宣泰医药(688247.SH)：恩杂鲁胺片获美国FDA批准文号

智通财经2025-06-26

智通财经APP讯，宣泰医药(688247.SH)公告，公司收到美国食品药品监督管理局(简称“美国FDA”)的通知，公司向美国FDA申报的恩杂鲁胺片的简略新药申请(简称“ANDA”，即美国仿制药申请)获得暂时批准。恩杂鲁胺片是一种雄激素受体抑制剂，本次获批的适应症为：去势抵抗性前列腺癌;转移性去势敏感性前列腺癌。

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