Breaking: NHSA Releases Preliminary Review Results for 2025 National Reimbursement Drug List and Commercial Innovative Drug Catalog

China’s National Healthcare Security Administration (NHSA) has published the initial format review results for the 2025 adjustment of the National Reimbursement Drug List (NRDL) and the newly launched Commercial Health Insurance Innovative Drug Catalog. This milestone kicks off the substantive evaluation and negotiation process for expanding access to innovative therapies while balancing cost controls across China’s healthcare system.
(NHSA announcement, NHSA PDF list)

What Is the “Initial Format Review”?

The initial format review is the first screening step after companies submit applications for inclusion or renewal in the NRDL or commercial innovative drug catalog. Its main role is to verify that the submissions are complete and comply with formal documentation requirements.

• Passing this stage does not guarantee final inclusion; drugs must still undergo expert clinical and pharmacoeconomic evaluation, price negotiations, or competitive bidding.

Key Statistics and Trends for 2025

• Basic NRDL applications:
  • 718 total submissions covering 633 generic names.
  • 534 passed initial review, including 310 generic names outside the current directory (up from 249 in 2024).
• Commercial Innovative Drug Catalog:
  • 141 generic names submitted, with 121 passing initial review.

This increase in passing submissions indicates stronger industry engagement and a richer pipeline of innovative and rare disease therapies.

Eligibility and Declaration Criteria

• The NRDL’s directory-external drugs eligible for review include those approved between January 1, 2020 and June 30, 2025, covering new drugs, generics, expanded indications, pediatric and rare disease treatments, and national essential medicines.
• The commercial innovative drug catalog targets exclusive, high-value drugs, including biologics, advanced therapies, and orphan drugs.

Spotlight on Selected Drugs

The preliminary lists feature a wide range of therapies, reflecting China’s push for innovation across multiple domains:

Basic NRDL (directory-external examples)

• Ivosidenib Tablets (AML)
• Belzutifan Tablets (von Hippel-Lindau disease)
• Orelabrutinib Injection (oncology)
• Pediatric formulations such as Benzene Sulfonic Acid Amlodipine Oral Suspension
• Traditional Chinese Medicines like Danggui Buxue Tang Granules

Commercial Innovative Drug Catalog

• CAR-T therapies such as Axicabtagene Ciloleucel Injection
• Monoclonal antibodies like Adbelizumab Injection
• Enzyme replacement therapies for rare diseases (Idursulfase Beta Injection)
• Novel small molecules like Semaglutide Tablets (oral GLP-1 agonist)

What This Means for Pharma

• Opportunities:
  • The commercial innovative drug catalog offers a pathway for premium therapies to gain partial reimbursement coverage, complementing the NRDL’s public insurance system.
  • Rare disease and pediatric drugs continue to be policy priorities, attracting favorable review treatment.
• Challenges:
  • NHSA’s focus on affordability means companies should prepare for aggressive price negotiations. Prior NRDL inclusions have seen price cuts of 50-60%.
  • Drugs exceeding basic coverage scope face higher scrutiny and uncertain final outcomes.

Next Steps

• NHSA is inviting public feedback on the preliminary list before finalizing it.
• Following public comments, the process will proceed with expert evaluations, price negotiations (for NRDL), and price consultations (for the commercial innovative catalog).
• Final inclusion announcements are expected later this year, paving the way for 2026 reimbursement.

Sources:

• NHSA official release: nhsa.gov.cn
• Preliminary drug list PDF: download
• Commercial innovative drug catalog results: nhsa.gov.cn