On June 29, 2026, the National Healthcare Security Administration (NHSA) of China published the preliminary formal review results for the 2026 National Reimbursement Drug List (NRDL) and the newly established Commercial Health Insurance Innovative Drug Catalog. This dual-track announcement marks the first official gate of the 2026 national drug reimbursement cycle, exposing the strategic intentions of both multinational and domestic pharmaceutical companies seeking coverage in the world’s second-largest pharmaceutical market.
According to the official NHSA notice and companion policy interpretation, a total of 818 submission items were received, covering 674 unique generic names (molecules). Following the preliminary verification of application criteria, 557 drugs passed the basic medical insurance catalog preliminary review, while 54 drugs passed the commercial health insurance innovative drug catalog preliminary review.
To global biopharmaceutical executives, market-access directors, and business development (BD) teams, these numbers are highly significant—but they are also frequently misread. Passing the preliminary formal review is not equivalent to final catalog inclusion. It represents only an eligibility qualification. Every drug on these lists must still navigate public supervision, verification, expert panel review, and face-to-face price negotiation (for the basic catalog) or price consultation (for the commercial catalog).
This article provides an in-depth, numbers-first analysis of the 2026 dual-track catalog. It details the categories of protection that dominate the NRDL, ranks the types of submissions, traces the historical evolution of the NHSA negotiation process since 2018, explains the four-stage formal review mechanics, maps out the critical July deadlines, and provides a strategic playbook for market-access and business development teams.
Disclaimer: This analysis is intended for informational and strategic purposes for pharmaceutical professionals. It does not constitute investment or financial advice.
The Historical Context: The Evolution of NHSA Negotiations (2018–2026)
To properly interpret the 2026 preliminary review numbers, we must place them within the context of China's pricing and reimbursement reforms over the past eight years. Since the establishment of the NHSA in 2018, the NRDL has moved from an irregular, multi-year update schedule to a highly structured, annual adjustment cycle.
Historically, this evolution is characterized by three major phases:
- The High-Discount Era (2018–2020): During the initial rounds, the NHSA focused heavily on oncology and high-cost patented drugs. Negotiated discounts were steep, with average price cuts commonly reported in the roughly 50%–to–60% range and some individual products cut far more, as the agency leveraged the scale of the Chinese market to drive down prices. While volume expanded rapidly, global manufacturers faced intense pressure to maintain global pricing corridors.
- Standardization and the "115% Rule" (2021–2024): The NHSA introduced formalized pharmacoeconomic (PE) evaluations and budget impact analyses. It established the "115% rule" for negotiations: a manufacturer’s bid must be within 115% of the NHSA's confidential target price (calculated by economic experts) to remain in the negotiation. If the second bid failed to meet this threshold, the drug was excluded. This period also saw the introduction of simplified renewal rules, which reduced price cuts for existing catalog entries with stable volumes.
- The Dual-Track and Innovation Splitting (2025–2026): Recognizing that ultra-expensive cell and gene therapies could not survive the pricing floors of the basic NRDL social security fund, the NHSA launched the Commercial Health Insurance Innovative Drug Catalog. This separate track allows manufacturers of highly innovative, high-cost therapies to obtain reimbursement access via commercial health insurance networks (often integrated with local government-backed Huiminbao policies) without undergoing the massive national price cuts required by the basic NRDL.
The chart below illustrates this historical trajectory:
[2018 - 2020] ────────────────► [2021 - 2024] ────────────────► [2025 - 2026]
High-Discount Era Standardized PE Evaluations Dual-Track Framework
- Focus on Oncology/Blockbusters - Confidential Target Pricing - Basic NRDL (Social Security)
- 60% - 80% average price cuts - "115% Rule" for Bidding - Commercial Innovation Catalog
- Global pricing pressure - Simplified renewals - Segmented access strategies
By segmenting the reimbursement landscape into two tracks, the NHSA aims to balance two competing priorities: maintaining the fiscal solvency of the public social security fund and encouraging the launch of cutting-edge biopharmaceutical innovations in China.
