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復星醫藥(02196.HK):復宏漢霖授予Accord在美國及加拿大就HLX02獨家商業化及與相關權利許可
格隆匯 10-08 16:23

格隆匯10月8日丨復星醫藥(02196.HK)公告,上海復星醫藥(集團)股份有限公司(以下簡稱“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”)授予AccordHealthcareInc.(以下簡稱“Accord”)在區域內(即美國、加拿大,下同)就HLX02(即注射用曲妥珠單抗;以下簡稱“該產品”)獨家商業化(包括但不限於出口、進口、推廣、儲存、要約出售及分銷等商業化行為)及與相關權利的許可(以下簡稱“本次合作”)。

該產品為集團(即公司及控股子公司/單位,下同)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。

截至公告日,該產品用於HER2陽性的轉移性乳腺癌、HER2陽性的早期乳腺癌及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;該產品用於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營銷授權申請(即MAA)已獲歐盟委員會批准。該產品於區域內的開發、註冊、生產、銷售等還須得到區域內相關監管機構的批准。

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