China Medical System （867.HK, 8A8.SG）NDA for the Improved New Drug ZUNVEYL for Alzheimer’s Disease Accepted in China

Core Viewpoint - China Medical System Holdings Limited (CMS) has received acceptance for the New Drug Application (NDA) of ZUNVEYL, an improved new drug for treating mild-to-moderate Alzheimer's dementia, by the National Medical Products Administration of China (NMPA) [1] Product Overview - ZUNVEYL is a new generation acetylcholinesterase inhibitor (AChEI) approved by the U.S. FDA in July 2024 for the same indication [2] - The drug works by inhibiting the breakdown of acetylcholine, thereby increasing its levels in the central nervous system, which may alleviate cognitive and memory impairments [2] - ZUNVEYL is designed to have a better gastrointestinal safety profile, with GI adverse events reported at less than 2% and no insomnia observed [2] - The product is expected to improve patient compliance and address the urgent need for safer therapies in Alzheimer's treatment [2][4] Alzheimer's Disease Context - Alzheimer's disease is a leading cause of dementia, accounting for 50% to 70% of all dementia cases, with approximately 9.83 million patients in China, of which 7.93 million have mild-to-moderate forms [3] - The aging population is expected to increase the burden of Alzheimer's disease in the future [3] Market Need and Challenges - Current treatments for Alzheimer's primarily focus on improving cognitive symptoms, but high incidences of side effects lead to a significant discontinuation rate of 55% among patients after one year [4] - The need for safer therapies is critical to improve adherence and reduce the burden on patients and caregivers [4] Licensing and Collaboration - CMS entered into a License, Collaboration, and Distribution Agreement with Alpha Cognition Inc. for ZUNVEYL, granting CMS exclusive rights to develop and commercialize the product in Asia (excluding Japan and the Middle East), Australia, and New Zealand [5] - The agreement has a term of twenty years, with potential automatic renewals every five years [5] Strategic Impact - The swift submission of the NDA in China reflects CMS's efficient resource allocation and robust registration capabilities [6] - ZUNVEYL is expected to diversify CMS's innovative drug portfolio and enhance its competitiveness in the market [6][7] - The product will complement CMS's existing central nervous system products, potentially improving treatment options for Alzheimer's patients in China [7]