Workflow
氯雷他定片
icon
Search documents
中外药企将在更高维度展开竞争
Zheng Quan Ri Bao· 2025-10-22 16:40
Core Viewpoint - The recent cancellation of 80 drug registration certificates by the National Medical Products Administration reflects routine business decisions by companies in response to market changes, particularly due to the impact of generic drugs and evolving market dynamics [1][2]. Group 1: Drug Registration Cancellations - The cancellation includes drugs such as Loratadine tablets from Fresenius Kabi and Doxorubicin hydrochloride injection from Pfizer, indicating a shift in the market landscape [1]. - The cancellations are attributed to factors such as patent expirations leading to reduced profit margins, supply chain issues, and unclear commercial prospects for certain drugs in the domestic market [1][2]. Group 2: Market Mechanisms and Competition - The cancellations are a result of market mechanisms, with sufficient alternative supplies available domestically, including 35 approved Loratadine tablet products and 33 approved inhalation solutions of Salbutamol [2]. - The rise of high-quality generic drugs has provided patients with more accessible and affordable medication options, demonstrating the improvement of China's pharmaceutical industry and supply chain resilience [2]. Group 3: Shift in Pharmaceutical Strategy - The trend reflects a broader shift in the pharmaceutical industry, where multinational companies are adjusting their product lines in response to intense domestic competition and the "patent cliff" effect, leading to the replacement of original drugs by more cost-effective generics [2]. - The era of relying on profits from expired patents is ending, giving way to a new ecosystem driven by innovative drugs, as policies like centralized procurement and drug price negotiations push for rational pricing and resource allocation towards clinically valuable innovative drugs [2]. Group 4: Investment in Innovation - Multinational pharmaceutical companies are increasing their investment in innovative drug research in China, with Boehringer Ingelheim announcing over 5 billion yuan in R&D investment over the next five years [3]. - Companies like AstraZeneca, Pfizer, and Novartis are expanding collaborations with Chinese biotech firms, indicating a competitive landscape focused on innovation and clinical value [3].
多款进口药退出中国 涉及抗过敏、肿瘤等领域的畅销品
Guo Ji Jin Rong Bao· 2025-10-21 15:28
Core Viewpoint - The recent decision by the National Medical Products Administration to cancel the registration certificates of 80 drugs, including commonly used medications, has led to significant price increases for certain products, such as the compound drug Taining suppository, which is now priced over 900 yuan for a box of six [1][2]. Group 1: Drug Cancellations - The cancellation includes various commonly used drugs, such as loratadine tablets, finasteride tablets, and vitamin B2 tablets, all of which were voluntarily requested by the companies, indicating a strategic business decision rather than a response to safety concerns [2][3]. - The majority of the cancelled drugs are not exclusive products, meaning that other companies holding similar product registrations can continue their production and sales, mitigating potential supply shortages [2][3]. Group 2: Foreign Pharmaceutical Companies - Over 40 of the cancelled drugs are produced by foreign companies, reflecting a strategic adjustment in response to the implementation of national centralized procurement policies that have significantly reduced drug prices [2][3]. - Notable products among the cancellations include loratadine tablets from Fecar Huari, salbutamol inhalation solution from GlaxoSmithKline, and the compound drug Taining suppository from Xi'an Janssen, all of which were once market leaders [2][3]. Group 3: Market Dynamics - The cancellation of these drugs is indicative of a broader trend where foreign pharmaceutical companies are shifting their focus to more competitive innovative drugs due to declining profit margins on original drugs amid increasing competition from generic products [3][4]. - The market for inhalation medications, such as salbutamol, is becoming increasingly competitive as domestic companies improve their product quality and pricing, leading to a loss of market share for original products [4][5]. - The ongoing price control measures for chronic disease medications, including diabetes drugs, are further squeezing the profit margins of original drugs, prompting companies to rationally decide to cancel their product registrations when market returns do not cover operational costs [5].
多款进口药退出中国,涉及抗过敏、肿瘤等领域的畅销品
Guo Ji Jin Rong Bao· 2025-10-21 14:36
本次药品注销还有一个特点,就是80个注销药品中,有40多个生产商是外资企业。业内认为,这是 国家集采政策全面推行下,药品价格大幅下降,外资药企为了保住药品高额利润而主动调整销售策略的 一种表现。 10月21日,记者在美团等互联网药品销售平台看到,由西安杨森制药有限公司生产的复方角菜酸酯 栓(商品名:太宁栓)一盒6枚标价已经超过900元。 造成该药品离奇涨价的原因在于,国家药品监督管理局近期发布消息,决定注销氯雷他定片等80个 药品注册证书,这也意味着这些药品后续将在国内停止生产销售。 80个药品停止生产销售 记者注意到,除了复方角菜酸酯栓,此次注销的药品中还包含多款临床常用药,例如,抗过敏药物 氯雷他定片、男性健康药物非那雄胺片、维生素补充药物维生素B2片等。值得注意的是,这80多个药 品注销均为"依申请注销",即均由企业主动申请注销,很可能是一种商业选择行为,并非被吊销或是存 在危害人体健康等状况。 不过,这些注销药品绝大多数都不是独家产品,相关企业的批文注销也不影响其他持有同通用名批 文产品企业的正常生产销售活动,一定程度上缓解了同类药品断供的现象。 费卡华瑞的氯雷他定片也在注销行列。费卡华瑞是中国和瑞典 ...
