编者按： 长期以来，我国创新药商业化面临着"进院难、支付难"的结构性困境，尤其是高值创新药，常常受限于 基本医保"保基本"的定位而难以纳入报销范围。此次政策组合拳的核心逻辑，在于通过明确的分工，厘 清了政府与市场的支付边界。 对外经济贸易大学创新与风险管理研究中心副主任龙格在接受采访时指出，《商保创新药目录》聚焦超 出基本医保保障范围，但临床价值显著的创新药，作为基本医保目录的补充。两者形成了"医保保基 本、商保接高端"的分工：基本医保覆盖基础药品，商保目录则满足多元化、高层次需求，并为创新药 提供"先商保后医保"的梯度准入路径。 具体而言，新版基本医保目录继续发挥"压舱石"作用。2025年医保目录新增114种药品，谈判/竞价成功 率高达88.19%，创下近七年新高。新增药品中，50种为1类创新药，重点覆盖肿瘤、慢性病、罕见病等 领域。调整后的目录内药品总数增至3253种，其中西药1857种、中成药1396种，极大地提升了重点领域 的用药保障水平。 与此同时，首版《商保创新药目录》则精准承接了基本医保"溢出"的高端需求。首批商保目录共纳入19 种药品，涵盖了CAR-T疗法、神经母细胞瘤和戈谢病等罕见病特效药以 ...

南方财经全媒体记者 孙诗卉 实习生 徐若萱 2025年12月7日，国家医保局与人力资源社会保障部联合发布了《国家基本医疗保险、生育保险和工伤保险药品目录（2025年）》（以下简称 2025年医保目录）及首版《商业健康保险创新药品目录》（以下简称《商保创新药目录》），两份目录均将于2026年1月1日起正式实施。 作为构建多层次医疗保障体系的里程碑事件，业内人士表示，此次"双目录"的同步发布，意味着我国医药支付体系正式进入"基本医保+商业健 康险"双轮驱动的新阶段。 长期以来，商业健康险在特药责任设计上存在"专业性不足"的痛点。资深从业者迈伦向21世纪经济报道记者指出，保险公司缺乏药物经济学专 家，自行制定目录难度极大。此次《商保创新药目录》的制定相当于为保险行业提供了一份官方背书的、高质量的"药品池"，极大地降低了产 品开发的准入门槛和信息不对称风险。 对于消费者而言，这一政策不仅夯实了基础用药的保障底线，更使得此前因价格高昂而难以企及的百万级CAR-T疗法、前沿阿尔茨海默病药物 等高值创新药，有了实质性的支付解决方案。 承接医保"溢出"创新药支付需求 长期以来，我国创新药商业化面临着"进院难、支付难"的结构性 ...

Core Insights - The 2025 National Medical Insurance Drug List has been officially released, adding 114 new drugs, including 50 innovative Class 1 drugs, with a negotiation success rate of 88%, the highest in seven years [1][3] - The first version of the commercial insurance innovative drug list has been introduced, featuring 5 CAR-T cell therapies and 19 high-priced innovative drugs, marking a significant expansion in coverage [1][5] - The adjustment reflects a strategic upgrade in China's medical insurance from "basic coverage" to "basic + high-end coverage," addressing the demand for accessible and affordable innovative drugs [1][9] Drug Additions and Market Impact - The new drug list includes 114 drugs, with 44% being Class 1 innovative drugs, and a total of 3,253 drugs now covered under the insurance [3] - Notable winners include Heng Rui Pharma, which secured 20 new drug approvals, and Eli Lilly, whose drug Tirzepatide has entered the Chinese market, benefiting 140 million diabetes patients [3][4] - The inclusion of CAR-T therapies in the commercial insurance list allows for reimbursement of high-cost treatments, which were previously inaccessible to many patients [5][7] Innovations in Treatment - The new list includes significant advancements in treatments for Alzheimer's disease, with two new drugs targeting amyloid beta accumulation, providing options for over 10 million patients in China [7] - The addition of 13 rare disease drugs fills coverage gaps in four rare disease areas, expanding the total number of rare disease drugs covered to approximately 100 [8] - The adjustment also emphasizes pediatric medications, with a separate review channel for children's formulations, indicating a positive shift in addressing children's healthcare needs [9] Strategic Implications - The 2025 adjustment signifies a shift towards a dual-track medical payment system in China, combining basic medical insurance with commercial insurance to meet both fundamental and advanced healthcare needs [9] - The rapid inclusion of innovative drugs into the insurance system reflects a decade of progress in China's pharmaceutical landscape, transitioning from rare domestic innovations to a robust pipeline of new therapies [9]

