SINOMAB BIO-B (03681) flagship product, Shuxilizumab, applies for new drug research for the treatment of Alzheimer's disease and has been accepted by the National Medical Products Administration.

Understanding that China Antibody Pharmaceuticals Limited (03681), a Hong Kong biopharmaceutical company focusing on research, development, manufacturing, and commercialization of immunotherapies for immune-related diseases, is delighted to announce that on November 14th, the company has submitted a new drug research application for its flagship product, Suciraslimab (SM03), targeting mild cognitive impairment or mild dementia caused by Alzheimer's disease, to the Center for Drug Evaluation of the China National Medical Products Administration, and it has been accepted. If the application is approved, the company will conduct clinical research projects for the treatment of early symptomatic Alzheimer's disease in China, including mild cognitive impairment or mild dementia caused by Alzheimer's disease. Suciraslimab, as the company's flagship product, is a first-in-class anti-CD22 monoclonal antibody product developed by the company, which can be used to treat conditions such as rheumatoid arthritis, as well as other diseases including systemic lupus erythematosus (SLE), non-Hodgkin's lymphoma (NHL), Sjgren's syndrome (SS), and Alzheimer's disease. Clinical studies have confirmed its efficacy in treating autoimmune diseases and controlling inflammation, with excellent long-term safety and rare severe adverse reactions. It also has the potential to become a new treatment for Alzheimer's disease. This new drug research application primarily targets Alzheimer's disease, and the company will initiate Phase I clinical trials in China after approval. Alzheimer's disease, as the most common type of dementia, is a progressive neurodegenerative disease with insidious onset. Mild cognitive impairment is an important stage for intervening in Alzheimer's disease and may delay its onset. This is the main stage of application for the new drug research of Suciraslimab. Its mechanism of action may also address the safety issues faced by current anti-beta-amyloid antibody immunotherapies. After binding to CD22, Suciraslimab can play a role through a dual mechanism of promoting the clearance of beta-amyloid deposits and inhibiting neuroinflammation. It has greater therapeutic advantages compared to approved products that only clear beta-amyloid. With its unique mechanism of action, Suciraslimab may also reduce the clinical safety risks of beta-amyloid antagonist therapies and alleviate adverse reactions related to amyloid-related imaging abnormalities (ARIA). According to the mechanism of action, Suciraslimab does not directly antagonize beta-amyloid, but achieves the goal of clearing beta-amyloid deposits by regulating microglia, the main phagocytic cells responsible for clearing beta-amyloid in the brain. Microglia also express CD22 on their surface, and their expression levels are elevated in Alzheimer's disease. Literature published in the scientific journal Nature has shown that microglia can phagocytize and clear beta-amyloid, and targeting CD22 significantly accelerates and promotes this process. Internal studies at the company have shown that Suciraslimab has dual actions that other beta-amyloid antibody antagonists do not possess. On one hand, it promotes microglial phagocytosis and clearance of beta-amyloid deposits, reducing neurotoxicity caused by deposition plaques. On the other hand, Suciraslimab has anti-inflammatory effects and can act within the central nervous system to inhibit brain inflammation. Importantly, because Suciraslimab does not directly bind to beta-amyloid, it can effectively avoid inflammatory cell activation caused by A-IgG immune complexes, reduce increased blood-brain barrier permeability caused by inflammatory reactions, and effectively avoid ARIA and its associated severe adverse reactions. Suciraslimab's revolutionary dual mechanism of action is expected to efficiently clear beta-amyloid in a safer manner, improve symptoms of Alzheimer's disease, reduce the safety risks that current beta-amyloid antagonist immunotherapies struggle to address, and become the next generation of drugs for treating Alzheimer's disease. With the accelerated aging of the population, the number of elderly dementia patients, mainly those with Alzheimer's disease, continues to increase. It severely threatens the health and quality of life of the elderly and urgently requires the development of effective treatment methods. According to a report by Chen Zhu, Vice Chairman of the Standing Committee of the 13th National People's Congress, President of the Red Cross Society of China, and member of the Chinese Academy of Sciences, there are 10 million Alzheimer's disease patients in China, and the number is expected to continue to rise. According to the "China Alzheimer's Disease Report 2022," Alzheimer's disease imposes an annual economic burden of 1.6 trillion yuan and is the 5th leading cause of death among Chinese residents. The "China Alzheimer's Disease Report 2021" also indicates that the prevalence and mortality rates of Alzheimer's disease and other dementias in China are slightly higher than the global average, demonstrating the vast prospects of the patient demand side. Globally, there are currently over 55 million dementia patients, and this number is expected to increase to nearly 139 million by 2050. Over 10 million new cases of dementia are diagnosed worldwide each year. The company believes that the development of Suciraslimab for early symptomatic Alzheimer's disease provides a new possibility for effective treatment for Alzheimer's disease patients, and it has great market potential. The company is also committed to advancing the research of Suciraslimab for multiple indications. The Phase III confirmatory clinical study for the treatment of rheumatoid arthritis (RA) was completed unblinding and preliminary statistical analysis on April 26th, 2023, fulfilling the primary endpoint. The related biologics license application was accepted by the National Medical Products Administration in September 2023 and is currently undergoing technical evaluation. The Phase III extension trial for RA is also being conducted in China. Dr. Leung Jui-On, the Executive Director, Chairman, and CEO of China Antibody Pharmaceuticals Limited, said, "The number of Alzheimer's disease patients is increasing year by year, bringing a heavy burden to countless families. The key strategy to alleviate Alzheimer's disease is to develop targeted new drugs for medical intervention during the early stage of the disease. The acceptance of this new drug research application for Suciraslimab as a treatment for Alzheimer's disease will help it exert its unique mechanism of action and therapeutic advantages, delay the progression of Alzheimer's disease, improve patients' quality of life, and alleviate the social and economic burden of the disease. Our company is full of confidence in the tremendous clinical trial and commercial development prospects of Suciraslimab as a new drug. We also believe that this new drug can provide effective and safe treatment options for the Alzheimer's disease population in China, hoping to benefit more Chinese patients in the future. In addition to this, our company will continue to promote product research and accelerate commercialization progress, striving to improve drug accessibility and remain committed to."The concept of independent innovation is constantly striving to become a leading global biopharmaceutical company in developing innovative drugs to meet unmet medical needs. english: