Lilly's Alzheimer's Therapy Kisunla™ (Donanemab Injection) Approved in China as Class 1 Innovative Drug

Today, the National Medical Products Administration of China approved Eli Lilly and Company's (NYSE: LLY) Alzheimer's disease therapy, Jinenji.^®(Donanemab Injection, intravenous infusion once every four weeks) is used to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in adults.Ji Neng Da^®It is the only therapy targeting amyloid with evidence supporting that treatment can be stopped after the clearance of amyloid plaques, which can help reduce the treatment burden for patients by decreasing the number of infusions and treatment costs.^i,ii,iii,ivFollowing the United States, Japan, and the United Kingdom, China is the country that has approved Jynneos.^®Another major market for listing.

Alzheimer's disease is a fatal condition that leads to the gradual decline of memory and other cognitive functions, and is one of the leading causes of death. It is estimated that 32 million people worldwide are living with Alzheimer's dementia and have confirmed amyloid pathology.^vChina currently has nearly 9.83 million Alzheimer's disease patients.^viMoreover, the ranking of total deaths caused by dementia in China has risen from the tenth position in 1990 to the fifth position in 2019.^viiAt the same time, Alzheimer's disease also brings a heavy economic burden to families and society. A study showed that in 2015, the annual cost for Alzheimer's patients in China reached 1.1 trillion RMB, accounting for about 1.47% of the Gross Domestic Product (GDP). It is estimated that by 2030, the socioeconomic cost of Alzheimer’s disease in China will reach 3.2 trillion RMB and will rise to 11.9 trillion RMB by 2050.^viii

"Today's approval marks an important milestone in our commitment to transforming Alzheimer's treatment in China. Due to the accelerating aging population, Alzheimer's disease has become a significant healthcare burden in China. We hopeJi Neng Da^®"It provides an opportunity for early intervention for patients, thereby helping to slow the progression of this serious disease. Eli Lilly has never stopped innovating. For over 35 years, we have been committed to research and breakthroughs in the field of Alzheimer's disease, dedicating resources and efforts to continuously pursue real change for patients. Today’s approval is the best interpretation of our mission. We will continue to work hand-in-hand with healthcare professionals, patient groups, and all stakeholders to expand access to early precise diagnosis and innovative therapies, improving their quality of life. This is not only Eli Lilly's firm commitment to patients but also a reflection of our efforts to create a society full of care and hope for those affected by Alzheimer's disease."

Amyloid is a protein naturally produced by the body that can clump together to form amyloid plaques. The excessive accumulation of amyloid plaques in the brain may lead to memory and thinking problems associated with Alzheimer's disease. ^ix,xJi Neng Da^®It can help the body clear excessive accumulation of amyloid plaques and slow down the conditions that may lead to people's inability to remember information, cook, manage finances, and maintain independent self-care abilities.^ii,iv,v,xi

In the TRAILBLAZER-ALZ 2 Phase III study, patients in the earlier stages of the disease used donanemab.^®The effect was better. During the 18-month trial period, participants were divided into two groups for analysis: a group with earlier disease progression (having low to moderate levels of tau protein) and the overall population, including participants with low, moderate, and high tau levels.^xii,xiii,xivUse Jienengda^®Treatment can significantly slow clinical decline in both groups.^xiiIn patients with earlier disease progression, they received Jienengda.^®Patients treated with the drug showed a 35% significant reduction in the rate of decline in the integrated Alzheimer's Disease Rating Scale (iADRS), which includes memory, thinking, and daily functioning, compared to placebo. According to the iADRS scale, the drug treatment significantly slowed the decline by 22% in the overall population.^xii,xvIn two groups of subjects, those receivingJi Neng Da^®Subjects treated showed up to a 39% reduction in the risk of disease progression to the next clinical stage compared to those receiving placebo.^xvi

Ji Neng Da^®(Donanemab Injection) has been approved by the China National Medical Products Administration for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease in adults. Donanemab^®It is the only therapy targeting amyloid with evidence supporting discontinuation after clearing amyloid plaques. Donanemab^®It is a prescription medicine administered intravenously once every four weeks, with the first three doses at 700 mg, followed by 1400 mg.

TRAILBLAZER-ALZ 2 (NCT04437511) is a Phase 3, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of donanemab in patients with early symptomatic Alzheimer's disease and confirmed Alzheimer's neuropathological changes. The trial, based on cognitive assessments combined with evidence of Alzheimer’s pathology, enrolled 1,736 participants from 8 countries. The results of the TRAILBLAZER-ALZ 2 Phase 3 study have been published in the Journal of the American Medical Association (JAMA).

Eli Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, which aims to research preventive treatment for disease progression in participants with preclinical Alzheimer's disease; TRAILBLAZER-ALZ 5, a clinical trial for early symptomatic Alzheimer's disease being conducted in several countries, including China; and TRAILBLAZER-ALZ 6, which aims to expand our understanding of ARIA through novel MRI sequences, blood-based biomarkers, and different dosing regimens of donanemab.

Eli Lilly and Company is a pharmaceutical company dedicated to improving human health through scientific innovation and benefiting patients worldwide. As a leader in the healthcare industry, Eli Lilly and Company has nearly 150 years of history. Today, our medicines have helped tens of millions of people globally. Harnessing the power of biotechnology, chemistry, and genomic medicine, our scientists are actively advancing new medical breakthroughs to address severe global health challenges. We are redefining therapies for diabetes and obesity, reducing the long-term impact of obesity on the body; supporting prevention and treatment efforts for Alzheimer's disease; providing solutions for a range of immune-mediated diseases that threaten human health; and transforming difficult-to-treat cancers into manageable conditions. Every step Eli Lilly and Company takes toward a healthier world is driven by our belief in "making life better for millions of patients." This includes innovative clinical trials aimed at addressing multiple global challenges, while ensuring the accessibility and affordability of medicines. For more information about Eli Lilly and Company, please visit: www.lilly.com.

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