By Fineline Cube 
China’s National Medical Products Administration (NMPA) released the ninety-eighth batch of the Reference Listed Drugs (RLD) Catalog for chemical generics, adding 48 new drug specifications and supplementary information for 14 previously listed specifications, primarily involving additional Marketing Authorization Holders (MAHs).
Catalog Update Summary
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Batch Number | 98th RLD Catalog |
| Total Specifications | 62 drug specifications (or varieties) |
| New Entries | 48 specifications entering RLD Catalog for the first time |
| Supplementary Updates | 14 specifications (primarily adding MAHs) |
| Key Change | Expansion of MAH listings for existing reference drugs |
RLD Catalog Significance
- Generic Development Pathway: Inclusion in the RLD Catalog is a prerequisite for generic drug manufacturers to conduct bioequivalence studies and file abbreviated new drug applications (ANDAs) in China.
- Market Access Impact: The 48 new specifications unlock the pathway for dozens of generic competitors, potentially reducing drug prices by 30‑70% upon market entry.
- MAH Flexibility: Adding MAHs to existing entries (14 specifications) allows multiple manufacturers to reference the same innovator product, fostering competition and supply chain resilience.
Market Context & Outlook
| Drug Category | Estimated Number of New Generics Enabled | Market Size (2024) | Potential Price Reduction |
|---|---|---|---|
| Cardiovascular | 12 specifications | ¥8.5 billion (US$1.2 billion) | 40‑60% |
| Anti‑infectives | 15 specifications | ¥6.2 billion (US$850 million) | 35‑55% |
| CNS agents | 8 specifications | ¥4.1 billion (US$560 million) | 30‑50% |
| Metabolic/Endocrine | 13 specifications | ¥5.8 billion (US$790 million) | 45‑65% |
- Volume‑Based Procurement (VBP): New RLD entries will likely be included in future national VBP rounds, accelerating generic substitution and hospital adoption.
- Timeline: Generic manufacturers typically require 12‑18 months to complete BE studies and secure NMPA approval; first generics could launch by H2 2027.
- Revenue Impact: The 48 new specifications represent >¥25 billion (US$3.4 billion) in originator sales at risk of generic erosion by 2028.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the timing of generic launches, market share erosion, and VBP inclusion. Actual results may differ due to regulatory review timelines, manufacturer development capacity, and policy changes.-Fineline Info & Tech