智通财经APP讯，海思科(002653.SZ)披露近日收到美国食品药品监督管理局(“FDA”)的 Study May Proceed Letter，根据FDA相关规定，经审查，公司2025年5月递交的HSK47388片临床试验申请符合药品注册的有关要求，同意本品开展临床试验。
公告称，HSK47388片是公司自主研发的口服、强效、高选择性的药物，拟用于自身免疫疾病的治疗。临床前研究结果显示，HSK47388可以剂量依赖地抑制大鼠炎症反应，同时也表现出了良好的耐受性和较大的安全窗，是一款极具开发潜力的药物，有望为自身免疫疾病患者提供一种新的治疗选择。
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