Seven Commercial Insurance-Listed Innovative Drugs Advance to Expert Review Stage in China's 2026 National Reimbursement Drug Negotiation

Based on the publicized results, the number of drugs that passed the preliminary formal review for inclusion in the National Basic Medical Insurance Catalog and the Commercial Health Insurance Catalog are respectively557, 54. The majority of the varieties declared in this application are new drugs, with 343 new generic name drugs approved within five years, accounting for more than half. Among them, ADC,GLP-1、CAR-T, radiopharmaceuticals, and rare disease therapies all have blockbuster products under regulatory review. Biokin, BeiGene,3SBio,CARsgen Therapeutics and other domestic innovative pharmaceutical companies made a concentrated appearance.

Vying for the “Ticket” to National Medical Insurance Coverage

The number of drug varieties declared this year has further increased, with a total of 818 declaration materials received, covering 674 generic drug names, representing an increase of 100 submissions and 41 generic names compared to last year. Excluding pre-declared varieties, the overall pass rate for preliminary formal review reached 92%, an increase of 8 percentage points from the previous year. Regarding the "dual rise" in both the number of declarations and the pass rate, the National Healthcare Security Administration stated that this not only reflects the continuous increase in the number of new drugs launched in China and the high regard and active participation of pharmaceutical companies in the catalog adjustment, but also demonstrates that enterprises have a clearer understanding of the declaration rules and are engaging in more rational declaration practices.

The ADC sector is one of the most closely watched fields this year. Biokin’s Lunkangyilongtuomab for Injection, Lepu Bio’s Weibeketuotamab, and Hengrui Medicine’s Ruikangtrastuzumab for Injection have all passed formal review. Among these, Biokin’s Lunkangyilongtuomab has high expectations from the industry. This Class 1 new drug, conditionally approved for marketing in China on June 22, is used to treat locally advanced or metastatic nasopharyngeal carcinoma and is the world’s only approved EGFR×HER3 bispecific antibody-drug conjugate (ADC).

Currently, the Chinese ADC market is dominated by AstraZeneca/Daiichi Sankyo’s trastuzumab deruxtecan. First approved for marketing in February 2023, the drug has had multiple indications included in the National Reimbursement Drug List, generating RMB 640 million (JPY 14.1 billion) in revenue in China in 2025. Global sales reached USD 831 million in the first quarter of 2026, a year-on-year increase of 34%, indicating sustained strong growth momentum. However, trastuzumab deruxtecan’s advantageous indications are concentrated in the field of breast cancer, whereas the initial indication for lenconetamab is nasopharyngeal carcinoma; thus, the two do not constitute direct competition in the short term. Industry experts believe that with multiple domestically produced ADC products from companies such as Biokin, Lepu Biopharma, and Hengrui Medicine participating intensively in the current round of negotiations, the competitive landscape of the domestic ADC market is poised for change.

The GLP-1 metabolic field has also garnered significant attention. Pfizer’s efraglutide injection and Innovent’s mazdutide injection have both passed preliminary review, with the two products regarded as direct competitors. Efraglutide, independently developed by Shengwei Da Biopharma and commercially promoted by Pfizer, was first approved for marketing in China in January 2026 for the treatment of type 2 diabetes. In March, its new indication was approved for long-term weight management in adult patients, in conjunction with a reduced-calorie diet and increased physical activity.

Frost & Sullivan predicts that the market size of GLP-1 in China will range from 23 billion to 45 billion yuan in 2026, and it will exceed 100 billion yuan by 2030. As domestically produced innovative drugs such as Pfizer/Innovent's Enoxaglutide and Innovent's Mazdutide participate intensively in this round of national medical insurance negotiations, industry insiders predict that the GLP-1 sector will fully transition from a "race to market" into a new phase of "accelerated volume expansion under medical insurance."

Commercialization Path for High-Priced Innovative Drugs: National Reimbursement Drug List (NRDL) Inclusion Is an Indispensable RouteCarsgen Therapeutics’ surucabtagene autoleucel injection, the world’s first CAR-T product for solid tumors, has strategically secured an early position through pre-submission. HeYuan Bio’s naqiocabtagene autoleucel injection and JW Therapeutics’ riqcabtagene autoleucel injection have passed the initial review for inclusion in the National Reimbursement Drug List (NRDL), leveraging their existing listing in the 2025 Commercial Health Insurance Directory, and are now seeking to transition from the commercial insurance directory to the NRDL.

