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"其他正常报价的企业，导致整个品种的中选价过低，本次集采优化了价差控 制"锚点"的选择，不再简单选用最低报价。 在此前的集采实践中，过度追求低价中标曾引发医药企业对行业内卷的担忧。第11批国家集采在规则设 计上不再唯低价，而是设立了理性价格区间，给予企业在合理范围内竞争的空间。据业内人士分析，锚 点价格相当于一个参考分数线。其计算方式，据第十一批国家集采文件，锚点价格是同品种有效申报入 围企业"单位可比价"平均值的50%、最低"单位可比价"二者取高值。 经济观察网 国庆中秋长假即将结束，据国家医保局此前发布的采购文件， 第十一批药品集采将于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。 （原标题：第十一批国采节后开标，将遵循"反内卷"原则） ...

Core Viewpoint - The new procurement rules aim to prevent pharmaceutical companies from engaging in harmful price competition while ensuring quality and affordability for patients, aligning with medical insurance cost control requirements [2][3]. Group 1: New Procurement Rules - The latest round of centralized drug procurement involves 55 types of drugs, including those for infections, tumors, allergies, diabetes, and cardiovascular diseases [2]. - The new bidding rules optimize the price difference calculation anchor, moving away from a simple lowest price model, requiring the lowest bidder to justify their pricing and commit to not pricing below cost [2][3]. - A "revival" mechanism has been introduced, allowing mainstream brands that did not win in the first round to qualify at the highest proposed winning price, recognizing the market value of quality brands [3]. Group 2: Quality and Compliance - The new rules impose strict quality controls, requiring that the production lines of bidding drugs have no violations of quality management standards in the past two years, with comprehensive inspections and product sampling by regulatory authorities [3]. - The reporting rules have shifted from generic drug names to allowing medical institutions to report based on specific brand names, emphasizing respect for doctors' prescribing autonomy and ensuring patient access to medications [3]. Group 3: Industry Impact and Future Outlook - The new procurement rules are expected to accelerate the reshaping of the pharmaceutical industry, with many companies likely to be eliminated due to severe product homogeneity [4]. - Companies are reminded that competing solely on price is not sustainable; they must focus on quality and innovation to thrive in the industry [4]. - Continuous feedback from stakeholders is essential for evaluating the impact of the new rules, ensuring that the procurement policy remains effective and beneficial for both patients and companies [4].

9月24日，云南省医保局向四川百利药业有限责任公司（简称"百利药业"）发出公开问询函。 一、请详细说明你公司马来酸依那普利口服溶液的出厂价格、终端价格，以及研发投入、生产制造、期间费用等各项价格构成情况。 不同于已经进入集采的片剂，马来酸依那普利口服溶液目前还较为稀缺，根据国家药监局数据查询系统的信息，仅有两家生产企业。相较于片剂，口服溶 液的研发和生产门槛更高，需要解决药物的溶解度、稳定性、口感、防腐等一系列技术问题。 二、请详细说明你公司马来酸依那普利口服溶液近5年各年度销售量、销售金额，以及你公司作为生产研发企业的实际利润等情况。 三、请详细说明你公司马来酸依那普利口服溶液出厂价格和终端价格之间价差的合理性、必要性，以及终端价格构成中所含全部销售费用的资金支出去向 等情况。 资料显示，马来酸依那普利是一种血管紧张素转化酶抑制剂（ACEI），呈白色至灰白色结晶性粉末，临床主要用于治疗各期原发性高血压、肾性高血压 及充血性心力衰竭，并能改善症状性心衰患者的生存率及降低住院风险。 公开函件显示，百利药业生产的马来酸依那普利口服溶液挂网价格高达558元，与同通用名不同剂型（片剂，单价8元左右）存在近70倍价差。 ...

