石药集团(01093)：瑞戈非尼片获药品注册批件

智通财经

01-20

智通财经APP讯，石药集团(01093)发布公告，集团开发的瑞戈非尼片( 40mg )已获得中华人民共和国国家药品监督管理局颁发的药品注册批件，并视同通过仿制药质量和疗效一致性评价。

瑞戈非尼是一种小分子口服多靶点激酶抑制剂，适用于治疗既往接受过以氟尿嘧啶、奥沙利铂和伊立替康为基础的化疗，以及既往接受过或不适合接受抗VEGF治疗、抗EGFR治疗( RAS野生型 )的转移性结直肠癌( m CRC )患者;既往接受过甲磺酸伊马替尼及苹果酸舒尼替尼治疗的局部晚期的、无法手术切除的或转移性的胃肠道间质瘤( GIST )患者;既往接受过索拉非尼治疗的肝细胞癌( HCC )患者。

该产品的获批将进一步丰富集团在抗肿瘤领域的产品线。

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