2026 China NRDL Negotiations: Record Submissions, Pre-Approval Access, and the Rise of ADCs, CAR-T, and Bispecific Antibodies
核心洞察
The 2026 NRDL preliminary review saw 818 dossiers covering 674 APIs, with a 92% preliminary eligibility approval rate, up 8 percentage points from last year.
A new pre-submission mechanism allows drugs that have completed technical review but lack formal approval to enter the NRDL process, shifting access planning to the R&D stage.
ADC, bispecific antibody, CAR-T, GLP-1 (搜索), and autoimmune therapies dominate the candidate list, with companies like BeiGene (搜索), 3SBio (搜索), and Bio-Thera Solutions (搜索) actively participating.
The 2026 National Reimbursement Drug List (NRDL) adjustment process has entered its formal negotiation phase, with the National Healthcare Security Administration (搜索) (NHSA) releasing preliminary eligibility review results that underscore both record-breaking industry engagement and a fundamental shift in how innovative drugs access China's public insurance system. A total of 818 application dossiers covering 674 distinct active pharmaceutical ingredients (APIs) were submitted this year—an increase of 100 dossiers and 41 APIs compared to 2025. Excluding pre-submitted products, the overall preliminary eligibility approval rate reached 92%, an 8-percentage-point improvement over last year.
The NHSA stated that this reflects "both the continuous growth in the number of newly launched drugs in China and heightened engagement by pharmaceutical companies in the NRDL adjustment process, as well as improved understanding of submission guidelines and more rational filing behavior among companies."
Pre-Submission Mechanism Reshapes Market Access Timelines
Among the most consequential reforms in this year's finalized work plan is the introduction of a pre-submission mechanism, which allows drugs that have completed technical review but have not yet received formal marketing approval to participate in formulary submission in advance. Historically, innovative drug developers have frequently encountered the problem of "marketing approval arriving after the NRDL submission deadline," forcing products to wait an additional full year for negotiation eligibility.
"The introduction of the pre-submission mechanism essentially represents an institutional correction to the timing mismatch between regulatory review/approval and NRDL access," Guo Xinfeng, General Manager of Nanjing Evidence-Based Biotech, told Caixin. "For innovative drugs nearing the final stage of regulatory approval, being able to enter the NRDL submission process immediately upon completion of technical review helps shorten the time gap between approval, NRDL inclusion, and hospital adoption—securing a more critical market entry window for companies."
This shift is already visible in practice. Among the second batch of 26 innovative drugs announced for reference-drug pre-consultation in May, seven had not yet received formal marketing approval, including Lanoconazole Hydrochloride Tablets, Pombilitase Alfa for Injection, Selvemigumab Injection, and Gumokizumab Injection. This means certain innovative drugs are entering the NHSA's value assessment framework even before obtaining marketing authorization.
The '5+3' Window and Renewal Rules Favor Innovation
Two additional provisions have been formally retained: the "5+3" submission window for conditionally approved drugs and the linkage mechanism between the commercial health insurance innovative drug list and the NRDL. Under the "5+3" rule, conditionally approved drugs remain eligible for NRDL submission within five years of approval; if such a drug transitions to full approval within those five years, it may continue to be submitted for an additional three years.
The finalized renewal framework also offers structural benefits to Class 1 new drugs. In addition to drugs on the negotiated list for four consecutive years qualifying for a 50% reduction in required price cuts, companies may proactively request re-negotiation when entering the stepwise price-reduction mechanism under simplified renewal—and the resulting price reduction may not necessarily exceed the percentage determined through simplified renewal.
Conversely, non-exclusive drugs face intensified pricing pressure. The official proposal stipulates that if the listed procurement price of a drug with the same generic name exceeds 1.8 times or 3 times the national reimbursement benchmark, it will trigger a mandatory "yellow flag" or "red flag" alert, respectively.
