华森制药(002907.SZ):CX001缓释片获得药物临床试验批准

智通财经网
Jul 02, 2025

智通财经APP讯,华森制药(002907.SZ)发布公告,公司于近日收到国家药品监督管理局(以下简称“国家药监局”)核准签发的《药物临床试验批准通知书》。经审查,2025年4月16日受理的CX001缓释片临床试验申请符合药品注册的有关要求,同意本品开展“用于治疗带状疱疹后神经痛”适应症的临床试验。

CX001缓释片为公司自研产品,将速释制剂改良为缓释制剂(胃滞留缓释片),该缓释制剂可降低给药频率、增加患者顺应性、提高睡眠质量。本次申请开展临床试验的适应症为用于治疗带状疱疹后神经痛。

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