北海康成-B(01228.HK)新藥CAN108上市申請獲受理 或納入優先審評
北海康成-B(01228.HK)宣佈,用於治療Alagille綜合症的產品Maralixibat口服液(CAN108),其新藥上市申請已獲中國國家藥品監督管理局正式受理,並擬納入優先審評程序。
公司表示,該產品用於治療1歲及以上的Alagille綜合症患者的膽汁淤積性瘙癢,此前已獲得美國食品藥品監督管理局批準用於治療Alagille綜合症患者。
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