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復星醫藥(02196.HK):馬來酸阿伐曲泊帕片新增適應症註冊申請獲受理

格隆匯12月22日丨復星醫藥(02196.HK)公吿,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“本公司”)控股子公司上海復星醫藥產業發展有限公司(以下簡稱“復星醫藥產業”)許可引進的馬來酸阿伐曲泊帕片(商品名:蘇可欣®,以下簡稱“該藥品”)用於治療對既往治療反應不佳的成人慢性免疫性血小板減少症(ITP)(以下簡稱“本次新增適應症”)的藥品註冊申請獲國家藥品監督管理局審評受理。

該藥品為化學藥品,系復星醫藥產業於2018年3月獲美國AkaRx,Inc.(為Swedish Orphan BiovitrumAB控股子公司;以下簡稱“AkaRx”)關於該藥品在區域內(即中國大陸及香港特別行政區,下同)獨家銷售代理權(包括為實現銷售享有的獨家註冊、開發權)的許可,AkaRx仍為該藥品在區域內的權利人,復星醫藥產業在區域內的銷售由AkaRx負責供貨。

2020年4月該藥品獲批於中國境內(不包括港澳台地區,下同)上市,適應症為適用於擇期行診斷性操作或者手術的慢性肝病相關血小板減少症的成年患者。截至本公吿日,除蘇可欣®外,於中國境內尚無其他阿伐曲泊帕片上市。2021年度,蘇可欣®於中國境內的銷售額約為人民幣4.26億元。

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