Core Viewpoint - The announcement of the largest Alzheimer's disease registration study in China has been made by Wanbangde, focusing on the clinical trial of its new drug, Huperzine A controlled-release tablets, for treating mild to moderate Alzheimer's disease [1][3]. Group 1: Drug Development and Clinical Trials - Wanbangde's subsidiary has completed the enrollment of 50 subjects for the Phase II/III clinical trial of Huperzine A controlled-release tablets, which received approval for the key registration trial in July [1][2]. - The drug is designed to improve cognitive function and has shown potential in preclinical studies to slow the progression of Alzheimer's disease, with benefits including the reduction of β-amyloid protein, anti-inflammatory effects, and neuroprotection [2][3]. - The controlled-release technology used in the formulation allows for a smoother drug release profile, enhancing patient compliance and safety by enabling once-daily dosing [2]. Group 2: Company Background and Market Position - Wanbangde is based in Taizhou, Zhejiang, a significant hub for raw material drug production in China, and focuses on the pharmaceutical manufacturing and healthcare industry, covering various therapeutic areas including cardiovascular, neurological, respiratory, digestive, and mental health [1]. - The company has established a reputation in the neurological treatment field, with its Huperzine A injection recognized as a first-line medication for memory disorders caused by dementia and other brain conditions [1][2].

Core Viewpoint - Wanbangde (002082.SZ) announced the completion of enrollment for 50 subjects in the key Phase II/III clinical trial of its new drug, Huperzine A controlled-release tablets, aimed at treating mild to moderate Alzheimer's disease dementia [1] Group 1: Company Developments - Wanbangde's wholly-owned subsidiary, Wanbangde Pharmaceutical Group Co., Ltd., is conducting the clinical trial for Huperzine A, which is classified as a Class 2 new drug [1] - The drug is a cholinesterase inhibitor designed to improve cognitive function and has shown potential in preclinical studies to delay the progression of Alzheimer's disease [1] Group 2: Drug Characteristics and Potential - Huperzine A exhibits a range of benefits, including the reduction of beta-amyloid protein, anti-inflammatory effects, antioxidant stress response, and neuroprotection [1] - The drug is expected to become a broad-spectrum treatment for Alzheimer's disease dementia [1]

完成 50 例受试者入组的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 万邦德医药控股集团股份有限公司（以下简称"公司"）全资子公司万邦德 制药集团有限公司的 2.2 类新药石杉碱甲控释片用于治疗轻、中度阿尔茨海默病 型痴呆的 II/III 期关键注册临床试验，于近日完成 50 例受试者入组。现将相关 情况公告如下： 一、产品基本情况 名称：石杉碱甲控释片 英文名称：Huperzine A Controlled-Release Tablets 证券代码：002082 证券简称：万邦德 公告编号：2025-066 万邦德医药控股集团股份有限公司 关于石杉碱甲控释片 II/III 期临床试验 临床研究阶段：Ⅱ/Ⅲ期 临床研究组长单位：首都医科大学宣武医院 石杉碱甲是用于改善认知功能的胆碱酯酶抑制剂，临床前研究展现出延缓阿 尔茨海默病疾病进展的潜力及广泛的综合获益，包括对β淀粉样蛋白的降低作用， 抗炎、抗氧化应激以及神经元保护作用，有望成为具有广谱抗阿尔茨海默病型痴 呆的药物。 石杉碱甲控释片是公司自主研发的用于治疗轻、中度阿尔茨海默病型痴呆的 2.2 类新 ...

Group 1 - The core announcement is that Wanbangde (002082) has completed the enrollment of 50 subjects for its Phase II/III pivotal registration clinical trial of the new drug, Huperzine A controlled-release tablets, aimed at treating mild to moderate Alzheimer's disease [1] Group 2 - The drug is classified as a Class 2 new drug, indicating its potential significance in the pharmaceutical market [1] - The completion of subject enrollment marks a critical step in the clinical trial process, which is essential for regulatory approval [1] - The trial's focus on Alzheimer's disease highlights the growing demand for effective treatments in this therapeutic area, reflecting broader industry trends [1]

Core Viewpoint - Wanbangde (002082.SZ) announced the completion of participant enrollment for its Phase II/III clinical trial of the new drug Huperzine A controlled-release tablets for treating mild to moderate Alzheimer's disease [1] Group 1: Company Developments - Wanbangde's wholly-owned subsidiary, Wanbangde Pharmaceutical Group Co., Ltd., has completed the enrollment of 50 subjects for the critical registration clinical trial [1] - Huperzine A is a cholinesterase inhibitor aimed at improving cognitive function [1] Group 2: Drug Potential - Preclinical studies have shown that Huperzine A has the potential to delay the progression of Alzheimer's disease and offers broad benefits, including the reduction of beta-amyloid protein, anti-inflammatory effects, antioxidant stress response, and neuroprotection [1] - The drug is expected to become a broad-spectrum treatment for Alzheimer's disease-related dementia [1]

