SHENZHEN, CHINA – China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 28 July 2025, the New Drug Application (NDA) for improved new drug ZUNVEYL (Benzgalantamine Gluconate Enteric-coated Tablets) (“ZUNVEYL” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA). The Product is indicated for the treatment of mild-to-moderate dementia of the Alzheimer’s type in adults.

About Product ZUNVEYL

ZUNVEYL was approved in July 2024 by the U.S. Food and Drug Administration (FDA) for the treatment of mild-to-moderate dementia of the Alzheimer’s type in adults. As a new generation of acetylcholinesterase inhibitor (AChEI), ZUNVEYL can inhibit the acetylcholinesterase from breaking down the neurotransmitter acetylcholine, increase the level of acetylcholine in the central nervous system, and therefore alleviate cognition and memory impairment in Alzheimer’s disease patients. As a prodrug of galantamine, ZUNVEYL remains inert as it passes through the stomach and the intestine, and eventually releases the active drug into the bloodstream after being metabolized by the liver. With such a mechanism of action, ZUNVEYL is expected to have equivalent efficacy as galantamine with the potential of reducing gastrointestinal (GI) side effects and addressing certain tolerability issues. Galantamine has accumulated extensive evidence of efficacy and demonstrated long-term clinical benefit in the treatment of mild-to-moderate dementia of the Alzheimer’s type since the approval of FDA in 2001^[1]. Moreover, GI adverse events documented across all studies for ZUNVEYL were less than 2% and no insomnia was observed^[2]. As the second oral therapy approved by FDA for the treatment of Alzheimer’s disease during the past decade, ZUNVEYL demonstrates a potentially better gastrointestinal safety profile to improve compliance of Alzheimer’s disease patients and therefore brings clinical benefits. Patent in regard to use of ZUNVEYL has already been granted in China.

About Alzheimer’s Disease

Alzheimer’s disease is a chronic, progressive neurodegenerative disease characterized by progressive decline in memory and other cognitive functions, among which some of the patients will progress to dementia. Dementia is a kind of syndrome with acquired cognitive function impairment as the core symptom, and can lead to the reduction of patients’ daily living, learning, working and social interaction ability. Alzheimer dementia accounts for 50% to 70% of all types of dementia^[3,4]. According to the epidemiological study results published in the Lancet Public Health^[5], there are about 9.83 million patients with Alzheimer dementia in China, of which 7.93 million are mild-to-moderate^[6]. With the intensifying aging trend, the number of patients and the consequent disease burden will further increase in the future.

Currently the clinical treatment of Alzheimer’s disease can be categorized as improving cognitive symptoms and decelerating disease progression^[7], and AChEI belongs to the former. According to the Research Report on the Diagnosis and Treatment of Alzheimer’s disease Patients in China^[8], the high incidence of side effects is one of the major pain points for existing drugs for Alzheimer’s disease, and drug intolerance is one of the challenges in current treatment of Alzheimer’s disease. Tolerability affects therapy adherence, with data showing that 55% of Alzheimer’s disease patients discontinue their medication after one year, mainly due to GI side effects and insomnia. Medication discontinuation can cause risk to patients themselves, and dissatisfaction and burden among patient’s family, physicians, and caregivers^[9]. Therefore, Alzheimer’s disease patients still have an urgent need for safer therapies.

On 8 January 2025, the Group through a wholly-owned subsidiary of the Company entered into a License, Collaboration and Distribution Agreement (the “Agreement”)  with Alpha Cognition Inc. (“Alpha”) of the improved new drug ZUNVEYL for the treatment of mild-to-moderate dementia of the Alzheimer’s type. In accordance with the Agreement, the Group is entitled to an exclusive right to develop, register, manufacture, import, export and commercialize the Product in Asia (excluding Japan and the Middle East region), Australia and New Zealand (the “Territory”), Alpha reserves the right to manufacture and supply in the Territory. The term of cooperation commences on the effective date of the Agreement and extends for twenty years (the “Initial Term”), it may be automatically renewed every five years upon the expiration of the Initial Term unless terminated by notice from either party.

Around six months after obtaining the above rights of ZUNVEYL, the Group promptly submitted the NDA in China, demonstrating its efficient allocation of resources and robust capabilities in registration promotion. ZUNVEYL will further diversify the Group’s innovative drug product matrix and enhance the Group’s comprehensive competitiveness. The Product will synergize with the Group’s various central nervous system products including the innovative drug VALTOCO (diazepam nasal spray) and the original brand drug Deanxit (flupentixol and melitracen tablets) on sale and the innovative drug Y-3 for Injection under development in terms of expert network and market resources. Relying on the Group’s successful commercialization experience and compliant and efficient commercialization system, if ZUNVEYL is approved for marketing, it will bring a new drug option for the treatment of cognitive impairment in Chinese Alzheimer’s disease patients, meeting the clinical need for drugs of both efficacy and safety, improving disease diagnosis and treatment practices, thereby benefiting patients. The Product is expected to have a positive impact on the Group’s financial results.

Reference:

1. Xu, Hong et al. Long-term Effects of Cholinesterase Inhibitors on Cognitive Decline and Mortality. Neurology vol. 96,17 (2021): e2220-e2230. doi:10.1212/WNL.0000000000011832
2. Safety profile of ZUNVEYL as disclosed by Alpha:  https://www.alphacognition.com/investors/news/alpha-cognitions-oral-ther…
3. 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment (Chapter 1): Dementia Classification and Diagnostic Criteria [J]. National Medical Journal of China, 2018, 98 (13): 965-970. DOI: 10.3760/cma.j.issn.0376-2491.2018.1003
4. 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment (Chapter 2): Guidelines For Diagnosis and Treatment of Alzheimer’s Disease [J]. National Medical Journal of China, 2018,98 (13): 971-977. DOI: 10.3760/cma.j.issn.0376-2491.2018.13.004
5. Jia, Longfei et al. Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study. The Lancet. Public health vol. 5,12 (2020): e661-e671. doi:10.1016/S2468-2667(20)30185-7
6. Yuan, Jing et al. Severity Distribution of Alzheimer’s Disease Dementia and Mild Cognitive Impairment in the Framingham Heart Study. 1 Jan. 2021: 807-817.
7. Mayo Clinic. 2024. Alzheimer’s Disease: Therapies to Improve Cognitive Symptoms and Decelerate Disease Progression. https://www.mayoclinic.org/zh-hans/diseases-conditions/alzheimers-diseas…
8. Research Report on the Diagnosis and Treatment of Alzheimer’s Disease Patients in China (2020). Alzheimer’s Disease Chinese (ADC). https://www.adc.org.cn/index.php/book/chinaadzlxzbg2020/chinaadzlxzbg2020-381.html
9. Data on patient discontinuation as disclosed by Alpha:  https://www.alphacognition.com/investors/news/alpha-cognitions-oral-therapy-zunveyl-receives-fda-approval-to-treat-alzheimers-disease-

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs. 

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients. 

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries, strengthening the competitiveness of the cardio-cerebrovascular/ gastroenterology/ ophthalmology/ skin health businesses. Among them, the skin health business has become a leading enterprise in its field, bringing economies of scale in specialty therapeutic fields. Meanwhile, CMS continuously deepens its business development in Southeast Asia and the Middle East regions, further escorting the sustainable and healthy development.

CMS Disclaimer and Forward-Looking Statements

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Source: China Medical System Holdings Ltd.