Core Viewpoint - The recent adjustment of the National Medical Insurance Drug List and the Commercial Health Insurance Innovative Drug List signifies the successful completion of the annual national medical insurance drug negotiation process, emphasizing the goals of "filling gaps, encouraging innovation, and optimizing structure" [1][10]. Group 1: Drug List Adjustments - A total of 114 new drugs were added to the list, with 111 being newly launched within the last five years, representing 97.3% of the additions, including 50 first-class innovative drugs [2][11]. - The total number of drugs in the directory has increased to 3,253, with 1,857 Western medicines and 1,396 traditional Chinese medicines, significantly enhancing the coverage for critical areas such as cancer, chronic diseases, and rare diseases [2][11]. - The new directory includes drugs that address gaps in basic medical insurance, such as treatments for triple-negative breast cancer, pancreatic cancer, and lung cancer, as well as medications for rare diseases and chronic conditions [2][11]. Group 2: Support for Innovation - The negotiation success rate for this year reached 88.19%, the highest in recent years, with 127 drugs participating and 112 achieving success, indicating a strong support for genuine innovation [4][13]. - The selection process for drugs involved strict evaluations, with only 41.48% of the 331 drugs reviewed passing the expert assessment, reflecting a focus on high-quality submissions [5][14]. - The pricing assessment for drugs is based on their clinical value, with a higher willingness to pay for drugs that demonstrate significant clinical benefits, aligning with the principle of "paying more for quality life" [6][14]. Group 3: Commercial Health Insurance - The first version of the commercial health insurance innovative drug directory includes 19 high-priced innovative drugs, aimed at establishing a multi-tiered insurance system [8][16]. - The directory is designed to enhance the attractiveness of insurance products, potentially increasing the insurance uptake and improving the profitability structure of insurance companies [9][17]. - The commercial insurance directory complements the basic medical insurance list, facilitating a clearer distinction in coverage and promoting the development of a multi-layered medical insurance system [9][17].

在2025年国家基本药品目录调整中，谈判成功率达到88%，较上一年的76%有明显提升，创近七年新 高。与此同时，在新晋"国谈药"中，有111种为5年内新上市品种，50种为1类新药，无论是比例还是数 量也均创下历年新高。 而与此同时，仍有近百种（98种）药品在形式审查阶段，就被"国谈"拒之门外。近六成目录外药品在专 家评审阶段未过评，过评率连续两年不足50%。15种药在过评后最终谈判/竞价失败。 "一进一拒"，从正反两个维度体现了国家医保局价值购买的方向——在基本医保的保障边界内，支持真 创新，支持差异化创新。 部分业界观点认为，这一方面是因为在申报和形式审查环节，药企申报意愿持续提升，对规则的认知也 更加清晰，形式审查通过数量和通过率不断提升；另一方面，也与目录内药品涵盖适应证不断丰富，创 新药市场上同靶点、同机制、同适应证药品竞争激烈，医保基金紧平衡等多重原因下，国家医保局对创 新要求不断拔高有关。 182种药未过评背后："四不改"、价格与价值不匹配 国家基本药品目录谈判走进第八个年头，已形成了一套成熟的谈判流程：药企自主申报，专家综合评 审，价格谈判/竞价，最终公布谈判结果。 在今年"国谈"中，国家医保局 ...

