Gyre Therapeutics今日宣布,中国国家药品监督管理局(NMPA)已正式授予其核心药物海酮内酯(研发代号F351)的新药上市申请(NDA)优先审评资格。该药物拟用于治疗慢性乙型肝炎(CHB)引发的肝纤维化。
此次优先审评资格的获得,意味着该药物的审评流程有望大幅提速,为亟需创新疗法的肝纤维化患者带来了新的希望。肝纤维化是慢性肝病进展为肝硬化和肝癌的关键环节,目前临床治疗选择有限。
Gyre Therapeutics今日宣布,中国国家药品监督管理局(NMPA)已正式授予其核心药物海酮内酯(研发代号F351)的新药上市申请(NDA)优先审评资格。该药物拟用于治疗慢性乙型肝炎(CHB)引发的肝纤维化。
此次优先审评资格的获得,意味着该药物的审评流程有望大幅提速,为亟需创新疗法的肝纤维化患者带来了新的希望。肝纤维化是慢性肝病进展为肝硬化和肝癌的关键环节,目前临床治疗选择有限。
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