Eli Lilly's Donanemab Injection Designated for Breakthrough Therapy in China for Early Symptomatic Alzheimer’s Disease

According to the SmartCom APP, on January 9, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration showed,Eli Lilly and Company (LLY.US)’s submitted Class 1 new drug, donanemab injection, is proposed to be included in the breakthrough treatment category for the treatment of early symptomatic Alzheimer's disease.Including mild cognitive impairment caused by Alzheimer's disease and mild Alzheimer's disease. Public information shows that donanemab, which targets β-amyloid plaques known as N3pG, has submitted a Biologics License Application (BLA) in the United States and has been granted Priority Review by the FDA.

It is reported that Donanemab is aβ-Amyloid SubtypesN3pGCombined monoclonal antibody.It can bind to β-amyloid in amyloid plaques in the brains of Alzheimer's patients, thereby promoting the clearance of amyloid plaques in the patient's brain.Previously, donanemab had been granted Breakthrough Therapy designation by the FDA. In August 2022, the FDA accepted the Biologics License Application for donanemab and granted it Priority Review for accelerated approval to treat early Alzheimer's disease.

According to the biomarker study results previously published by Eli Lilly, donanemab not only leads to the rapid clearance of amyloid plaques, but alsoSignificantly reduce the level of P-tau217 in patients' plasma. This is an investigational blood biomarker developed by Eli Lilly, associated with amyloid, tau pathology, and the diagnosis of Alzheimer's disease. Additionally,Donanemab can also reduce the levels of GFAP, an inflammatory biomarker associated with astrocytosis in the brain.. This evidence suggests that the drug can reduce various pathological processes associated with Alzheimer's disease.

At the Alzheimer's Disease Clinical Trials Conference held at the end of 2022, Eli Lilly and Company announced positive data from a Phase 3 clinical trial of donanemab. After six months of treatment, donanemab reduced amyloid plaque levels in the brains of early Alzheimer’s patients by 65.2% compared to baseline, while the active control group saw a reduction of 17.0%.This data shows that donanemab can rapidly and effectively alter the biology of Alzheimer's disease in the early stages of treatment.。

Previously published results of a Phase 2 clinical trial in a medical journal showed that donanemabCan slow down the decline of cognitive and daily living abilities in patients with early-stage Alzheimer's disease.. Meanwhile, Positron Emission Tomography (PET) imaging showed that donanemabCan quickly clear amyloid protein deposits in patients' brainsSix months after receiving the treatment, 40% of patients tested negative in PET scans, meaning that the levels of amyloid plaque in their brains were not significantly different from those of healthy individuals.

According to the China Drug Clinical Trial Registration and Information Disclosure Platform, Eli Lilly and Company launched an international multicenter (including China), randomized, double-blind, placebo-controlled, Phase 3 study in China in September 2022 to evaluate donanemab.Early symptomatic Alzheimer's disease with brain tau protein pathology (including mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease)Safety and efficacy in subjects. The Chinese part of the study was conducted byJia Jianping, Chief Physician of Xuanwu Hospital, Capital Medical UniversityServe as the Principal Investigator,To be conducted across nearly 50 research centers in China, with a target enrollment of 400 participants in China.。