药物临床试验登记与信息公示平台数据显示，万邦德制药集团有限公司的石杉碱甲口服溶液与石杉碱甲 注射液在中国健康受试者中的单中心、随机、开放、单次给药、两周期、两序列、交叉设计的药代动力 学比较研究的Ⅰ期临床试验已启动。临床试验登记号为CTR20255231，首次公示信息日期为2025年12月 30日。 该药物剂型为溶液剂，用法为在空腹状态下，口服给药0.22mg，240mL温水送服，单次给药。本次试验 主要目的为比较石杉碱甲口服溶液和石杉碱甲注射液在中国健康受试者空腹状态下单次给药的药代动力 学特征。次要目的为评估石杉碱甲口服溶液的相对生物利用度，评估空腹状态下两种制剂的安全性。 石杉碱甲口服溶液为化学药物，适应症为重症肌无力。重症肌无力是一种神经肌肉接头传递功能障碍的 获得性自身免疫性疾病，主要表现为部分或全身骨骼肌无力和极易疲劳，活动后症状加重，休息和胆碱 酯酶抑制剂治疗后症状减轻，诊断依赖临床表现及相关检查。 风险提示：市场有风险，投资需谨慎。本文为AI大模型基于第三方数据库自动发布，任何在本文出现 的信息（包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不 构成个人投资建 ...

12月29日晚万邦德（002082）公告称，全资子公司万邦德制药集团有限公司的新药WP107(石杉碱甲口 服溶液)治疗重症肌无力的I期临床试验，获得了温州医科大学附属第二医院温州医科大学附属育英儿童 医院医学伦理委员会的审查批件，批准项目开展。 万邦德表示，此次临床试验获得临床单位伦理审查批件后，短期内对公司经营业绩不会产生重大影响， 公司将按照相关规定和要求继续开展临床试验。公司将积极推进上述研发项目，并严格按照有关规定及 时对项目后续进展情况履行信息披露义务。 经营总部位于浙江台州的万邦德，聚焦医药制造和医疗器械大健康产业，产品涉及心脑血管、神经系 统、呼吸系统、消化系统和精神系统等多个治疗领域。 值得一提的是，在神经系统领域，万邦德的石杉碱甲注射液，是作为改善痴呆患者及脑器质性病变所致 记忆障碍、良性记忆障碍和重症肌无力的一线用药。其核心成分石杉碱甲为国内外首创药物，荣获国家 技术发明奖二等奖、国家自然科学二等奖，更在全球布局获得美国、欧洲、日本等多国专利。 公告显示，万邦德于2023年12月获得美国食品药品监督管理局(FDA)授予的石杉碱甲治疗重症肌无力的 孤儿药认定；WP107(石杉碱甲口服溶液)用 ...

公告显示，万邦德于2023年12月获得美国食品药品监督管理局(FDA)授予的石杉碱甲治疗重症肌无力的 孤儿药认定，于2025年1月WP107口服溶液用于治疗全身型重症肌无力获得美国FDA新药临床试验许 可，2025年7月获得国家药品监督管理局2.2类新药临床试验批准通知书，已正式开展I期临床试验工 作。此次收到伦理批件，旨在比较石杉碱甲口服溶液和石杉碱甲注射液在中国健康受试者空腹状态下单 次给药的药代动力学特征，评估石杉碱甲口服溶液的相对生物利用度及空腹状态下两种制剂的安全性。 北京商报讯(记者王寅浩宋雨盈)12月29日，万邦德（002082）发布公告称，公司全资子公司万邦德制药 集团有限公司的新药WP107治疗重症肌无力的I期临床试验获得了温州医科大学附属第二医院温州医科 大学附属育英儿童医院医学伦理委员会的审查批件，批准项目开展。 ...

公司获得国家药监局的《药物临床试验批准通知书》后，积极推进药学和临床工作，已正式开展I期临 床试验工作。此次收到温州医科大学附属第二医院温州医科大学附属育英儿童医院医学伦理委员会的审 查批件，旨在比较石杉碱甲口服溶液和石杉碱甲注射液在中国健康受试者空腹状态下单次给药的药代动 力学特征，评估石杉碱甲口服溶液的相对生物利用度及空腹状态下两种制剂的安全性。 智通财经APP讯，万邦德(002082.SZ)发布公告，公司全资子公司万邦德制药集团有限公司的新药WP107 治疗重症肌无力的I期临床试验获得了温州医科大学附属第二医院温州医科大学附属育英儿童医院医学 伦理委员会的审查批件，批准项目开展。 ...

