国产首款重组人凝血因子VIIa仿制药获批上市

CPHI制药在线
04 Jul

关注并星标CPHI制药在线7月3日,国家药监局宣布正大天晴“重组人凝血因子VIIa”(TQG203)正式获批上市!作为国内首个打破外资垄断的国产仿制药,它终结了诺和诺德同类产品长达十余年的“独家供应”,让45万中国血友病患者迎来“救命药”本土化破局的关键一步。高难仿制,技术壁垒如何被攻破?重组人凝血因子 VIIa 的仿制难度极高,主要于其复杂的分子结构。该药物由 406 个氨基酸组成双链结构,且...

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