"可以看出，进入商保目录的药品，都是以治疗为主，且在同领域内价值大且价格高。"黄心宇表示，当 前目录动态调整机制基本成熟，预期稳定。同时，目录结构进一步优化，注重填补空白与提高基金使用 效率并重。 2026年1月1日起，新版国家医保药品目录及首版商保创新药目录将在全国范围内正式实施。此次目录调 整堪称是医保目录诞生以来创新药规模最大的一次扩容，标志着我国创新药产业迎来政策与支付的双重 利好。本次医保目录调整在创新药纳入方面有哪些核心变化？首设商保创新药目录背后有何深层考 量？"双目录"支付机制下，医药企业又该如何布局研发？ 尽显临床导向 "111种为5年内新上市品种，50种为I类新药，无论是占比还是数量都创历年新高。"在近期举行的目录 解读会上，国家医疗保障局医药管理司司长黄心宇介绍，新版国家医保药品目录在新增114种药品的同 时，调出了29种临床没有供应或可被其他药物更好替代的药品。 黄心宇表示，新增药品普遍具备三大共性，或填补空白、或同类更优、或更具性价比。"比如治疗三阴 乳腺癌的芦康沙妥珠，此前医保目录中并无针对该病症的药物，此次纳入填补了空白。该领域此前仅上 市一款进口药物，因价格昂贵未能通过专家评审 ...

Core Insights - The new National Medical Insurance Drug List and the first Commercial Insurance Innovative Drug List have been officially released, including over a hundred innovative drugs, set to be implemented on January 1 next year [1] Group 1: New Drugs Included in the Medical Insurance List - 98% of the drugs included in the medical insurance list are new drugs approved within the last five years, with 50 of them being first-class new drugs, marking a historical high [2] - A significant portion of the newly added drugs addresses high-demand conditions such as cancer, chronic diseases, and rare diseases, with 36 cancer drugs included, accounting for approximately 30% of the total [2] - The inclusion of innovative drugs is expected to alleviate clinical pain points, particularly for conditions previously lacking effective treatments, such as triple-negative breast cancer and pancreatic cancer [3] Group 2: Coverage and Clinical Value - The new medical insurance directory covers a wide range of diseases, including metabolic diseases and rare diseases, with drugs like KARS-targeted therapies now included [3] - Chronic disease medications, such as the cholesterol-lowering drug Increlex and the dual-target diabetes drug Tirzepatide, have also been added to the list [4] - The approval rate for drugs entering the expert review stage has decreased to 41.48%, with 331 drugs evaluated and only 129 passing the review [5] Group 3: Criteria for Inclusion - The "Four No Changes" principle restricts the inclusion of drugs that do not alter the main components, indications, administration routes, or clinical value, focusing on "true innovative" drugs that fill existing gaps [6] - Several first-class new drugs did not pass the expert review due to insufficient clinical value, despite being new compounds [7] - Experts emphasize the need to avoid homogenized innovation that wastes resources, advocating for genuine innovation that demonstrates real clinical benefits [8] Group 4: Commercial Insurance Innovative Drug List - The first Commercial Insurance Innovative Drug List includes advanced therapies such as CAR-T cell therapy, monoclonal antibodies, and small molecule targeted drugs, with 19 drugs included [10] - To facilitate the implementation of the commercial insurance innovative drug list, the National Medical Insurance Bureau has provided supportive measures, including exemptions from certain monitoring and payment frameworks [11] - The successful implementation of this new system requires careful consideration of actuarial pricing and the establishment of efficient communication platforms between commercial insurance and medical enterprises [11]

