昭衍助力首个国产重组人凝血因子Ⅶa类生物制品获批上市!7月3日,正大天晴收到国家药品监督管理局(NMPA)核准签发的《药品注册证书》,批准注射用重组人凝血因子Ⅶa N01用于凝血因子Ⅷ或Ⅸ抑制物>5个Bethesda(BU)单位的成人及青少年(12岁以上)先天性血友病患者的出血治疗。在此项目中,昭衍新药作为正大天晴的合作伙伴,严格按照NMPA的指导原则,为其量身打造了覆盖药效、药代动力学研究、毒理...
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