SHENZHEN, CHINA, July 28, 2025 (GLOBE NEWSWIRE) -- China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 28 July 2025, the New Drug Application (NDA) for improved new drug ZUNVEYL (Benzgalantamine Gluconate Enteric-coated Tablets) (“ZUNVEYL” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA). The Product is indicated for the treatment of mild-to-moderate dementia of the Alzheimer’s type in adults. About Product ZUNVEYL ZU ...

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格隆汇7月28日丨康哲药业(00867.HK)宣布，改良型新药ZUNVEYL(拟定通用名：葡萄糖酸苯加兰他敏 肠溶片)(「ZUNVEYL」或「产品」)新药上市许可申请(NDA)已于2025年7月28日获得中国国家药品监 督管理局(NMPA)受理。产品拟用于治疗成人轻度至中度阿尔茨海默型痴呆症状。 集团于2025年1月8日，通过公司全资附属公司与Alpha Cognition Inc. (「Alpha」)就用于治疗轻度至中度 阿尔茨海默型痴呆症状的改良型新药ZUNVEYL签订许可、合作与经销协议(「协议」)。根据协议，集 团获得了在亚洲(除日本、中东地区)、澳洲、新西兰(「区域」)开发、注册、生产、进口、出口和商业 化产品的独家权利，Alpha保留在区域内生产供应的权利。合作期限自协议签署之日起二十年(初始期 限)，初始期限到期後除非任一方通知终止，否则协议每五年自动延期。 ZUNVEYL将使集团创新药产品矩阵更加多元化，提升集团综合竞争实力，且产品可与集团在售创新药 维图可(地西泮鼻喷雾剂)、原研品牌药黛力新(氟哌噻吨美利曲辛片)以及在研创新产品注射用Y-3等系列 中枢神经品种在专家网络与市场资源方面协同。凭 ...

自願性及業務進展公告 就治療輕度至中度阿爾茨海默型癡呆症狀的 改良型新藥ZUNVEYL中國上市許可申請已獲受理 China Medical System Holdings Limited（「本公司」，連同其附屬公司統稱為「本集團」） 欣然宣佈，改良型新藥ZUNVEYL（擬定通用名：葡萄糖酸苯加蘭他敏腸溶片） （「ZUNVEYL」或「產品」）新藥上市許可申請（NDA）已於二零二五年七月二十八 日獲得中國國家藥品監督管理局（NMPA）受理。產品擬用於治療成人輕度至中度阿爾 茨海默型癡呆症狀。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 本公告乃由本公司自願刊發，旨在向潛在投資者及本公司股東通知本集團最新業務進 展，建議股東和投資者在進行本公司股票及其他證券的交易時謹慎操作。 ZUNVEYL於二零二四年七月獲得美國食品和藥物管理局（FDA）批准上市用於治療成 人輕度至中度阿爾茨海默型癡呆症狀，屬於新一代乙酰膽鹼酯酶抑制劑（AChEI），通 過抑制乙酰膽鹼酯酶 ...

Core Insights - Alpha Cognition is a relatively unknown pharmaceutical company that launched its first commercial product, Zunveyl (benzgalantamine), in March for the symptomatic treatment of mild-to-moderate Alzheimer's disease [1] - The company received FDA approval for Zunveyl in July 2024, marking a significant milestone in its product development [1] Company Overview - Alpha Cognition operates in the pharmaceutical industry, focusing on treatments for Alzheimer's disease [1] - The launch of Zunveyl represents the company's entry into the market with a product aimed at addressing a critical health issue [1] Product Details - Zunveyl is specifically designed for the symptomatic treatment of mild-to-moderate Alzheimer's disease, indicating a targeted approach to a prevalent condition [1] - The approval from the FDA is a crucial step for the company, as it allows for commercial sales and distribution of Zunveyl [1]