Core Viewpoint - The article discusses the recent update of China's National Medical Insurance Drug List, which includes 114 new drugs, highlighting the introduction of a commercial health insurance innovative drug directory alongside the basic insurance list, aiming to enhance patient access to innovative treatments and address gaps in drug coverage [6][13]. Group 1: New Drugs in the National Medical Insurance Directory - A total of 114 new drugs have been added to the directory, covering various treatment areas including 36 for tumors, 12 for chronic diseases, and 10 for rare diseases, with the number of class 1 new drugs increasing from 38 to 50, setting a new historical high [6][7]. - Notable "star drugs" include LuKangsa Tazhu (for tumors), Fluorazirase tablets, and Spilumab (for specific dermatitis), which will benefit a wide range of patients, including those with triple-negative breast cancer and chronic sinusitis [7][8]. Group 2: Financial Impact on Patients - The average price reduction for negotiated drugs has historically been around 60%, with 112 out of 127 drugs successfully negotiated this year, resulting in significant cost savings for patients [9]. - The introduction of Spilumab, priced at around 1,000 yuan per injection, is expected to significantly lower the financial burden on patients, making innovative treatments more accessible [9]. Group 3: Implementation Challenges - There are concerns regarding the "last mile" issue in drug availability at hospitals, as many negotiated drugs are still provided through external pharmacies, and hospitals may hesitate to prescribe these due to cost concerns [10][11]. - The new regulations require that hospitals must not limit the availability of negotiated drugs based on overall budget constraints, ensuring that these drugs are accessible to patients [11]. Group 4: Changes in the Drug Directory - This year, 29 drugs were removed from the directory due to being replaced or not produced, with a total of 467 drugs removed over the past eight years for similar reasons [12]. - A six-month transition period has been established for patients using drugs that are not renewed in the directory, ensuring continuity of care [12]. Group 5: Commercial Health Insurance Innovative Drug Directory - The newly established commercial health insurance innovative drug directory includes 19 drugs, focusing on high-value innovative treatments that cannot be covered by the basic insurance directory [13][15]. - The drugs in this directory are characterized by high innovation, significant clinical value, and the need for diverse payment options, with 50% being class 1 new drugs [15]. Group 6: Benefits for Patients - The commercial health insurance directory aims to provide a curated list of high-quality drugs, reducing the selection burden for insurance companies and potentially lowering costs for patients through reduced premiums or increased reimbursement rates [16]. - The integration of the commercial insurance directory with existing medical insurance systems is being explored to enhance patient experience and access to innovative treatments [16]. Group 7: Future Prospects and Challenges - The implementation of the commercial health insurance innovative drug directory is dependent on market mechanisms, with insurance companies determining the usage and timing of these drugs [19]. - Emphasis on actuarial pricing and collaboration between insurance companies and pharmaceutical firms is crucial for the sustainable rollout of these innovative drugs [19].

Core Insights - The success rate of negotiations for the National Essential Medicines List reached 88% in 2025, a significant increase from 76% the previous year, marking a seven-year high [1] - A total of 114 new drugs were added to the list, including 50 innovative first-class drugs, indicating a record number both in terms of proportion and quantity [2] - Nearly 100 drugs (98) were rejected during the formal review stage, with over 60% failing to pass expert evaluation, reflecting a continuous decline in the approval rate [1][4] Group 1: Negotiation Process and Outcomes - The negotiation process has matured over the past eight years, involving self-application by pharmaceutical companies, expert evaluations, and price negotiations, resulting in 718 submissions and 535 passing the formal review [2] - The expert evaluation phase saw a pass rate of 41.48%, with 129 drugs proceeding to negotiations, of which 112 were successfully included in the National Essential Medicines List [2] - The total number of drugs in the list increased to 3,253, with 1,857 Western medicines and 1,396 traditional Chinese medicines [8] Group 2: Reasons for Rejection - The decline in approval rates for drugs in the expert evaluation phase is attributed to increased clarity in application processes and heightened competition among similar drugs [4] - Several rejected drugs included first-class innovative drugs, with reasons such as lack of significant clinical value compared to existing treatments [5] - Four main reasons for rejection were identified: lack of innovation, high prices, and insufficient clinical necessity [6] Group 3: Support for True Innovation - The focus on "true innovation" emphasizes filling clinical gaps, offering superior alternatives, and providing better cost-effectiveness [7] - Successful new entries into the list included innovative treatments for various cancers and chronic diseases, reflecting a commitment to enhancing healthcare coverage [8] - The National Healthcare Security Administration aims to maintain a dynamic adjustment of the drug list to meet evolving clinical needs [8] Group 4: Value-Based Purchasing - The negotiation process incorporates a systematic value assessment, including expert evaluations and price calculations, to ensure fair pricing [9] - Recent improvements in price calculation methods aim to enhance fairness and scientific rigor in the evaluation process [10] - The emphasis on differentiated innovation requires pharmaceutical companies to provide substantial clinical evidence to support claims of added value [11]

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]

