復星醫藥(02196.HK)收到馬來酸阿伐曲泊帕片《進口藥品註冊證》
格隆匯4月16日丨復星醫藥(02196.HK)公告,近日,公司控股子公司上海復星醫藥產業發展有限公司收到國家藥品監督管理局關於馬來酸阿伐曲泊帕片的《進口藥品註冊證》,批准該新藥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。
復星醫藥產業於2018年3月獲美國AkaRx Inc.關於該新藥在區域內(即中國大陸及香港特別行政區)的獨家銷售代理權(包括為實現銷售享有的獨家註冊、開發權)的許可,AkaRx仍為該新藥在區域內的權利人,復星醫藥產業在區域內的銷售將由AkaRx負責供貨。
該新藥為化學藥品,主要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、腫瘤化療引起的血小板減少症等。2018年5月,AkaRx的阿伐曲泊帕片(商品名稱:Doptelet)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獲美國FDA(即美國食品藥品監督管理局)上市批准。2019年6月,該新藥用於腫瘤化療引起的血小板減少症的III期臨牀試驗申請已獲國家藥監局批准。
截至本公告日,於全球上市的阿伐曲泊帕片僅為AkaRx的Doptelet,於中國境內(不包括港澳台地區)尚無具有自主知識產權、且與該新藥同類產品上市。根據IQVIAMIDASTM最新數據,2019年度,Doptelet於全球銷售額約為343萬美元。
截至2020年3月,集團現階段針對該新藥累計研發投入為人民幣約3,964萬元(未經審計;包括許可轉讓費)。
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