Understanding the Dual-Track Catalog System
The 2026 adjustment cycle represents the full operationalization of China's "dual-track" reimbursement framework. The two tracks function under distinct funding pools, eligibility criteria, and pricing dynamics:
1. The Basic Medical Insurance Catalog (NRDL)
This is the core public catalog, funded directly by the national social security fund. It covers essential, clinical-standard drugs and is designed to provide broad national coverage. Because the fund operates under strict budget constraints, price negotiations are aggressive.
For an innovative drug, entry into the basic NRDL unlocks reimbursement across China's basic medical insurance system, which covers well over 95% of the country's population — the access lever that makes NRDL inclusion the single most consequential commercial milestone for a launched drug in China. The trade-off is price: the discount required to enter is typically steep, with negotiated cuts historically averaging roughly half of the launch price in many rounds.
2. The Commercial Health Insurance Innovative Drug Catalog
Designed specifically for high-cost, high-value therapies (such as CAR-T therapies, gene therapies, and ultra-orphan drugs), this track is funded by commercial health insurance policies. Rather than national social security funding, reimbursement is administered through commercial insurance pools and municipal Huiminbao programs.
This track allows manufacturers to negotiate a "price consultation" that preserves a higher pricing structure. While the reimbursed patient volume is significantly smaller than that of the basic NRDL, it provides a viable pathway for specialty drugs that would otherwise be locked out of the Chinese market due to global pricing constraints.
Dissecting the June 29 Numbers
The 2026 preliminary formal review results demonstrate a marked increase in submission activity and a high administrative pass rate. The overall preliminary pass rate for the 2026 cycle was 92 percent (excluding pre-declarations), representing an 8 percentage point increase compared to the 2025 cycle. The total number of submissions rose by approximately 100, and the number of unique generic names increased by 41 compared to last year's cycle.
The table below provides a comprehensive numeric breakdown of the submissions and preliminary pass rates published by the NHSA on June 29, 2026.
| Catalog Track | Application Status | Applied Submissions (Generics) | Passed Preliminary Review | Preliminary Pass Rate |
|---|---|---|---|---|
| Basic NRDL Track | Outside Existing Catalog | 375 | 334 | 89.1% |
| Inside Existing Catalog | 229 | 223 | 97.4% | |
| Commercial Track | Outside Existing Catalog | 57 | 53 | 93.0% |
| Inside Existing Catalog | 1 | 1 | 100.0% | |
| Total (Deduplicated) | Overall Submissions | 818 (674 Generics) | 557 (Basic) / 54 (Comm.) | 92.0% (Avg) |
Basic NRDL Track Analysis
- Outside-Catalog Applications (375 Applied / 334 Passed): These represent new drug launches or indications seeking public reimbursement for the first time in China. Among these, 343 outside-catalog applications fell under Condition 1, which covers drugs that obtained a new generic name or approved indication within the past five years (specifically since January 1, 2021). The 89.1% pass rate indicates that while the NHSA is welcoming new registrations, it rejected 41 applications due to incomplete data or failure to meet the strict entry criteria.
- Inside-Catalog Applications (229 Applied / 223 Passed): These are drugs already on the NRDL seeking renewal, price renegotiation for expiring contracts, or additions of newly approved indications. The high pass rate (97.4%) is standard, as existing catalog entries have established safety and volume baselines.
Commercial Innovation Track Analysis
- Outside-Catalog Applications (57 Applied / 53 Passed): This is the focus area for high-cost oncology, gene therapies, and specialty biologics. The 53 drugs that passed this gate represent products that would struggle to survive the standard NRDL pricing floor but can secure meaningful regional reimbursement under commercial coverage.
- Inside-Catalog Applications (1 Applied / 1 Passed): Represents the initial commercial catalog trial drug seeking renewal.
Why "Passed Preliminary Review" is Not "Included"
For launch planners, corporate finance teams, and BD valuation models, the distinction between passing the preliminary review and winning catalog inclusion is critical. Under the NHSA's work plan, the catalog adjustment process is divided into four distinct phases. The June 29 announcement represents only the completion of Phase 1.