Core Insights - The approval rate for drugs outside the national essential drug list has reached a four-year low during the expert review phase, indicating increasing scrutiny and higher standards for innovation [1][4] - The success rate for negotiations in the upcoming 2025 national essential drug list has improved to 88%, up from 76% the previous year, marking a seven-year high [1] - A total of 114 new drugs will be added to the national essential drug list, including 50 innovative first-class drugs, reflecting a significant increase in both quantity and quality [2][8] Group 1: Approval Rates and Trends - The approval rate for drugs in the expert review phase has declined for two consecutive years, with only 41.48% of drugs passing this stage this year [2][3] - In the past three years, the number of drugs passing the formal review has increased, but the expert review approval rate has decreased from 74.2% to 47.0% [3] - Nearly 60% of drugs outside the essential list failed to pass the expert review, highlighting a trend towards stricter evaluation criteria [1][4] Group 2: Reasons for Non-Approval - Several drugs, including first-class innovative drugs, were not approved due to lack of significant clinical value compared to existing treatments [5][6] - The "Four No Changes" principle (no change in active ingredient, indication, administration route, or clinical value) has been identified as a key reason for low approval rates [6] - High prices and mismatched value with existing treatments have also contributed to the rejection of certain drugs, with examples of significant price discrepancies noted [6] Group 3: Support for True Innovation - The national healthcare authority emphasizes support for "true innovation" and "differentiated innovation," aiming to exclude drugs that do not significantly advance clinical outcomes [5][7] - Successful drugs entering the essential list share common characteristics such as filling therapeutic gaps and offering superior alternatives [7] - The overall speed and quantity of innovative drugs entering the national essential drug list have increased, addressing various medical needs including major diseases and rare conditions [8] Group 4: Value-Based Pricing and Evaluation - The negotiation process for the national essential drug list has evolved to include a more systematic and scientific value assessment, enhancing fairness and rigor in price evaluations [10] - The approach to pricing has shifted to support higher payment thresholds for drugs with greater innovation, reflecting a value-based pricing model [10][11] - The importance of robust clinical evidence in supporting claims of additional benefits for new drugs has been highlighted, particularly in competitive therapeutic areas [11][12]

对此，国家知识产权局、公安部、国家市场监督管理总局近日联合部署了知识产权代理行业专项整治行 动，强调要在申请端、审查端、代理端协同发力，从源头上遏制不以真实发明活动为基础的专利申请和 不以产业化为目的的专利买卖行为。这直接抬高了"伪创新"的制度成本。 国家知识产权局近期出台了《知识产权促进民营经济发展实施办法》（以下简称《办法》）。在知识产 权强国建设迈入新阶段、发展新质生产力成为核心任务的当下，我国正通过一套系统性强、针对性高的 政策工具，精准破解制约民营企业创新的知识产权瓶颈，为其高质量发展筑牢制度基石。 破解"不敢创" 当前，部分民营企业尤其是科技型中小企业在创新活动中仍存顾虑，其核心关切之一在于，当创新成果 面临侵权风险时，维权可能面临成本高、周期长、举证难等问题。这在一定程度上影响了企业的创新投 入意愿和创新预期。《办法》围绕知识产权创造、保护、运用、服务等环节系统部署，从多个方面优化 知识产权环境，切实保护民营经济组织合法权益，维护公平市场竞争秩序。 国家知识产权局新闻发言人、办公室主任衡付广介绍，在知识产权创造方面，通过持续提升审查质量与 效率，更大力度实施按需审查，有效应对民营企业"创新快、保 ...

Core Viewpoint - The introduction of the commercial insurance innovative drug directory will create a win-win situation for patients, insurance companies, and hospitals, allowing patients access to innovative drugs, insurance companies to benefit from discounts, and hospitals to enhance their diagnostic capabilities and influence [1][7]. Summary by Sections Commercial Insurance Directory Release - On December 7, the National Medical Insurance Administration released the adjusted national basic medical insurance directory and the first version of the commercial insurance innovative drug directory, adding 114 new drugs to the basic insurance directory and 19 drugs to the commercial insurance directory [2]. Support for Innovation - The National Medical Insurance Administration aims to clarify the boundaries of basic medical insurance coverage and leave room for the development of commercial insurance, focusing on supporting true and differentiated innovations rather than redundant innovations [3][15]. Drug Selection Criteria - The drugs included in the commercial insurance directory are characterized by high innovation, significant clinical value, non-replaceability by existing basic insurance drugs, and strong insurability [6][11]. Market Dynamics - The commercial insurance directory is expected to provide coverage primarily for high-cost treatments after second and third-line therapies, indicating that it is designed to supplement existing basic insurance rather than simply overlap with it [7][10]. Insurance Product Development - Insurance companies are encouraged to design products that align with the commercial insurance directory, focusing on specific populations and innovative drugs [8][10]. Challenges and Considerations - The main challenges for commercial insurance include improving the efficiency of claims processing, ensuring that products cover truly innovative drugs, and addressing the potential issue of adverse selection if sick individuals are more inclined to purchase insurance [12][13]. Future Outlook - The commercial insurance directory is expected to officially launch on January 1, 2026, with insurance companies likely to introduce corresponding products shortly thereafter [10][12]. Regulatory Support - The National Medical Insurance Administration is committed to supporting true innovation and has implemented stricter evaluation criteria for new drugs, resulting in a lower approval rate for submissions [16][18]. Financial Impact - As of October 2025, the medical insurance fund has paid over 460 billion yuan for negotiated drugs, benefiting over 1 billion patients and driving related sales exceeding 670 billion yuan, demonstrating substantial financial support for the development of innovative drugs [18].

