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遠大醫藥(00512.HK)合作夥伴滴眼液新藥上市申請獲美國FDA批准
阿思達克 03-07 17:37
遠大醫藥(00512.HK)表示,在眼科領域的合作夥伴台新藥股份公布其用於眼科術後抗炎鎮痛的激素納米混懸滴眼液GPN00833(APP13007)的新藥上市申請(NDA)近日正式獲得美國食品藥品監督管理局(FDA)批准。 集團擁有該產品在中國大陸、香港和澳門地區的獨家開發和商業化權利,此次該產品的重大海外進展將會進一步為中國的註冊工作提供支持。目前,該產品已於2023年4月在中國獲批開展III期臨床研究,並已完成首例患者入組給藥。
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