Core Viewpoint - The company has entered into an exclusive licensing agreement with Qilu Pharmaceutical Co., Ltd. for the research, development, and commercialization of LAE 002 (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 - The licensing agreement allows Qilu Pharmaceutical to exclusively develop and commercialize LAE 002 (afuresertib) in mainland China, Hong Kong, Macau, and Taiwan [1]. - The company will receive a non-refundable upfront payment of up to RMB 530 million and milestone payments until the first indication receives new drug application approval in China [1]. - The total potential upfront and milestone payments could reach RMB 2.045 billion, along with a tiered sales revenue share ranging from over ten percent to over twenty percent [1][2]. Group 2 - LAE 002 (afuresertib) is a potent AKT inhibitor that targets all three AKT isoforms (AKT1, AKT2, and AKT3) and is one of only two AKT inhibitors in late-stage clinical development for breast and prostate cancer [2]. - The company has initiated a Phase III clinical trial (AFFIRM-205) for HR+/HER2- breast cancer, with recruitment progressing as planned, aiming to complete subject enrollment by Q4 2025 and submit a new drug application to the Chinese National Medical Products Administration 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 LAE 002 (afuresertib) [2].
来凯医药-B(02105)与齐鲁制药就LAE 002 (AFURESERTIB)签订中国地区的独家许可协议