Core Insights - The collaboration between LaiKai Pharmaceuticals and Qilu Pharmaceutical involves an exclusive licensing agreement for the AKT inhibitor LAE002 (afuresertib) in China, with potential financial benefits for LaiKai reaching up to 2.045 billion yuan [1][10] - LAE002 is a potent AKT inhibitor that targets 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 globally [4][10] - The ongoing Phase III clinical trial for LAE002 targeting HR+/HER2- breast cancer is progressing as planned, with an expected submission for new drug application (NDA) to the Chinese regulatory authority in 2026 [10] Financial Aspects - LaiKai Pharmaceuticals can receive an upfront payment of up to 530 million yuan and additional milestone payments, potentially totaling 2.045 billion yuan [1] - The agreement includes a tiered royalty structure based on future net sales in China, with rates ranging from over 10% to over 20% [1] Clinical Development - LAE002 is currently in Phase III clinical trials for HR+/HER2- breast cancer, with recruitment expected to be completed by Q4 2025 [10] - The drug is also in clinical trials for metastatic breast cancer and hormone-resistant prostate cancer in various regions, including China and the United States [8][10] Market Context - Breast cancer is the leading cause of cancer-related deaths among women globally, with approximately 2.29 million new cases and 666,000 deaths annually [7] - In China, breast cancer ranks as the second most common cancer among women, with 70% of patients being HR+/HER2- type [7]
来凯医药与齐鲁制药强强联手:20.45亿授权AKT抑制剂LAE002,猛攻乳腺癌百亿市场