Core Insights - The company Wanbangde is making significant progress in the development of new drugs for Alzheimer's disease, particularly with its controlled-release tablet of Huperzine A (FN12), which is currently in the II/III phase of clinical trials [1][2] - The drug has shown promising safety and efficacy results, with the potential to improve cognitive function in patients [1] - Wanbangde is also expanding its product portfolio in the peptide drug sector, focusing on new compounds that target various mechanisms, including those related to Alzheimer's disease [3] Group 1: Alzheimer's Disease Drug Development - Wanbangde has been dedicated to Alzheimer's disease drug research for many years, aiming to develop new treatment options for patients globally [1] - The controlled-release tablet of Huperzine A is part of the largest known Alzheimer's disease registration study in China, with collaboration from over 50 research institutions [2] - Preliminary studies indicate that Huperzine A can significantly enhance cognitive function and has multiple beneficial effects, including anti-inflammatory and neuroprotective properties [1][2] Group 2: Peptide Drug Research - The company is developing a new class of peptide drugs that have shown excellent results in preclinical animal studies, including weight loss and improvements in diabetes-related metrics [3] - The peptide drugs have received orphan drug designation from the FDA, indicating their potential for treating rare diseases [3] - Wanbangde is also exploring new targets and mechanisms for Alzheimer's disease treatment through its peptide drug research, aiming to establish a strong position in the global Alzheimer's drug development landscape [3]

Core Insights - The company is deeply engaged in the research and development of new drugs for Alzheimer's disease (AD), aiming to create new treatment options for global AD patients [1][2] - The key registration clinical trial for the company's controlled-release donepezil tablets (FN12) is progressing smoothly, being the largest known AD registration study in China [1] - Preliminary data indicates that the controlled-release donepezil tablets have good safety profiles and can significantly improve cognitive function in patients [1] - The company is also developing a new class of peptide drugs targeting different mechanisms, showing promising results in preclinical studies for weight loss and other metabolic benefits [1][2] Alzheimer's Disease Research - The company has been conducting extensive research on Alzheimer's disease, with a focus on the controlled-release donepezil tablets, which are currently in Phase II/III clinical trials [1] - Collaboration with CROs is emphasized to expedite the acquisition of effective data to validate the drug's efficacy and safety [1] - The controlled-release donepezil tablets are believed to offer differentiated clinical benefits due to their multifaceted actions, including anti-inflammatory and neuroprotective effects [1] New Drug Development - The company is advancing its peptide drug project, which is a new compound targeting melanocortin receptors, showing excellent weight loss effects in preclinical animal studies [1] - The peptide drug also demonstrates potential in lowering blood sugar levels and improving indicators related to diabetic complications [1] - The company has received orphan drug designation from the FDA for this peptide drug, indicating its potential significance in treating rare diseases [1]

一、注册证书基本信息 药品通用名称：枸橼酸西地那非口服混悬液 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗 漏。 万邦德医药控股集团股份有限公司（以下简称"公司"）全资子公司万邦德制药集团浙江医药销售有限公 司（以下简称"万邦德销售公司"）获得西班牙Farmalider, S.A.（以下简称"Farmalider"）的枸橼酸西地那 非口服混悬液(以下简称"西地那非口服混悬液"）在中国大陆市场10年的独家进口权和独家销售权，近 日收到Farmalider授权方NULIFE GROUPE LIMITED礼易集团有限公司（以下简称"礼易集团"）的通 知，获悉西地那非口服混悬液已取得国家药品监督管理局核准签发的《药品注册证书》。现将有关事宜 公告如下： 英文名/拉丁名：Sildenafil Citrate Oral Suspension 登录新浪财经APP 搜索【信披】查看更多考评等级 枸橼酸西地那非是治疗勃起功能障碍的主要产品。根据米内网数据显示，2024年男性勃起功能障碍用药 国内市场约83亿元，其中西地那非内服制剂全年销售额约51亿元。 枸橼酸西地那非口服混悬液是西 ...

一纸国家药品监督管理局核准批文，宣告万邦德（002082）通过引进创新型药剂，成功进入ED治疗领 域。 总部位于浙江湖州的万邦德，聚焦医药制造和医疗器械大健康产业，主营业务集医药制造和医疗器械研 发、生产、销售于一体。今年前三季度，公司营业总收入10.18亿元，净利润为446.78万元。 11月26日晚，万邦德公告称，万邦德全资子公司万邦德制药集团浙江医药（600216）销售有限公司(下 称"万邦德销售公司")获得西班牙Farmalider,S.A.(以下简称"Farmalider")的枸橼酸西地那非口服混悬液(下 称"西地那非口服混悬液")在中国大陆市场10年的独家进口权和独家销售权，近日收到Farmalider授权方 NULIFE GROUPE LIMITED礼易集团有限公司(下称"礼易集团")的通知，获悉西地那非口服混悬液已取 得国家药品监督管理局核准签发的《药品注册证书》。 对于此次批文的影响，万邦德表示，西地那非口服混悬液取得《药品注册证书》，标志着公司未来10年 可独家进行该产品在中国大陆市场的进口和销售。公司通过引进创新型剂型进入ED领域，能够更好满 足不同群体的用药需求。 据悉，枸橼酸西地那非 ...

每经AI快讯，11月26日，万邦德公告，公司全资子公司万邦德制药集团浙江医药销售有限公司收到国 家药品监督管理局签发的枸橼酸西地那非口服混悬液《药品注册证书》。该产品用于治疗男性勃起功能 障碍（ED）。 ...