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万邦德:在研新药Ⅱ/Ⅲ期临床试验完成首例受试者入组
Zheng Quan Shi Bao Wang· 2025-08-29 13:10
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].