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THE FOUR-STAGE NHSA CATALOG PROCESS
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[ Phase 1: Preparation & Application ] (Completed June 10)
│
▼
[ Phase 2: Formal Review ] (Current Stage)
- June 29: Preliminary list published
- June 29 - July 5: Public notice and supervision window (7 days)
- July 3: Supplement deadline for pre-declared approvals
- Late July: Verification and Final Formal Review Announcement
│
▼
[ Phase 3: Expert Review ] (August - September)
- Clinical value scoring
- Pharmacoeconomic evaluation (PE)
- Budget impact analysis (BIA)
- Determination of "target price" bounds
│
▼
[ Phase 4: Negotiation & Bidding ] (October - November)
- Face-to-face price negotiation (Basic NRDL)
- Price consultation (Commercial catalog)
- Final catalog publication & implementation (January 1, 2027)
=============================================================================
The Role of Expert Review (Phase 3)
During Phase 3, an independent panel of clinical specialists, pharmacoeconomists, and healthcare fund managers evaluates the passed drugs. They assign scores based on clinical efficacy, safety, pharmacoeconomic value (PE), and budget impact on the insurance fund.
Even if a drug passes the preliminary review with high marks, the expert panel can reject it if the pharmacoeconomic data does not show superiority over existing, lower-cost standard clinical treatments. For expensive innovative drugs, the expert panel calculates a confidential "target price" that the NHSA negotiators will use as a hard ceiling.
The Negotiation Gate (Phase 4)
Phase 4 is the famous face-to-face negotiation. The manufacturer is given two opportunities to bid. If the manufacturer's lowest bid is not within 115% of the NHSA's confidential target price, the drug is immediately rejected and fails to enter the catalog.
Therefore, a drug passing preliminary review only means it has won the qualification to participate in these negotiations. If the manufacturer's global pricing strategy cannot accommodate the deep price cuts demanded by the NHSA, the asset will remain out-of-pocket.
Critical Dates, Deadlines, and Pre-Declaration Boundaries
The 2026 cycle operates under a strict, non-negotiable timeline. Market-access teams must manage two critical boundaries:
The June 10 Application and Technical-Review Boundary
The official application window for the 2026 catalog ran from June 1 to June 10, 2026, closing at exactly 20:00 on June 10. To be eligible for standard entry, a drug must have obtained its NMPA marketing-authorization approval before June 10.
However, the NHSA provides a pre-declaration pathway for drugs that are in the final stages of regulatory review. Under this pathway, if a drug's technical review by the CDE (Center for Drug Evaluation) was completed before June 10, the manufacturer could pre-declare the drug, even if the formal NMPA approval certificate had not yet been physically issued. The June 29 preliminary list contains several of these pre-declared assets:
- 49 pre-declarations for drugs outside the basic catalog.
- 11 pre-declarations for new indications of existing basic catalog drugs.
- 4 pre-declarations for drugs outside the commercial catalog.
The July 3 Supplement Deadline (17:00)
For these pre-declared drugs, the clock is ticking. The NHSA guidelines establish a strict supplement deadline: July 3, 2026, at 17:00.
By this deadline, any manufacturer that pre-declared a drug must upload the official, signed NMPA marketing-authorization approval document to the NHSA portal. If a manufacturer fails to submit the formal approval certificate before 17:00 on July 3, the pre-declared drug is treated as "not passed" and is immediately deleted from the catalog adjustment cycle. No extensions are permitted. Market-access teams must work closely with their regulatory affairs colleagues to ensure CDE-to-NMPA certificate issuance is expedited and uploaded before this cutover.
The Public-Notice Window (June 29 – July 5)
The publication of the preliminary list on June 29 triggers a 7-day public-notice window ending July 5, 2026. During this period, the public, competitor companies, and healthcare providers can submit feedback or challenge the eligibility of any listed drug.
For example, if a competitor discovers that a listed drug’s approved indication does not match the criteria claimed in the application, they can submit an official challenge. The NHSA verifies all feedback and removes any ineligible entries before publishing the final formal-review roster in late July.
Strategic Playbook for Market-Access and BD Teams
To maximize the value of a China commercial portfolio during this critical window, biopharmaceutical companies should implement the following targeted maneuvers:
1. Competitor Intelligence Mapping
During the July public-notice window, companies should systematically map the submissions of their competitors, applying the same structured coverage-analysis discipline used in other markets. By analyzing which indications have passed preliminary review, access teams can project:
- Which therapeutic areas will face crowded negotiations in October.
