China’s Drug Catalog Reform Creates New Pathways for Innovative Therapies

China’s drug catalog reform creates new pathways for innovative therapies as the healthcare reimbursement landscape undergoes further adjustments. On June 16, 2025, the National Healthcare Security Administration (NHSA) initiated consultations on the adjustment of the National Basic Medical Insurance Drug List and the launch of the first Commercial Health Insurance Innovative Drug List, a dual-catalog system poised to change market access for innovative therapies.

Policy Shift: Dual Catalogs for Broader Coverage

The reform introduces a complementary access mechanism:

The Basic Medical Insurance Catalog continues to cover essential therapies.
The new Commercial Insurance Catalog targets high-value, high-cost innovative drugs that are currently excluded from public reimbursement.

Drugs eligible for the commercial catalog must:

Demonstrate high innovation and clinical value.
Offer significant patient benefit.
Be excluded from the basic catalog due to cost or positioning.

Two categories are prioritized:

New chemical entities approved between Jan 1, 2020 and the plan’s release.
Rare disease therapies approved prior to the announcement.

This framework enables premium pricing and multi-tiered reimbursement, offering manufacturers a strategic alternative to traditional NHSA negotiations.

Regulatory Pathway: What Overseas Manufacturers Need to Know

To access China’s commercial insurance catalog, overseas manufacturers must:

Appoint a qualified local legal entity with risk and quality management capabilities.
Provide marketing authorization from the country of origin OR secure special NMPA validation.
Submit a non-infringement patent declaration for China.

The registration process includes:

IND submission to NMPA
Clinical trials (Phases I-III)
NDA filing with comprehensive quality and safety data
Technical review and approval by NMPA

Priority review pathways are available for rare disease drugs and therapies with urgent clinical need, with timelines as short as three months.

Pipeline Spotlight: Likely Candidates for Inclusion

The following therapies are strong contenders for the first commercial catalog:

CAR-T cell therapies: e.g. Carteyva® (倍诺达, relma-cel), Yikaida® (奕凯达, axi-cel), etc., already included in Huimin Insurance (urban customized commercial health insurance).
PD-(L)1 inhibitors: including imported products Opdivo® (nivolumab), Keytruda® (pembrolizumab), Tecentriq® (atezolizumab), IMFINZI® (英飞凡, durvalumab); China domestically developed Hansizhuang® (汉斯状, serplulimab), Annike® (安尼可, penpulimab), and Airuili® (艾瑞利, adebrelimab).
11 innovative drugs approved by NMPA on May 29: spanning oncology, metabolic diseases, and chemotherapy supportive treatment, including:
- Famitinib Malate Capsules (Jiangsu Hengrui Pharmaceuticals): Multi-target tyrosine kinase inhibitor for tumors.
- Suzhou Zelgen Biopharmaceuticals’ gimigatinib hydrochloride tablets, the first domestically developed JAK/ACVR1 dual inhibitor for myelofibrosis.

Market Outlook: Commercial Insurance as a Growth Lever

China’s commercial insurance currently accounts for just 3.3% of total health expenditures, despite the healthcare industry targeting a ¥16 trillion scale by 2030. With out-of-pocket payments at 27%, significantly above the OECD average of ~20%, the commercial catalog offers a scalable solution to relieve public funding pressure and expand access.

This imbalance between innovation and reimbursement is particularly striking. China has become the world’s second-largest biopharmaceutical innovation hub, contributing over 30% of the global drug development pipeline. Yet, its share of global drug sales remains just 3-5%, underscoring the disconnect between R&D output and commercial uptake.

The current insurance infrastructure reflects this gap. While the health industry is projected to reach ¥16 trillion, commercial insurance coverage remains below ¥900 billion, with pure health insurance at ~¥200 billion and public welfare insurance generating less than ¥20 billion. This disparity highlights the untapped potential for commercial insurance to play a more strategic role in funding innovative therapies.

Recent pilot programs in Shanghai and Guangzhou have demonstrated successful integration of commercial and public insurance systems, enabling instant compensation and one-stop settlement across multiple hospitals.

Policy signals from National Healthcare Security Administration (NHSA) suggest further flexibility:

Relaxation of self-pay rate assessments.
Exemption from centralized procurement and DRG/DIP constraints.
Greater autonomy for hospitals in prescribing based on clinical need.

Together, these developments point to a transformative moment for market access in China. The commercial drug catalog could become a key lever for expanding reimbursement, accelerating uptake of innovative therapies, and unlocking new growth for international manufacturers.

References

Further Information

To read the official announcement about the consultations on the adjustment of the National Basic Medical Insurance Drug List and the launch of the first Commercial Health Insurance Innovative Drug List issued by the National Healthcare Security Administration (NHSA) on June 16, 2025, please click here.

If you are an international pharmaceutical manufacturer with questions about product registration or reimbursement access under China’s new 2025 drug catalog reform, please contact Cisema.