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復星醫藥(600196.SH)就HLX10聯合化療用於一線治療局部晚期或轉移性鱗狀非小細胞肺癌啟動III期臨牀研究
格隆匯 08-14 18:28

格隆匯8月14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(“復宏漢霖”)於中國境內(不包括港澳台地區,下同)就HLX10(即重組抗PD-1人源化單克隆抗體注射液;“該新藥”)聯合化療(卡鉑-白蛋白紫杉醇)用於一線治療局部晚期或轉移性鱗狀非小細胞肺癌啟動III期臨牀研究。

該新藥為集自主研發的創新型治療用生物製品,主要用於實體瘤治療,目前正進一步探索慢性乙型肝炎治療的可能性。截至本公告日,該新藥用於實體瘤治療於台灣地區處於臨牀I期試驗中,並已獲國家藥品監督管理局、美國食品藥品監督管理局臨牀試驗批准;該新藥用於慢性B肝炎(即慢性乙型肝炎)已獲台灣“衞生福利部”臨牀試驗批准;該新藥聯合化療(順鉑+5-FU)用於一線治療局部晚期轉移性食管鱗癌於中國境內處於臨牀III試驗中。

截至公告日,於中國境內上市的重組抗PD-1人源化單克隆抗體注射液包括默沙東製藥有限公司的可瑞達®、美國百時美施貴寶公司的歐狄沃®。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),2018年度,重組抗PD-1人源化單克隆抗體注射液於中國境內銷售額約為人民幣2668元。

截至20197月,集團現階段針對該新藥累計研發投入為人民幣約17696萬元(未經審計)

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