Nearly Half of Newly Added Drugs Are Class-1 Innovatives! 2025 National Reimbursement Drug List Released: All Five CAR-T Therapies Break Through via Commercial Insurance, Marking the Dawn of a 'Value-Based Era' for Innovative Drug Payment

This morning, at the 2025 High-Quality Development Conference for Innovative Drugs held in Baiyun District, Guangzhou, the much-anticipated annual National Reimbursement Drug List (NRDL) assessment results for 2025 were officially announced. Reporters from Cailian Press witnessed the event on-site. Under the newly introduced "National Health Insurance + Commercial Insurance" dual-track collaboration model, after five days of intense negotiations involving hundreds of companies, an overall success rate of 88% was achieved — with 114 drugs entering China’s National Reimbursement Drug List, including 50 Class I new drugs, and 19 innovative drugs being included in the commercial insurance innovative drug directory.

In the negotiation phase for the commercial insurance innovative drug list, all five CAR-T products that have garnered significant market attention were included in the list. Major multinational companies like Pfizer and Johnson & Johnson also entered with key products. Regarding the basic medical insurance, Hengrui Pharma (600276.SH) successfully negotiated the inclusion of 10 drugs, including trastuzumab deruxtecan. Innovent Bio (01801) also successfully incorporated seven innovative products (including newly added indications). The Alzheimer's disease treatment drug, which has drawn high social attention, was included in the commercial insurance innovative drug list. Additionally, a group of products targeting rare diseases and unmet clinical needs, such as velaglucerase alfa and lucermetinib tablets, were included in either the basic list or the commercial insurance innovative drug list.

Multiple businesspeople and experts told Caixin that this year's National Healthcare Security Administration (NHSA) negotiations and their outcomes fully reflect the country’s emphasis on and support for innovative drugs. They believe that the expansion of the medical insurance catalog and the innovation in the commercial insurance catalog bring new opportunities to the industry, especially by providing more guarantees for the payment system of high-value drugs. Some industry insiders expressed concerns about the implementation of the commercial insurance mechanism, particularly on how to balance costs and effects and ensure the sustainability of payments, which will be the key to future reforms.

Truly Support Innovation! Nearly Half of Newly Added Drugs Are First-in-Class

This morning, at the 2025 High-Quality Development Conference of Innovative Drugs held at the Guangzhou Baiyun International Convention Center, the adjustment results of the 2025 National Medical Insurance Drug Catalog were officially announced, witnessed by more than 1,200 people from government, insurance, and pharmaceutical sectors on-site.

Zheng Xuanbo, Director of the Work-related Injury Insurance Department of the Ministry of Human Resources and Social Security, stated at the conference that the 2025 National Medical Insurance Drug Catalog successfully added 114 drugs, of which 50 are Class I innovative drugs, and 19 drugs were included in the first edition of the Commercial Insurance Innovative Drug Directory. The overall success rate was 88%, a significant increase from 76% in 2024.

Zhang Ke, Secretary of the Party Leadership Group and Director of the National Healthcare Security Administration, stated at the conference that the administration has adjusted the medical insurance drug list for eight consecutive years, including this year, with a total of 949 new drugs added. The medical insurance fund has spent over 460 billion yuan on negotiated drugs during their agreement periods, driving sales exceeding 600 billion yuan.

The National Healthcare Security Administration stated that, on the basis of adhering to the principles of "ensuring basic needs" and "doing our best within our capabilities," this adjustment follows the approach of "addressing shortcomings, encouraging innovation, and optimizing structure." By leveraging institutional, policy, and market advantages, we will steadily advance "strategic purchasing" and "value purchasing," with a focus on supporting "genuine innovation" and "differentiated innovation." We aim to achieve the goals of further enhancing the capacity and level of protection, improving patient access to new drugs, and guiding the pharmaceutical industry to place greater emphasis on innovation.

"The biggest change in this year's national negotiation is the establishment of a 'Commercial Insurance Innovative Drug List' based on basic medical insurance, with a significant proportion of newly included innovative drugs in the basic medical insurance. Many innovative drugs for major diseases have been incorporated into the new version of the medical insurance directory, reflecting the principle of respecting innovation value and meeting clinical needs," Jin Chunlin, Director of the Shanghai Health Development Research Center, told reporters from Cailian Press.

Several enterprise representatives who participated in the previous on-site negotiations told Caixin that this year's overall results were "in line with expectations." From initial communications and material preparation to formal consultation sessions, the policy rhythm was clear, and the negotiation logic remained stable. "This year, the predictability for companies has significantly improved."

The medical market director of Chongqing Bochuang Pharmaceutical, who participated in this year's on-site negotiations, told the Caixin reporter that this year’s national negotiation was "generally in line with expectations" and "sent a clear signal of supporting genuine innovation." Moreover, compared with previous years, this year’s negotiation process was more transparent, with the expert panel communicating more frankly and directly on-site, showing greater friendliness to enterprises. The attention to clinical value, real benefits, and cost-effectiveness has significantly increased.

