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]

Core Viewpoint - The company has completed the enrollment for the Phase III clinical trial AFFIRM-205, evaluating the combination therapy of LAE002 (afuresertib) and 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 aimed at assessing the antitumor efficacy and safety of the combination therapy [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 the research, development, and commercialization of LAE002 (afuresertib) in the Chinese region, including mainland China, Hong Kong, Macau, and Taiwan [1]

香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部 或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立之有限公司） （股份代號：2105） 來凱醫藥有限公司 Laekna, Inc. 自願公告 LAE 002 (AFURESERTIB)針對HR + / HER2 -局部晚期或轉移性乳腺癌 之III期臨床試驗(AFFIRM -205)已完成入組 本 公 告 由 來 凱 醫 藥 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）自 願 作 出，以告知本公司股東及潛在投資者本集團最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本集團已完成LAE 002 (afuresertib)聯 合 氟 維 司 群 針 對 治 療 HR + / HER2 - 局 部 晚 期 或 轉 移 性 乳 腺 癌（「 LA / m BC 」）伴 隨 PIK3CA / AKT1 / PTEN基因 ...