海正药业(600267.SH):HS236胶囊获药物临床试验批准通知书
格隆汇7月30日丨海正药业(600267.SH)公布,近日,公司收到国家药品监督管理局核准签发的HS236胶囊(50mg、200mg)的《药物临床试验批准通知书》。
HS236为成纤维细胞生长因子受体4(FGFR4)选择性抑制剂,HS236胶囊主要适用于治疗肝细胞肝癌和其他晚期恶性实体瘤。截至目前,国内外有部分制药公司在进行FGFR4抑制剂的研发,尚未有FGFR4特异性抑制剂类药品上市销售。
2020年5月,公司向国家药品监督管理局提交该药品临床注册申请获得药品审评中心正式受理。后续公司将按照上述药物临床试验通知书要求进行本品临床试验研究。截至目前,公司在该药品研发项目上已投入约2072万元人民币。
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