阿尔茨海默病（俗称"老年痴呆症"）的治疗是一项世界性难题，但全球医学界的探索从未止步。日前， 国内最大规模阿尔茨海默病注册研究正式开启。 在今日公告中，万邦德还指出，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。 据了解，石杉碱甲控释片是万邦德自主研发的用于治疗轻、中度阿尔茨海默病型痴呆的2.2类新药，采 用双相控释技术，平缓药物释放峰谷曲线，并延长药物体内释放时间，从而实现快速起效，减少不良反 应，提升给药剂量与良好的安全性。同时，控释技术支持每天一次给药，提高患者的用药便利性和长期 依从性。 另外，万邦德还表示，此次开展的II/III期临床研究，是中国目前已知规模最大的阿尔茨海默病注册研 究。公司积极推进受试者入组，公司将继续与首都医科大学宣武医院等全国50多家研究机构紧密合作， 进一步验证药物的安全性、有效性，为产品的最终上市申请提供关键数据支撑。 据悉，万邦德办公地浙江台州，是我国原料药的生产重地，涌现出了一批知名药企。其中，万 ...

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]

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 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]

Group 1: Company Overview - The company introduced its innovative drug pipeline, focusing on Alzheimer's disease and related research [1] - The Alzheimer's II/III clinical trial is the largest key registration study in China, designed scientifically with dual endpoints (ADAS-Cog and ADCS-ADL) to evaluate cognitive function and daily living abilities [2] Group 2: Alzheimer's Disease Research - The clinical trial employs a multi-center, randomized, double-blind design with placebo and positive drug controls, assessing the drug's impact on disease progression and biomarkers [2] - The drug Huperzine A is a cholinesterase inhibitor showing potential benefits in anti-inflammation, cholinergic regulation, neuroprotection, mitochondrial protection, and antioxidant stress [2] - The controlled-release formulation of Huperzine A aims for rapid onset, reduced adverse reactions, and improved patient compliance with once-daily dosing [2] Group 3: ALS (Amyotrophic Lateral Sclerosis) Development - The company is developing WP205 for ALS, which has received orphan drug designation from the FDA and is patent pending [3] - The company plans to explore the multi-target mechanism of Huperzine A in ALS treatment and has patented core compounds for drug development targeting MCR [3]

Core Viewpoint - Wanbangde's subsidiary has initiated a critical II/III phase clinical trial for its new drug, Huperzine A controlled-release tablets, aimed at treating mild to moderate Alzheimer's disease, marking a significant step in the company's research and development efforts [1][3]. Group 1: Clinical Trial and Drug Development - The clinical trial for Huperzine A controlled-release tablets is the largest known Alzheimer's disease registration study in China, employing a multi-center, randomized, double-blind design with placebo and positive drug controls [1][3]. - Huperzine A is a cholinesterase inhibitor that has shown potential in preclinical studies to delay the progression of Alzheimer's disease, with benefits including reduction of β-amyloid protein, anti-inflammatory, antioxidant effects, and neuroprotection [1][3]. - The controlled-release technology used in Huperzine A tablets allows for a smoother drug release profile, enhancing patient compliance with once-daily dosing and improving safety [1][2]. Group 2: Financial Performance and Market Position - In the first half of 2025, the company reported a revenue of 579 million yuan, a decrease of 23.15% year-on-year, and a net profit of 13.46 million yuan, down 64.29% year-on-year [2]. - Huperzine A injection, a first-line treatment for memory disorders, holds a market share of 24.37%, ranking second in the Huperzine A formulation market [2]. - The company is recognized for its technological authority and market exclusivity, being the sole manufacturer of Huperzine A injection and participating in the formulation of industry standards [2]. Group 3: Research Collaboration and Future Prospects - The company collaborates with over 50 research institutions, including Capital Medical University Xuanwu Hospital, to validate the safety and efficacy of Huperzine A controlled-release tablets, providing critical data for future market applications [3]. - The clinical trial will also explore Aβ-PET imaging to observe changes in amyloid protein deposition, further validating the drug's potential to delay disease progression [3].

Core Viewpoint - Wanbangde Pharmaceutical's subsidiary has initiated the first patient enrollment for a pivotal Phase II/III clinical trial of its new drug, Huperzine A controlled-release tablets, aimed at treating mild to moderate Alzheimer's disease dementia, marking it as the largest known Alzheimer's registration study in China [1] Group 1 - The clinical trial employs a multi-center, randomized, double-blind, and double-dummy design, including both placebo and positive drug controls [1] - Huperzine A controlled-release tablets are a self-developed Class 2 new drug by the company, utilizing a biphasic controlled-release technology [1] - The drug aims to achieve rapid onset of action, reduce adverse reactions, and enhance patient medication convenience and long-term adherence [1]

Core Viewpoint - Wanbangde Pharmaceutical Holdings Group Co., Ltd. has launched a national conference for the Phase II/III clinical trial of its new drug Huperzine A controlled-release tablets for Alzheimer's disease, emphasizing the importance of local research and collaboration among experts [1][2]. Group 1: Clinical Trial Launch - The national launch conference for the Phase II/III clinical trial of Huperzine A controlled-release tablets was held in Beijing [1]. - Experts gathered to discuss the significance of the trial and to collaborate on high-quality development of the drug [1]. Group 2: Research and Development Insights - Professor Jia Jianping highlighted the trial's importance and encouraged local researchers to take pride in their work [1]. - Zhao Guanjia, the director of Wanbangde's research institute, discussed the company's focus on Huperzine A and its extensive groundwork in related research [1]. Group 3: Safety and Efficacy - Researcher Gan Yong shared the development history of Huperzine A controlled-release tablets, noting the urgent need for effective and well-tolerated drugs for Alzheimer's patients [2]. - Director Yan Feng provided insights into the safety profile of the drug, indicating that preliminary data supports its good safety and pharmacological characteristics [2]. Group 4: Training and Standardization - The conference included comprehensive training on the research protocol, operational processes, and key execution points to ensure a unified understanding among all researchers [2].