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石四药集团(02005.HK):治疗肿瘤口服片剂新药申请获国家药品监督管理局受理
格隆汇 01-15 17:39

格隆汇1月15日丨石四药集团(02005.HK)发布公告,NP-01片(25mg及50mg)的新药申请已获中国国家药品监督管理局药品审评中心受理(受理号:CXHL2000022及CXHL2000023)。该产品为用于治疗肿瘤的口服片剂。

公告表示,NP-01为集团与国内研究机构共同开发,具有自主知识产权的全新小分子化合物,其专利已经在中国、美国和欧洲获得授权,属于化学药品1类新药。研究表明,NP-01在胃癌、肝癌、肺癌、前列腺癌等多种肿瘤动物模型中表现出优异的抗肿瘤活性,具有良好的药代动力学特征,兼具良好的安全性和耐受性,特别是在胃癌PDX模型(人源肿瘤异种移植模型)中显示优于已经上市的抗胃癌小分子靶向药物的抑瘤活性,并且有望拓展至肝癌、肺癌、前列线癌等其他肿瘤,全球尚无同靶点药物获批上市。

NP-01为适度选择性的KDR/MET/Axl多靶点激酶抑制剂,可以实现对肿瘤新生血管的控制,调控肿瘤微环境,激活自身免疫系统,提高肿瘤治疗效果,通过对KDR-MET-Axl的协同作用,有望解决原发和获得性耐药的问题。NP-01也优化激酶选择性,可以实现安全性与有效性的平衡。  

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