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On June 29, the National Healthcare Security Administration announced the list of drugs and related information that passed the preliminary formal review for inclusion in the 2026 National Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance Drug Catalog (hereinafter referred to as the “Basic Medical Insurance Catalog”) and the Commercial Insurance Innovative Drug Catalog (hereinafter referred to as the “Commercial Insurance Catalog”).
The million-dollar-priced CAR-T therapies, which attract significant attention in the annual National Reimbursement Drug List (NRDL) updates, are precisely the high-cost drugs referenced by the National Healthcare Security Administration. In 2025, the national NRDL negotiations formally introduced the “Commercial Insurance Innovative Drug Catalog” mechanism for the first time, with five CAR-T therapies passing the expert review for inclusion in this catalog.They are Juventas’s naqiorencel, Caribou Biosciences’ icariorencel, Fosun Kite’s axicabtagene autoleucel, JW Therapeutics’ relmacabtagene autoleucel, and CARsgen Therapeutics’ zevorcabtagene autoleucel.Three of these products have simultaneously applied for inclusion in both the National Basic Medical Insurance Drug List and the Commercial Health Insurance Innovative Drug List, with the potential to reduce patient financial burden through a “basic medical insurance + commercial health insurance” combined model.Among the drugs that have passed the initial review for inclusion in the National Basic Medical Insurance Catalog, two highly anticipated CAR-T cell therapy drugs, also known externally as “million-yuan anti-cancer drugs,”Juventas' Nakiocel Injection and JW Therapeutics' Relmacabtagene Autoleucel Injection。Public information indicates that the prices for these two CAR-T therapies are RMB 999,000 per infusion and RMB 1.29 million per infusion, respectively.Both passed the initial review under “Out-of-Catalogue Condition 5,” which specifically refers to products already included in the 2025 Edition of the Commercial Health Insurance Innovative Drug Catalogue.
Juventas’ independently developed, original CAR-T cell therapy product, Yuanruida® (naciolence injection), has achieved a historic breakthrough in the recent adjustment of the commercial insurance innovative drug catalog: the newly added indication submitted for inclusion in the commercial insurance catalog has successfully passed the formal review, making it the first innovative drug to expand its indications within the catalog and pass the preliminary review since the implementation of the National Commercial Health Insurance Innovative Drug Catalog system.It is worth noting that Hengrui Dasheng'sRelnioreucel Injection (approved for marketing in July 2025), Precision Biotech’s Pujioerucel Injection (approved for marketing in November 2025)All were included in the preliminary review list of off-formulary drugs for this year’s commercial insurance innovative drug catalog.In this year's catalog application, established a pre-submission mechanism for the first time, namely, allowing drugs that have completed technical review but have not yet received formal approval to be submitted for pre-declaration. Industry analysis suggests that the pre-declaration mechanism bridges the time gap, securing valuable submission opportunities for innovative drugs in the final stages of approval. In previous years, drugs were required to be formally approved before the submission deadline; however, many new drugs faced delays in the final review and certification processes, causing them to miss the National Reimbursement Drug List (NRDL) negotiations for that year. The pre-declaration system can shorten the cycle from new drug launch to NRDL inclusion by 3–6 months, enabling drugs to “participate in the same year’s negotiations upon approval.”Following the inclusion of the CAR-T product zevorikicel injection in commercial insurance last year,CAR-T Therapy Surucabtagene Autoleucel Injection from Legend Biotech (02171.HK) Also Passes Preliminary Review for This Year’s Commercial Insurance Directory, following the newly implemented "pre-submission" pathway. According to available information, Shuairui Kiorencel Injection was approved for market launch on June 22, with a price of RMB 990,000 per dose. It is indicated for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma that is CLDN18.2-positive, HER2-negative, and has failed at least two prior lines of therapy.The world's first approved CAR-T therapy for solid tumors, achieving a historic leap for CAR-T therapy from hematologic malignancies to solid tumors.Bopidacagi Injection is China’s first AAV gene therapy drug, indicated for the treatment of adult patients with moderate to severe hemophilia B (congenital factor IX deficiency) as a one-time treatment regimen. This product applied for inclusion in the inaugural list of innovative drugs covered by commercial health insurance in 2025 and passed the preliminary review, but was ultimately not included in the final official list.In addition, several blockbuster drugs have also appeared on the preliminary review list for inclusion in the National Reimbursement Drug List. These include Baili Tianheng’s (688506.SH) lunkangyilongtuomab, the world’s first bispecific antibody-drug conjugate (ADC); Xianweida’s enoglutide, the world’s first cAMP-biased GLP-1 receptor agonist; and Innovent Biologics’ (1801.HK) mazdutide, a dual GCG/GLP-1 receptor agonist.References:
https://www.nhsa.gov.cn/art/2026/6/29/art_109_21131.html?sessionid=
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