Core Insights - The recent release of the "National Drug Centralized Procurement Document" by the National Organization for Drug Procurement has sparked significant attention and discussion within the pharmaceutical industry, particularly due to multiple adjustments in the procurement rules [1] - The principle of "no new drugs in centralized procurement" has been reiterated, indicating that innovative drugs will not be included in the procurement process, which has led to a temporary surge in the capital market [1] - The adjustments signal a strong shift in China's pharmaceutical industry from "generic low prices" to "innovation-driven" development [1] Group 1: Changes in Procurement Rules - The latest procurement rules emphasize rational pricing rather than solely focusing on low prices, addressing previous concerns about extreme low pricing practices that could harm quality [2][3] - The introduction of a new price control mechanism based on "50% of the average bid" rather than the lowest bid aims to prevent companies from underbidding to win contracts, thus promoting a more balanced competition [2][3] - A requirement for companies to submit a "Price Reasonableness Declaration" if their bids are below the established price point is intended to ensure that pricing reflects actual costs and quality considerations [3] Group 2: Impact on Market Dynamics - The introduction of the "brand-based reporting" mechanism allows medical institutions to report expected usage by specific brands, aligning procurement more closely with clinical needs and reducing discrepancies between reported and actual demand [4][5] - This change is expected to influence companies' pricing strategies and market predictions significantly, as it will better match supply with actual clinical usage [4][5] - The new rules also raise the qualification thresholds for bidders, requiring at least two years of production experience and compliance with GMP standards, thereby enhancing the overall quality of products in the market [6] Group 3: Regulatory Enhancements - The regulatory framework has been strengthened with comprehensive checks and product sampling to ensure the quality of selected drugs, with a 100% pass rate reported for recent inspections [6] - The introduction of a "first report leniency" mechanism encourages companies to report any irregularities in bidding practices, promoting transparency and accountability within the procurement process [6] - The evolution of these procurement rules is viewed as a significant indicator of the government's commitment to building a stable, efficient, and sustainable pharmaceutical supply system, moving from aggressive price reductions to long-term stability [6]

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]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The innovative drug industry is entering a rapid growth phase, with significant investment opportunities expected in the next 6-12 months [3] - The pharmaceutical sector is experiencing a shift from generic drugs to innovative drugs, with major companies showing robust performance and growth driven by internationalization and commercialization capabilities [5][14] - The optimization of centralized procurement policies and the support of commercial insurance are expected to benefit the pharmaceutical industry in the long term [6][31] Summary by Sections 1. Performance Overview - The pharmaceutical sector's performance in the first half of 2025 shows steady growth, with a transition from generic to innovative drugs. Key companies like Hengrui Medicine reported a revenue of 15.76 billion yuan (up 15.88% year-on-year) and a net profit of 4.45 billion yuan (up 29.67% year-on-year) [5][14] - China National Pharmaceutical Group also achieved double-digit growth, with a revenue of 17.58 billion yuan (up 9.8% year-on-year) and a net profit of 3.39 billion yuan (up 13.10% year-on-year) [5][14] - The innovative drug revenue for Hengrui Medicine exceeded 60%, with significant contributions from newly approved drugs [16] 2. Market Dynamics - The National Healthcare Security Administration has initiated adjustments to the national basic medical insurance and commercial health insurance drug directories, which are expected to enhance the market for innovative drugs [6][29] - The recent centralized procurement policies have shifted from broad price reductions to more refined management, which is anticipated to stabilize the expectations for generic drug businesses [6][34] 3. Recommended Stocks - Recommended stocks in the pharmaceutical and biotechnology sector include Hengrui Medicine, CSPC Pharmaceutical Group, East China Pharmaceutical, and others, which are expected to benefit from the ongoing transformation and innovation in the industry [7][30] 4. Innovation and Internationalization - The report highlights that many traditional pharmaceutical companies are undergoing innovation transformations, with significant R&D investments expected to yield results in the near future. For instance, Hengrui Medicine and CSPC Pharmaceutical Group are projected to exceed 5 billion yuan in R&D expenses [36] - The total amount of license-out transactions for Chinese innovative drugs reached nearly 66 billion USD in the first half of 2025, indicating a strong internationalization trend [36]

