By Fineline Cube The National Healthcare Security Administration (NHSA) has published the inaugural list of 31 innovative drugs eligible for China’s first-ever reference drug pre-communication initiative, as outlined in its February 2026 policy document. The program aims to establish early pricing and reimbursement dialogue with pharmaceutical companies ahead of formal National Reimbursement Drug List (NRDL) negotiations.
Program Framework
| Component | Details |
|---|---|
| Initiative | Reference Drug Pre-Communication Program |
| Administering Agency | National Healthcare Security Administration (NHSA) |
| First Batch Drugs | 31 Category 1 innovative medicines |
| Application Deadline | End of March 2026 |
| Implementation Timing | To be initiated “at an appropriate time” per NHSA guidance |
| Eligibility Criteria | Three conditions based on approval status and timeline |
Eligibility Conditions
Condition 1 (24 drugs)
- Approved for marketing by China’s national drug regulatory authority within five years (after January 1, 2021)
- Represents majority of submissions including products from Sanofi, GSK, Pfizer, Novartis, and Merck
Condition 2 (1 drug)
- Approved within five years with major changes in indications/functions
- Requires specific approval documents for such changes
- Only Emicizumab (Roche) qualifies under this category
Condition 3 (6 drugs)
- Not yet approved but marketing applications accepted and passed technical review
- Includes candidates from domestic innovators like Changshan ConjuChem, Hangzhou Aomo, and Innovent Biologics
Notable Submissions by Company
Multinational Pharmaceutical Companies
- Sanofi: Aficamten (Condition 1)
- Roche: Emicizumab (Condition 2)
- GSK: Depemokimab (Condition 1)
- Pfizer: Marstacimab (Condition 1)
- Novartis: Remibrutinib, Atrasentan (both Condition 1)
- Merck Serono: Pimicotinib (Condition 1)
- Boehringer Ingelheim: Nerandomilast, Zongertinib (both Condition 1)
Leading Chinese Biopharmaceutical Companies
- Innovent Biologics: Mazdutide (Condition 3), Picankibart (Condition 1)
- Chia Tai Tianqing: Culmerciclib, Rovadicitinib (both Condition 1)
- Suzhou Ascentage Pharma: Lisaftoclax (Condition 1)
- Jiangsu Hengrui: Zeprumetostat (Condition 1)
- Hangzhou Sciwind Biosciences: Ecnoglutide (Condition 1)
Strategic Implications
For Pharmaceutical Companies
- Early Engagement: Opportunity to influence pricing expectations before formal NRDL negotiations
- Market Access Acceleration: Potential for faster reimbursement decisions through proactive dialogue
- Competitive Positioning: First-mover advantage in establishing value propositions with payers
- Risk Mitigation: Reduced uncertainty around reimbursement timelines and pricing levels
For China’s Healthcare System
- Budget Impact Management: Enhanced ability to forecast and manage pharmaceutical expenditure
- Innovation Incentives: Structured pathway for premium pricing of truly innovative therapies
- Patient Access: Improved timeline predictability for accessing cutting-edge treatments
- International Alignment: Brings China closer to global health technology assessment practices
Market Context
- NRDL Significance: Inclusion in China’s National Reimbursement Drug List can increase sales by 300-500% within first year
- Pricing Pressure: Average price reductions of 50-60% in recent NRDL negotiations create need for early strategic planning
- Innovation Focus: All 31 drugs are Category 1 (first-in-class or best-in-class) innovations, reflecting NHSA’s priority on high-value therapies
- Domestic vs. International: Balanced representation demonstrates China’s dual commitment to supporting domestic innovation while maintaining access to global breakthroughs
Next Steps
The NHSA will initiate pre-communication sessions “at an appropriate time,” likely following internal prioritization based on clinical urgency, budget impact, and therapeutic area gaps. Companies should prepare comprehensive health economic dossiers and value-based pricing proposals.
Forward‑Looking Statements
This brief contains forward-looking statements regarding regulatory processes, market access strategies, and commercial expectations related to China’s reference drug pre-communication initiative. Actual outcomes may differ due to policy changes, competitive dynamics, and evolving healthcare priorities.-Fineline Info & Tech