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復星醫藥(600196.SH):馬來酸阿伐曲泊帕片用於ITP獲批臨牀試驗
格隆匯 10-13 16:22

格隆匯10月13日丨復星醫藥(600196.SH)宣佈,近日,公司控股子公司復星醫藥產業收到國家藥品監督管理局關於同意其獲許可的馬來酸阿伐曲泊帕片用於成人慢性免疫性血小板減少症適應症(ITP)開展臨牀試驗的通知書。復星醫藥產業擬於近期條件具備後於中國境內(不包括港澳台地區,下同)開展該新藥針對該適應症的III期臨牀試驗。

復星醫藥產業於2018年3月獲美國AkaRx, Inc.(現為Swedish Orphan Biovitrum AB之控股子公司;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。截至該公告日,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、中國境內上市,適用於慢性免疫性血小板減少症(ITP)已於美國上市。此外,該新藥用於腫瘤化療引起的血小板減少症(CIT)亦於近期完成國際多中心III期臨牀試驗,初步分析試驗結果未達到預設主要複合終點;據此,復星醫藥產業將結合對該臨牀研究試驗及結果的分析,進一步評估確定該適應症於中國境內的臨牀開發策略、優化臨牀試驗設計並確定註冊策略。

根IQVIA MIDASTM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。

截至2020年9月,集團現階段針對該新藥累計研發投入約為人民幣1.06億元(未經審計;包括許可轉讓費)。

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