Core Viewpoint - The National Healthcare Security Administration of China announced the 11th batch of centralized drug procurement, including 55 drug varieties, with bidding scheduled for October 21 in Shanghai. The procurement process emphasizes principles such as "stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition" [1] Group 1: Procurement Adjustments - The new procurement scheme allows medical institutions to report quantities based on specific brands rather than just generic names, aligning supply with clinical needs more effectively [1] - The procurement process aims to better respect clinical medication choices and address patient concerns regarding brand preferences [1] Group 2: Quality Control Requirements - New requirements for quality control have been introduced, mandating that bidding drug manufacturers or contract producers must have over two years of experience in producing similar formulations [1] - Bidding drugs must pass pre-market GMP compliance checks to mitigate quality risks associated with inexperienced manufacturers [1] Group 3: Selection Rules Changes - The selection rules have been significantly adjusted to avoid solely relying on the lowest bid, introducing a benchmark price that considers the higher value between 50% of the average comparable unit price and the lowest comparable unit price [1]

Policy Developments - The National Healthcare Security Administration (NHSA) released the 11th batch of national drug centralized procurement documents, emphasizing principles of "stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition" [2] - The new procurement strategy optimizes "anchor prices" by not simply selecting the lowest bid but using the higher value between the average of "comparable unit prices" and the lowest "comparable unit price" at 50% [2] Drug and Device Approvals - Fosun Pharma announced that its subsidiary, Fuhong Hanlin, received EU approval for two drugs, BILDYOS® and BILPREVDA®, for treating osteoporosis in high-risk patients [4] - Renfu Pharma's subsidiary received a tentative FDA approval for Oxcarbazepine extended-release tablets, aimed at treating partial seizures in patients aged 6 and above, with a total R&D investment of approximately 15 million RMB [5] Capital Markets - LuKang Pharmaceutical plans to acquire a 1.9231% stake in Shandong Lukang Hecheng Pharmaceutical Co., with the final amount to be determined through bidding [7] - GE Healthcare responded to rumors about selling its Chinese business, stating its commitment to providing high-quality medical services in China [8] Industry Events - The NHSA announced the interim results of expert reviews for the 2025 National Basic Medical Insurance Directory and commercial insurance innovative drug directory adjustments [10][11] - In the first half of 2025, China's innovative drug licensing transactions reached nearly $66 billion, indicating a significant increase in international recognition and commercial value of Chinese innovative drugs [12] - The National Medical Products Administration established a review center in the Beijing-Tianjin-Hebei region to enhance drug and medical device evaluation services [13] - Approximately 100 rare disease drugs have been included in the basic medical insurance directory, covering 42 types of rare diseases [14]

Monetary Policy - The People's Bank of China announced adjustments to the 14-day reverse repurchase operations to maintain ample liquidity in the banking system, implementing fixed quantity and interest rate bidding with multiple price levels starting from September 19 [1] Government Policies - The State Council held a meeting to discuss the implementation of domestic product standards in government procurement, emphasizing fair competition and the need for a reasonable transition period for businesses to adapt [2] - The meeting also approved the draft revision of the Banking Supervision Law, aiming to enhance the stability of financial institutions and protect consumer rights [2] Pharmaceutical Industry - The 11th batch of national drug centralized procurement includes 55 drugs, with a focus on balancing price and quality, and introduces measures to prevent price wars and ensure compliance with GMP standards [3] Stock Market Regulations - Four A-share companies, including Fudan Forward and Creative Information, will face risk warnings and trading suspensions due to financial fraud, reflecting a strict regulatory stance against such activities [4] Immigration Policy - The U.S. has significantly increased the H-1B visa application fee to $100,000, impacting major tech companies that rely on foreign talent, with the fee applicable only to new applications [5] Real Estate Market - Shanghai's authorities announced adjustments to property tax policies to support housing demand, including tax exemptions for certain high-level talent and first-time homebuyers [6][7] Stock Market Performance - U.S. stock indices reached new historical highs, with significant gains in major tech stocks, while Chinese concept stocks showed mixed performance [8] Upcoming Financial Announcements - A press conference on the achievements of the financial sector during the 14th Five-Year Plan will be held on September 22, along with the announcement of the Loan Prime Rate (LPR) [9][10] IPO and Stock Unlocking - The China Securities Regulatory Commission approved IPO registrations for two companies, and over 600 billion yuan worth of restricted shares will be unlocked this week, with significant unlocks from companies like Hehe Information and Ziyuan Food [11][12][13][14]

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].