Core Points - The 11th batch of national organized drug procurement was held in Shanghai on October 27, involving 55 drug varieties across various therapeutic areas including anti-infection, anti-tumor, asthma, diabetes, cardiovascular, and neurological drugs [2][9] - The procurement process introduced new mechanisms such as "revival for non-selected" opportunities to encourage more companies to participate at suitable prices, extending the bidding time compared to previous batches [9][10] - The procurement emphasizes principles of maintaining clinical stability, ensuring quality, preventing excessive competition, and avoiding collusion among related companies [10][11] Group 1: Procurement Details - The procurement involved 55 drug varieties and was conducted with a focus on transparency and public engagement, including online explanations of selection rules for medical institutions [11] - Since 2018, 10 batches of drug procurement have been conducted, covering 435 drug types and nearly 800 pharmaceutical companies, with over 2000 representative products involved [9][10] - The bidding process was structured to allow medical institutions to report quantities either by generic name or specific brand, with 77% of the 46,000 institutions reporting by brand [10] Group 2: Competitive Landscape - The average number of companies bidding per drug variety was 14, indicating a competitive environment, although some drugs had significantly more bidders, leading to intense competition [11][13] - The National Medical Insurance Administration issued a warning in August for companies to conduct cost-benefit analyses and maintain rational pricing strategies in light of high competition [13]

Core Viewpoint - The article discusses the 11th batch of national organized drug procurement, highlighting its focus on transparency, quality assurance, and competitive pricing mechanisms in the pharmaceutical industry [3][10][13]. Group 1: Procurement Details - The 11th batch of drug procurement includes 55 varieties, covering treatment areas such as anti-infection, anti-tumor, asthma, diabetes, cardiovascular, and neurological drugs [3]. - The procurement process involved a two-round revival mechanism, allowing more companies to qualify, which is expected to extend the bidding time compared to previous batches [10]. - Since 2018, the national level has conducted 10 batches of drug procurement, covering 435 drugs and nearly 800 companies, involving over 2,000 representative products [10]. Group 2: Principles and Optimizations - The procurement adheres to principles of stabilizing clinical use, ensuring quality, preventing excessive competition, and avoiding collusion [10][11]. - The reporting method for medical institutions has been optimized, allowing them to report either by generic name or specific brand, with 77% of the 46,000 institutions reporting by brand [10]. - Quality standards have been raised, requiring that production lines have no GMP violations in the past two years [10]. Group 3: Transparency and Competition - A significant highlight of this procurement is its emphasis on transparency, with the procurement office publicly explaining the selection rules and conducting online sessions for medical institutions [13]. - On average, 14 companies have applied for each variety, indicating that most companies are expected to qualify, although competition may be fierce for some varieties with a high number of bidders [13][15]. - The National Medical Insurance Administration issued a warning in August for companies to conduct cost-benefit analyses and maintain rational pricing in light of high competition [15].

Core Viewpoint - The 11th batch of national organized drug procurement has introduced new rules to ensure quality and prevent price undercutting, with a focus on maintaining clinical stability and quality assurance [4][8]. Group 1: Procurement Process - The 11th batch of drug procurement involved 55 varieties, with over 400 participating companies [3]. - The submission process included a pre-check and security check for companies, with material acceptance starting at 7:30 AM and ending at 10:30 AM [3]. Group 2: New Pricing Rules - The new pricing mechanism sets a "reference price" as the higher of 50% of the average "unit comparable price" of valid applicants or the lowest "unit comparable price," preventing extreme low bids from disrupting normal pricing [4]. - All bidding companies must commit to not pricing below their cost and must provide a rationale for any low bids to address quality concerns [4]. Group 3: Competitive Landscape - Nine varieties in the procurement have over 20 competing companies, indicating that more than half will not be selected based on a maximum of 10 entrants [6]. - The most competitive product is the Theophylline injection, with 48 bidding companies, and a market size of 650 million yuan in 2024 [7]. - Other competitive products include Cefazolin injection with 41 bidders and Famotidine injection with 38 bidders, with market sizes of approximately 2.6 billion yuan and 1.63 billion yuan respectively [7]. Group 4: Quality Assurance Measures - The National Medical Insurance Administration has raised quality assurance standards, requiring bidders to have at least two years of production experience and compliance with GMP standards [8]. - These measures aim to mitigate quality risks associated with inexperienced manufacturers and ensure the reliability of selected drugs [8]. Group 5: New Opportunities for Non-Selected Companies - The procurement process now includes a "revival" opportunity for non-selected companies if they can accept the winning bid price, addressing high demand from medical institutions [7].

Core Points - The 11th batch of national organized drug procurement will take place on October 27, 2025, involving 55 drug varieties and over 400 participating companies [1] - The new procurement rules emphasize quality assurance and prevent price undercutting, with a new "anchor" price set at the higher of 50% of the average comparable price of valid applicants or the lowest comparable price [2] - There is intense competition for certain drug varieties, with nine varieties having more than 20 competing companies, indicating that over half will not qualify [3] Group 1 - The most competitive drug is theophylline injection, with 48 companies bidding, and a projected market size of 650 million yuan in 2024 [4] - Other highly competitive drugs include cefazolin injection with 41 bidders and famotidine injection with 38 bidders, with market sizes of approximately 2.6 billion yuan and 1.63 billion yuan respectively [4] - The procurement process introduces a "revival" opportunity for non-selected companies if they can accept the winning bid price [4] Group 2 - The National Medical Insurance Administration has set higher quality assurance requirements for bidding companies, mandating at least two years of production experience and compliance with GMP standards [5]

