智通财经APP讯，汇宇制药(688553.SH)发布公告，公司全资子公司四川汇宇海玥医药科技有限公司(以下简称“汇宇海玥”)于2025年11月21日收到国家药品监督管理局核准签发的《受理通知书》，HYP-6589片(项目研发代号为“HY-0006”)用于开展与奥希替尼联合治疗靶点驱动基因阳性的晚期非小细胞肺癌的临床试验申请获得受理。
HYP-6589片是公司全资子公司汇宇海玥开发的高选择性SOS1小分子抑制剂，其注册分类为化学药1类创新药。根据国家药品监督管理局发布的《化学药品注册分类及申报资料要求》(2020年第44号)，HYP-6589为新的结构明确的，具有药理作用的化合物，公司已获批并正在中国开展单药治疗晚期实体瘤的临床研究。
本次新增申请开展与奥希替尼联合治疗靶点驱动基因阳性的晚期非小细胞肺癌的临床试验研究。截至本公告披露日，国内外尚无同类产品获批上市。
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