In addition to hot sectors such as ADCs, GLP-1s, and CAR-T therapies, the fields of autoimmune diseases and hematologic malignancies have also seen the emergence of several blockbuster products. Anmukita (Anakinra Biosimilar? No, likely a specific IL-17A inhibitor from 3SBio), an injection developed by 3SBio Biopharmaceutical Co., Ltd. as a key representative of domestically produced IL-17A inhibitors, has advanced to the preliminary review list for drugs outside the current directory. Also included is Sotoclax tablets, a next-generation highly selective BCL-2 inhibitor independently developed by BeiGene. This product represents an iterative innovative drug in the field of hematologic malignancies and had previously been included in the second batch of reference drug pre-communication lists by the National Healthcare Security Administration (NHSA). As one of the first beneficiaries of the new regulation granting a five-year eligibility period for application starting from the date of conditional marketing approval, its seamless transition from pre-communication to preliminary review is regarded by the industry as a microcosm of the NHSA’s accelerated support for source innovation.

Commercial Insurance Formulary Submissions Are Becoming More Rational

In addition to the National Reimbursement Drug List (NRDL), the commercial insurance drug list is being updated concurrently. This year, 57 off-list generic names were submitted for inclusion in the commercial insurance drug list, representing a decline from the 141 products submitted during last year’s initial adjustment of the list. Ultimately, 53 off-list generic names and one on-list generic name passed the preliminary review.

The commercial insurance formulary also covers multiple therapeutic areas, including oncology and chronic diseases, and consists exclusively of Western medicines. Notably, several radiopharmaceuticals are included in the formulary, such as Lutetium (177Lu) dotatate injection, Yttrium-90 microspheres injection, and Flubetaben injection.

The National Healthcare Security Administration has previously clarified that the commercial insurance drug list primarily targets innovative drugs that “exceed the scope of basic medical insurance coverage, cannot be temporarily included in basic medical insurance, but feature high levels of innovation, significant clinical value, substantial patient benefits, and strong insurability.” This initiative aims to expand payment channels for innovative drugs beyond basic medical insurance and promote the development of a multi-tiered healthcare security system.

Experts engaged in pharmacoeconomic research have stated that, on one hand, compared to the “trial-and-error” approach during the initial application process, pharmaceutical companies now have a deeper understanding of the directory positioning and selection criteria for this commercial insurance directory adjustment, leading to more rational application decisions. On the other hand, against the backdrop of imperfect supporting measures such as hospital listing implementation and claims settlement coordination, some companies remain in a wait-and-see stance.

Professor Wang Jian, Deputy Dean of the Dong Fureng Institute of Economic and Social Development at Wuhan University, pointed out that commercial health insurance will play a key supplementary role within the multi-tiered medical security system. From an international perspective, the establishment of a commercial insurance formulary serves as a crucial foundation for the refined management of commercial health insurance, while also functioning as a transitional pool. Innovative drugs first accumulate real-world data through commercial insurance channels; only after their clinical value and cost-effectiveness are verified is consideration given to their inclusion in the National Reimbursement Drug List (NRDL). This approach aims to promote the development of a multi-tiered medical security system and alleviate the dilemma surrounding high-priced innovative drugs, where treatments are available but unaffordable for patients.

The 2026 adjustment to the National Reimbursement Drug List (NRDL) introduced three new eligibility criteria for drugs not currently included in the list, among which is the inclusion of drugs listed in the 2025 Commercial Health Insurance Innovative Drug Catalog. This measure aims to align the NRDL with the commercial insurance catalog and stabilize enterprises’ enthusiasm for participating in the commercial insurance catalog application process.

Notably, seven innovative drugs already included in the 2025 commercial health insurance catalog are seeking inclusion in the new round of the National Reimbursement Drug List (NRDL), having passed the preliminary formal review for NRDL adjustments.

The public notice period for the preliminary review results runs from June 29 to July 5. Subsequently, multiple stages—including expert evaluation and negotiated bidding—must be completed before a final determination is made on inclusion in the new edition of the catalog. The National Healthcare Security Administration (NHSA) stated that it will next verify the relevant drug information based on feedback received during the public notice period and from concerned departments, finalize the list of drugs that have passed the formal review, and announce it to the public. Meanwhile, regardless of whether the final formal review results are positive or negative, they will be communicated to the applying enterprises through the 2026 Basic Medical Insurance Catalog and Commercial Insurance Catalog Adjustment Application Module.