Core Points - The 11th batch of national drug centralized procurement took place on October 27, involving 55 drug varieties across various therapeutic areas including anti-infection, anti-tumor, asthma, diabetes, cardiovascular, and neurological drugs [1][8] - The procurement process has introduced a "two-round revival" mechanism, which will extend the time required for the bidding compared to previous batches [8] - The procurement aims to maintain clinical stability, ensure quality, prevent excessive competition, and avoid collusion among related companies [11] Group 1: Procurement Process - The bidding process began with a pre-inspection of application materials and company registration starting at 7:00 AM, followed by the acceptance of application materials from 7:30 AM to 10:30 AM [1][5] - The procurement office has publicly explained the selection rules for drug varieties and provided detailed guidance for medical institutions on reporting requirements [12] Group 2: Competitive Landscape - Since 2018, the national level has conducted 10 batches of drug procurement, covering 435 drug varieties and nearly 800 pharmaceutical companies, involving over 2,000 representative products [11] - The average number of companies applying for each drug variety in this batch is 14, indicating a competitive environment, especially for certain products with a high number of bidders [12] Group 3: Quality and Compliance - The procurement process has raised quality standards by requiring that production lines have no GMP violations in the past two years [11] - Measures have been implemented to prevent collusion among companies with related interests, treating them as a single entity for bidding purposes [11]

Core Insights - The 11th batch of national organized drug procurement will involve 55 varieties, with over 400 companies participating in the bidding process [1] - The new procurement rules emphasize quality assurance and prevent price undercutting, with a new "anchor" price system established [1][4] - There is intense competition for certain drug varieties, with some having over 20 bidding companies, indicating a high likelihood of many companies being eliminated [2][3] Group 1: Procurement Process - The procurement event took place on October 27, 2025, with a structured process for material submission and company registration [1] - The submission process included pre-checks and security checks, with a strict timeline for material acceptance [1] Group 2: Competition Analysis - Nine drug varieties have more than 20 bidding companies, suggesting that over half of these companies will not be selected [2] - The most competitive drug is theophylline injection, with 48 bidding companies, followed by cefazolin injection and famotidine injection with 41 and 38 companies respectively [3] Group 3: Market Insights - The domestic market size for theophylline injection is projected to be 650 million yuan in 2024 [3] - Cefazolin injection has a stable market size of approximately 2.6 billion yuan from 2022 to 2024 [3] - Famotidine injection's sales for 2024 are estimated at 1.63 billion yuan, with 616 million yuan in sales for the first half of 2025 [3] Group 4: Quality Assurance - The National Medical Insurance Administration has set higher quality assurance standards for bidding companies, requiring at least two years of production experience and compliance with GMP [4] - The new rules aim to mitigate quality risks associated with inexperienced manufacturers [4]

Core Viewpoint - The eleventh batch of national organized drug procurement has commenced, involving over 400 companies and covering 55 drug varieties, with a focus on quality control and fair competition in pricing [1] Group 1: Procurement Details - The procurement process started at 7:30 AM in Qingpu District, Shanghai, with public disclosure of application information at 10:30 AM [1] - The procurement includes significant products such as cefoperazone injection and dapagliflozin oral sustained-release formulation, projected to achieve sales in the billions for 2024 [1] - Major pharmaceutical companies like Heng Rui Medicine, Qilu Pharmaceutical, and AstraZeneca are participating with multiple products [1] Group 2: Procurement Rules - The new procurement rules emphasize "stabilizing clinical use, ensuring quality, preventing internal competition, and avoiding collusion" [1] - For the first time, medical institutions are allowed to report quantities based on brand names, enhancing the focus on quality control [1] - Each participating company must commit to pricing no lower than their costs, with lower-priced bids requiring a justification for their pricing to promote healthy market competition [1]

"赛能赶上黄金了，一天一个价。" "赛能是不是要停产了，哪里的医院还能开？" 近日，红星资本局注意到，硫酸羟氯喹片原研药赛能缺货、涨价的消息在社交平台上传播。 资料配图 图据视觉中国 原研药赛能价格翻倍 多地线下药房缺货 近日，家住广东的刘女士（化名）向红星资本局表示，今年她因为备孕查出身体免疫系统问题，医生开了一款硫酸羟氯喹片，但吃了一段时间 发现指标还在增加，便在医生的建议下换成了原研药赛能。 "（当时）医院只能开那一款，我已经两个月没在医院开药了。"刘女士称，她主要在电商平台买药，一盒10片装的赛能够吃5天。但最近，她突 然发现原本四五十元一盒的药已经涨价至八九十元，"吃不起了"。刘女士甚至开始将目光投向较为便宜的海外版赛能。 同样面临着缺药焦虑的还有浙江的吴女士（化名）。吴女士告诉红星资本局，她发现赛能在国庆后突然涨价了，每盒从40元涨到了60元，于是 立即在网上下单了40盒，买完两天后发现又涨价至80元，"一天一个价"。她表示，作为一款长期要吃的药，一般不能随意更换或停药，但如果 之后价格继续涨也没有办法，只能换药。 【原研进口】赛能 硫酸羟氯喹片 ¥300.00 0.2g*10片/盒 共5件 不支 ...

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].

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].