海普瑞获批H1710临床试验

财中社
18 Feb

  2月18日,海普瑞(002399/09989)发布公告,近日公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,批准注射用H1710开展临床试验。

  该药物的适应症为晚期实体瘤,属于化学药品1类,申请人为公司。审批结论表明,H1710符合药品注册的相关要求,允许在晚期实体瘤患者中进行临床试验。

  H1710是公司自主研发的候选药物,具有全球开发及商业化权益。它是一种靶向乙酰肝素酶的全新化合物,表现出高效高选择性的乙酰肝素酶抑制活性,并在多种肿瘤动物模型中显示出显著的抑瘤作用。截至公告日,全球尚无同一分子机制的同类产品上市。需要注意的是,药品获得临床试验通知书后,仍需进行临床试验并取得相关数据,才能最终上市,存在一定的不确定性。

  2024年前三季度,海普瑞实现收入40.69亿元,归母净利润7.8亿元。

(文章来源:财中社)

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