Memantine hydrochloride

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。近日，国家药监局（NMPA）官网显示，齐鲁制药有限公司按2.2类改良型新药申报的利培酮口溶膜获批上市。这是国内首个该剂型的获批产品，也是公司上市的第六款口溶膜药物，用于治疗双相情感障碍和精神分裂症。截图来源：NMPA官网利培酮（Risperidone）为苯并异噁唑衍生物，是一种第二代抗精神病药物（非典型抗精神药物），通过拮抗多巴胺D2受体和5-HT2A受体，调节中枢神经递质平衡，有效改善精神分裂症患者的阳性症状（如幻觉、妄想）和阴性症状（如情感淡漠、社交退缩）。截图来源：摩熵医药全球药物研发数据库利培酮原研企业为强生（Janssen）公司，最初于1992年在欧盟上市，1999年进入国内市场。据摩熵医药数据库显示，近三年来中国院内市场利培酮销售额均超过10亿元，累计销售额突破121亿。截图来源：摩熵医药全国医院销售（全终端）数据库从市场份额来看，齐鲁制药占比最高，达到28.53%，西安杨森以20.72%紧随其后。此次齐鲁制药推出改良型新药，有望进一步扩大其在利培酮市场的份额。截图来源：摩熵医药全国医院销售（全终端）数据库而我国目前院内抗精神病药物市场规模约90亿元，利培酮片和利培酮口崩片分别位列该市场TOP5与TOP7。截图来源：摩熵医药全国医院销售（全终端）数据库精神疾病患者的用药困境长期存在。据世卫组织2022年数据显示，全球超过10亿人患有精神障碍，其中精神分裂症患者约2300万，中国患者人数超过640万。截图来源：摩熵医药流行病学数据库利培酮作为全球抗精神分裂症处方量最大的药物之一，国内已有口服溶液、片剂、口腔崩解片、注射用微球等多种剂型获批。截图来源：摩熵医药中国药品批文数据库齐鲁制药在利培酮领域表现突出，目前已获批利培酮片、利培酮口崩片、利培酮口溶膜3款产品，其中利培酮口溶膜为国内首家获批，利培酮口崩片为国内首家过评。利培酮口溶膜也是齐鲁制药上市的第六款口溶膜药物。此前，公司已成功将阿立哌唑口溶膜、奥氮平口溶膜、盐酸美金刚口溶膜、孟鲁司特钠口溶膜、他达拉非口溶膜等5款产品推向市场。截图来源：摩熵医药中国药品审评数据库值得关注的是，去年业内盛传口溶膜难获批，改良型新药更无望，海思科与Aquestive联合申报的5.1类利鲁唑口腔膜撤回申请、力品药业2.2类盐酸多奈哌齐口溶膜被驳回，这两事一度令行业丧失信心。今年以来，江苏和晨与江苏恒瑞的昂丹司琼口溶膜相继仿制成功，齐鲁制药的利培酮口溶膜也获批上市，打破了口溶膜难获批的传言，使其再度受市场关注。但齐鲁这款利培酮口溶膜获批历程艰难：2014年申报临床，后试验暂停、批件失效，2022年重启并按2.2类申报临床，同年11月提交上市，2023年12月递交发补资料，终在2025年7月获批。按审评时限，该项目耗时近3年，远超常规上市申请获批时限（中位数18个月）。图源：Susan 法研社口溶膜作为国内近年的新兴剂型，虽技术壁垒高、生产设备昂贵、前期投入大，但市场表现亮眼：问世仅数年，现有7个品种已创下超3亿元的市场规模，其中齐鲁与恒瑞合计占据99%份额，发展空间广阔。若口服剂型向口溶膜的转化路径能真正打通，未来入局企业必将增多。这一市场值得我们持续关注！END本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-2025052024年医药企业综合实力排行榜-202505中国带状疱疹疫苗行业分析报告-2025052023H2-2024H1中国药品分析报告-202504数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025032024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-202501小分子化药白皮书（上）-2025012024年中国医疗健康投融资全景洞察报告-2025012024年医保谈判及市场分析报告-202501近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

VANCOUVER, British Columbia & DALLAS--(BUSINESS WIRE)--Alpha Cognition Inc. (Nasdaq: ACOG) (“Alpha Cognition” [ACI], or the “Company”), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced China Medical System Holdings Limited (CMS) New Drug Application (NDA) for ZUNVEYL has been accepted by the National Medical Products Administration of China (NMPA) for review for the treatment of mild-to-moderate Alzheimer’s dementia. “We are pleased to announce the NMPA acceptance of the ZUNVEYL New Drug Application, marking a significant milestone in our mission to bring innovative treatments to patients in need," said Michael McFadden, Chief Executive Officer of Alpha Cognition. "This acceptance reflects the strength of our partnership with CMS and the dedication of our team. We look forward to working closely with our partner throughout this important review process as we move one step closer to potentially delivering this important therapy to the Asia market." Alpha Cognition will rely on successful regulatory and commercial expertise of CMS in the Chinese market and will benefit financially from advances in China and other Asia territories. The Company is eligible to receive regulatory, sales milestones, and royalties should ZUNVEYL be approved for marketing in China and other Asia territories. According to the epidemiological study results published in the Lancet Public Health, there are about 7.93 million patients with mild-to-moderate Alzheimer dementia in China. With the intensifying aging trend, the number of patients and the consequent disease burden will further increase in the future. The Company anticipates additional progress across other countries with regulatory advancement and ZUNVEYL commercial approvals. 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. ALPHA-1062 (benzgalantamine) formulated as a delayed release oral tablet (ZUNVEYL®), is FDA 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. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as a sublingual formulation for cognitive Impairment with mTBI. INDICATION AND USAGE 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 to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. 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. Anesthesia: See Drug Interactions Section Cardiovascular Conditions: Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction. Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Gastrointestinal Conditions: 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). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL. Genitourinary Conditions: Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Neurological Conditions: Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL. Pulmonary Conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions. ADVERSE REACTIONS The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. DRUG INTERACTIONS Use with Anticholinergics: Galantamine has the potential to interfere with the activity of anticholinergic medications. Use with Cholinomimetics and Other Cholinesterase Inhibitors: A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data may cause fetal harm. Hepatic Impairment: In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended. Renal Impairment: In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended. 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 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. 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 China, and the potential regulatory approval and commercialization of the Company’s products in China. 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 November 6, 2024 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.