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健友股份(603707.SH):子公司白消安注射液獲國家藥監局藥品註冊證書
格隆匯 01-18 16:17

格隆匯1月18日丨健友股份(603707.SH)公佈公司子公司健進製藥有限公司(以下簡稱“健進製藥”)產品於近日收到國家藥監局關於核准簽發白消安注射液(規格:10ml:60mg)藥品註冊證書的通知(藥品批准文號:國藥準字H20213017)。

白消安注射液(Busulfan Injection)主要適用於聯合環磷酰胺,作為慢性髓性白血病同種異體的造血祖細胞移植前的預處理方案。原研藥品於1999年得到FDA批准在美國上市(商品名:白舒非®),申請人為OTSUKA(大冢製藥),原研藥品已在中國上市。目前中國國內同規格仿製藥有效批件除健進外,僅有華潤雙鶴藥業股份有限公司一家。

截至目前,該產品項目已投入研發費用約為757.79萬元人民幣。

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