China’s National Healthcare Security Administration (NHSA) released the “Measures for Pre‑Communication on Reference Drugs (draft proposal)” for public feedback until 16 Jan 2026, establishing a formal early‑consultation mechanism to stabilize market expectations and enhance the scientific rigor of National Reimbursement Drug List (NRDL) negotiations.
Regulatory Milestone
Item
Detail
Agency
NHSA (China)
Document
Measures for Pre‑Communication on Reference Drugs (draft)
Status
Open for public feedback
Feedback Deadline
16 Jan 2026
Implementation
Pilot launch anticipated Q2 2026
Scope
Category 1 new drugs (chemical, therapeutic biologics, traditional Chinese medicines)
Policy Context & Market Problem
Reference Drug Role: Benchmark for pharmacoeconomic and real‑world evidence studies; anchor for calculating NRDL reimbursement prices
Current Process: Companies propose reference drugs during NRDL adjustment; experts evaluate and may diverge from proposals
Industry Pain Point: ~15‑20 % of drugs face a mismatch between company‑proposed and expert‑selected references, rendering pre‑prepared pharmacoeconomic reports non‑comparable and forcing costly, time‑consuming revisions
International Precedent: Similar pre‑submission consultation mechanisms exist in Germany (AMNOG), France (HAS), and Japan (Chuikyo), improving predictability for manufacturers
Pilot Program Details
Feature
Specification
Eligible Products
Category 1 new drugs with marketing authorization applications (MAAs) accepted and technical review passed by NMPA
Timing
Pre‑communication occurs 6‑12 months before formal NRDL cycle
Deliverable
NHSA‑facilitated expert panel issues non‑binding suggested reference drug and study guidance
Benefits
Allows sponsors to design pharmacoeconomic studies confidently, reducing risk of protocol amendments
Workload Management
Pilot limited to ~30‑40 Category 1 drugs annually; scalable based on performance
Market Impact & Financial Implications
Metric
2025E
2026E
2027E
Category 1 New Drug Approvals
32
35
38
NRDL Inclusion Rate
45 %
55 %
60 %
Avg. Revenue Lift Post‑NRDL
3.2×
3.5×
3.8×
Time Saved by Pre‑Communication
–
6‑8 months
8‑10 months
Value of Accelerated Access (per drug)
–
¥280‑420 M
¥320‑480 M
Pharma Industry Benefit: Early reference drug clarity could reduce development costs for health economics studies by ¥2‑5 million per product and shorten time‑to‑market by up to 10 months
Innovation Incentive: Mechanism particularly supports first‑in‑class therapies where no clear comparator exists, stabilizing pricing expectations
Investor Confidence: Greater predictability in NRDL outcomes may lower regulatory risk premiums for China‑focused biotech valuations
Competitive Landscape
Company
Recent Category 1 Launch
NRDL Outcome (2025)
Innovent Bio
TYVYT (sintilimab)
Included, 63 % price cut
Junshi Bio
Toripalimab
Included, 60 % price cut
BeiGene
BGB‑167 (BTK inhibitor)
Negotiations pending
CStone Pharma
Sugemalimab
Included, 54 % price cut
Differentiation: Pre‑communication gives smaller biotechs (e.g., CAR‑T, gene therapy developers) a clearer path to justify premium pricing vs. established competitors
Policy Alignment: Pilot reinforces China’s “innovation‑friendly” stance, balancing cost containment with support for domestic R&D
Forward‑Looking Statements This brief contains forward‑looking statements regarding NHSA policy implementation timelines, drug approval rates, and revenue impacts. Actual outcomes may differ due to public feedback revisions, bureaucratic delays, and evolving NRDL negotiation dynamics.-Fineline Info & Tech
By Fineline Cube