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賽生藥業(06600.HK):與美納里尼就Orserdu®於中國訂立許可及合作協議
格隆匯 11-07 06:19

格隆匯11月7日丨賽生藥業(06600.HK)發佈公吿,公司已與美納里尼集團(“美納里尼”)旗下BerlinChemie AG訂立許可及合作協議,授權集團根據此前美納里尼與Radius Health, Inc.(“Radius”)的總許可協議於中國獨家開發及商業化Orserdu® (Elacestrant)(“Orserdu®”)。Orserdu®為第一個也是唯一一個專門用於治療具有ESR1突變的ER+、HER2-晚期或轉移性乳腺癌(“mBC”)患者的療法,其獲美國食品藥品監督管理局(“FDA”)授予的優先審批資格與快速通道認定並於2023年1月獲FDA批准,隨後亦於2023年9月獲歐盟委員會批准。許可協議項下擬進行交易旨在將此創新治療方法引入中國,前提是獲得中國的監管批准。

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