Core Insights - The article emphasizes the need to resolve the contradiction between the high costs of CAR-T therapy and the payment system, which relies on both technological cost reduction and the expansion of research pipelines to access a broader patient market [1] - The focus is on the potential market growth in the solid tumor sector, which could significantly alter the CAR-T market landscape [1] Industry Trends - The global CAR-T research initially focused on hematological tumors, with existing products targeting CD19 and BCMA, covering conditions like non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). The research is now expanding towards solid tumors, with the proportion of clinical trials for solid tumors expected to rise from 15% in 2020 to 30% by 2025 [2][3] - The incidence of solid tumors is significantly higher than that of hematological cancers, indicating a potential exponential growth in the patient population. This growth can help distribute costs through economies of scale and enhance market competitiveness [2] Patient Population Insights - In China, the annual incidence rates for NHL and MM are 6.97 and 1-2 per 100,000 respectively, with approximately 40,000 new cases of DLBCL and 14,000-28,000 new cases of MM each year [2] - For solid tumors, the annual incidence of gastric cancer is between 10-20 per 100,000, with 140,000-280,000 new cases annually, and liver cancer has a similar incidence rate with a potential treatable population of 98,000-196,000 patients per year [3] Technical Challenges - Solid tumors present unique challenges for CAR-T therapies, including tumor microenvironment suppression, antigen heterogeneity, infiltration barriers, and T cell exhaustion [4] Domestic Trends - In China, all six approved CAR-T therapies target hematological tumors, but the proportion of clinical trials for solid tumors is expected to reach 42% by 2024. Key drivers for this shift include technological advancements, policy support, and a large patient base for solid tumors [5] Company Pipeline Analysis - Companies are focusing on expanding their CAR-T pipelines to include solid tumors, with several firms reporting promising clinical trial results and plans for future submissions [6][10][15][20][23][35] - For instance, Kexing Biopharm's Claudin18.2 CAR-T for gastric cancer has shown a 22% objective response rate in Phase II trials, while another company, Yuanqi Bio, reported a 56.5% response rate for GPC3 CAR-T in liver cancer [5][10] Market Potential - The potential market for CAR-T therapies in solid tumors is vast, with estimates suggesting that the annual patient population for gastric and liver cancers alone could reach between 126,000 and 280,000, far exceeding the total for hematological cancers [3][5]

Core Insights - The article discusses the transformative impact of CAR-T therapy in cancer treatment, highlighting its shift from a laboratory concept to a viable treatment option for patients with relapsed/refractory tumors [1] - The Chinese biopharmaceutical sector, particularly in cell therapy, is gaining significant attention from both domestic and international investors, with over $5 billion in business development (BD) transactions in 2024 alone [2] - The analysis aims to decode the investment logic in innovative drugs, focusing on the challenges and opportunities within the cell therapy landscape, particularly CAR-T [3] Industry Overview - The CAR-T market is characterized by a critical contradiction: while the therapy shows significant efficacy, its high costs (often exceeding 1 million yuan per treatment) limit patient access [5][6] - The demand for CAR-T therapy is substantial, with approximately 25,000 new cases of multiple myeloma and 60,000 new cases of non-Hodgkin lymphoma annually in China, yet many patients are deterred by the high costs [5] Payment System Challenges - Commercial health insurance currently supports CAR-T therapy, but only 42% of the available plans explicitly cover CAR-T treatments, with reimbursement rates for pre-existing condition patients being particularly low [6] - For widespread adoption, the cost of CAR-T treatments must drop below 300,000 yuan, which would allow for basic medical insurance coverage [6] Cost Reduction Strategies - The high costs of CAR-T therapy stem from its personalized and high-tech production model, but technological advancements are expected to reduce these costs significantly [9][10] - Key factors influencing cost reduction include: 1. **Vector Technology**: Transitioning from viral to non-viral vectors can reduce costs by 30%-50% [9] 2. **Autologous vs. Allogeneic**: Allogeneic CAR-T can lower costs to one-third or half of autologous CAR-T by enabling batch production [10] 3. **Production Processes**: Automation can reduce production time from over 14 days to about 30 hours, cutting costs by over 40% [11] Investment Analysis Framework - The analysis will evaluate nine CAR-T companies based on several dimensions, including: 1. **Technology Iteration and Cost Control**: Assessing the core technology routes and potential for cost reduction [13] 2. **Market Potential**: Estimating the patient population for various indications [14] 3. **Economic Viability and Market Access**: Identifying which companies are likely to secure market access based on cost control and pipeline potential [15] 4. **International Expansion Opportunities**: Evaluating the potential for products in international markets [16] 5. **Commercialization Capabilities**: Analyzing sales figures, production capacity, and investment relationships [17] Company-Specific Insights - The analysis focuses on nine leading CAR-T companies in China, which are at the forefront of CAR-T development, including those with approved products and those in critical clinical stages [18] - Each company's technology route and cost assessment will be detailed, highlighting their strategies for cost reduction and market positioning [26][30] Future Directions - The article anticipates that the adoption of allogeneic CAR-T technology will significantly reduce costs in the mid-term (2025-2028) and further advancements in non-viral vector technology will continue to drive down costs in the long term [24][25]