智通财经APP讯，来凯医药-B(02105)发布公告，集团已完成LAE002(afuresertib)联合氟维司群针对治疗HR+/HER2-局部晚期或转移性乳腺癌(“LA/mBC”)伴随 PIK3CA/AKT1/PTEN基因改变患者的III期临床试验AFFIRM-205入组。
III 期临床试验AFFIRM-205为一项多中心、随机、双盲、安慰剂对照的关键性研究，旨在评估该联合疗法的抗肿瘤疗效及安全性。集团目标于2026年上半年公布此项III期关键研究的顶线数据，并于同年稍晚时间向中国国家药品监督管理局药品审评中心提交新药上市申请。集团与齐鲁制药有限公司已于 2025年11月12日签订独家许可协议。根据许可协议的条款及条件，齐鲁制药获得在中国地区(包括中国内地、香港特别行政区、澳门特别行政区及台湾地区)进行LAE002(afuresertib)的研究、开发及商业化的独家许可。
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