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January 8, 2025 VANCOUVER, B.C. and Dallas, TX. Alpha Cognition, Inc. (Nasdaq: ACOG) (“ACI” or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, and China Medical System Holdings Limited (CMS) (867.HK), a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability in the People’s Republic of China, today announced an exclusive licensing agreement for the development, manufacturing and commercialization of ZUNVEYL (benzgalantamine) in Asia (excluding Japan), Australia and New Zealand.
2025年1月8日不列颠哥伦比亚省温哥华市和德克萨斯州达拉斯市阿尔法认知有限公司(纳斯达克股票代码:ACOG)(“ACI”或“公司”)是一家开发用于治疗神经退行性疾病的新型治疗药物的生物制药公司,而中国医疗系统控股有限公司(CMS)(867.HK)是一家将制药创新和商业化与中华人民共和国强大的产品生命周期管理能力联系起来的平台公司,今天宣布了一项独家许可协议,用于开发,制造和商业化ZUNVEYL(苯加兰他敏)在亚洲(不包括日本),澳大利亚和新西兰。
ZUNVEYL is a next generation acetylcholinesterase inhibitor approved in the US for the treatment of mild-to-moderate Alzheimer’s disease..
ZUNVEYL是美国批准用于治疗轻度至中度阿尔茨海默病的下一代乙酰胆碱酯酶抑制剂。。
Terms of the agreement total $44 million, which includes $6 million in total upfront payments split into tranches and development and commercial milestone payments. Additionally, ACI is eligible to receive royalties on net sales of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand. CMS will be responsible for the regulatory, development, manufacturing, and commercialization of ZUNVEYL in the licensed territories..
协议条款总计4400万美元,其中包括600万美元的预付款,分为分期付款、开发和商业里程碑付款。此外,ACI有资格获得ZUNVEYL在亚洲(不包括日本)、澳大利亚和新西兰净销售额的版税。CMS将负责ZUNVEYL在许可地区的监管、开发、制造和商业化。。
“We are excited to partner with CMS to distribute ZUNVEYL, an FDA-approved oral treatment for mild-to-moderate Alzheimer’s disease. The product has significant potential in China and we believe that CMS has the commitment and expertise to manage the complex regulatory and commercial landscape in these territories,” said Michael McFadden, CEO of Alpha Cognition.
Alpha认知首席执行官迈克尔·麦克法登(MichaelMcFadden)表示:“我们很高兴与CMS合作,分销ZUNVEYL,这是一种FDA批准的治疗轻度至中度阿尔茨海默氏病的口服药物。该产品在中国具有巨大潜力,我们相信CMS有能力管理这些地区复杂的监管和商业环境。”。
“With their strong track record of developing and commercializing CNS therapies in China, we believe CMS is the ideal partner to advance ZUNVEY’s regulatory development in a region where 50 million people are estimated to have Alzheimer’s disease.”.
“凭借其在中国开发和商业化中枢神经系统疗法的良好记录,我们相信CMS是推动ZUNVEY在该地区监管发展的理想合作伙伴,该地区估计有5000万人患有阿尔茨海默氏病。”。
Alpha Cognition remains on track to launch ZUNVEYL in the United States in Q1 2025. The company will provide a corporate update and present its Launch Strategy on January 28, 2025 at 4pm EST.
Alpha认知将于2025年第一季度在美国推出ZUNVEYL。该公司将于2025年1月28日美国东部时间下午4点提供公司最新信息并介绍其发布策略。
About CMS
关于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 FIC and BIC innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products.
CMS是一家平台公司,将药物创新和商业化与强大的产品生命周期管理能力联系起来,致力于提供有竞争力的产品和服务,以满足未满足的医疗需求。CMS专注于全球FIC和BIC创新产品,并有效促进创新产品的临床研究,开发和商业化。
CMS deeply engages in several specialty therapeutic fields, such as cardio-cerebrovascular, central nervous system, gastroenterology, dermatology and ophthalmology, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products.
