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多款进口药退出中国,背后比我们想象的更复杂
创业邦· 2025-10-27 10:11
Core Viewpoint - The article discusses the complexities of China's healthcare system, particularly the challenges of balancing quality, cost, and accessibility in the context of imported and domestic pharmaceuticals [6][19]. Group 1: Drug Registration and Market Dynamics - The National Medical Products Administration (NMPA) recently announced the cancellation of 80 drug registration certificates, with over 55% being products from foreign or joint venture companies, indicating a trend of imported drugs exiting the Chinese market [8][9]. - The cancellation of these drugs was initiated by the companies themselves, suggesting a strategic business decision rather than regulatory enforcement [8]. Group 2: Quality and Efficacy of Pharmaceuticals - Both original and generic drugs have identical active ingredients, but differences in formulation and manufacturing processes can lead to variations in clinical effectiveness [11][12]. - The quality of domestic generic drugs has improved significantly due to stricter regulations, but there remains a gap in bioequivalence standards compared to international benchmarks [15][19]. Group 3: Healthcare Financing and Policy - China's healthcare system faces the "impossible triangle" of quality, cost, and accessibility, necessitating the use of low-cost generic drugs to meet the basic healthcare needs of a large population [19][20]. - The government prioritizes the reimbursement of generic drugs over original drugs to ensure the sustainability of the healthcare system, which can lead to limitations on the availability of higher-priced original medications [20][24]. Group 4: Innovation and Future Directions - The introduction of innovative drugs into the healthcare reimbursement system has become more efficient, with the average time from market entry to reimbursement reduced to less than two years [22][24]. - The savings from using generic drugs are being redirected to subsidize the costs of innovative drugs, highlighting a strategic approach to healthcare funding [24][27]. Group 5: Patient Choices and Market Dynamics - There is a call for more flexibility in the healthcare system to allow wealthier patients to access original drugs, suggesting a need for a multi-tiered healthcare financing model [26][27]. - The article emphasizes the importance of maintaining a balance between cost control and individual patient needs, advocating for a system that supports both generic and innovative drug development [26][27].
跨国药企的中国“棋局”:进退间找寻“价值竞争”定位
2 1 Shi Ji Jing Ji Bao Dao· 2025-10-27 07:02
Core Insights - The recent announcement by the National Medical Products Administration (NMPA) to cancel the registration of 80 drugs, primarily from foreign pharmaceutical companies, reflects strategic market adjustments rather than a long-term withdrawal from the Chinese market [1][2][11] - The Chinese medical market is projected to grow significantly, from $1.4 trillion in 2014 to $2.1 trillion by 2030, indicating strong potential for both foreign and domestic pharmaceutical companies [1][8] Group 1: Market Dynamics - Over 55% of the canceled drug registrations are from foreign or joint-venture pharmaceutical companies, highlighting their significant presence in the market [1] - The reasons for drug cancellations include raw material shortages, declining market performance, and competitive pressures from centralized procurement policies [2][3] - The market is experiencing a dual phenomenon of "exit and return," where some original research drugs are leaving the market while others are re-entering after strategic adjustments [1][4] Group 2: Strategic Adjustments - Companies like Sanofi and GSK have withdrawn certain products due to poor sales performance and competitive pricing pressures from domestic firms [2][3] - The trend of original research drugs exiting the market is seen as a temporary strategy to avoid damaging brand value in a highly competitive environment [5][11] - The return of some original research drugs, such as the enzyme replacement therapy for a rare disease, demonstrates the feasibility of re-entering the market through policy channels [4][5] Group 3: Future Opportunities - The Chinese pharmaceutical market is expected to see a shift towards innovative drugs, with their market share projected to increase from 34% in 2024 to nearly 60% by 2030 [9][10] - Cross-border collaborations are on the rise, with a significant increase in partnerships between Chinese and American companies, indicating a growing interest in the Chinese market [10][11] - Companies are encouraged to focus on value competition rather than price competition, particularly in the context of an aging population and increasing demand for quality medications in county-level markets [7][11]
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
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][3]. Group 1: Drug Cancellations - A total of 80 drugs, including popular medications like loratadine tablets and finasteride tablets, have been voluntarily deregistered by the manufacturers, indicating a strategic business decision rather than regulatory enforcement [3][5]. - The deregistered drugs are not exclusive products, allowing other companies with similar generic products to continue production and sales, which mitigates potential supply shortages [3][5]. - Over 40 of the deregistered drugs are produced by foreign companies, reflecting a response to the implementation of national centralized procurement policies that have significantly reduced drug prices [3][4]. Group 2: Market Impact - The deregistration of drugs like Taining suppository and loratadine tablets is attributed to a lack of sustainable raw material supply and the need for foreign companies to adjust their sales strategies to maintain profit margins [5][6]. - The cancellation of key oncology drugs, such as doxorubicin injection, highlights the challenges faced by original drug manufacturers due to the rapid growth of generic alternatives and ongoing price pressures from centralized procurement policies [5][6]. - The market for inhaled medications, such as salbutamol solutions, is also affected, as domestic companies are increasingly able to produce high-quality generics at competitive prices, further squeezing the market share of original products [6][7].
