By Fineline Cube 
The National Health Commission (NHC) released the Fourth Batch of the National Catalogue of Encouraged Generic Drugs, comprising 21 drug varieties and 47 specifications. The catalogue focuses on four strategic priorities: innovative mechanisms, international guideline alignment, pro‑fertility formulations, and rare disease access.
Catalogue Summary
| Item | Detail |
|---|---|
| Issuing Authority | National Health Commission (NHC) |
| Catalogue | Fourth Batch, National Encouraged Generic Drugs |
| Release Date | 04 Jan 2026 |
| Scope | 21 drug varieties, 47 specifications |
| Strategic Focus | Clinical gaps, innovation, fertility support, accessibility |
Four Prioritization Strategies
1. Innovative Mechanisms & Radiopharmaceuticals
- Difelikefalin: First‑in‑class kappa opioid receptor agonist for moderate‑to‑severe pruritus in hemodialysis patients (significant unmet need in CKD)
- Four Radiopharmaceuticals: Covering therapeutic, diagnostic, and localization applications—not yet marketed in China
- Market Gap: Addresses domestic R&D weaknesses in novel targets; positions China to capture ¥8‑12 billion radiopharmaceutical market by 2030
2. International Guideline‑Aligned Therapies
- Suvorexant: Dual orexin receptor antagonist for insomnia, addressing sleep onset/maintenance with reduced daytime sleepiness vs. benzodiazepines
- Strategic Value: Supplements limited domestic options; aligns with WHO and AASM guidelines; estimated ¥2‑3 billion market potential in China
3. Pro‑Fertility Formulations
- Progesterone Vaginal Sustained‑Release Gel/Suppository: Used in IVF‑ET cycles
- Advantage: Eliminates injection‑site reactions (redness, induration, panniculitis) from oil‑based injections; improves patient compliance
- Policy Synergy: Directly supports China’s pro‑fertility initiatives; addresses side‑effect barriers in 3‑4 million annual IVF cycles
4. Rare Disease Accessibility
- Deflazacort: Glucocorticoid for Duchenne Muscular Dystrophy (DMD), a rare pediatric disease
- Market Need: Estimated 6,000‑8,000 DMD patients in China; limited treatment options beyond corticosteroids
- Reimbursement Pathway: Catalogue inclusion facilitates 2026‑2027 NRDL negotiation under rare disease provisions
Market Implications
Innovation Incentive: The catalogue signals ¥50‑80 billion in additional R&D investment over three years, focusing on oncology, rare diseases, and advanced therapeutics.
Industry Transformation: Accelerates shift from “imitation” to “innovation”, strengthening domestic pharmaceutical competitiveness.
Manufacturing Priorities: Companies with capabilities in complex generics, radiopharmaceuticals, and novel delivery systems (e.g., vaginal sustained‑release) will gain procurement advantages.
Patient Access: Shortens time‑to‑market for high‑value generics by 12‑18 months, improving affordability and clinical options.
Forward‑Looking Statements
This brief contains forward‑looking assessments regarding market size, investment flows, and policy impact resulting from the Fourth Batch catalogue. Actual outcomes may differ due to implementation details, competitive responses, and reimbursement negotiations.-Fineline Info & Tech