What is the progress of Donanemab’s participation in clinical trials in China?

2024YearDecemberMonth18The State Food and Drug Administration of China (NMPA) officially approved the marketing of donenezumab injection (trade name "Jinengda") developed by Eli Lilly for the treatment of patients with mild cognitive impairment and mild dementia caused by Alzheimer's disease (AD). This is the fourth country in China to approve this drug after the United States, Japan and the United Kingdom, providing a new treatment option for patients with early AD. In addition, multiple channels such as the National Medical News also announced that this drug has been approved for marketing in China, confirming its indications and dosage regimen.

Xuanwu Hospital of Capital Medical University, as the leading unit in China for the phase III clinical trial of donenezumab (TRAILBLAZER-ALZ 2 ), has successfully conducted relevant research. 2025Year3Monday31 The Disease Medical Center prescribed the first prescription of donenezumab injection to the first batch of patients with Alzheimer's disease. Among them, the first prescription in the country has been implemented simultaneously in Xuanwu Hospital and Hainan Ruijin Hospital. 5 patients started treatment simultaneously. On the same day, Hainan Hospital of Ruijin Hospital affiliated to Shanghai Jiao Tong University also passed the "first-in-first-out" policy, laying the path for the launch of donenemab in the country, and the first patient completed the medication.

Preliminary data from a number of domestic first-line centers (such as Xuanwu and Ruijin) show that donelezumab is intravenously injected once every 4 weeks, and 66% of patients patients can clear amyloid; its phase III data also shows that cognitive and functional decline is slowed by 35%, and the risk of early-stage patients is reduced by 39%. In the data from Ruijin Hainan, plaque reduction was 61% at 6 months and 12 months80%, 18months84%, and cognitive function continues to improve, reflecting the obvious value of early intervention.

The launch and first clinical application of donenemab have attracted great attention from top hospitals such as Xuanwu Hospital and Ruijin Hainan Hospital, and have gradually become popular in many centers across the country. At present, with the multi-center clinical trial led by Xuanwu as the core, a network for early diagnosis and early treatment has been established. Experts generally believe that this is a "milestone" progress in the domestic Alzheimer's disease treatment system. In the future, with the improvement of drug supply channels and the expansion of the "first-in-first-out" policy, it is expected that more centers will include donenemab treatment pathways, covering a wider range of early AD patients, significantly improving China's early diagnosis and early treatment capabilities.

Reference materials:https://www.drugs.com/donanemab.html