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健友股份(603707.SH):子公司獲得美國FDA瑞加諾生注射液藥品註冊批件
格隆匯 04-12 15:46

格隆匯4月12日丨健友股份(603707.SH)公佈,公司子公司香港健友于近日收到美國食品藥品監督管理局(以下簡稱“美國FDA”)簽發的瑞加諾生注射液,0.4mg/5mL(0.08mg/mL)(ANDA號:212806)批准信。

瑞加諾生注射液原研藥品,由ASTELLAS PHARMA US INC持有,2008年4月10日經FDA批准在美國上市。商品名為LEXISCAN,規格為0.4mg/5mL(0.08mg/mL),NDA申請號為N022161。

經查詢,美國境內目前僅有原研藥品(LEXISCAN)獲批上市。目前國內僅有海融製藥1家公司的國產瑞加諾生注射液獲批上市。經查詢,瑞加諾生注射液2020年美國市場銷售額約為6億美元。

截至目前,公司在瑞加諾生注射液研發項目上已投入研發費用約人民幣3199萬元。

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