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八成创新药上市两年内入医保
第一财经· 2026-02-05 15:29
Core Viewpoint - The article discusses how the strategic purchasing mechanism of medical insurance, centered around centralized bulk purchasing and drug price negotiations, is reshaping China's pharmaceutical industry landscape [3]. Group 1: Policy Changes and Trends - Since 2018, China's pharmaceutical policy has shifted to a value-oriented and collaborative governance phase, with medical insurance transitioning from a passive payer to an active strategic purchaser [3][4]. - The establishment of a national drug price negotiation mechanism supports the accessibility of innovative and high-priced drugs, emphasizing clinical value and cost-effectiveness [4][5]. - The proportion of new drugs entering the medical insurance directory within the same year of approval has increased from 32% in 2019 to 97.6% in 2023, significantly reducing the time from drug approval to insurance reimbursement from five years to just over one year [4]. Group 2: Drug Procurement and Pricing - The centralized procurement system has expanded, with 490 types of drugs procured over eight years, covering various treatment areas including chronic diseases and cancer [7]. - In 2024, 28.6% of the newly negotiated drugs were cancer medications, and 71% of the new varieties were domestic innovative drugs, indicating a rapid shift towards high-value areas in the pharmaceutical industry [5][6]. Group 3: Challenges and Recommendations - The article highlights challenges such as inadequate quality supervision in bulk purchasing, insufficient collaboration between medical insurance and pharmaceutical innovation, and the need for improved access to rare disease medications [8][10]. - Recommendations include enhancing clinical monitoring of selected drugs, establishing a unified drug usage tracking system, and developing a multi-tiered payment system to address the accessibility of innovative drugs [10][11].
华润双鹤药业股份有限公司关于控股子公司双鹤天安药业(贵州)股份有限公司 盐酸吡格列酮分散片获得药品补充申请批准通知书的公告
Core Viewpoint - The company has received approval from the National Medical Products Administration for the drug Pioglitazone Hydrochloride Dispersible Tablets, which is expected to enhance market competitiveness and sales potential in the future [1][2]. Group 1: Drug Approval and Development - The company’s subsidiary, Shuanghe Tianan Pharmaceutical, received the approval notice for Pioglitazone Hydrochloride Dispersible Tablets from the National Medical Products Administration [1]. - The consistency evaluation for this drug began in 2017, with the application submitted in December 2024 and approval received in November 2025 [2]. - The total R&D investment for this drug's consistency evaluation has reached RMB 8.8227 million (unaudited) [2]. Group 2: Market Situation of Similar Drugs - Pioglitazone tablets, developed by Takeda Pharmaceutical, were approved in the U.S. in July 1999 and in China in 2004, but have since been withdrawn from the market [3]. - The global sales of Pioglitazone tablets are projected to be USD 254 million in 2024, with "ACTOS" contributing USD 41.6958 million [3]. - In China, the total sales of Pioglitazone tablets in the medical and retail markets are estimated at RMB 349 million in 2024, with Shuanghe Tianan holding a market share of 10.46% [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].