復星醫藥(600196.SH):控股子公司獲臨牀試驗通知書
格隆匯10月17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”)收到國家藥監局關於同意注射用HLX55單抗用於轉移性或複發性實體瘤治療開展臨牀試驗的通知書。復宏漢霖及漢霖製藥擬於近期條件具備後於中國境內(不包括港澳台地區,下同)開展該新藥的I期臨牀試驗。
該新藥為集團(即公司及控股子公司/單位,下同)獲Kolltan Pharmaceuticals, Inc.許可、並後續自主研發的創新型治療用生物製品,主要用於轉移性或複發性實體瘤的治療。2019年8月,該新藥獲國家藥監局臨牀試驗註冊審評受理。截至本公告日,該新藥用於無其他標準治療的晚期實體瘤治療已獲台灣“衞生福利部”臨牀試驗批准。
截至本公告日,在全球範圍內尚無該新藥的同類產品上市。截至2019年9月,本集團現階段針對該新藥累計研發投入為人民幣約6623萬元(未經審計;包括許可費)。
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