Core Viewpoint - The company has entered into an exclusive licensing agreement with Qilu Pharmaceutical for the research, development, and commercialization of LAE002 (afuresertib) in specified regions of China, which is expected to enhance its financial strength and accelerate the drug's regulatory approval and commercialization process [1][2]. Group 1: Licensing Agreement Details - The licensing agreement grants Qilu Pharmaceutical exclusive rights to LAE002 (afuresertib) in China, including mainland China, Hong Kong, Macau, and Taiwan [1]. - The company will receive a non-refundable upfront payment and milestone payments totaling up to RMB 5.3 billion until the first indication receives new drug application approval in China [1]. - The total potential upfront and milestone payments from the agreement could reach RMB 20.45 billion, along with a tiered sales revenue share ranging from over ten percent to over twenty percent [1]. Group 2: Clinical Development and Strategic Goals - LAE002 (afuresertib) is a potent AKT inhibitor that targets all three AKT isoforms and is one of only two AKT inhibitors in late-stage clinical development for breast and prostate cancer [2]. - The company has initiated the Phase III clinical trial (AFFIRM-205) for HR+/HER2- breast cancer, with recruitment progressing as planned, aiming to complete subject enrollment by Q4 2025 [2]. - The company plans to submit a new drug application to the National Medical Products Administration in China in 2026 [2]. - The board believes that the licensing agreement aligns with the best interests of the company and its shareholders, providing an opportunity to maximize the commercial value of LAE002 (afuresertib) [2]. - The upfront and milestone payments will strengthen the company's financial position to support future developments [2]. - The company is actively engaging with multiple potential partners to establish strategic collaborations to expedite the clinical development and commercialization of its candidate drug assets [2].

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。 Laekna, Inc. 來凱醫藥有限公司 （於開曼群島註冊成立之有限公司） （股份代號：2105） 內幕消息 與齊魯製藥就LAE 002 (AFURESERTIB)簽訂 中國地區的獨家許可協議 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」）根據香港 聯合交易所有限公司證券上市規則（「上市規則」）第13.09條及香港法例第571章證 券及期貨條例第XIVA部項下的內幕消息條文（ 定義見《上市規則》）的規定作出。 緒言 本公司董事（「董事」）會（「董事會」）欣然宣佈，於2025年11月12日，本集團與齊魯 製藥有限公司（「齊魯製藥」）已訂立獨家許可協議（「許可協議」）。 許可協議的主要條款 據 本 公 司 所深 知 及 確 信 ， 齊 魯 製 藥及 其 股 東 均 獨 立 於 本公 司 及 其 關 連 人 士（ 定 義 ...