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復星醫藥(600196.SH):控股子公司獲美國FDA藥品臨牀試驗批准

格隆匯5月6日丨復星醫藥(600196.SH)公佈,公司控股子公司上海復宏漢霖生物技術股份有限公司及其控股子公司(以下合稱“復宏漢霖”)於近日收到美國FDA(即美國食品藥品監督管理局)關於同意HLX22(即抗人表皮生長因子受體-2(HER2)人源化單克隆抗體注射液)聯合曲妥珠單抗及化療一線治療HER2陽性的晚期胃癌(以下簡稱“該治療方案”)開展臨牀試驗的函。復宏漢霖擬於條件具備後於美國開展該治療方案的III期臨牀試驗。

該治療方案中所涉HLX22為本集團(即本公司及控股子公司/單位,下同)自AbClon,Inc.許可引進,並後續自主研發的新型靶向HER2的單克隆抗體,擬用於胃癌和乳腺癌等實體瘤的治療。截至本公吿日,HLX22單藥用於治療HER2過表達晚期實體瘤已於中國境內(不包括港澳台地區,下同)完成I期臨牀研究、HLX22聯合注射用曲妥珠單抗及化療一線治療HER2陽性的局部晚期/轉移性胃癌(GC)於中國境內處於II期臨牀試驗階段、HLX22聯合漢斯狀®(斯魯利單抗注射液)聯合標準治療(即曲妥珠單抗聯合化療)一線治療局部晚期/轉移性胃癌(GC)已於中國境內獲II期臨牀試驗批准。

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