经济观察报 记者 张铃 12月7日，国家医保局发布了调整后的国家基本医保目录，以及首版商保创新药目录。基本医保目录共 新增114种药品，商保目录纳入19种药品。 目录发布后，人们普遍关心的问题是，两大目录会带给患者哪些保障，医保是如何支持创新的。对于处 于探索期的商保目录，人们有更多好奇：怎么落地？怎么报销？带病可以投保吗？医院会进药吗？ 12月9日，针对公众关切，国家医保局举行了2025年医保药品目录解读会。经济观察报记者参会并现场 采访了有关专家。 "通过今年的双目录并行，我们要厘清基本医保的保障边界，为商保发展留出空间，共同构建多元化医 疗保障体系。"在12月9日的解读会上，国家医保局医药服务管理司司长黄心宇介绍，在基本医保目录调 整时，国家医保局更愿意支持真创新、差异化创新，不愿意支持内卷式创新。 对于商保目录的落地，黄心宇提到国家医保局的三点考虑：其一，国家医保局会和各地加强沟通，用好 用足"三除外"（即商保目录内药品不纳入基本医保自费率指标、 不纳入集采中选可替代品种监测范 围、 不纳入按病种付费范围）政策，推动药品入院；其二，不改变药品市场挂网价，折扣让利于商保 公司，并传导至患者以及创新药行业 ...

Core Viewpoint - Yiling Pharmaceutical's innovative traditional Chinese medicine, Qifang Nasal Tablets, has been included in the national medical insurance catalog for the first time, providing a new treatment option for patients with allergic rhinitis [1][2]. Group 1: Product and Innovation - Qifang Nasal Tablets is a Class 1 innovative drug aimed at treating persistent allergic rhinitis, which affects over 200 million patients in China, with a prevalence rate of 17% [3]. - The inclusion of Qifang Nasal Tablets in the national medical insurance directory is a recognition of its innovation, clinical efficacy, and safety [2]. - The formulation of Qifang Nasal Tablets is based on traditional Chinese medicine theories, integrating classic prescriptions and innovative ingredients to address both symptoms and underlying causes of allergic rhinitis [3][4]. Group 2: Clinical Efficacy and Research - The efficacy and safety of Qifang Nasal Tablets have been validated through rigorous clinical trials, including randomized, double-blind, placebo-controlled studies published in an international SCI journal [4]. - The clinical trials demonstrated a total effective rate of 74.71% in symptom improvement, with a patient satisfaction improvement rate of 89% [4]. - The drug exhibits multiple pharmacological effects, including anti-allergic, anti-inflammatory, and immune regulation, supporting its comprehensive treatment approach [4]. Group 3: Market Position and Competitors - Qifang Nasal Tablets offers a holistic regulatory advantage over other treatments for allergic rhinitis, addressing nasal, ocular, and systemic symptoms effectively [5]. - In addition to Qifang Nasal Tablets, Yiling Pharmaceutical has 11 other proprietary products included in the new medical insurance directory, enhancing its market presence [5].

