Core Viewpoint - Recent innovations in Alzheimer's disease drugs have shown promising results in clinical trials, particularly the long-term efficacy of therapies like donanemab, but concerns about long-term effects and safety remain [3][4]. Group 1: Clinical Trial Results - Eli Lilly's donanemab has demonstrated a significant slowing of disease progression in Alzheimer's patients over a three-year follow-up, with early treatment showing a 27% reduced risk of advancing to the next disease stage compared to delayed treatment [3][4]. - Over 75% of early-treated patients achieved amyloid clearance within 76 weeks, and the rate of amyloid plaque re-deposition was slow at approximately 2.4 CL/year during the longest observation period of 2.5 years [3][4]. Group 2: Safety and Side Effects - No new safety signals were observed during the long-term extension phase of the study, but previously noted issues related to amyloid-targeting treatments, such as ARIA (Amyloid-related imaging abnormalities), remain a concern [4]. - ARIA-related symptoms, including edema and bleeding, primarily occur within the first six months of treatment, and patients with the ApoE4 allele are at higher risk for these complications [4]. Group 3: Market Context and Patient Demographics - Donanemab was recently introduced in China, but the long-term efficacy in the Chinese patient population is yet to be validated due to the timing of its market entry [4][5]. - The earlier launched drug, lecanemab, has also shown a 34% reduction in cognitive decline over four years, with no new safety issues reported, although this data does not include Chinese patients [5]. - China has approximately 9.83 million Alzheimer's patients, with an estimated 20% being in the early stages of the disease, indicating a significant potential market for innovative treatments [5].

Core Insights - The aging population in China is leading to an increased threat from Alzheimer's disease (AD), which has become the fifth leading cause of death in the country, following cardiovascular diseases, malignant tumors, chronic respiratory diseases, and diabetes [1] - There is a significant disease burden from Alzheimer's and other dementias in China, exceeding the global average, necessitating effective intervention measures to help patients capture the early intervention window [1] - Eli Lilly's TRAILBLAZER-ALZ2 long-term extension study results indicate that treatment with donanemab significantly slows disease progression, with benefits increasing over three years [1][2] Company Insights - Eli Lilly's TRAILBLAZER-ALZ2 study is a double-blind extension phase aimed at evaluating the long-term efficacy and safety of donanemab in early symptomatic Alzheimer's patients [2] - Participants originally receiving donanemab either continued treatment or switched to a placebo, while the placebo group began receiving donanemab under blind conditions [2] - The study included an external control group from the Alzheimer's Disease Neuroimaging Initiative (ADNI) to measure treatment outcomes [2] Study Results - Key preliminary results from the TRAILBLAZER-ALZ2 study show that participants receiving donanemab experienced sustained clinical benefits over three years, with a 0.6-point reduction in cognitive decline at 18 months and a 1.2-point reduction at 36 months on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) [3] - Early use of donanemab reduced the risk of disease progression to the next stage by 27% compared to delayed treatment [3] - Over 75% of participants treated with donanemab achieved amyloid clearance within 76 weeks, and the rate of amyloid plaque re-deposition remained slow at approximately 2.4 CL/year over a maximum observation period of 2.5 years [3] - No new safety signals were observed during the long-term extension phase, confirming the existing safety profile of donanemab [3]