CMS深入从事心脑血管、中枢神经系统、胃肠病学、皮肤病学和眼科等多个专业治疗领域,并已开发出成熟的商业化能力、广泛的网络和专家资源,使其主要市场产品在学术和市场上处于领先地位。
For more information about CMS, please visit .
有关CMS的更多信息,请访问。
https://web.cms.net.cn/en/home
https://web.cms.net.cn/en/home
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About Alpha Cognition Inc.
关于Alpha认知公司。
Alpha Cognition Inc. 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 (“mTBI”), for which there are currently no approved treatment options..
Alpha认知公司是一家商业化的生物制药公司,致力于为患有神经退行性疾病的患者开发治疗方法,例如阿尔茨海默病和轻度创伤性脑损伤的认知障碍(“mTBI”),目前尚无批准的治疗方案。。
ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition.
ZUNVEYL是一种专利药物,被批准为新一代乙酰胆碱酯酶抑制剂,用于治疗阿尔茨海默病,预计胃肠道副作用最小。ZUNVEYL的活性代谢物与多奈哌齐和利凡斯的明不同,因为它结合神经元烟碱受体,最明显的是α-7亚型,已知其对认知有积极影响。
ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI..
ALPHA-1062也正在与美金刚联合开发,用于治疗中度至重度阿尔茨海默氏痴呆症,并作为mTBI认知障碍的鼻内制剂。。
For further information:
更多信息:
Investor Relations
投资者关系
IR@alphacognition.com
IR@alphacognition.com
https://www.alphacognition.com/
https://www.alphacognition.com/
Forward-looking Statements
前瞻性声明
This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.
本新闻稿包括适用证券法意义上的前瞻性声明。除历史事实陈述外,本新闻稿中包含的任何信息都可能是前瞻性陈述,反映了公司对未来事件的当前观点,并受到已知和未知风险、不确定性、假设和其他因素的影响,这些因素可能导致实际结果、活动水平、绩效或成就与这些前瞻性陈述所表达或暗示的信息存在重大差异。
In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future.
在某些情况下,您可以通过“可能”、“可能”、“将要”、“可能”、“将要”、“应该”、“期望”、“打算”、“计划”、“目标”、“预期”、“相信”、“估计”、“预测”、“项目”、“潜在”、“目标”、“寻求”、“沉思”、“继续”和“正在进行”等词语来识别前瞻性陈述,也可以通过这些术语的否定词或其他旨在识别未来陈述的可比术语来识别前瞻性陈述。
Forward‐looking statements may include statements regarding the potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company’s timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company’s planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S.
前瞻性声明可能包括关于许可协议对ZUNVEYL在亚洲(不包括日本)、澳大利亚和新西兰的开发和商业化的潜在好处的声明,公司在美国和中国推出ZUNVEYL的时间和计划活动,公司计划的企业更新电话的时间,ZUNVEYL在美国上市的潜在时间。
and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company’s business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company’s potential growth opportunities in China, the timing and results of the Company’s milestone payments for China, the Company’s regulatory submissions in.
和中国,ZUNVEYL在中国的潜在未来发展,ZUNVEYL在中国的潜在市场规模,公司在中国推出ZUNVEYL的业务战略,ZUNVEYL在中国的市场规模和需求,公司在中国的潜在增长机会,公司在中国的里程碑付款的时间和结果,公司在年提交的监管报告。
www.sedar.com
www.sedar.com
and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at
以及公司向美国证券交易委员会(“SEC”)提交的文件,包括公司于2024年11月6日提交给SEC的s-1/A表注册声明中标题为“风险因素”的风险因素,可在
www.sec.gov
www.sec.gov
. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.
。这些前瞻性声明仅在本新闻稿发布之日起生效,公司没有义务出于任何原因修改或更新任何前瞻性声明,即使将来有新信息可用,但法律要求的除外。