12月7日，医保、商保"双目录"发布。国家医保局、人力资源社会保障部印发《国家基本医疗保险、生育保险和工伤保险药品目录》以及《商业健康保险 创新药品目录》（2025年）。新版目录将于2026年1月1日在全国范围内正式实施。 2025年国家医保药品目录新增114种药品，其中，50种为1类创新药。同时，首版商保创新药目录共纳入19种药品，既有CAR-T等肿瘤治疗药品，也有神经 母细胞瘤、戈谢病等罕见病治疗药品，还有阿尔茨海默病治疗药品等，涉及北海康成、复星医药、药明巨诺、百济神州等国内多家上市药企。 图片来源：国家医保局网站 支持"真创新" 本次调整后，2025年国家医保药品目录内药品总数增至3253种，其中西药1857种、中成药1396种，肿瘤、慢性病、精神疾病、罕见病、儿童用药等重点领 域的保障水平得到明显提升。 中国证券报记者梳理发现，恒瑞医药、信达生物、众生药业、智翔金泰、康诺亚等多家国内上市公司产品被纳入。 恒瑞医药共有11款抗肿瘤产品被纳入，包括5款首次纳入国家医保目录的创新产品，3款创新药的关键新适应症，以及3款重点产品的医保目录内续约。恒 瑞医药肿瘤领域共16款已上市创新药中，已有14款纳入国家医 ...

看好医药"四重共振"投资机会 20251204 摘要 医药板块在 2025 年虽有修复，但未成市场主线，申万医药生物指数排 名靠后。经历四年调整后，板块已显现反弹迹象，预计 2026 年仍有上 涨空间，当前调整主因资金面，而非基本面恶化，提供布局良机。 2025 年医药行业经历多波行情，包括春节后的估值修复、3 月医药会议 数据超预期，以及 4 月地缘政治冲击后的创新药韧性。二季度末至三季 度初出现回调，但整体基于资金面，当前是布局医药股的良好时机。 当前最看好创新药、医疗器械和 CRO/CDMO 服务三条主线。创新药作 为排头兵，催化剂多且确定性高，估值逐步稳定；医疗器械受益于技术 进步和需求增长，发展潜力巨大；CRO/CDMO 服务受益于全球制药外 包需求增加。 转型老药企在创新药领域表现出色，拥有稳定收入和业绩作为估值参考， 估值重塑进行中，研发能力逐渐被市场认可，且在国际化方面展现出潜 力，BD 方面具有未被充分定价的潜力。 创新药投资具有临床试验时间点和数据确定性提高的特点。公司临床经 验和平台成熟度提升，监管审批时间缩短，临床数据预测更准确，同类 产品数据提供参考，核心管线数据波动减少。 Q&A ...

Core Insights - The private equity sector is actively engaging in research and investment strategies, with over 900 private equity firms participating in A-share company research activities in September, totaling nearly 2800 instances of research [1][3] - Key sectors attracting attention include electronics, machinery, pharmaceuticals, and power equipment, indicating a structural market trend supported by policies aimed at economic growth and wealth reallocation [1][6] Private Equity Research Activity - In September, 979 private equity fund managers participated in A-share company research, covering 529 stocks across 30 primary industries, with a total of 2789 research instances [3] - Among these, 41 large private equity firms participated, covering 189 stocks with 318 research instances [3] Top Stocks and Industries - The top ten stocks researched in September included: - Maiwei Biotech (88 instances, +2.33%) - Lankai Technology (71 instances, +25.96%) - Juguang Technology (67 instances, +17.47%) - Jing Sheng Mechanical (63 instances, +50.85%) - Yuchuang Environmental (28 instances, +1.60%) [4][5] - The electronics sector had the highest research frequency with 554 instances, followed by machinery equipment with 444 instances, and pharmaceuticals with 333 instances [6][7] Investment Focus - Private equity firms are particularly interested in innovative biopharmaceutical companies like Maiwei Biotech, which has attracted significant attention due to its dual-target small nucleic acid drugs and other promising projects [5] - Investment strategies are shifting towards sectors with high growth potential, such as technology and pharmaceuticals, as well as companies benefiting from policies aimed at reducing competition [5][8] Market Outlook - The overall sentiment indicates that despite market volatility, there are still opportunities for growth in Chinese assets, driven by favorable economic policies and a shift in global investment strategies [5][8]