- The likelihood of price-matching demands by the NHSA (if multiple drugs with the same mechanism of action are negotiating, the NHSA will often drive prices down to the lowest common denominator).
- Potential "skinny labeling" opportunities to avoid direct therapeutic price wars.
2. Pharmacoeconomic (PE) Dossier Optimization
With Phase 3 expert review scheduled for August and September, PE teams have less than 60 days to refine their clinical value arguments. The dossier must focus on Chinese-specific data:
- Local Comparator Costs: Contrast the drug's efficacy against local Chinese standards of care, not global comparators.
- Real-World Evidence (RWE): If the drug has been available in Hainan Boao Lecheng or the Greater Bay Area under early-access schemes, leverage local real-world outcomes to prove clinical value to the expert panel.
- Budget Impact Modeling: Construct models demonstrating that although the unit cost of the innovative drug is higher, it reduces overall hospital stay durations and downstream medical complications, preserving the social security fund's budget.
3. BD Asset Valuation and Exclusivity Modeling
For business development teams evaluating licensing deals (in-licensing or out-licensing China rights), the dual-track catalog numbers demand a sophisticated valuation model:
- Do Not Underwrite Early Access: Do not assume 2026 reimbursement in valuation models based on a drug passing preliminary review. Keep the probability of success (PoS) adjusted until the final negotiation results are published in late November. The reasoning mirrors coverage-eligibility logic at launch: a filing or listing is a gate to compete, not a guarantee of paid access.
- Model the Commercial Catalog Track: For orphan and cell-therapy assets, run parallel pricing models. Calculate the revenue potential of the Commercial Track (higher price, lower volume, limited regional coverage) versus the Basic NRDL Track (lower price, higher volume, national coverage).
- Incorporate the Data Protection Exclusivity Cliff: Cross-reference catalog entry timing with NMPA's data protection status. If a drug secures a 6-year reliance-based data protection block (under Announcement No. 47), the pricing strategy can afford to be more conservative during the first three years of launch.
China Dual-Track vs. US Medicare Drug Price Negotiations
As global payers implement direct price negotiations, biopharmaceutical manufacturers face parallel challenges in both China and the United States. While the legal systems differ, the underlying commercial pressures are remarkably similar.
The table below compares the key attributes of the China NHSA negotiation process with the US CMS Medicare Drug Price Negotiation Program (under the Inflation Reduction Act [IRA], focusing on the June 2026 IPAY 2029 proposed rule). For manufacturers operating in both markets, the two systems are best read together — the mechanics that follow the headline negotiated price in the US have direct conceptual parallels in China's multi-stage process.
| Strategic Dimension | China NHSA Negotiation Cycle | US CMS Medicare Negotiation (IRA IPAY 2029) |
|---|---|---|
| Negotiation Trigger | Voluntary manufacturer application (for new entry or renewal) | Mandatory selection by CMS based on high Medicare spend |
| Product Selection Scale | 800+ submissions; 600+ molecules eligible annually | Up to 20 selected drugs annually (Part B + Part D) |
| Pricing Floor/Ceiling | Determined by confidential expert pharmacoeconomic panels | Statutorily capped at a percentage of Non-FAMP |
| Formulary Access Guarantee | Mandatory inclusion in national catalog; provincial hospitals must still list the drug | Mandatory Part D formulary coverage; MFP defined as "negotiated price" |
| Alternative Access Pathways | Dual-track: Commercial Innovation Catalog for high-cost therapies | No formal dual-track; alternative commercial coverage depends on private insurers |
| Enforcement Penalty | Exclusion from public hospital market (effectively zero commercial volume) | 95% excise tax on sales or heavy civil monetary penalties |
The major strategic difference lies in the selection and application mechanism. The China NHSA system is voluntary and opportunity-driven—manufacturers choose to enter the negotiation process to unlock the massive volume of the public hospital market. In contrast, the US IRA system is mandatory and penalty-driven—the government selects the top-spend drugs, and manufacturers cannot opt out without withdrawing all products from Medicare and Medicaid.