"Medicare inclusion provides clear guidance for the market priority of the product." Sunsheng Pharmaceutical's (002317.SZ) antiviral drug Arbidol tablets, used to treat influenza A, has been successfully included in the national medical insurance catalog. The company told reporters from the Financial Associated Press that it plans to focus its sales team and academic promotion resources on medical insurance products, combine real-world data, deepen cooperation with experts, and enhance the clinical recognition of the product.

Five CAR-T Products Achieve Breakthroughs in Commercial Insurance; Multiple Key Innovative Drugs Successfully Negotiated

Reporters from Cailian News learned on the scene that the 2025 National Medical Insurance Drug Catalog has included some drugs that fill the gaps in basic medical insurance coverage, such as medications for major diseases like triple-negative breast cancer, pancreatic cancer, and lung cancer; drugs for rare diseases such as Langerhans cell histiocytosis and chelation-intolerant thalassemia; and medications for chronic diseases like diabetes, hypercholesterolemia, and autoimmune diseases.

Specific to companies, Innovent Bio has successfully included seven innovative products (including new indications) in the 2025 updated National Medical Insurance Catalog released today. These include the expanded indications of mature products such as the PD-1 inhibitor Tyvyt® (Sintilimab Injection), as well as several recently launched drugs targeting areas like oncology and chronic diseases. Hengrui Pharma is also a "big winner" in this national negotiation, with ten of its products being included in the updated National Medical Insurance Drug Catalog for the first time, covering multiple fields such as oncology, metabolism, cardiovascular diseases, immune system diseases, and ophthalmology.

In the most watched aspect of the commercial insurance innovative drug list, among the 19 drugs included in the first edition of the commercial insurance innovative drug list, there are not only tumor treatment drugs such as CAR-T, but also rare disease treatment drugs like those for neuroblastoma and Gaucher's disease, as well as drugs for Alzheimer's disease.

At the previous National Healthcare Security Administration negotiation scene, reporters from Cailian She learned that Fosun Kite's Axicabtagene Ciloleucel Injection, Wuxi Jw Therapeutics-B (02126)'s Relmacabtagene Autoleucel Injection, Hekang Biotech's Naxicabtagene Autoleucel Injection, IASO Biotherapeutics' Ebcartagene Autoleucel Injection, and AscendGene BioPharma's Zevorcabtagene Autoleucel Injection all underwent on-site price negotiation sessions for innovative drug listings in commercial insurance directories.

In the final outcome, all five CAR-T products successfully negotiated. In multiple previous National Reimbursement Drug List (NRDL) negotiations, these products had repeatedly attempted to enter the basic medical insurance system as "life-saving drugs for major diseases," but they consistently struggled to strike a balance between cost-effectiveness and affordability. This year, after the introduction of commercial insurance pathways, some companies finally achieved their goal.

KaiXing Life Sciences' parent company, CARsgen Therapeutics-B (02171), told Cailian News that the inclusion of its CAR-T product in the commercial insurance catalog marks a crucial step forward in the payment system’s support for high-value innovative therapies, sending a clear and positive signal. This move not only fully recognizes the clinical value of cell and gene therapies but also indicates that the exploration of a diversified payment system has entered a substantive phase. The policy helps effectively address industrialization challenges such as high costs and complex manufacturing faced by the industry and boosts confidence in long-term investment within the sector.

CARsgen Pharma also expressed that it looks forward to taking the inclusion in the commercial insurance innovative drug directory as an opportunity to form a stronger synergy in payment access, hospital implementation, and other aspects. This will help push cutting-edge therapies from technological breakthroughs towards large-scale application, ultimately benefiting more patients.

Besides CAR-T products, in terms of innovative drugs from foreign companies, Pfizer, Eli Lilly, Johnson & Johnson, Eisai, and other multinational pharmaceutical enterprises have also made gains in the commercial insurance innovative drug list. Some products demonstrated more flexible pricing strategies during previous negotiation discussions. For instance, Eisai's new Alzheimer's drug Lecanemab Injection and Eli Lilly's Donanemab both entered the 2025 commercial insurance innovative drug list.

Included in the national medical insurance is Connoymab-B (02162) with its domestically produced, first-of-its-kind IL-4Rα monoclonal antibody Kanyueda® (Sipuchiba Monoclonal Antibody), making it one of the most closely watched companies in this year's national negotiations. Dr. Bo Chen, Chairman and Chief Executive Officer of Connoymab, stated to the Cailian Press, "The inclusion of our company in the national medical insurance demonstrates the country’s full recognition and strong support for the clinical value and differentiated innovation of domestically produced innovative drugs. Encouraged and driven by national policies, Connoymab will continue to uphold the concept of 'true innovation,' focus on addressing unmet clinical needs of patients, and develop more globally competitive innovative drugs to benefit more patients in China and around the world through original innovation."

After this adjustment, the total number of drugs in China's national medical insurance drug list has increased to 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines. The level of coverage for key areas such as cancer, chronic diseases, mental illnesses, rare diseases, and pediatric medications has significantly improved.