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 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 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 Insights - The National Healthcare Security Administration (NHSA) has published the preliminary review results for the 2025 medical insurance and commercial insurance innovative drug directory, with significant changes in the approval status of six drugs compared to the previous version [1][2]. Summary by Categories Drug Approval Changes - Six drugs have had their approval status changed, with two drugs (Injectable Risperidone Microspheres and Injectable Triptorelin Acetate) being disapproved, while two others (Levodopa Injection and Calcium Gluconate Sodium Chloride Injection) have been approved [1][3]. - The oral suspension of Ursodeoxycholic Acid remains approved, but the conditions for approval have been adjusted [1][3]. Application Statistics - For the 2025 directory adjustment, the NHSA received 718 applications, involving 633 drug generic names, with 535 passing the preliminary review [1][2]. - The approval rate has increased significantly, reaching 84.52% this year, compared to 68.42% in 2023 and 76.66% in 2024 [2]. Notable Drugs - Levodopa Injection, used for Parkinson's disease, has been approved and is not an exclusive product, indicating its potential for broader market access [4]. - Injectable Ceftriaxone Sodium Sulbactam, another approved drug, is noted for its broad antibacterial spectrum and safety profile [4]. - The oral suspension of Ursodeoxycholic Acid has had its approval conditions modified to include rare disease categories [6]. Innovative Drug Directory - The commercial insurance innovative drug directory has been introduced alongside the basic medical insurance directory, with 141 applications received, of which 121 passed the preliminary review [2]. - A significant number of drugs in both directories are new, with 303 in the basic medical insurance directory meeting specific conditions for approval [7]. Rare Disease Drugs - The directories include a total of 37 rare disease drugs in the basic medical insurance directory and 35 in the commercial insurance innovative drug directory, with 19 drugs approved in both [10][11]. - Notable rare disease drugs include those from Merck and other companies, which have gained attention for their potential market impact [11][12]. Market Trends - The introduction of the commercial insurance innovative drug directory is expected to enhance market access for several high-profile drugs, including CAR-T therapies that have previously struggled to gain approval [9][12]. - The performance of rare disease drug companies has seen significant stock price increases, indicating strong market interest and potential for growth [13].

Core Viewpoint - The National Healthcare Security Administration (NHSA) has officially announced the preliminary review results for the adjustment of the 2025 medical insurance and commercial insurance innovative drug catalog, indicating an increase in the number of drugs passing the review and the overall approval rate compared to previous years [1][2]. Summary by Relevant Sections Drug Review Changes - Six drugs underwent changes in their review status, with two drugs, injectable risperidone microspheres and injectable triptorelin, being disapproved, while injectable levodopa and calcium gluconate sodium injection were approved [1][5][6]. - The injectable risperidone microspheres, an exclusive product of Shengzhao Pharmaceuticals, was first launched in mainland China in February 2025 for treating mental disorders [6][7]. - The injectable triptorelin, also an exclusive product, was launched in 2023 for treating prostate cancer and precocious puberty [7]. Approval Statistics - A total of 718 applications were received for the 2025 catalog adjustment, involving 633 drug generic names, with 535 passing the preliminary review, resulting in an approval rate of 84.52% [1][2]. - The approval rates have shown a significant increase over the past three years, with 68.42% in 2023, 76.66% in 2024, and 84.52% in 2025 [2]. Innovative Drug Catalog - The commercial insurance innovative drug catalog was introduced for the first time, with 141 applications received, involving 141 drug generic names, and 121 passing the review [3]. - Among the drugs, 79 were submitted for both the basic medical insurance catalog and the commercial insurance innovative drug catalog [3]. Notable Products - Several notable products are highlighted, including CAR-T products that have previously failed to enter the medical insurance catalog but are now included in the commercial insurance innovative drug catalog [11][12]. - Unique products such as the first and only AKT inhibitor and the only Trop-2 ADC for breast cancer treatment are also included in the catalogs, indicating a focus on innovative therapies [13][14]. Rare Disease Medications - The review process has also included rare disease medications, with 37 drugs in the basic medical insurance catalog and 35 in the commercial insurance innovative drug catalog, of which 19 are approved in both [15][16]. - The approval of rare disease drugs is seen as a significant development, with companies like Beihai Kangcheng gaining attention for their innovative products [20].

Financial Performance - The company's investment income increased by 593.87% compared to the same period last year, primarily due to the termination of recognition of financial assets measured at amortized cost as investment income [1] - Fair value changes resulted in a loss of 4.7671 million yuan, an increase compared to the same period last year, mainly due to changes in the fair value of other non-current financial assets [1] - Asset impairment losses increased by 149.00% year-on-year, mainly due to the impairment provision for intangible assets (trademarks and patents) of the subsidiary Kangci Medical [1] - Credit impairment losses decreased by 103.81% year-on-year, mainly due to changes in the provision for bad debts of receivables [1] - Asset disposal income increased by 15.6225 million yuan, primarily from the disposal of land and properties of the subsidiary Kangci Medical located in Jiangshan [1] - Non-operating income decreased by 6.7666 million yuan compared to the same period last year, mainly due to a decrease in other non-operating income [1] Cash Flow Analysis - The net cash flow from operating activities increased by 193 million yuan year-on-year, mainly due to an increase in the recovery of accounts receivable and an increase in the use of payable notes for purchasing goods [4] - Cash inflow from investment activities increased by 317.55% year-on-year, primarily due to the disposal of land and properties of the subsidiary Kangci Medical [4] - The net cash flow from financing activities decreased by 557.32% year-on-year, mainly due to an increase in debt repayment during the reporting period [4] Profit Distribution Plan - The company plans not to distribute profits for the 2024 fiscal year, which includes no cash dividends, no bonus shares, and no capital reserve conversion to share capital, with the remaining undistributed profits carried forward to the next year [8][9] - The decision is based on the company's current operational development plans and the need to ensure funding for ongoing projects and R&D [8][9] Asset Impairment Provision - The company plans to recognize an asset impairment provision of 26.2414 million yuan for the fiscal year 2024, following a comprehensive review of various asset categories [10][19] - The provision includes specific amounts for receivables, inventory, and intangible assets, reflecting a cautious approach to financial reporting [12][14][16] Credit and Financial Support - The company intends to apply for a comprehensive credit limit of up to 2.1 billion yuan for 2025 to meet the funding needs of its various business developments [23] - The company also plans to provide financial assistance to its subsidiary, Kangci Medical, with a borrowing limit of up to 50 million yuan at an interest rate of 4% [46][48]