海创药业(688302.SH)：HP568片用于治疗ER+/HER2-晚期乳腺癌临床试验申请获美国FDA批准

智通财经2024-12-30

智通财经APP讯，海创药业(688302.SH)公告，公司收到美国食品药品监督管理局(简称“FDA”)的临床研究继续进行通知书，公司自主研发的HP568片用于治疗雌激素受体(ER)阳性和人表皮生长因子受体2(HER2)阴性的晚期乳腺癌(ER+/HER2-晚期乳腺癌)的临床试验申请正式获得FDA批准。此前，HP568片中国同适应症的临床试验申请已于2024年10月获得中国国家药品监督管理局批准。

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