Donepezil Hydrochloride

VANCOUVER, British Columbia & DALLAS--(BUSINESS WIRE)--Alpha Cognition Inc. (NASDAQ: ACOG) (the “Company” or “Alpha Cognition”) today announced three upcoming presentations at the 2025 Alzheimer’s Association International Conference (the “AAIC”), taking place July 27–31, 2025 in Toronto, Canada. The presentations will highlight clinical studies supporting ZUNVEYL (benzgalantamine), the Company’s lead product and a novel galantamine prodrug approved by the FDA in July 2024 and commercially launched in March 2025. The studies demonstrated bioequivalence to galantamine IR and ER and were integral to the NDA submission and approval. “We’re excited to share data that underscore ZUNVEYL’s potential to deliver meaningful clinical benefit to patients,” said Dr. Denis Kay, Chief Scientific Officer at Alpha Cognition. “We believe ZUNVEYL offers an attractive new option for Alzheimer’s disease patients and caregivers.” Presentation Schedule at AAIC 2025: Bioequivalence to Galantamine ER under Steady State Conditions Poster #107147 | July 27, 2025 Bioequivalence to Galantamine IR under Fed and Fasting Conditions Poster #107030 | July 28, 2025 Dose Proportionality Across 5–15 mg Range under Fasting Conditions Poster #107255 | July 30, 2025 About ZUNVEYL ZUNVEYL is a twice-daily treatment designed to address the cognitive symptoms of mild-to-moderate Alzheimer’s disease. By enhancing cholinergic function in the brain, ZUNVEYL supports memory, learning, and overall cognitive function, offering a meaningful improvement for patients and their caregivers. Targeted for the long-term care market, ZUNVEYL is uniquely positioned to address the needs of a growing patient population in a segment valued at $2 billion annually in the United States. Alpha Cognition is committed to ensuring ZUNVEYL is accessible to patients and caregivers, supported by robust market access strategies and a dedicated commercial team. About Alpha Cognition Inc. 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. For more information, please visit www.alphacognition.com. INDICATION ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. IMPORTANT SAFETY INFORMATION Contraindications ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or any inactive ingredients in ZUNVEYL. Warnings and Precautions Serious Skin Reactions: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of (ZUNVEYL) tablets. If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Cardiovascular conditions: Cholinesterase inhibitors, including ZUNVEYL, may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil. Peptic ulcer disease and gastrointestinal bleeding: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Genitourinary conditions: Although not observed in clinical trials of ZUNVEYL, bladder outflow obstruction may occur. Pulmonary conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease. Monitor for respiratory adverse effects. Adverse Reactions The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Drug Interactions Cholinesterase inhibitors, including galantamine, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol. These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Forward-Looking Statements 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. 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. Forward-looking statements may include statements regarding the presentation of ZUNVEYL at the 2025 Alzheimer’s Association International Conference, the contraindications of ZUNVEYL, the warning and precautions of ZUNVEYL, the adverse reactions of ZUNVEYL, the clinical benefits of ZUNVEYL to patients, ZUNVEYL’s efficacy and tolerability, ZUNVEYL’s long-term benefits, the Company’s timing and planned activities to launch ZUNVEYL, potential timing for the availability of ZUNVEYL, potential future developments of ZUNVEYL, the potential market size for ZUNVEYL, the Company’s business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company’s products. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL , risks related to the Company’s intellectual property in relation to ZUNVEYL , risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at 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 January 10, 2025 and available at 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.

4月8日，NMPA下发药品批准文件，昂丹司琼口溶膜新增一家过评企业。沉寂多时的口溶膜市场，终于又冒了个头。此次获批的是昂丹司琼注射液的改良剂型，最早在美国上市。2022年1月，恒瑞首家以3类仿制获批上市，适应症为：放化疗、手术引起的恶心、呕吐。止吐药市场是个真金白银的大盘，年销破百亿不是梦。昂丹司琼口溶膜上市当年就进了医保，谈判价4mg为13.74元/片，8mg为23.5元/片。这个价格不高不低，很美好。进医保后，销量起飞、涨势惊人。2023年，医院全终端销售接近6000万；而2024年仅前两个季度就以赶超23年全年，突破7000万，全年破亿轻轻松松。可以预见，昂丹司琼口溶膜后面还有很大上升空间。但这不是重点。重点是：口溶膜终于又又又批了！口溶膜真的是好久没见过有企业获批了。上一个顺利获批的口溶膜企业及品种还是2024年1月5日，力品药业的阿立哌唑口溶膜。内卷成这样的制药产业，一种剂型长达一年多都没有获批，着实罕见。更别说这一年里，连着几个坏消息：2022年12月，四川科伦2.2类申报的枸橼酸西地那非口溶膜被驳回；2024年5月，海思科联手Aquestive申报的5.1类利鲁唑口腔膜撤回申请，理由是“准入和商业化前景不明”；2024年7月，力品药业的盐酸多奈哌齐口溶膜被下发通知件，更戏剧性的是，海思科同一天也收到通知件，两家一起被驳回。厄运一个接着一个。当时圈里人一度断言：口溶膜，批不出来了。但现在看，至少3类仿制还是能批的。昂丹司琼就是例子。然而话虽如此，口溶膜核心问题还在：2.2类改良的口溶膜，能不能批？除了昂丹司琼口溶膜之外，目前在审的5款口溶膜，清一色走的都是2.2类。可偏偏这条路走的最艰难。CDE对2.2类改良的要求是——具有明显的临床优势，提高有效性、提高安全性、改善依从性。问题是，“明显临床优势” 这几个字就像紧箍咒，谁碰谁头疼。口溶膜有个最大的问题在于，载药量过小，一般药物活性成分占整个制剂的5%～30%，口溶膜载药量由于口腔黏膜的面积有限，又得保持膜剂的特性，有效性非常难证明，这也是普遍认为口溶膜难以获批的原因。还有一个隐形杀手：口崩片。同样无需用水送服，同样是提高患者的顺应性，口崩片研发难度更低，且生产成本低。就算这样，依旧有企业不死心。齐鲁、科伦、上海欣峰等企业均有品种在等待评审。布瑞哌唑口溶膜甚至已经有5家企业提交了11条上市申请，都是走的2.2类改良申报，结果如何就让我们拭目以待了。图：口溶膜申请上市企业，图源：摩熵医药参考：药筛↓ 扫码加入药通社交流群 ↓投稿/内容沟通：华籍美人（Ww_150525）*添加请注明备注及来意