Million-Dollar CAR-T Therapies Now Reimbursable: 50 Class 1 Innovative Drugs Included in Dual Insurance Directories

On December 7, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security jointly released the “National Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance Drug Catalog (2025)” and the inaugural “Commercial Health Insurance Innovative Drug Catalog (2025),” marking a significant milestone in China’s healthcare security systemSynergistic Development of Basic Coverage and High-End SupplementationTaking a crucial step forward.

This adjustment not onlyInclusion of 114 Additional Drugs, and further with50 Class I Innovative DrugsThe high proportion underscores support for pharmaceutical innovation, while the concurrently launched commercial insurance catalog for innovative drugs has established a coverage pathway for high-value medications such as CAR-T, TCE therapies, and bispecific antibodies, providing clear industrial guidance and market signals to practitioners, investment institutions, and experts in the biopharmaceutical sector.

According to official documents and supporting interpretations, the 2025 adjustment of the National Reimbursement Drug List (NRDL) demonstratesA large number of new additions, strong innovative attributes, and high clinical valueKey Highlights. The overall highlights can be elaborated from three aspects: the structure of newly added drugs, optimization of the catalog system, and the pace of implementation.

Of the 114 newly added drugs, 111 were launched in the past five years, accounting for 97.3%; among them, 50 are Class 1 innovative drugs approved by the National Medical Products Administration, marking a significant increase in the proportion of innovative drugs in the updated list.Meanwhile,The negotiation success rate increased from 76% in 2024 to 88% this year., reflecting a significant improvement in the efficiency with which the national health insurance system incorporates high-value innovative drugs.

Of the 114 drugs added to the National Reimbursement Drug List in this round,Oncology drugs accounted for the highest proportion, with a total of 36 varieties.; additionally, 12 drugs are designated for the management of chronic diseases such as diabetes, 13 belong to anti-infective agents, and 10 are therapeutics for rare diseases. Overall, a cohort of drugs with significant clinical value that fill gaps in basic medical insurance coverage has been successfully included in the formulary, further improving the accessibility landscape for major diseases, chronic conditions, and rare diseases.

In the oncology field, life-saving drugs such as sacituzumab govitecan for triple-negative breast cancer (TNBC), liposomal irinotecan for pancreatic cancer, and pirtobrutinib, a targeted therapy for mantle cell lymphoma (MCL), have all been successfully included.

In the field of chronic disease management, inclisiran sodium, a long-acting lipid-lowering drug that significantly reduces low-density lipoprotein cholesterol (LDL-C) with only two injections per year, and tirzepatide, a highly anticipated dual-target innovative drug for diabetes and weight loss, have both been included in the national medical insurance list. This inclusion will effectively enhance the quality and accessibility of long-term chronic disease management.

Highlights in the Rare Disease Field Stand Out, Fosun Pharma’s luvomitinib tablets have been included in the current National Reimbursement Drug List. As the first and currently only drug in China with dual indications for adult Langerhans cell histiocytosis (LCH) and histiocytic neoplasms, as well as type 1 neurofibromatosis (NF1) in children and adolescents aged 2 years and older, it works by highly selectively inhibiting MEK1/2 protein activity, thereby blocking aberrant activation of the MAPK signaling pathway, suppressing tumor cell proliferation, and inducing apoptosis.

After adjustment,The total number of drugs included in the National Reimbursement Drug List reaches 3,253, comprising 1,857 Western medicines (accounting for 57.1%) and 1,396 traditional Chinese patent medicines (accounting for 42.9%)., the proportion of Western medicines hit a record high.

This timeA total of 29 drugs with limited clinical value or insufficient supply were removed., including certain older antibiotics and adjuvant drugs with insufficient evidence of efficacy and significant controversy surrounding their use. By adopting a dynamic approach that adds new entries while removing outdated ones, the structure of the National Reimbursement Drug List (NRDL) is optimized and fund efficiency is improved, thereby creating space for truly valuable new drugs.

In accordance with the requirements of the "Notice,"The new edition of the National Reimbursement Drug List (NRDL) will officially take effect on January 1, 2026, and the 2024 edition will be simultaneously repealed.For negotiated drugs that were removed from the coverage list due to unsuccessful renewal, the national government has established a six-month transition period (ending on June 30, 2026). During this period, medical insurance funds will reimburse expenses according to the original payment standards to prevent interruptions in patients’ medication access. All provinces are required to complete the listing of newly added drugs on provincial procurement platforms by the end of December 2025, and to facilitate the completion of pharmacy and therapeutics committee adjustments at designated medical institutions by the end of February 2026, ensuring rapid clinical availability of these drugs.

