马吉妥昔单抗注射液
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多款知名进口药告别国内市场,个别集采品种注销
Guan Cha Zhe Wang· 2025-10-21 13:13
在国家药监局公布的目录中,以费卡华瑞的氯雷他定片为例,据丁香园用药助手信息,该产品商品名为 可米,用来治疗过敏性鼻炎等,属于甲类非处方药、甲类医保用药;费卡华瑞不仅是产品的上市许可持 有人,也是其生产企业。 费卡华瑞全称为"费森尤斯卡比华瑞制药有限公司",它是中国和瑞典两国间的首家合资企业,产品主要 覆盖在肠外营养、肠内营养及其配套器械领域,工厂位于江苏无锡。 10月15日晚,国家药监局公众号显示,注销费卡华瑞的氯雷他定片(10mg,国药准字H20040557)等80 个药品的注册证书。对于药品而言,注销注册证,意味着该药品后续将停止生产销售等行为。 同时,依据国家药监局公布的具体目录,这80个药品的注销情形均为"依申请注销"。也就是,它们均由 企业主动申请注销,更可能是一种商业选择行为,而非被吊销或是存在危害人体健康等状况。 智通财经记者注意到,在这80个药品中,有一系列来自外资药企或是中外合资公司的产品;按照注册证 数量粗略估算,此次注销的产品中超过55%的是外资公司的产品,剩下为本土公司产品。 近些年,国内医药产业发生了深刻变化。在国家药品集中采购、国家药品谈判等政策不断推进的过程 中,本土公司快速崛起 ...
多款知名进口药告别国内市场
Xin Lang Cai Jing· 2025-10-20 01:34
Core Viewpoint - The National Medical Products Administration (NMPA) has announced the cancellation of registration certificates for 80 drugs, including the antihistamine Loratadine tablets (10mg) from Ferring Pharmaceuticals, indicating a shift in the pharmaceutical landscape in China, particularly affecting foreign and joint-venture companies [1][4]. Group 1: Drug Cancellations - The cancellation of the registration certificates for these drugs is categorized as "voluntary cancellation," suggesting a strategic business decision by the companies rather than regulatory enforcement or health concerns [1][4]. - Over 55% of the cancelled products are from foreign companies, highlighting the competitive pressure faced by multinational pharmaceutical firms in the Chinese market [1][4]. - The cancelled Loratadine tablets, known as "Kemi," have been on the market for over 20 years, indicating that the cancellation pertains to older product registrations [4][5]. Group 2: Market Dynamics - The domestic pharmaceutical industry has undergone significant changes due to policies like centralized drug procurement and price negotiations, leading to the rise of local companies and a reevaluation of foreign firms' strategies in China [1][4]. - The presence of multiple manufacturers for Loratadine tablets (35 for 10mg and 16 for 5mg) suggests that the impact of the cancellation on patient access to medication will be minimal [6][8]. - Other notable cancellations include GSK's inhalation solution for Salbutamol and Pfizer's Doxorubicin injection, both of which are significant in their respective therapeutic areas [7][9]. Group 3: Implications for Future Products - The cancellation of the Dapagliflozin and Metformin combination tablets by Boehringer Ingelheim indicates a strategic withdrawal from upcoming centralized procurement rounds, reflecting the competitive nature of the diabetes medication market [8][9]. - The cancellation of high-profile oncology drugs like Doxorubicin and the rare disease treatment Vimizim underscores the importance of commercial viability in determining a drug's market presence [9][14]. - The withdrawal of drugs from the GLP-1 category, such as Liraglutide by Sanofi, suggests a shift in focus towards more competitive products within the diabetes treatment landscape [12][13].