海思科(002653.SZ)获得创新药HSK46575片新增适应症IND申请受理

智通财经12-22 17:36

智通财经APP讯，海思科(002653.SZ)发布公告，公司子公司辽宁海思科制药有限公司于近日收到国家药品监督管理局下发的《受理通书》，涉及药品：“HSK46575”。本次获得受理的为本品联合奥拉帕利片或联合多西他赛和泼尼松片用于前列腺癌的治疗适应症的临床试验申请。

HSK46575片是公司自主研发的一种口服、强效和高选择性的小分子抑制剂，拟用于前列腺癌的治疗。临床前研究结果表明，本品靶点明确、疗效确切、安全性好，是一款极具开发潜力的小分子药物，临床应用的效益/风险比高，具有广阔的临床应用前景，有望成为前列腺癌的有效治疗药物并解决目前临床用药匮乏的难题。根据国家药品监督管理局关于发布《化学药品注册分类及申报资料要求》的通告(2020年第44号)中化学药品注册分类的规定，本品属于化学药品1类。

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