Eli Lilly's Breakthrough 1-Class New Drug Donanemab Approved in China for Early Alzheimer’s Disease

Intelligent Finance APP learned on December 18 that Eli Lilly and Company (LLY.US) has just announced that the marketing application for its Class 1 new drug, donanemab injection, has been approved by the China National Medical Products Administration (NMPA). According to the priority review disclosure of the NMPA Center for Drug Evaluation (CDE), this approval is for the treatment of early Alzheimer's disease, meaning treatment should begin when patients are in the mild cognitive impairment stage or mild dementia stage of the disease.

Donanemab is a medication administered through intravenous infusion once every four weeks. The product received initial approval from the U.S. FDA in July 2024 for the treatment of adults with early symptoms of Alzheimer's disease (brand name: Kisunla). This drug was previously selected for inclusion in the "Top 10 Potential Blockbuster Pipelines of 2024" list by industry media Evaluate. Additionally, according to a previous press release from Eli Lilly and Company, donanemab is the first amyloid plaque-targeting therapy with evidence showing that treatment can be stopped after the clearance of amyloid plaques, which is expected to reduce treatment costs and decrease the number of infusions.

According to the public press release by Eli Lilly, the Phase 3 study named TRAILBLAZER-ALZ 2 showed that patients in the earliest stage of disease progression had the best response to donanemab. Over the 18-month trial period, participants were divided into two groups for analysis: one group with earlier stages of disease progression (with low to moderate levels of tau protein) and the overall population, including subjects with low, moderate, and high tau levels. The study demonstrated that donanemab significantly slowed cognitive and functional decline in patients with early symptoms of Alzheimer's disease and delayed disease progression.