Lilly China Successfully Hosts Alzheimer's Disease Summit at CIIE, Highlighting Early Diagnosis and Innovative Pipeline

-- Patient-centeredCenter, Focusing on Early Diagnosis and Treatment of Alzheimer's Disease

ShanghaiNovember 7, 2022PR Newswire -- November 6, 2022, the Eli Lilly China Alzheimer's Disease High-Level Forum successfully concluded at the CIIE. Director Shen Yifeng of the Office of the Clinical Trial Institution at Shanghai Mental Health Center, Professor Li Xia from Shanghai Mental Health Center, Tang Bin from Shanghai Jianai Public Welfare Development Center, Mr. Julio Gay-Ger, President and General Manager of Eli Lilly China, Dr. Wang Li, Senior Vice President of Eli Lilly and Company and Head of Drug Development and Medical Affairs at Eli Lilly China, attended the forum.

This forum focuses on"Patient-Centered, Focusing on Early Diagnosis and Treatment of Alzheimer's Disease" as the theme, discussions were held extensively and in-depth on patient-centered clinical development, creating an environment for the diagnosis, treatment, awareness improvement, and future development of Alzheimer's disease. The aim is to promote the enhancement of early diagnosis and treatment awareness and capabilities for Alzheimer's disease, improving patients' quality of life.

The burden of disease is becoming increasingly heavy,Early Diagnosis and Treatment of AD Cannot Be Delayed

Alzheimer's Disease (AD) is an insidious onset and progressively developing neurodegenerative disease. The main manifestations are cognitive decline, psychiatric symptoms and behavioral disorders, and a gradual decrease in daily living abilities.

Currently, there are over50 million dementia patients, of which AD patients account for approximately 60-80%.^[1]In China, the number of AD patients is expected to increase from 10 million in 2020 to over 40 million by 2050, and with the rapid aging of the population, the incidence of AD is also continuously rising.

AD has become a disease that seriously endangers the health of Chinese people and imposes a heavy socio-economic burden. In 2019, AD became the fifth leading cause of death in China, and it is projected that by the end of 2050, the annual treatment cost for AD patients in China will reach $1.8 trillion.^[2]However, in stark contrast, the awareness of AD among the public and society in China is still insufficient, and there remains a shortage of specialized clinical physicians dedicated to the diagnosis and treatment of AD, which has also led to low diagnosis and treatment rates.

The prevention and treatment of AD is a global challenge, primarily due to the difficulty in early detection. The disease progresses slowly or with subtle symptoms, which are often overlooked by patients and their families. By the time most patients seek medical attention due to noticeable symptoms, the disease has often reached an advanced stage and become irreversible.

“Before the appearance of typical symptoms, a series of pathological and physiological changes may occur in the brain tissue of AD patients. During this process, mild cognitive impairment (MCI) emerges as the earliest clinically symptomatic stage, with a high likelihood of progressing to AD dementia. Therefore, this stage becomes the most crucial window for early detection, diagnosis, and prevention of AD. Intervention at the MCI stage may be the most effective strategy to delay the progression of AD. Currently, among people aged 60 and above in China, approximately 38.77 million have MCI, with an overall prevalence rate of about 14.7%. The incidence of MCI is relatively higher in populations with multiple chronic diseases.^[3]"If you suspect that your memory or that of an elderly family member is declining, or if there are changes in abilities or temperament, it's advisable to visit a hospital for relevant examinations. Early diagnosis and early treatment can help prevent the onset of AD," suggested Professor Li Xia from the Shanghai Mental Health Center.

Huge Treatment Needs Far from Met, Innovative Therapies Expected to Reshape Diagnosis and Treatment Landscape

Currently, there is no clinical treatment available that can slow downTherapies for the progression of AD. Currently approved first-line treatment drugs are mainly cholinesterase inhibitors alone or in combination with glutamate receptor antagonists, which are only used for symptom improvement and lack drugs targeting specific pathological mechanisms.

Since the mechanism of the disease has not been fully elucidated, recentlyOver the past 20 years, the failure rate of new drug development for AD has exceeded 98%, the highest among all fields, with nearly all potential drugs ending in failure. Meanwhile, issues such as the long-term efficacy and convenience of non-drug treatments still need to be addressed. This highlights the significant unmet clinical treatment needs for AD, a common chronic disease in the elderly.

