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復星醫藥(600196.SH):女性絕經後骨質疏鬆症治療藥臨牀試驗申請獲受理
格隆匯 03-09 16:34

格隆匯3月9日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海復宏漢霖生物技術股份有限公司(以下簡稱“復宏漢霖”)及上海復宏漢霖生物製藥有限公司(以下簡稱“漢霖製藥”)收到《受理通知書》(受理號:CXSL2000043國),其研製的重組抗RANKL全人單克隆抗體注射液(即HLX14;以下簡稱“該新藥”)用於高危骨折風險的女性絕經後骨質疏鬆症治療獲國家藥品監督管理局臨牀試驗註冊審評受理。

該新藥由集團自主研發,系Denosumab(商品名:Prolia®)的生物類似藥,擬用於高危骨折風險的女性絕經後骨質疏鬆症治療。截至本公告日,於全球上市的RANKL靶點的單克隆抗體藥品有Amgen,Inc.的Prolia®、Xgeva®等,其中Xgeva®在2019年於中國境內(不包括港澳台地區,下同)上市。

根據IQVIAMIDAS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,RANKL靶點的單克隆抗體藥品於全球的銷售額約為50.29億美元。截至2020年1月,集團現階段針對該新藥累計研發投入為人民幣約4577萬元(未經審計)。

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