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 ...
80个药品注册证书注销背后:中国医药摆脱“批文经济”的阵痛
Guan Cha Zhe Wang· 2025-10-21 08:30
10月15日,国家药品监督管理局发布第102号公告,决定注销氯雷他定片等80个药品注册证书。 根据《中华人民共和国药品管理法》相关规定,对疗效不确切、不良反应大或者因其他原因危害人体健康的药品,应当注销药品注 册证书。而这仅仅是冰山一角——据不完全统计,近一年内国家药监局已注销626个药品注册证书,其中89%为企业主动撤销。 在集采常态化、监管趋严、行业整合加速的多重压力下,中国医药行业正进入"大浪淘沙"的关键时期。曾经依靠"批文经济"躺赚的 时代已经终结,低质量仿制药的生存空间被急剧压缩。 这场淘汰赛不仅关乎企业的生死存亡,更将重塑整个行业的竞争格局。从扬子江药业占据氯雷他定市场近60%份额的"赢家通吃", 到196家医药企业2024年宣布裁员的行业寒冬,一个更加集中、更加规范、更加残酷的新医药时代正在到来。 氯雷他定片的启示:百家争鸣背后的产能过剩困局 此次被注销的药品中,费森尤斯卡比华瑞制药有限公司(费卡华瑞)的氯雷他定片作为"领衔"品种,格外引人关注。这个看似不起眼 的抗过敏药物,恰恰是中国仿制药产能过剩问题的典型缩影。 氯雷他定作为第二代抗组胺药物,用于缓解过敏性鼻炎、荨麻疹等症状,市场需求相对稳定 ...
氯雷他定、万托林在列 进口药密集退出国内市场
Xi Niu Cai Jing· 2025-10-21 03:08
Core Points - The National Medical Products Administration (NMPA) announced the cancellation of registration certificates for 80 drugs, including well-known imported medications such as Fexofenadine tablets and Salbutamol inhalation solution [2][5] - Over 55% of the canceled drugs are from foreign pharmaceutical companies or joint ventures, while the remainder are from domestic companies [5] - The cancellations cover multiple therapeutic areas, including allergy treatment, respiratory diseases, diabetes, and oncology [5] - All cancellations were initiated by the companies themselves, indicating a commercial decision rather than safety concerns [5] Drug Specifics - Fexofenadine tablets (10mg) are used for allergic rhinitis and are classified as a Class A over-the-counter and Class A medical insurance drug, also part of the fourth batch of national centralized procurement [5] - GlaxoSmithKline's Salbutamol, an important emergency medication for asthma and COPD patients, is also part of the fourth batch of centralized procurement [5] - Other notable drugs in the cancellation list include Pfizer's Doxorubicin injection, Janssen's Tainin suppository, and Sanofi's GLP-1 diabetes drug Liraglutide injection [5] - Boehringer Ingelheim has preemptively canceled the approval for Dapagliflozin tablets, which were set to be included in the upcoming eleventh batch of centralized procurement, thus forfeiting its qualification for the next round of procurement [5] Market Impact - The withdrawal of these imported drugs is expected to have a limited impact on patient medication options, as there are many high-quality generic alternatives available in the domestic market that have passed consistency evaluations [5]
早报 | 胖东来设开放日,参观一次收2万;苹果股价创历史新高;多款知名进口药告别国内市场;多方回应酒店花洒有粪便
虎嗅APP· 2025-10-20 23:58
Group 1 - Apple's stock price reached an all-time high of $262.24, with a 3.94% increase, bringing its total market capitalization to $3.89 trillion. Early sales of the iPhone 17 series in China and the U.S. are 14% higher than the iPhone 16 series, with the basic model's sales in China nearly doubling [2] Group 2 - DeepSeek released a new OCR model that can process over 200,000 pages of data daily using a single A100 GPU. The model achieves nearly 10 times lossless context compression while maintaining an accuracy rate above 97% [3] Group 3 - SpaceX is falling behind schedule on NASA's Artemis lunar program, prompting the U.S. Transportation Secretary to reopen contract bidding to other companies. The Artemis program aims to establish a long-term human presence on the Moon [4][5] Group 4 - The Vietnamese stock market experienced its largest drop since April, with the Ho Chi Minh Index falling nearly 5.5%. Approximately 150 stocks hit the daily limit down, primarily in the real estate, securities, and banking sectors [6] Group 5 - The European Union agreed to gradually stop importing natural gas from Russia by January 2028, with a ban on new contracts starting January 2026 [7][8] Group 6 - The Chinese pharmaceutical market is undergoing significant changes, with the National Medical Products Administration canceling the registration of 80 drugs, including well-known allergy and cancer treatments, due to the rise of domestic companies [11][12] Group 7 - 25 provinces in China have begun direct disbursement of maternity benefits to individuals, with plans for nationwide implementation by November 1 [13] Group 8 - Amer Sports announced a new interim general manager for its Arc'teryx brand in Greater China, following the departure of the previous GM. The new appointee will oversee operations during a transitional period [16][19] Group 9 - NVIDIA's CEO Huang Renxun announced plans to deploy $500 billion in AI supercomputing technology over the next three to four years, indicating a significant shift in global industry dynamics [27]
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].