What is reassuring is that,"As research deepens, it is now known that the severity of AD is related to the deposition of fibrillar amyloid-beta protein plaques in the brain. Immunotherapy, represented by monoclonal antibodies targeting Aβ and Tau proteins, is currently the most popular direction in the development of AD treatment drugs. Among them, the monoclonal antibodies targeting β under research have achieved exciting results and may become a 'promising candidate' for AD treatment, with the potential to reshape the AD diagnosis and treatment landscape. I hope this disruptive therapy can enter clinical use in China as soon as possible, allowing more Chinese AD patients to benefit sooner." Shen Yifeng, Director of the Office of the Drug Clinical Trial Institution at the Shanghai Mental Health Center, said with great anticipation.

Unite and focus, with multi-party support to alleviateProgress of AD

Based on the currentCurrent Status of AD Diagnosis and Treatment: Tang Bin from Shanghai Jian'ai Public Welfare Development Center shared during the forum roundtable dialogue: "The difficulties surrounding AD patients and their families stem not only from the disease itself but also from environmental influences and pressures. Cognitive biases and lack of understanding in the social environment can lead to a sense of stigma for both patients and their families. Therefore, paying attention to the emotional needs of patients and their families can also help slow down the progression of the disease. We hope that through our actions, more people will become aware of and pay attention to AD and other forms of cognitive disorders. This is also the original intention behind the establishment of 'Dementia Friends (China).' Of course, this requires more investment in medical resources and greater social attention. We hope more hospitals will establish relevant departments, and more people across society will join us to raise awareness, concern, and understanding of AD, reduce social prejudice, and enable patients to live with quality and dignity."

DespiteAD Drug Development Faces Numerous Challenges; Eli Lilly Remains Deeply Committed to Unraveling the Complex Mysteries of AD. Dr. Li Wang, Senior Vice President of Eli Lilly and Company and Head of Lilly China Drug Development and Medical Affairs Center, stated: "With continuous advancements in foundational Alzheimer's disease (AD) research, our pipeline has evolved from early gamma-secretase inhibitors to beta-secretase inhibitors, and now to antibodies targeting Aβ. Currently, the accumulation of extracellular β-amyloid plaques in brain neurons is considered the mainstream mechanism behind AD. Donanemab, an investigational novel antibody drug developed by Eli Lilly, targets a form of β-amyloid plaque known as N3pG. Clinical studies suggest that it significantly slows the decline in cognitive and daily functioning in patients with early symptomatic AD. Recently, the National Medical Products Administration approved Eli Lilly to conduct a Phase III clinical trial in China for Donanemab injection to treat early symptomatic AD. We hope to gain strong support from Chinese clinical research institutions, investigators, and trial participants to complete the study as soon as possible, introduce this product to China at an early date, and allow Chinese patients to benefit from innovative international pharmaceuticals."

Eli Lilly China President and General Manager Jiliwen Ji stated: "The 'Healthy China 2030' Planning Outline proposes efforts to achieve a strategic shift 'centered on health' and proactively address the strategic needs of 'healthy aging.' Currently, China has entered an aging society, and with the extension of life expectancy, the public's demand for quality of life, particularly maintaining normal cognitive function, is also increasing. Alzheimer’s disease (AD) is the leading cause of cognitive impairment in the elderly. As a global leader and practitioner in the field of neurodegenerative diseases, Eli Lilly has been deeply committed to this area for thirty-four years, with a comprehensive R&D pipeline. We continually uphold our commitment to introducing high-quality innovative drugs in China, bringing new hope to the prevention and control of Alzheimer’s disease. In the future, we will highly focus on the AD field, integrate premium resources, actively play a leading role in innovation, and center on patients. Together with the Chinese government, clinical experts, scholars, patient organizations, and other forces, we will provide ongoing support for the development of chronic disease prevention and treatment, such as AD, helping to achieve the goals of 'Healthy China 2030' at an early date."。”

Statement:

1、   The mentioned product is an investigational drug usage and has not been approved in mainland China.
2、   Eli Lilly does not recommend any unapproved drugs./Indications for Use

[1] Alzheimer's Association. Facts and Figures. https://www.alz.org/alzheimers-dementia/facts-figures. Accessed December 8, 2020.
[2] Jia, et al. Lancet Neurol 2020;19:81-92.
[3] Dementia and Cognitive Impairment Group, Neurology Branch of Chinese Medical Association. Chinese Expert Consensus on Diagnosis and Treatment of Alzheimer's Disease-Derived Mild Cognitive Impairment 2021[J]. Chinese Journal of Neurology, 2022, 55(5):20.