微芯生物(688321.SH)公告称，公司全资子公司微芯生物科技（美国）有限公司收到FDA的书面回复，公司自主研发的CS231295关于晚期实体瘤的临床试验申请获得FDA受理。该药物为透脑AuroraB选择性抑制剂，有望为存在类似遗传缺陷的不同类型肿瘤及肿瘤脑转移提供全新解题思路。目前全球尚无同类设计的药物进入临床试验阶段。本次申请为新药临床试验申请，自提交日起若30日内未收到FDA的通知，或30日内收到FDA同意开展临床试验的通知，公司即可按照提交的方案开展临床试验。
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