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年销超10亿元肾病创新药遇首仿!云顶新耀发文声讨
Jing Ji Guan Cha Wang· 2025-12-30 06:31
为捍卫自家核心产品的专利保护期,创新药企云顶新耀(HK01952,股价44.62港元,市值157.75亿港元)在官方微信公众号上主动"开火"。 12月23日,云顶新耀发布声明称:"近期,我司注意到,有针对我司上市许可产品布地奈德肠溶胶囊(耐赋康)的仿制药品的上市许可获得批准。" 云顶新耀方面认为,耐赋康的相关技术在中国受到专利保护,该专利目前处于有效状态,其专利权有效期直至2029年5月7日届满。针对任何涉嫌违反上述规 定及承诺的侵权行为,云顶新耀称保留依法采取一切后续行动的权利。 图片来源:云顶新耀微信公众号 据《每日经济新闻》记者(以下简称"每经记者")检索,12月22日,国家药品监督管理局官网曾发布药品批准证明文件送达信息,其中海南合瑞制药股份有 限公司(以下简称"海南合瑞")的布地奈德肠溶胶囊(国药准字H20256302)显示已于12月16日得到批准。 12月24日晚间,每经记者联系到海南合瑞董事长钟正明,他对此回复称:"目前我们正在跟相关专业的法律人士进行咨询和沟通,是否侵权关键还是要看技 术方案是否落入对方专利权保护的范围。(布地奈德肠溶胶囊)上市销售与否,我们现在还没有做最后的决定。" 耐赋康首 ...
又一企业被暂停采购资格,多家企业深陷吲哚布芬片专利纠纷
Xin Jing Bao· 2025-08-08 14:05
Core Points - The Shanghai Municipal Medical Procurement Management Office has suspended the procurement qualifications of certain drugs, including indobufen tablets produced by Shandong Modern Pharmaceutical Technology Co., Ltd due to patent disputes [1][2] - A total of seven companies have been suspended from procuring indobufen tablets since 2024, indicating a significant impact on the market [2][3] Industry Overview - Indobufen tablets, a new type of antiplatelet drug, were first developed by Farmitalia Carlo Erba in Italy and have become a substitute for patients intolerant to aspirin due to their lower side effects [2] - The sales of indobufen tablets have seen substantial growth, with sales reaching over 1 billion yuan in 2022 and projected to exceed 1.6 billion yuan in 2024, reflecting an 18.12% year-on-year increase [3] Patent and Legal Issues - The core patent for indobufen, covering specific crystal forms and their preparation methods, was granted to a subsidiary of Huadong Medicine, which has initiated extensive legal actions against other companies for patent infringement [4] - Indobufen tablets were excluded from the 11th batch of national procurement due to high patent infringement risks, despite meeting procurement conditions [5]