellCept®),於1996年2月14日在歐洲獲批上市;1998年8月12日獲得美國FDA批准上市;目前原研未在國內上市。江蘇吳中醫藥集團有限公司蘇州製藥廠、重慶萊美藥業股份有限公司、宜昌東陽光長江藥業股份有限公司、石藥集團歐意藥業有限公司、雙鶴藥業(海南)有限責任公司、山西普德藥業有限公司和上海上藥新亞藥業有限公司的注射用嗎替麥考酚酯仿製藥已獲批上市。公司子公司注射用嗎替麥考酚酯按新化學藥品4類註冊申報,並獲得批准,為國內首家通過注射用嗎替麥考酚酯一致性評價的企業(此類藥品視同通過仿製藥一致性評價)。
截至目前,公司在注射用嗎替麥考酚酯研發項目上已投入研發費用約人民幣1232.80萬元。
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