LAEKNA-B (02105) announced that its Phase III clinical trial, AFFIRM-205, evaluating LAE 002 (afuresertib) in combination with fulvestrant, has achieved strong positive topline results. The trial involved patients with HR+/HER2- locally advanced or metastatic breast cancer who had disease progression following prior endocrine therapy with or without a CDK4/6 inhibitor and had PIK3CA, AKT1, or PTEN alterations. This pivotal study successfully met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival compared to the control group. AFFIRM-205 was a multicenter, randomized, double-blind, placebo-controlled study designed to assess the anti-tumor efficacy and safety of the combination therapy. It enrolled 261 subjects, 70.5% of whom had previously received a CDK4/6 inhibitor. The study met its primary endpoint, with the LAE 002 (afuresertib) plus fulvestrant group showing a median PFS of 7.6 months versus 2.0 months for the placebo plus fulvestrant group, resulting in a hazard ratio of 0.33. Once-daily oral treatment with LAE 002 (afuresertib) was well-tolerated, with a very low discontinuation rate due to adverse events. The overall safety profile was consistent with prior data evaluating this combination. Detailed results are scheduled for presentation at an upcoming international scientific conference. Based on these positive Phase III results, the group, in collaboration with Qilu Pharmaceutical, plans to soon submit a New Drug Application for LAE 002 (afuresertib) to the Center for Drug Evaluation of China's National Medical Products Administration. The group entered into an exclusive licensing agreement with Qilu Pharmaceutical for the China region in November 2025. Under this agreement, the group is eligible to receive up to RMB 2.045 billion in upfront and milestone payments. The group is also entitled to receive tiered royalties on future net sales of LAE 002 (afuresertib) in the licensed territory, with rates ranging from the low teens to low twenties percentage-wise. The group plans to seek strategic partners outside China to accelerate the global development and commercialization of LAE 002 (afuresertib). Approximately 50% of breast cancer patients have alterations in PIK3CA, AKT1, or PTEN.