The preliminary review list for the 2026 National Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance Drug Formulary, along with the Commercial Health Insurance Innovative Drug Directory, has been released.
Notably, several innovative drugs already included in the 2025 commercial insurance directory are now seeking entry into the upcoming national formulary. Among them are two CAR-T cell therapies, each priced at nearly one million yuan per dose.
Additionally, the preliminary review list features several other high-profile medications. These include the world's first dual-specificity antibody-drug conjugate, Baili Tianheng's (688506.SH) Lun Kang Yi Long Tuo Dan Kang, the world's first cAMP-biased GLP-1 receptor agonist, Xianweida's E Nuo Ge Lu Tai, and the GCG/GLP-1 dual-target drug Ma Shi Du Tai from Innovent Biologics (1801.HK).
Two High-Value Cancer Therapies Pass Initial Review
These two CAR-T therapies were first included in the commercial health insurance directory last year.
The preliminary review assesses whether a drug meets the annual application criteria for the national formulary and commercial insurance directory and checks the completeness of the submitted information. This year, 818 applications were submitted, covering 674 distinct drug entities. Following review, 557 and 54 drugs have passed the initial screening for the national formulary and commercial insurance directory, respectively.
The two CAR-T therapies that have passed the initial national formulary review, often referred to as "million-yuan cancer drugs," are He Yuan Sheng Wu's Na Ji Ao Lun Sai injection and JW Therapeutics' (2126.HK) Rui Ji Ao Lun Sai injection. Public information indicates their prices are 999,000 yuan and 1.29 million yuan per dose, respectively.
CAR-T therapy involves genetically modifying a patient's own immune cells to target and destroy cancer cells. It has shown significant efficacy for certain hard-to-treat blood cancers. However, due to its personalized, "one-patient, one-drug" nature, the cost is typically exorbitant, often reaching millions per treatment, placing it out of reach for many patients.
For years, the high price tag kept CAR-T therapies from entering national medical insurance price negotiations. In this context, the 2025 Commercial Health Insurance Innovative Drug Directory was established, initially including five CAR-T products, including the two mentioned above.
According to the latest information, the applications for Na Ji Ao Lun Sai and Rui Ji Ao Lun Sai injections passed the initial national formulary review under a specific criterion for drugs already listed in the 2025 commercial insurance directory. This pathway aims to bridge commercial and basic insurance, encouraging high-value innovative drugs to first enter the commercial market to accumulate clinical data and potentially reduce costs before transitioning to national reimbursement.
Following the inclusion of five CAR-Ts last year, this year's preliminary review for the commercial insurance directory has added two new CAR-T products: Heng Run Da Sheng's Lei Ni Ji Ao Lun Sai injection (approved in July 2025) and Jing Zhun Sheng Wu's Pu Ji Ao Lun Sai injection (approved in November 2025).
Other Notable Drugs Clear Preliminary Hurdle
Several other drugs from the 2025 commercial insurance directory have also passed the initial national formulary review. These include Alzheimer's treatments Duo Nai Dan Kang and Lun Ka Nai Dan Kang injections, the neuroblastoma treatment Na Xi Tuo Dan Kang injection, the rare disease drug Yan Suan Sha Bing Die Ling tablets for hyperphenylalaninemia, and the HER2 bispecific antibody Ze Ni Da Tuo Dan Kang injection.
As mentioned, other star drugs like Baili Tianheng's dual-specificity ADC, Xianweida's GLP-1 agonist, and Innovent's dual-target drug have also passed the initial national formulary review.
Following the inclusion of its CAR-T product Ze Wo Ji Ao Lun Sai last year, Carsgen Therapeutics (02171.HK) has another CAR-T therapy, Shu Rui Ji Ao Lun Sai injection, pass the initial commercial insurance review this year via a new "pre-application" system. This therapy was approved on June 22 with a price of 990,000 yuan per treatment. It is indicated for CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior therapies. It represents the world's first approved CAR-T therapy for a solid tumor, marking a historic expansion from blood cancers.
To expedite the inclusion of innovative drugs, this year's adjustment process allows for pre-application submissions for drugs that have completed technical review but have not yet received formal marketing approval by the start of the application period. Specifically, drugs that completed technical review before June 10 but lacked final approval could pre-apply, with required approval documents submitted by July 3.
Also passing the initial national formulary review via this pre-application system are two notable dry eye disease treatments: Jiangsu Hengrui Pharmaceuticals' (600276.SH; 1276.HK) new Cyclosporine Eye Drops (IV) and Zhaoke Ophthalmology's (6622.HK) Cyclosporine Ophthalmic Gel. Hengrui's product, approved in late June, is China's first and only 0.1% anhydrous cyclosporine eye drop.
The preliminary review process consists of four steps: initial review, public notice of initial results, verification, and final results announcement. The current public notice period runs from June 29, 2026, to July 5, 2026.
The next step involves verifying the drug information based on feedback received during the public notice period and from relevant authorities. The final list of drugs that pass the formal review will then be published. All applicants will receive feedback on the final outcome through the application system, regardless of whether their drug is accepted.
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