海正药业(600267.SH):子公司HS301片(40mg、80mg)获批开展局部晚期或转移性实体瘤临床试验
格隆汇1月25日丨海正药业(600267.SH)公布,近日,浙江海正药业股份有限公司全资子公司瀚晖制药有限公司(“瀚晖制药”)收到国家药品监督管理局核准签发的HS301片(40mg、80mg)的《药物临床试验批准通知书》。
HS301片是第二代口服NTRK/ROS1小分子激酶抑制剂,是一种泛癌种治疗药物,能够克服多种突变和耐药,适用于治疗含有NTRK1/2/3和ROS1融合阳性的实体瘤。
目前Roche公司的第一代NTRK/ROS1抑制剂恩曲替尼(Entrectinib,商品名Rozlytrek)以及礼来旗下LoxoOncology公司开发的第一代NTRK抑制剂拉罗替尼(Larotrectinib,商品名Vitrakvi)已在美国获批上市,在中国处于注册申报阶段;第二代NTRK/ROS1抑制剂均未上市。
后续瀚晖制药将按照上述《药物临床试验批准通知书》要求进行该品临床试验研究。截至目前,公司在该药品研发项目上已投入约3221万元人民币。
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