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骨化三醇软胶囊
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诚意药业:帕拉米韦注射液获批上市,适用于甲型及乙型流行性感冒
Core Viewpoint - Chengyi Pharmaceutical has received approval for its Palivizumab injection, marking a significant milestone in its drug development efforts and expanding its product line in the influenza treatment market [1][2] Group 1: Drug Approval and Market Position - The Palivizumab injection has been approved as a Class 3 chemical drug for the treatment of influenza A or B [1] - In 2023, the total sales of the four main influenza treatment drugs in the domestic market reached 11.405 billion yuan, with Oseltamivir holding the majority market share [1] - Palivizumab is recognized as the first innovative Class 1 anti-influenza drug approved in China, recommended in various influenza treatment guidelines [1] Group 2: Product Line Expansion and Financial Performance - Over the past year, Chengyi Pharmaceutical has launched multiple products in the formulation sector, continuously expanding its product line [2] - The company expects a net profit attributable to shareholders of 107 million to 119 million yuan for the first half of 2025, representing a year-on-year growth of 40% to 55%, primarily driven by the sales growth of joint-related drugs [2] - The company is also advancing its "Two Strong One Big Project" initiative in marine biomedicine, with a large-scale EPA fish oil production project underway, which is expected to become a core revenue driver alongside joint-related drugs [2]
葫芦娃(605199) - 海南葫芦娃药业集团股份有限公司关于获得骨化三醇软胶囊药品注册证书的公告
2025-02-28 09:00
海南葫芦娃药业集团股份有限公司 关于获得骨化三醇软胶囊药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 海南葫芦娃药业集团股份有限公司(以下简称"公司")近日收到国家药品监督管理 局(以下简称"国家药监局")核准签发的关于骨化三醇软胶囊的《药品注册证书》。现 将有关情况公告如下: 一、药品基本情况 证券代码:605199 证券简称:葫芦娃 公告编号:2025-008 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药 品注册的有关要求,批准注册,发给药品注册证书。质量标准、说明书、标签及生产工 艺照所附执行。药品生产企业应当符合药品生产质量管理规范要求方可生产销售。 二、药品研发及相关 骨化三醇软胶囊的适应症为:1.绝经后骨质疏松;2.慢性肾功能衰竭,尤其是接受血 液透析患者之肾性骨营养不良症;3.术后甲状旁腺功能低下;4.特发性甲状旁腺功能低 下;5.假性甲状旁腺功能低下;6.维生素 D 依赖性佝偻病;7.低血磷性维生素 D 抵抗型 佝偻病等。 该药品按照与参比制剂质量和疗效一致的技术 ...