SHENZHEN, CHINA – China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that 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（benzgalantamine delayed-release tablets）(“ZUNVEY” or  the “Product”)  for the treatment of mild-to-moderate dementia of the Alzheimer’s type. The Group is entitled to an exclusive right to develop, register, manufacture, import, export and commercialize the Product in Asia (excluding Japan), 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, which may be automatically renewed every five years upon the expiration unless terminated by notice from either party.

As the second oral therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease during the past decade, ZUNVEYL demonstrates a potentially better safety profile to improve compliance of patients and therefore brings clinical benefits.

CMS has rooted in the central nervous system therapeutic fields for years, continuously deploying and developing global differentiated and innovative products to strengthen its competitiveness in its advantageous specialty therapeutic fields. ZUNVEYL will further diversify our Group’s innovative drug product matrix and synergize with various central nervous system products including the marketed innovative drug VALTOCO (diazepam nasal spray), the original branded drug Deanxit (flupentixol and melitracen tablets) and the innovative pipeline drug Y-3 injection (a novel brain cytoprotectant that treats stroke). Leveraging its proven clinical development capability and compliant commercialization system with high efficiency, CMS will promote the approval of ZUNVEYL in China as soon as possible to bring a new drug option for the treatment of cognitive impairment in Alzheimer’s disease patients.

About ZUNVEYL

ZUNVEYL was approved in July 2024 by the U.S. FDA. 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]. 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, suggesting that Alzheimer’s disease patients still have an urgent need for safer therapies.

About ALPHA

Alpha is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and cognitive impairment with mild Traumatic Brain Injury. On July 2024, Alpha received approval by the FDA of its New Drug Application (NDA) for ZUNVEYL for the treatment of mild-to-moderate Alzheimer’s disease. Alpha will now focus on the development of commercial manufacturing and commercial sales of ZUNVEYL oral tablet formulation. Additionally, Alpha has three pre-clinical development programs: ZUNVEYL in combination with memantine for the treatment of moderate-to-severe Alzheimer’s disease, ALPHA-1062 sublingual formulation for the treatment of mild-to-moderate Alzheimer’s disease, ALPHA-1062 intranasal formulation for the treatment of cognitive impairment with mild Traumatic Brain Injury. For more information about Alpha and its pipeline, please visit: https://www.alphacognition.com/ .

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. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a “bridgehead” for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

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.0376-2491.2018.13.003
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 AD Patients in China (2020). Alzheimer’s Disease Chinese (ADC). https://www.adc.org.cn/index.php/book/chinaadzlxzbg2020/chinaadzlxzbg202…

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

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Source: China Medical System Holdings Ltd.