However, both systems are rapidly closing loopholes. While CMS is proposing to aggregate reformulations (such as IV-to-subcutaneous transitions using hyaluronidase) to prevent lifecycle extension, the NHSA is utilizing its dual-track system to segment the market, steering standard therapeutics to the budget-capped NRDL and high-cost innovations to commercial insurance pools.
Frequently Asked Questions (FAQ)
Is a drug that passed preliminary review guaranteed to be reimbursed in 2026?
No. Passing the preliminary review only means the drug has met the administrative criteria to enter the next stages of the catalog adjustment cycle. The drug must still pass the expert panel review (which evaluates clinical and economic value) and the face-to-face price negotiations in October/November. Historically, only a portion of the drugs that pass the preliminary review make it into the final NRDL.
What is the difference between the basic medical insurance catalog and the commercial innovation drug catalog?
The basic medical insurance catalog (NRDL) is funded by the public social security fund, offers national coverage, and requires deep price discounts during negotiations. The commercial health insurance innovative drug catalog is funded by commercial health insurance and local government-backed Huiminbao policies. It is designed for high-cost innovative drugs (such as CAR-T therapies), offering access to reimbursement with more flexible pricing terms but narrower, region-specific volumes.
What happens between preliminary review and final catalog inclusion?
The catalog process follows three main steps after the preliminary review:
- Public Notice Verification (June 29 - July 5): The NHSA reviews public comments and publishes the final verified list of candidates.
- Expert Review (August–September): A panel of experts scores the drugs based on clinical value, safety, and pharmacoeconomics, setting a confidential target price.
- Negotiations (October–November): The NHSA and manufacturers hold face-to-face sessions. If a price agreement is reached, the drug is included in the final catalog, which is published in late November and takes effect on January 1, 2027.
How does the "115% rule" operate during the negotiation phase?
The "115% rule" is a procedural gate used during the face-to-face negotiation sessions. The NHSA calculates a confidential target price for each drug based on expert inputs. The manufacturer is allowed to submit up to two price bids. If the manufacturer's lowest bid is higher than 115% of the NHSA's confidential target price, the negotiation is immediately terminated, and the drug fails to enter the catalog. If the bid is within the 115% threshold, the negotiators will work to align the final price with the target price.
Can a drug have different indications listed in the NRDL and the Commercial Innovation catalog?
Yes. Because the two catalogs operate on different funding and pricing models, a manufacturer can choose to negotiate reimbursement for standard, high-volume indications under the basic NRDL while seeking coverage for specialized, high-cost indications (such as a rare-disease sub-population) under the Commercial Innovation catalog. This allows for targeted pricing strategies that protect the global value of the asset.
What role does the local Chinese manufacturer or licensee play in the negotiation strategy for in-licensed assets?
For global pharmaceutical companies that have licensed their China commercialization rights to a local partner, the local licensee is the entity that formally interfaces with the NHSA. The local partner must lead the dossier submission, participate in the face-to-face negotiation sessions, and manage local hospital listing. Therefore, the global innovator must establish clear communication channels and pricing boundaries with the local licensee well before the October negotiation phase to ensure global pricing corridors are not violated.
Sources
- National Healthcare Security Administration (NHSA). Public Notice on the Preliminary Formal Review Results of the 2026 National Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance Drug Catalog Adjustment. Published June 29, 2026. NHSA 2026 Preliminary Notice
- National Healthcare Security Administration (NHSA). Official Policy Interpretation of the 2026 Drug Catalog Preliminary Formal Review Results. Published June 29, 2026. NHSA 2026 Policy Interpretation
- Eastmoney. NHSA: 557 Drugs Pass 2026 Basic Medical Insurance Catalog Preliminary Review. Financial News & Policy Verbatim. Published June 29, 2026. Eastmoney Financial Reporting
- China Pharmaceutical Innovation Association (Phirda). Public Notice of Drugs Passing the 2026 Catalog Preliminary Formal Review and Accompanying Industry Roster. Published June 30, 2026. Phirda Industry Notice
- Shuimu CRO. Analysis of the 2026 NRDL Catalog Adjustment Work Plan and 818 Submission Metrics. Industry Briefing. Published June 2026. Shuimu CRO Briefing
- Centers for Medicare & Medicaid Services (CMS). Medicare Drug Price Negotiation. CMS Medicare Drug Price Negotiation
