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復宏漢霖(02696.HK)注射用曲妥珠單抗獲歐洲藥品管理局積極審評意見
阿思達克 06-01 09:51
復宏漢霖(02696.HK)公布,近日公司商務合作夥伴Accord Healthcare的全資子公司遞交的HLX02(注射用曲妥珠單抗)用於HER2陽性的早期乳腺癌、HER2陽性的轉移性乳腺癌,以及未經治療的HER2陽性的轉移性胃癌或胃/食管交界處腺癌治療的營銷授權申請(MAA)獲歐洲藥品管理局人用醫藥產品委員會極審評意見,建議批准MAA。

該審評意見將會被遞交至歐盟委員會,將參考人用醫藥產品委員會的意見並在未來2至3個月做出最終審查決定。一旦獲得批准,HLX02將在所有歐盟成員國及冰島、列支敦士登和挪威(各自為歐洲經濟區國家)獲得集中上市許可。

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