According to Zhitong Finance APP, on December 18, Eli Lilly and Co (LLY.US) just announced that the application for the market launch of its Class 1 new drug, donanemab injection, has been approved by the National Medical Products Administration (NMPA) of China. Based on the priority review announcement from the NMPA Drug Evaluation Center (CDE), this drug has been approved 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.

Donanemab is an intravenous medication, injected once every four weeks. The product was first approved by the FDA in the USA in July 2024 for the treatment of adults with early symptoms of Alzheimer's disease (brand name: Kisunla). The drug was previously selected for the "Top 10 Potential Heavyweight R&D Pipelines of 2024" list by industry media Evaluate. Furthermore, Eli Lilly's previous press release indicated that donanemab is the first therapy with evidence suggesting that treatment can be stopped after the clearance of amyloid plaques, which is expected to reduce treatment costs and decrease the frequency of infusions.

According to Eli Lilly's public press release, a Phase 3 study named TRAILBLAZER-ALZ 2 shows that patients with the earliest disease progression benefit the most from donanemab. Within the 18-month trial period, participants were divided into two groups for analysis: one group with early-stage disease progression (with low to moderate levels of tau protein) and the overall population, including subjects with low, medium, and high tau levels. The study shows that donanemab can significantly slow cognitive and functional decline in patients with early symptoms of Alzheimer's disease, delaying disease progression.