China Medical System’s ZUNVEYL NDA Accepted by China’s NMPA for Alzheimer’s Treatment

China Medical System's ZUNVEYL NDA Accepted by China's NMPA for Alzheimer's Treatment

China Medical System Holdings Ltd (CMS; HKG: 0867, SGX: 8A8) announced on July 28, 2025, that its New Drug Application (NDA) for ZUNVEYL (proposed generic name: Beneglurant Gluconate Enteric-coated Tablets) has been accepted by China’s National Medical Products Administration (NMPA). The drug is intended for the treatment of mild to moderate Alzheimer’s-type dementia in adults.

ZUNVEYL: Next-Generation AChEI
ZUNVEYL is a next-generation acetylcholinesterase inhibitor (AChEI) licensed from Alpha Cognition Inc. It was approved in the United States in July 2024. As a prodrug of galantamine, ZUNVEYL offers comparable efficacy with reduced gastrointestinal side effects and improved tolerability. By inhibiting acetylcholinesterase and increasing central acetylcholine levels, it enhances cognitive and memory functions. Clinical studies have shown a favorable safety profile, with gastrointestinal adverse events below 2% and no reports of insomnia.

Global Licensing Agreement
CMS Group holds exclusive rights for the development, registration, manufacturing, import, export, and commercialization of ZUNVEYL in Asia (excluding Japan and the Middle East) and Australia/New Zealand. Alpha Cognition retains manufacturing and supply rights within the region. The collaboration spans an initial twenty-year term, with automatic renewal every five years thereafter unless terminated by either party.-Fineline Info & Tech