Core Viewpoint - The company has completed the enrollment for the Phase III clinical trial AFFIRM-205, evaluating the efficacy and safety of LAE002 (afuresertib) in combination with fulvestrant for treating HR+/HER2- locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN gene alterations [1] Group 1 - The Phase III clinical trial AFFIRM-205 is a multicenter, randomized, double-blind, placebo-controlled study [1] - The company aims to announce the top-line data from this critical Phase III study in the first half of 2026 [1] - A new drug application will be submitted to the National Medical Products Administration of China later in 2026 [1] Group 2 - The company has signed an exclusive licensing agreement with Qilu Pharmaceutical Co., Ltd. on November 12, 2025 [1] - Under the licensing agreement, Qilu Pharmaceutical has obtained exclusive rights for research, development, and commercialization of LAE002 (afuresertib) in China, including mainland China, Hong Kong, Macau, and Taiwan [1]
来凯医药-B(02105)：LAE002 (AFURESERTIB)针对HR+/HER2-局部晚期或转移性乳腺癌的III期临床试验(AFFIRM-205)已完成入组