Core Viewpoint - The company, He Yu-B (02256), has seen a significant stock price increase following the approval of its IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor, Goresan, for treating KRAS G12C mutated NSCLC in China, marking a progression to Phase II clinical trials. Additionally, the company has been included in the MSCI Global Small Cap Index, which is expected to enhance its global funding visibility and liquidity [1]. Group 1 - The stock price of He Yu-B increased by over 6% in early trading, currently up 4.92% at HKD 17.93, with a trading volume of HKD 39.0714 million [1]. - The IND application for the combination treatment of ABSK043 and Goresan has been approved in China, allowing the drug to enter Phase II clinical trials [1]. - The inclusion in the MSCI Global Small Cap Index is anticipated to boost the company's global funding attention and positively impact liquidity [1]. Group 2 - CICC's research report highlights that ABSK043 has the potential to be a globally competitive oral small molecule PD-L1 inhibitor [1]. - The company’s strategy of combining oral therapies is expected to offer better patient compliance and safety profiles compared to the traditional injection plus oral combination [1]. - Future clinical developments of the combination treatment are deemed worthy of attention [1].

Core Viewpoint - The company, He Yu-B (02256), has seen a significant stock price increase following the approval of its IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor, Goreserib, for treating KRAS G12C mutated NSCLC in China, and its inclusion in the MSCI Global Small Cap Index [1] Group 1: Clinical Development - The IND application for the oral PD-L1 inhibitor ABSK043 in combination with Goreserib has been approved in China, allowing it to enter Phase II clinical trials [1] - The combination therapy targets KRAS G12C mutations in non-small cell lung cancer (NSCLC) [1] Group 2: Market Impact - The stock price of He Yu-B rose over 6% in early trading, with a current increase of 4.92%, reaching HKD 17.93, with a trading volume of HKD 39.0714 million [1] - Inclusion in the MSCI Global Small Cap Index is expected to enhance the company's global visibility and potentially improve liquidity [1] Group 3: Analyst Insights - CICC's report highlights ABSK043 as a promising oral small molecule PD-L1 inhibitor with global potential [1] - The oral + oral combination therapy is anticipated to offer better patient compliance and safety profile compared to injection + oral combinations, warranting attention on future clinical developments [1]

Group 1 - The core viewpoint of the article is that HeYu has received IND approval in China for its oral PD-L1 inhibitor ABSK043 and the KRAS G12C inhibitor, which is expected to attract market attention due to its clinical progress [1] - HeYu has been included in the MSCI Global Small Cap Index, which is anticipated to enhance the company's global funding visibility and positively impact its liquidity [1] - The company maintains its profit forecast for the next two years at 48 million and 320 million, respectively, and has raised the target price by 33.3% to HKD 20, while maintaining an "outperforming the industry" rating [1]

Group 1 - The company maintains its net profit forecast for 2025 and 2026 at 48 million and 320 million respectively, while upgrading the target price by 33.3% to 20.0 HKD, indicating an upside potential of 18.3% from the current stock price [1] - The company announced the approval of its IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor for treating KRAS G12C mutated NSCLC in China, and it has been included in the MSCI global small-cap index [2][4] - ABSK043 is a promising oral small molecule PD-L1 inhibitor with good bioavailability and selectivity, showing good safety and anti-tumor activity in phase I studies, and is currently entering phase II clinical trials in combination with the KRAS G12C inhibitor [3] Group 2 - Being included in the MSCI global small-cap index is expected to enhance the company's visibility and liquidity, positively impacting global fund attention [4]

Group 1 - The core viewpoint of the report maintains the profit forecast for the company at 0.48 billion CNY for 2025 and 3.2 billion CNY for 2026, while raising the target price by 33.3% to 20.0 HKD, indicating an 18.3% upside potential from the current stock price [1] - The company has received IND approval in China for the oral PD-L1 inhibitor ABSK043 and the combination treatment with the KRAS G12C inhibitor for NSCLC [2] - ABSK043 is a promising oral small molecule PD-L1 inhibitor with good bioavailability and selectivity, showing good safety and anti-tumor activity in phase I studies [3] Group 2 - The company is advancing to phase II clinical trials for the combination of ABSK043 and the KRAS G12C inhibitor, which may offer better patient compliance and safety compared to injection plus oral combinations [4] - The company has been included in the MSCI Global Small Cap Index, which is expected to enhance global investor attention and improve liquidity [5]