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].
来凯医药-B与齐鲁制药就LAE 002 (AFURESERTIB)签订中国地区的独家许可协议