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復星醫藥(02196.HK):馬來酸阿伐曲泊帕片獲國家藥監局臨牀試驗註冊審評受理
格隆匯 08-12 20:46

格隆匯 8 月 12日丨復星醫藥(02196.HK)公告,近日,上海復星醫藥(集團)股份有限公司(以下簡稱“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”)收到《受理通知書》,其獲許可的馬來酸阿伐曲泊帕片(以下簡稱“該新藥”)用於慢性免疫性血小板減少症適應症(ITP)獲國家藥品監督管理局(以下簡稱“國家藥監局”)臨牀試驗註冊審評受理。

復星醫藥產業於2018年3月獲美國AkaRx,Inc.(為DovaPharmaceuticals,Inc.控股子公司;以下簡稱“AkaRx”)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(1)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、(2)腫瘤化療引起的血小板減少症、(3)慢性免疫性血小板減少症等。

截至公告日,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已於美國、歐盟、中國境內(不包括港澳台地區,下同)上市,適用於慢性免疫性血小板減少症已於美國上市。截至公告日,該新藥適用於腫瘤化療引起的血小板減少症於中國境內處於III期臨牀試驗中。

根據IQVIAMIDASTM最新數據(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商),2019年度,阿伐曲泊帕片於全球銷售額約為343萬美元。

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