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復星醫藥(600196.SH):貝伐珠單抗注射液獲藥品註冊申請受理
格隆匯 09-09 16:44

格隆匯 9 月 9日丨復星醫藥(600196.SH)公佈,近日,公司控股子公上海復宏漢霖生物製藥有限公司貝伐珠單抗注射液(即HLX04)用於轉移性結直腸癌及晚期、轉移性或複發性非小細胞肺癌治療獲國家藥品監督管理局(國家藥監局)品註冊審評受理。

該新藥為集團自主研發的單克隆抗體生物藥,擬主要用於轉移性結直腸癌、非小細胞肺癌、濕性年齡相關性黃斑變性和糖尿病性視網膜病變適應症的治療。截至本公告日,該新藥用於轉移性結直腸癌治療已完成III期臨牀研究,且已達到預設的主要研究終點該新藥用於濕性年齡相關性黃斑變性和糖尿病性視網膜病變適應症治療已獲國家藥監局臨牀試驗批准。

截至公告日,於中國境內(不包括港澳台地區,下同)上市的貝伐珠單抗包Roche Pharma (Schweiz) Ltd.的安維汀®、齊魯製藥有限公司的安可達®、信達生物製藥(蘇州)有限公司的達攸同®。根據IQVIA CHPA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;IQVIA CHPA據代表中國境內100張牀位以上的醫院藥品銷售市場,不同的藥品因其各自銷售渠道佈局的不同,實際銷售情況可能與IQVIACHPA數據存在不同程度的差異),2019年度,貝伐珠單抗於中國境內的銷售額約為人民幣28.83億元。

截至20208月,集團現階段針對該新藥累計研發投入約人民幣47171萬元(未經審計)。

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