Gelonghui November 15 | China Antibody-B (03681.HK) announced that on November 14, 2023, a new drug research application for sucilizumab for mild cognitive impairment or mild dementia caused by Alzheimer's disease has been submitted to the Drug Evaluation Center of China's State Drug Administration and has been accepted. The company plans to begin phase I clinical trials in China after the current new drug research application is approved. Once the current new drug research application is approved, the company will be able to carry out clinical research and development projects to treat early symptomatic Alzheimer's disease in China, including mild cognitive impairment or mild dementia caused by Alzheimer's disease.
Sucilizumab is a first-of-its-kind anti-CD22 monoclonal antibody product developed independently by the company. It is used to treat rheumatoid arthritis (RA). It also has the potential to treat other diseases such as systemic lupus erythematosus (SLE), non-Hodgkin lymphoma (NHL), dry syndrome (SS), and Alzheimer's disease. It uses a new mechanism of action that is very different from treatments currently on the market. Currently, there is a high conversion rate from mild cognitive impairment due to Alzheimer's disease to mild dementia, and from mild dementia to moderate to severe dementia. Therefore, slowing the progression of Alzheimer's disease and preventing early dementia from progressing further to middle to advanced dementia have become key strategies for treating mild cognitive impairment and mild dementia caused by Alzheimer's disease. Shucilizumab was also developed for this indication based on this strategy. After binding to CD22, sucilimab can act through the dual mechanism of promoting the removal of beta amyloid deposits and inhibiting neuroinflammation. Compared with other approved products that only remove beta amyloid protein, sucilimab has a therapeutic advantage. With this unique mechanism of action, sucilizumab may also reduce the clinical safety risks of beta-amyloid antagonist treatment and mitigate adverse effects associated with amyloid-related imaging abnormalities (ARIA), such as imaging abnormalities associated with Abeta amyloids-cerebral edema exudation (ARIA-E) or imaging abnormalities associated with Abeta amyloids-brain edema, and imaging abnormalities associated with Abeta amyloids-cerebral hemorrhage (ARIA-H).
A biological product license application for treatment of RA with sucilizumab was accepted by the State Drug Administration in September 2023, and is currently undergoing technical review. An extended phase III trial of RA is also ongoing in China.