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
Core Viewpoint - The National Medical Products Administration (NMPA) has announced the cancellation of registration certificates for 80 drugs, including Fecarwei's Loratadine tablets, indicating a shift in the pharmaceutical landscape where foreign and joint-venture companies are withdrawing products in response to domestic competition and policy changes [1][2]. Group 1: Drug Cancellations - The cancellation of the Loratadine tablets (10mg) by Fecarwei is a voluntary decision, reflecting a commercial choice rather than regulatory enforcement [1][2]. - Over 55% of the cancelled products are from foreign companies, highlighting the impact of domestic pharmaceutical policies on international players [1]. - The cancellation of older registration numbers, such as that of Loratadine, suggests a strategic withdrawal from the market rather than a response to safety concerns [2][3]. Group 2: Market Dynamics - The domestic pharmaceutical industry has undergone significant changes due to centralized drug procurement and price negotiations, leading to the rise of local companies and the reevaluation of foreign companies' strategies in China [1][2]. - The presence of multiple manufacturers for Loratadine in China (35 for 10mg and 16 for 5mg) indicates a competitive market where the impact of a single product's cancellation is minimal for patients [3]. - 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 [4][6]. Group 3: Implications for Future Products - The trend of foreign companies withdrawing from the market is evident with the cancellation of products like Metformin and Empagliflozin tablets by Boehringer Ingelheim, indicating a strategic retreat from upcoming centralized procurement rounds [5]. - The cancellation of high-revenue drugs, such as Doxorubicin, suggests a shift in focus towards more profitable or competitive products, as seen with the lipid formulation of Doxorubicin which has a much larger market presence [6]. - The withdrawal of drugs like Liraglutide by Sanofi reflects the challenges faced by older GLP-1 drugs in maintaining market share against newer entrants [8][9].
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
Core Insights - The National Medical Products Administration (NMPA) has announced the cancellation of 80 drug registration certificates, including loratadine tablets, highlighting a significant regulatory shift in China's pharmaceutical industry [1] - Over the past year, NMPA has canceled a total of 626 drug registration certificates, with 89% of these being voluntarily withdrawn by companies, indicating a trend towards industry consolidation and stricter regulations [1][7] - The cancellation of loratadine tablets reflects a broader issue of overcapacity in China's generic drug market, where competition has intensified significantly [2][5] Industry Trends - The Chinese pharmaceutical industry is undergoing a critical phase characterized by increased regulatory scrutiny, normalization of centralized procurement, and accelerated industry consolidation [1][7] - The era of "approval economy" is ending, leading to a drastic reduction in the survival space for low-quality generic drugs [1][7] - The market for loratadine is dominated by a few key players, with Yangtze River Pharmaceutical holding nearly 60% market share, while over 90 companies struggle for the remaining 25% [6] Company Dynamics - Major international pharmaceutical companies are withdrawing from the Chinese market, as seen with Sanofi and Merck Sharp & Dohme canceling multiple product registrations due to competitive pressures and pricing challenges [8][10] - Local companies are also forced to make tough decisions, with Taicang Pharmaceutical canceling 11 products, including commonly used medications, as a response to the pressures of centralized procurement [11][13] - The case of Hengrui Medicine voluntarily canceling a cancer drug registration signals a strategic shift towards innovation rather than competing in the generic drug space [14]
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].