福森药业(01652):“恩扎卢胺软胶囊”获批上市

智通财经
Oct 30

智通财经APP讯,福森药业(01652)发布公告,集团的全资附属公司嘉亨(珠海横琴)医药科技有限公司研发的“恩扎卢胺软胶囊”,上市申请已获得中国国家药品监督管理局批准,批准用于以下疾病的治疗:有高危转移风险的非转移性去势抵抗性前列腺癌(NM-CRPC)成年患者;雄激素剥夺治疗(ADT)失败后无症状或有轻微症状且未接受化疗的转移性去势抵抗性前列腺癌(CRPC)成年患者。

恩扎卢胺是一种雄激素受体抑制剂,作用于雄激素受体信号通路,可竞争性抑制雄激素与雄激素受体结合,进而抑制雄激素受体核移位以及雄激素受体与DNA的相互作用。恩扎卢胺主要代谢物N-去甲基–恩扎卢胺的体外活性与恩扎卢胺相似。恩扎卢胺在体外可抑制前列腺癌细胞增殖并诱导前列腺癌细胞死亡,且在小鼠前列腺癌移植瘤模型中可降低肿瘤体积。

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