摘要 第十一批国家集采延续了"保临床"的核心目标，通过引入按厂牌报量 与分量机制，减少药品替换，保证医疗机构用药延续性，但未按厂牌报 量的比例仍然较高，实际报量率仅为 50%左右。 集采规则在企业资质方面有所提高，要求至少两年制剂生产经验，并提 供 GMP 符合性检查资料，旨在保证药品质量，但同时也可能限制了部 分新进入者，特别是新型剂型企业的参与。 虽然规则设计上试图"反内卷"，但实际效果有限，单品竞争企业数量 平均达到 16 家，竞争依然激烈，企业可能仍需以极限成本价竞标，降 价幅度或将超过第十批集采。 新锚点价格规则（均价 50%与最低价 1.8 倍取高值）对整体价格水平的 改善作用有限，因为多数情况下入围报价仍低于均价 50%，最终参考的 锚点价仍然是最低价。 按厂牌报量的新调整意味着企业需要持续投入营销费用来推动医院报量， 鼓励企业在产品上市初期就积极进行医院推广开发，以争取更大的市场 份额。 Q&A 第十一批国采文件解读 20250922 第十批和第十一批国家集采的四大原则"稳临床、保质量、防围标、反内卷" 具体应该如何解读和理解？有哪些具体改进措施？ 在"稳临床"方面，主要针对去年（2024 年 ...

Core Viewpoint - The National Healthcare Security Administration has released the 11th batch of centralized drug procurement documents, emphasizing principles of stabilizing clinical needs, ensuring quality, preventing collusion, and countering excessive competition. Group 1: Stabilizing Clinical Needs - The primary goal of the procurement is to ensure clinical medication needs, with optimized reporting methods for medical institutions allowing for both generic and brand-specific reporting [4] - Approximately 46,000 medical institutions participated in this procurement, with 77% of the reported quantities specified by brand [4] - The procurement volume is set at 60% to 80% of the reported quantities, allowing institutions to choose brands for the remaining portion [4] - New selection rules encourage major companies to participate by offering opportunities to those whose products meet clinical demand but did not initially qualify [4] - Special attention is given to ensuring the supply of pediatric medications, with adjusted pricing rules for small specifications to encourage supply [4] Group 2: Ensuring Quality - The procurement process has incorporated higher quality control standards based on feedback from regulatory bodies [2] - Bidders must have at least two years of production experience for similar formulations, and their production lines must pass GMP compliance checks [4] - The assessment of production quality has been expanded to include the production line's compliance history [4] - Preference will be given to companies with stable quality and clinical recognition when bids are equal [4] Group 3: Preventing Collusion - Measures to prevent collusion have been enhanced, including treating closely related companies as a single entity during bidding [4] - A "first to report leniency" mechanism has been introduced to encourage reporting of collusion [4] - Stricter penalties will be applied to companies found to be colluding, including being placed on a violation list [4] Group 4: Countering Excessive Competition - The procurement will implement a "weak elimination" rule to prevent extreme price increases, with the highest valid bid being a critical measure [5] - Adjustments to price control mechanisms will ensure fairness and prevent excessively low bids from disrupting the market [5] - Companies are required to commit to not bidding below their costs, with explanations needed for any bids below the established price anchor [5] - The procurement process will strengthen the execution of selected results, holding companies accountable for timely delivery and medical institutions for adhering to procurement agreements [5]

据江苏华招网统计，按上市许可持有人统计，第11批拟采购的55个品种竞争格局均≥7家，截至9月9 日，竞争格局最高达到了52家，另外，也有2个品种竞争格局达到45家。 第11批集采方案此前先后两次征求相关部门、行业协会和企业等方面意见，在此基础上，国家医保局充 分遵循"稳临床、保质量、防围标、反内卷"的原则，细化完善药品集采规则，确保药品保质保供。 21世纪经济报道记者 闫硕 9月20日，第11批国家组织药品集中带量采购（简称"集采"）文件正式发布，涉及55个品种，符合要求 的企业可参与申报。 根据文件，在2025年9月28日（含）前获得国内有效注册批件且属于上述55个品种的产品可参与申报。 企业需在9月28日24点前在"国家医保服务平台"完成企业和药品相关信息首次填报并提交，24点后不再 受理首次填报提交的药品信息。如首次填报信息经审核后需修改或补充材料的，须于2025年9月29日16 点前再次提交。 上海市卫生和健康发展研究中心主任金春林向21世纪经济报道表示，此次最主要的变化在于"锚点价 格"，不再简单选用最低报价。另外，不同于之前只能按药品通用名报量，此次医疗机构既可像以前那 样按通用名报量，也可按具体 ...

今天，国家医保局发布第十一批国家组织药品集中采购文件。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。 一、关于"稳临床"。保障临床用药需求是集采的基本目标，也是优化集采措施的重点。 一是优化医疗机构报量方式。既往的化药集采中，医疗机构按药品通用名报量，第11批集采中，医疗机 构既可像以前那样按通用名报量，也可按具体品牌报量。医疗机构报量的品牌如果中选，将直接成为该 医疗机构的供应企业，提高临床需求与供应的匹配度。报量规则的完善得到了广大医疗机构和企业的支 持。有4.6万家医疗机构参加了本次集采报量，报量的77%具体到了品牌。 二是合理确定约定采购量。集采把医疗机构报量的60%~80%作为企业竞争标的，这部分也即是医疗机 构的约定采购量，剩余部分仍由医疗机构自主选择品牌。 三是采取更贴近临床用药实际的中选规则。对于医疗机构需求大但报价未入围的企业，如接受入围企业 的中选价格，给予中选机会，鼓励头部企业积极中选，更好满足临床需求。 四是关注儿童药供应保障。会同相关部门和专家专门论证儿童适宜小规格药品的比价规则，对小规格的 口服溶液、干混悬剂、颗粒剂、注射剂等儿童适宜剂型，用" ...