The National Healthcare Security Administration (NHSA) has recently released the list of drugs that have passed the initial formal review for the 2026 National Reimbursement Drug List (NRDL) and the Commercial Health Insurance Innovation Drug List. Information on the drugs included in these preliminary review lists has been made public.

This round of adjustments to the drug catalogs received 818 submissions from companies, covering 674 generic drug names. After review, 334 out of 375 generic names applying for inclusion outside the existing NRDL (excluding pre-application varieties) passed the initial review. For drugs already within the existing NRDL, 223 out of 229 generic names (excluding pre-application varieties) passed the initial stage.

Simultaneously, for the Commercial Health Insurance Innovation Drug List, 53 out of 57 generic names applying for inclusion outside the existing list (excluding pre-application varieties) passed the initial review. The one generic name already within the list that applied also passed. Additionally, 49 generic names (including 2 applying for new indications) were pre-applied for inclusion outside the basic NRDL, while 11 generic names within the basic NRDL pre-applied for new indications. Four generic names were pre-applied for inclusion outside the Commercial Health Insurance Innovation Drug List.

Some drugs were submitted for both the basic NRDL and the Commercial Health Insurance Innovation Drug List. However, due to differences in the application criteria for the two lists, there may be inconsistencies in the formal review outcomes between them.

Key Areas and Notable Drugs

Based on the initial review list, drugs applying for inclusion outside the basic NRDL that passed the initial stage cover multiple therapeutic areas including oncology, chronic diseases, autoimmune disorders, and rare diseases.

Several high-profile drugs appear on the initial review list. These include the world's first dual-specificity antibody-drug conjugate (ADC) Lun Kang Yi Long Tuo Dan Kang, the world's first cAMP-biased GLP-1 receptor agonist Ai Nuo Ge Lu Tai, the GCG/GLP-1 dual-target drug Ma Shi Du Tai, the first hepatitis D monoclonal antibody Li Bei Wei Ta Dan Kang, the novel Class 1 anti-insomnia drugs Fa Zan Lei Sheng Pian and Lai Bo Lei Sheng Pian, and Alzheimer's disease treatments Duo Nai Dan Kang Zhu She Ye and Lun Ka Nai Dan Kang Zhu She Ye.

The Commercial Health Insurance Innovation Drug List also covers areas like oncology and chronic diseases, with all listed drugs being Western medicines. Notably, several radiopharmaceuticals appear in this list, including Lutetium [177Lu] Te Xi Wei Pi Tai Zhu She Ye, Yttrium [90Y] Wei Qiu Zhu She Ye, and Fluorine [18F] Bei Ta Ben Zhu She Ye.

Characteristics of This Year's Submissions

The NHSA indicated that this year's submitted drugs exhibit several key characteristics. First, the number of submitted varieties has increased further. A total of 818 submissions were received, covering 674 generic names, representing an increase of 100 submissions and 41 generic names compared to 2025.

Second, the formal review pass rate has significantly improved. Excluding pre-application varieties, the overall initial formal review pass rate reached 92%, an 8 percentage point increase from last year. This suggests that most pharmaceutical companies accurately understood the catalog adjustment guidelines and submitted applications meeting the criteria.

Third, the majority of submitted drugs are new. Specifically, 343 drugs (excluding pre-application varieties) were submitted under the "Condition 1 for drugs outside the catalog," which pertains to new generic name drugs approved within the last five years.

Overall, both the quantity of submitted drugs and the proportion passing the formal review are higher than in previous years.

Introduction of the Pre-Application Mechanism

A notable development this year is the first-time establishment of a pre-application mechanism. This allows drugs that have completed technical review but have not yet received formal approval at the submission stage to be pre-applied. Industry analysis suggests this mechanism addresses timing gaps, providing valuable application opportunities for innovative drugs in the final stages of approval. In previous years, drugs were required to have formal approval before the submission deadline. Many new drugs, whose review was concluding or whose approval certificates were delayed, missed the annual national negotiation. The pre-application mechanism can shorten the cycle from drug launch to potential inclusion in the reimbursement list by 3 to 6 months, aiming for "participation in the annual negotiation upon approval."

The NHSA stated that for pre-applied drug varieties and indications, it has coordinated with relevant departments for verification. The final results will be determined based on the feedback received during the review. Companies are reminded to submit approval document information within the specified timeframe; failure to submit or submission of incorrect information by the deadline will be regarded as a failure to pass.

Next Steps for High-Cost Drugs

The NHSA also specifically mentioned that some high-cost drugs, or those potentially exceeding the reimbursement system's capacity, have passed the initial formal review this year. This only signifies that they meet the application criteria and can proceed to the next stage. Whether such drugs will ultimately be included in the reimbursement catalogs still depends on undergoing multiple rigorous subsequent procedures, including expert review, exclusive negotiations, or non-exclusive competitive bidding, before a final decision is made.