ADCs, Bispecific Antibodies, and CAR-T Therapies Dominate the Candidate List
The preliminary review list encompasses nearly all of the most competitive technological directions in China's innovative drug sector. Blockbuster candidates from antibody-drug conjugates (ADCs), bispecific antibodies, CAR-T cell therapies, autoimmune disease treatments, and GLP-1 (搜索) receptor agonists have all been submitted.
Notable ADC and bispecific antibody entries include Bio-Thera Solutions (搜索)' recently approved global first-in-class bispecific ADC lunsekimab (搜索), Kelun-Biotech's bolutuzumab vedotin for injection, Zai Lab's imported vistusertib vedotin, BeiGene (搜索)'s HER2 (搜索)-targeted bispecific zanidatamab, and Lepu Biopharma's domestic first-in-class EGFR (搜索)-targeted ADC vibecotamab.
In autoimmune disease, 3SBio (搜索)'s Anmuqita mab (搜索)—a domestically developed IL-17A (搜索) inhibitor and China's first homegrown product approved for once-every-eight-weeks dosing during the maintenance phase—has advanced to the preliminary review list. BeiGene (搜索)'s next-generation, highly selective BCL-2 (搜索) inhibitor socoralimab (搜索) tablets have likewise passed preliminary review, progressing seamlessly from pre-consultation to formal review in what industry observers regard as emblematic of the state's accelerated pathway for truly innovative therapies.
CAR-T cell therapy also features prominently. CARsgen Therapeutics (搜索)' Soreqilimab Injection (搜索)—the world's first CAR-T therapy for solid tumors—appears on the preliminary review list. The company stated it is "actively building a diversified payment ecosystem encompassing both basic medical insurance and commercial health insurance to significantly improve patient access."
The GLP-1 (搜索) therapeutic area constitutes another major focal point. Mazdutide injection from Innovent Bio and Enotiglutide injection from Sciwind Biosciences have both cleared preliminary review, while Hansoh Pharmaceutical has applied to expand the reimbursement scope of its already-listed PEGylated Lixisenatide injection.
Commercial Insurance List Sees Rationalized Engagement
Despite strong prior market interest, the Commercial Health Insurance Innovative Drug List saw significantly contracted submissions. A total of 57 out-of-catalog generic drug names applied this year, with 53 passing initial formal review—a sharp decline from the 141 products that applied during last year's inaugural adjustment.
Zhao Heng, founder of Latitude Health, told Caixin that "commercial health insurance still lacks truly mature payment cases, so companies remain generally cautious." He added that "whether enthusiasm for the Commercial Health Insurance Innovative Drug List will grow further hinges on whether concrete, replicable, and sustainable payment mechanisms can be successfully established."
Xu Yucai, a senior expert in healthcare reform, noted that companies are not unwilling to participate; rather, "it remains uncertain whether inclusion in the list will actually translate into viable reimbursement. If payment models, product design, and claims mechanisms are not yet mature, companies find it difficult to accurately assess commercial potential, naturally dampening their willingness to engage."
Market Response and Strategic Implications
On June 29, the day the preliminary review list was released, the Tonghuashun Innovative Drug Index rose 5.39% at midday. 3SBio (搜索) surged by 20%, Bio-Thera Solutions (搜索) gained 12.69%, CARsgen Therapeutics (搜索) climbed 5.55%, and BeiGene (搜索)'s A-share listing advanced 10.41%.
"As health insurance negotiations gradually shift from an 'access-focused bargaining game' toward a 'comprehensive value assessment,' the competitive focus for innovative drug companies is evolving—from merely securing regulatory approval toward validating clinical value, generating real-world evidence, and ensuring long-term payment sustainability," Guo Xinfeng said.
The NHSA emphasized that the formal review is merely the first step in the drug list adjustment process. Drugs passing initial review must still undergo expert evaluation, price negotiation, or consultation before final inclusion decisions are made. Nevertheless, the integration of reference-drug pre-consultation, pre-submission, and formal review into a cohesive pathway signals that NRDL eligibility considerations are progressively shifting forward to the regulatory approval and even R&D stages—potentially the most significant signal emerging from the 2026 national reimbursement negotiations.