Core Viewpoint - The eleventh batch of national drug centralized procurement emphasizes a balanced approach to quality, price, supply, and clinical needs, marking a significant shift from a focus solely on low prices to a more comprehensive evaluation of drug procurement [3][4][5] Group 1: Procurement Changes - The eleventh batch will cover 55 varieties and 162 specifications, including key areas such as antiviral drugs and innovative treatments for kidney diseases, with various dosage forms [1] - The procurement process will no longer simply select the lowest price; instead, it will require the lowest bidders to justify their pricing, ensuring a more rational competition [4][5] - A new "anchor price" mechanism will be introduced to prevent excessively low bids from distorting the market, setting a price floor at 50% of the average bid if the lowest bid falls below this threshold [4][5] Group 2: Clinical Considerations - Medical institutions can now report quantities based on specific brands, enhancing the alignment between clinical needs and supply, which is expected to improve the effectiveness of the procurement policy [6][7] - This change acknowledges the importance of brand trust and patient adherence, particularly for complex formulations, moving away from a purely generic approach [7] Group 3: Quality Requirements - New qualification requirements for bidding companies include having at least two years of production experience in similar formulations and compliance with Good Manufacturing Practice (GMP) standards [8] - The increased qualification standards are likely to favor larger, well-managed companies, potentially leading to industry consolidation as smaller firms may struggle to meet these criteria [8][9] - The focus on quality and stability in drug supply is expected to enhance the overall safety and continuity of clinical medication [8][9]

Core Viewpoint - The eleventh batch of national drug centralized procurement emphasizes a balanced approach to quality, price, supply, and clinical needs, marking a significant shift from a sole focus on low prices to a comprehensive evaluation of various factors [2][5]. Group 1: Key Highlights of the Eleventh Batch of Procurement - The procurement covers 55 varieties and 162 specifications, including key areas such as antiviral drugs and innovative treatments for kidney diseases [1]. - The new procurement rules are designed to prevent excessive low-price competition, ensuring that the lowest bid must be justified by the bidding company [4][6]. - The introduction of a "price anchor" mechanism aims to establish a reasonable price baseline, preventing bids from falling below 50% of the average winning price [5][8]. Group 2: Changes in Bidding Process - Medical institutions can now report quantities based on specific brands, enhancing the alignment between clinical needs and supply [9][10]. - New qualification requirements for bidding companies include a minimum of two years of production experience and compliance with Good Manufacturing Practice (GMP) standards [11]. - The increased qualification thresholds are expected to favor larger, well-managed companies, potentially leading to industry consolidation [12]. Group 3: Measures Against Collusion and Bid Rigging - The new rules include strict measures against collusion and bid rigging, treating closely related companies as a single entity during bidding [14]. - A "first to report leniency" mechanism encourages companies to provide evidence of collusion, promoting transparency [15]. - Enhanced penalties for collusion and bid rigging will be enforced, ensuring a fair competitive environment [16].

湘财证券认为，目前医保及商保目录调整将进入价格谈判阶段，研发创新能力较强的企业和独家品种， 有望通过以价换量获得更大的增量市场，带来增量需求。 受到医药集采反内卷提振，重仓创新药龙头的恒生医药ETF（159892）今日一度涨超2%，持仓股方 面，药明合联涨超5%，领涨医药板块，微创医疗、药明生物、晶泰控股跟涨。 近日国家医保局发布第十一批国家组织药品集中采购文件，明确第十一批集采将于10月21日在上海开 标。根据文件中披露的采购品种范围，本轮集采覆盖55个品种、162个品规，涉及抗流感药物、肾病治 疗创新药等重点领域，剂型涵盖口服常释剂型、吸入剂、外用贴剂等。 本次集采提出"反内卷"，药物集采并不是要打价格战，药品的价格和价值都需要平衡。相关机构坚 持"稳临床、保质量、防围标、反内卷"的原则，优化具体的采购规则，引导企业将精力投向药品质量提 升与研发创新，为医药行业整体迈向高质量发展筑牢基础。 ...

Core Viewpoint - The National Healthcare Security Administration (NHSA) of China has announced the 11th batch of centralized drug procurement, set to open bids on October 21 in Shanghai, covering 55 varieties and 162 specifications of drugs, including key areas such as antiviral drugs and innovative treatments for kidney diseases [1] Group 1: Procurement Details - The procurement will include various dosage forms such as oral sustained-release formulations, inhalants, and topical patches [1] - The new procurement scheme emphasizes principles of "stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition" [1] Group 2: Price Control Mechanism - A significant highlight of this round of procurement is the optimization of the price difference control "anchor," which aims to ensure fairness by controlling the price difference of selected bids [1] - The new approach will prevent individual companies from submitting abnormally low bids that could disrupt normal pricing, thus avoiding the previous phenomenon where drug prices dropped to mere cents [1]

旗帜鲜明地反对过度"内卷" 上海市卫生和健康发展研究中心主任金春林在接受《每日经济新闻》记者采访时表示，第十一批集采的 调整幅度比较大，体现了从"唯低价是取"转向质量、价格、供应、临床需求并重的综合评价导向。 "可以说，这是集采实施7年以来的一个里程碑批次。"金春林强调，第十一批集采不再仅仅追求简单的 药品价格下降，而是更加注重精准对接临床、患者和药企之间的供需平衡。核心在于通过"稳临床、保 质量、防围标、反内卷"四大原则，推动临床合理用药和医药行业的双向良性发展。 以下是记者根据集采文件以及采访梳理的第十一批集采的四大亮点。 9月20日，国家医保局发布第十一批国家组织药品集中采购文件，明确第十一批集采将于10月21日在上 海开标。根据文件中披露的采购品种范围，本轮集采覆盖55个品种、162个品规，涉及抗流感药物、肾 病治疗创新药等重点领域，剂型涵盖口服常释剂型、吸入剂、外用贴剂等。 据悉，本次集采方案制定和修改过程中，充分遵循了"稳临床、保质量、防围标、反内卷"的原则。其中 一大亮点在于优化价差控制"锚点"：为保证公平，本次集采继续对中选价差作一定控制。同时，为防范 个别企业报出异常低价"熔断"其他正常报价 ...

Core Viewpoint - The eleventh batch of national drug centralized procurement marks a significant shift from merely pursuing low prices to a more balanced approach that emphasizes quality, price, supply, and clinical needs [2][4]. Group 1: Key Highlights of the Eleventh Batch of Procurement - The procurement will cover 55 varieties and 162 specifications, including key areas such as antiviral drugs and innovative treatments for kidney diseases [1]. - The principles guiding this procurement include "stabilizing clinical use, ensuring quality, preventing collusion, and countering excessive competition" [2][3]. - A new price control mechanism has been introduced, which does not simply rely on the lowest bid but instead uses a "reference price" to prevent irrational price drops [3][4]. Group 2: Changes in Procurement Rules - Medical institutions can now report quantities based on specific brands, enhancing the alignment between clinical demand and supply [5][6]. - New qualification requirements for bidding companies have been established, including a minimum of two years of production experience and compliance with GMP standards [7]. - Measures to combat collusion and bid-rigging have been strengthened, including stricter rules for related companies and a "first to report" leniency policy [9]. Group 3: Implications for the Industry - The increased qualification requirements may favor larger, well-managed companies, potentially leading to industry consolidation [8]. - The focus on quality and comprehensive evaluation is expected to shift competition from price to overall capability and product quality [8]. - The new rules are anticipated to improve the stability of drug supply and ensure continuous clinical use [7].