健友股份(603707.SH):獲得異舒泛藍注射液藥物臨牀試驗批准通知書
格隆匯7月29日丨健友股份(603707.SH)宣佈,公司於近日收到國家藥監局核准簽發的《藥物臨牀試驗批准通知書》。藥品名稱為異舒泛藍注射液;劑型為注射劑;規格為5ml:50mg;受理號為CYHS1900840。
異舒泛藍注射液,1981年由HirschIn dustries開發,1981年07月29日經FDA批准在美國上市。商品名為LYMPHAZURIN®,規格為5ml:50mg,NDA申請號為N018310。HirschIn dustries之後被COVIDIEN收購,COVIDIEN成為該NDA的持有人。LYMPHAZURIN®是第一個也是唯一一個被FDA批准用於淋巴管造影術的染料示蹤劑。
異舒泛藍是一種生理惰性染料,沒有藥理作用,經皮下注射後,在軟組織中彌散度低,並與間質蛋白微弱結合,選擇性的與淋巴管結合,因此淋巴管和淋巴結可被明顯藍染從而與周圍組織區分開來,具有簡便、快捷、直觀等特點,是國外最常用的染料示蹤劑。目前國內無原研商品上市,也無同類仿製藥上市。
截至目前,該產品項目已投入研發費用約為639.40萬元人民幣。
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