China Medical System Holdings announced that China's National Medical Products Administration (NMPA) has accepted the new drug application for ZUNVYL (Benzgalantamine Gluconate Enteric-coated Tablets) on July 28, 2025. The drug is indicated for treating mild-to-moderate dementia of the Alzheimer's type in adults, marking a significant milestone for the company's neurological portfolio expansion.
Enhanced Safety Profile Addresses Treatment Challenges
ZUNVYL represents a new generation of acetylcholinesterase inhibitor (AChEI) designed to address critical tolerability issues plaguing current Alzheimer's treatments. As a prodrug of galantamine, ZUNVYL remains inert while passing through the stomach and intestine, releasing the active drug only after liver metabolism. This mechanism is expected to deliver equivalent efficacy to galantamine while potentially reducing gastrointestinal side effects.
Clinical data demonstrates ZUNVYL's improved safety profile, with gastrointestinal adverse events documented at less than 2% across all studies and no observed insomnia. This represents a substantial improvement over existing therapies, as data shows 55% of Alzheimer's patients discontinue their medication after one year, primarily due to gastrointestinal side effects and insomnia.
FDA Approval Validates Therapeutic Approach
The drug received FDA approval in July 2024 for treating mild-to-moderate dementia of the Alzheimer's type in adults, becoming only the second oral therapy approved by the FDA for Alzheimer's disease treatment during the past decade. Galantamine, the active compound, has accumulated extensive efficacy evidence and demonstrated long-term clinical benefit since its FDA approval in 2001.
Addressing Significant Unmet Medical Need
According to epidemiological study results published in the Lancet Public Health, China has approximately 9.83 million patients with Alzheimer's dementia, with 7.93 million classified as mild-to-moderate cases. Alzheimer's dementia accounts for 50% to 70% of all dementia types, and the patient population is expected to grow with China's intensifying aging trend.
Current treatment challenges extend beyond efficacy to tolerability concerns. According to the Research Report on the Diagnosis and Treatment of Alzheimer's Disease Patients in China, high incidence of side effects represents one of the major pain points for existing drugs, with drug intolerance presenting significant treatment challenges.
Strategic Partnership and Market Entry
China Medical System secured exclusive rights to ZUNVYL through a licensing agreement with Alpha Cognition Inc. on January 8, 2025. The agreement grants the company exclusive development, registration, manufacturing, import, export, and commercialization rights across Asia (excluding Japan and the Middle East), Australia, and New Zealand for an initial 20-year term with automatic five-year renewal options.
The company submitted the NDA approximately six months after obtaining licensing rights, demonstrating efficient resource allocation and robust registration capabilities. ZUNVYL is expected to synergize with the company's existing central nervous system portfolio, including VALTOCO (diazepam nasal spray), Deanxit (flupentixol and melitracen tablets), and the investigational drug Y-3 for Injection.
Clinical Impact and Commercial Potential
If approved for marketing, ZUNVYL would provide Chinese Alzheimer's patients with a new treatment option that addresses both efficacy and safety requirements. The drug's improved tolerability profile could enhance treatment adherence, potentially reducing the burden on patients, families, physicians, and caregivers associated with medication discontinuation.
The product is expected to have a positive impact on China Medical System's financial results, leveraging the company's established commercialization experience and compliant commercialization system. Patent protection for ZUNVYL's use has already been granted in China, providing intellectual property security for the commercial opportunity.
