LAEKNA-B (02105) announced on November 12, 2025, that the group has entered into an exclusive licensing agreement with Qilu Pharmaceutical Co., Ltd. (Qilu Pharma). Under the terms of the agreement, Qilu Pharma is granted exclusive rights to research, develop, and commercialize LAE 002 (afuresertib) in China, including the mainland, Hong Kong SAR, Macau SAR, and Taiwan (the licensed region). The group will be responsible for completing the Phase III clinical trial (AFFIRM-205) for HR+/HER2- breast cancer.
In return, the group is entitled to receive up to RMB 530 million in non-refundable upfront and clinical development milestone payments until the first indication secures New Drug Application (NDA) approval in China. The total potential payments under the agreement could reach RMB 2.045 billion. Additionally, the group will receive tiered royalties on future net sales of LAE 002 (afuresertib) in the licensed region, ranging from the low teens to low twenties percentage points.
LAE 002 (afuresertib) is a potent AKT inhibitor that targets all three AKT isoforms (AKT1, AKT2, and AKT3). It is one of only two AKT inhibitors globally in late-stage clinical development for breast and prostate cancers. LAEKNA has initiated the Phase III AFFIRM-205 trial for HR+/HER2- breast cancer, with patient enrollment progressing as planned. The group aims to complete enrollment by Q4 2025 and plans to submit an NDA to China’s Center for Drug Evaluation (CDE) in 2026.
The board believes this agreement aligns with the company’s and shareholders’ best interests, accelerating regulatory approval and commercialization of LAE 002 (afuresertib) in China while maximizing its commercial potential. The upfront and milestone payments will strengthen the group’s financial position to support future growth.
Currently, the group is actively engaging with multiple potential partners to expedite clinical development and commercialization of its drug candidates through strategic collaborations. With a solid financial standing, the company remains selective in evaluating partnership structures to ensure alignment of interests and maximize global potential.