来凯医药：LAE002新药上市申请获国家药监局受理

格隆汇08-12

来凯医药-B公告，LAE002(afuresertib)的新药上市申请已获中国国家药品监督管理局药品审评中心受理，用于治疗既往接受内分泌治疗后出现疾病复发或进展，伴有PIK3CA/AKT1/PTEN改变的HR+/HER2-局部晚期或转移性乳腺癌患者。此次申请基于III期临床试验AFFIRM-205的积极结果，该研究达到无进展生存期主要终点。公司与齐鲁制药于2025年11月订立独家许可协议，有资格获得总额最高达人民币20.45亿元的首付款及里程碑款项。

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