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復星醫藥(600196.SH):復宏漢霖與Intas簽訂許可協議 就相關合作達成正式協議
格隆匯 01-04 17:52

格隆匯 1 月 4日丨復星醫藥(600196.SH)公佈,2020929公司控股子公司復宏漢霖Intas的控股子公司Accord Healthcare Inc. (“Accord”)簽訂BindingTerm Sheet》即許可條款書,復宏漢霖擬授予Accord區域該產品獨家商業化相關權利的許可該許可的具體安排擬由雙方進一步商議確定,雙方簽訂正式協議並以該等協議約定為準且雙方同意在簽訂正式協議時,可由Accord股東Intas作為被許

基於上述《許可條款書》,202114,復宏漢霖Intas簽訂《License Agreement(“《許可協議》”)雙方就此次合作達成正式協議。

該產品為集團自主研發的單克隆抗體生物類似藥,主要用於HER2 陽性的轉移性乳腺癌、HER2 陽性的早期乳腺癌及HER2陽性的轉移性胃腺癌或胃食管交界處腺癌治療等。

截至公吿日,該產品用於HER2陽性的轉移性乳腺癌、HER2陽性的早期乳腺癌HER2 陽性的轉移性胃腺癌或胃食管交界處腺癌治療於中國境內(不包括港澳台地區)的上市註冊申請已獲國家藥品監督管理局批准;用於HER2陽性的早期乳腺癌、HER2陽性的轉移性乳腺癌及未經治療的HER2陽性的轉移性胃癌或胃/食管交界處腺癌治療於歐盟的上市申請(MMA)已獲歐盟委員會批准。該產品於區域內的開發、注冊、生產、銷售等還須區域內相關監管機構的批准。

截至202011月,集團現階段針對該產品累計研發投入約人民幣87652萬元(未經審計)。

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