Companies Shift to Clinical Value Competition, Industry Pays Special Attention to the Implementation of Commercial Insurance

In interviews, multiple corporate representatives told Caixin that companies have significantly different focuses when it comes to various medical insurance catalogs. The core negotiation for the basic medical insurance catalog revolves around "price reductions" and "sustainable payments," while the commercial insurance innovative drug catalog provides new pricing and payment opportunities for high-value innovative drugs, effectively unlocking previously restricted markets. Meanwhile, some companies admitted that the commercial insurance mechanism is still in the exploratory stage, with specific implementation methods and reimbursement chains still uncertain. "To a certain extent, we are also applying with a trial mindset," one corporate representative frankly stated.

For the first time, the inclusion of innovative drugs in the commercial insurance directory is widely regarded as highly significant by companies. A representative from Zhongsheng Pharmaceutical told reporters from Cailian Press: "This year's national negotiation has sent out a core signal of 'layered payment safeguarding innovation and value-oriented anchoring development.' By establishing the first-ever commercial insurance directory for innovative drugs, the diversified payment system provides broader market space for high-value products." The representative further analyzed that the policy adjustment clearly aims to encourage companies to pursue original innovation rather than merely imitation or 'involutionary' innovation. "The changes in national negotiation policies have made the 'innovation-payment-commercialization' chain for innovative drugs much smoother," he added.

The head of market medicine at an innovative pharmaceutical company told reporters from the Financial Associated Press: "A product entering the commercial insurance innovative drug directory marks a completely new phase in its lifecycle and provides significant positive momentum for commercialization." However, he also emphasized that whether it is basic medical insurance or commercial insurance, entering the directory is only the first step. The real challenge lies in the implementation stage. "Even after a new product enters the medical insurance system, extensive communication with the hospital pharmacy committee is still required, which is a complex and ongoing process. Many small and medium-sized enterprises struggle to cover enough hospitals, making it difficult to enter hospitals. We hope policies can further address this pain point and help companies solve the problem of implementation."

Regarding the future optimization direction of the medical insurance system, a representative from Sunsheng Pharmaceutical told reporters at Cailian She that from the perspective of innovative pharmaceutical companies, the company’s expectations for the upgrading of the medical insurance system mainly focus on enhancing the stability of the catalog and unifying data evaluation standards. "The long R&D cycle and large investment in innovative drugs mean that the predictability of catalog adjustments directly impacts corporate R&D decisions and commercialization strategies," he said. If a more stable catalog duration can be provided for innovative drugs with clinical value and urgent patient demand based on dynamic adjustments, companies will be able to plan production supply and academic promotion more accurately, avoiding resource waste.

At the same time, a representative from Zhongsheng Pharmaceutical emphasized that establishing more unified data evaluation standards is crucial for optimizing medical insurance access. "Currently, there are still differences in the criteria for accepting real-world evidence. Creating a unified evaluation framework and clarifying the core indicators of clinical data and health economics data will help companies enter the medical insurance catalog more efficiently, while promoting the objective assessment of innovative drug value."

Zhao Heng, founder of Latitude Health, a medical strategic consulting firm, stated that CAR-T and rare disease drugs account for a relatively high proportion in the commercial insurance catalog, reflecting a policy trend focusing on low-incidence catastrophic diseases. "Moreover, drugs targeting related points already included in the medical insurance catalog will no longer be incorporated into the commercial insurance catalog. For instance, since PD-1 has been included in the medical insurance catalog, drugs of the PD-1 category will no longer be covered by the commercial insurance catalog." He further pointed out that the ultimate development of the commercial insurance catalog still depends on the actual implementation situation, and whether it can be institutionalized remains to be seen in future developments.

Jin Chunlin also pays special attention to the implementation of the commercial insurance innovative drug list. He told reporters from Cailian News, "How the 19 varieties in the commercial insurance innovative drug list will be incorporated into specific commercial insurance plans, the scope of inclusion, and the specific volume growth of commercial insurance and惠民保are still key areas we will focus on observing over the next year. The actual implementation results will directly impact the mechanism improvement and further expansion of the commercial insurance innovative drug list."

It is reported that this year's adjustment of the medical insurance catalog is the eighth directory negotiation organized by the National Healthcare Security Administration since its establishment. Reviewing the data over the years, the decline in medical insurance negotiations has gradually stabilized: In 2022, 147 drugs participated in negotiations and bidding (including renewal varieties), with an average reduction of about 60.1%; In 2023, 143 off-directory drugs participated in the negotiation, 121 were successfully included in the medical insurance, with an average reduction of 61.7%; In 2024, a total of 117 off-directory drugs participated, of which 89 were successfully negotiated/bid, with a success rate of 76%, an average price reduction of 63%, and it is expected to reduce the burden on patients by more than 50 billion yuan in 2025.

According to the arrangement of the National Healthcare Security Administration, the healthcare security departments of all provinces (autonomous regions and municipalities) will complete the online listing of new drugs by the end of December 2025. The new version of the National Healthcare Security Drug Catalog will officially take effect on January 1, 2026.

This article is reprinted from "Cailian Press"; edited by Yan Wencai, Tongda Finance.