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復星醫藥(02196.HK)子公司斯魯利單抗注射液聯合重組抗EGFR人源化單克隆抗體注射液用於治療晚期實體瘤開展II期臨牀試驗獲批准
格隆匯 12-20 18:57

格隆匯12月20日丨復星醫藥(02196.HK)公吿,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收到國家藥品監督管理局關於同意斯魯利單抗注射液(即重組抗PD-1人源化單克隆抗體注射液)聯合重組抗EGFR人源化單克隆抗體注射液(即HLX07)用於治療晚期實體瘤開展II期臨牀試驗的批准。復宏漢霖擬於條件具備後於中國境內(不包括港澳台,下同)啟動相關適應症的II期臨牀試驗。

斯魯利單抗注射液、重組抗EGFR人源化單克隆抗體注射液(即HLX07)均為集團(即公司及控股子公司/單位,下同)自主開發的創新型治療用生物製品。截至本公吿日,斯魯利單抗注射液單藥及以其為核心的8項聯合療法正在全球多個國家和地區開展臨牀試驗;重組抗EGFR人源化單克隆抗體注射液(即HLX07)用於治療實體瘤於中國境內處於Ib/II期臨牀試驗中、於中國台灣完成Ia期臨牀試驗。

截至本公吿日,斯魯利單抗注射液聯合重組抗EGFR人源化單克隆抗體注射液(即HLX07)用於治療復發或轉移性頭頸部鱗狀細胞癌於中國境內處於II期臨牀試驗中。本次斯魯利單抗注射液聯合重組抗EGFR人源化單克隆抗體注射液(即HLX07)獲批用於晚期實體瘤治療的臨牀研究。截至本公吿日,中國境內尚無同類聯合用藥治療方案獲國家藥監局上市批准。

截至2021年11月,集團現階段針對斯魯利單抗注射液聯合重組抗EGFR人源化單克隆抗體注射液(即HLX07)相關治療方案的累計研發投入為人民幣3,147萬元(未經審計;不包含單藥)。

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