Core Viewpoint - The company has completed the enrollment for the Phase III clinical trial AFFIRM-205, evaluating the efficacy and safety of LAE 002 (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 topline data from this key 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 LAE 002 (afuresertib) in the Greater China region, including mainland China, Hong Kong, Macau, and Taiwan [1]
来凯医药-B(02105.HK)：LAE 002(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