As the first supplementary coverage catalog launched by the National Healthcare Security Administration, the “Catalog of Innovative Drugs for Commercial Health Insurance (2025)” focuses on innovative drugs with significant clinical value that fall outside the scope of basic medical insurance.Nineteen Included Drugs Cover Three Major Areas: Oncology, Rare Diseases, and Chronic Diseases, building a market bridge for enterprises between the pre-reimbursement phase and National Reimbursement Drug List (NRDL) inclusion. The products included this time come from 18 companies, including Eli Lilly, Pfizer, Luye Pharma, and BeiGene, featuring nine Class 1 national innovative drugs, demonstrating an innovation landscape where international pharmaceutical giants and domestic innovators advance in parallel.

The included drugs are all representative achievements of recent breakthroughs in pharmaceutical technology, covering frontier targets and novel-mechanism agents such as CAR-T, TCE therapies, and bispecific antibodies.—Among them are five CAR-T products already marketed in China (Fosun Kite’s axicabtagene ciloleucel, WuXi Juntai’s relmacabtagene autoleucel, IASO Bio’s ikocabtagene autoleucel, Healios Biopharma’s nakibacabtagene autoleucel, and Kaixin Life Sciences’ zevorcabtagene autoleucel), covering indications such as large B-cell lymphoma and multiple myeloma. Previously, the cost per treatment course for such products often exceeded RMB 1 million; their inclusion in commercial insurance coverage will significantly alleviate the financial burden on patients.

The table of contents also closely aligns with the critical clinical needs of diverse patient populations.: In response to the aging trend, two Alzheimer’s disease treatments—lecanemab and donanemab—have been simultaneously included, filling the gap in coverage for high-value innovative drugs in this field. Targeting the pediatric rare disease population, Canhelp Genomics’ velaglucerase beta for injection (approved just this May) has been successfully listed. As the first enzyme replacement therapy for Gaucher disease in China, its rapid inclusion vividly demonstrates an efficient response to the latest clinical protocols.

From the perspective of positioning,The basic medical insurance formulary prioritizes drugs with established safety and reliability, proven efficacy, and well-understood mechanisms of action, whereas the commercial health insurance formulary focuses on cutting-edge innovative products that offer significant clinical value but come at a higher price., forming a structure with basic medical insurance as the safety net and commercial health insurance expanding coverage.

The concurrent release of the 2025 National Reimbursement Drug List (NRDL) and the inaugural Commercial Health Insurance Innovative Drug List has sent the clearest signal to the industry: innovative drugs and therapies are becoming the core focus of national payment systems. From the changes in these two lists, three accelerating industrial trends can be clearly observed.

First, clinical value takes precedence as the core guiding principleR&D resources are being concentrated on “genuine innovation.” The National Reimbursement Drug List (NRDL) has significantly increased its acceptance of new drugs launched within the past five years and Class 1 innovative drugs, while commercial health insurance formularies are focusing on covering frontier therapies such as CAR-T, bispecific antibodies, and T-cell engagers (TCEs). It is foreseeable that future products capable of sustaining policy support will be concentrated in therapeutic areas characterized by prominent unmet clinical needs, confirmed efficacy, and significant patient benefits.

Second, Expansion of Indications Becomes a Competitive Focal Point, the development of single-product, multi-indication portfolios has become a foundational capability for pharmaceutical companies. The current National Reimbursement Drug List (NRDL) provides concentrated coverage across core therapeutic areas such as oncology, autoimmune diseases, metabolic disorders, and rare diseases, which will further intensify competition in these niche segments. Cases such as the inclusion of orelabrutinib’s new indications in the NRDL and the renewal of darolutamide for its dual indications have demonstrated that indication expansion is a key pathway to enhancing drug accessibility and consolidating market share. In the future, systematic development of single-product, multi-indication strategies will become a standard approach for innovative pharmaceutical enterprises.

Third, the dual-payment system of “basic medical insurance + commercial health insurance” is rapidly taking shape, substantially breaking through the commercialization bottlenecks for high-value innovative drugs.The launch of the commercial insurance innovative drug formulary has completely broken the limitation of relying solely on national medical insurance reimbursement for high-cost drugs. This multi-tiered payment structure clarifies the commercialization pathways for high-value sectors such as gene therapy and cell therapy, not only reducing the financial burden on patients but also expanding market opportunities for innovative pharmaceutical companies. Consequently, these related fields are poised to become core focal points for capital investment.

Overall, the centralized release of the dual catalogs not only signifies an expansion of coverage but also marks a shift in payment logic from “volume-based medical insurance” to “value-based payment.” For R&D professionals, investors, and industry decision-makers, graspingRising Share of Innovative Drugs, High-Value Drug Substitution, and Dual-Payment SynergyThree Fundamental Logics Will Help Accurately Identify R&D Priorities, Reimbursement Frameworks, and Market Opportunities for Innovative Drugs in the Next Cycle, Guiding the Industry Toward High-Quality Development That Prioritizes Clinical Value and Aligns with Reimbursement Systems.