By Fineline Cube 
The National Medical Products Administration (NMPA) announced that China approved 76 innovative drugs for marketing in 2025, a 58% surge from 2024’s 48 approvals and a new historical record. Concurrently, the total value of out‑licensing deals for Chinese innovative drugs surpassed USD 130 billion across 150+ transactions, nearly doubling from the previous year and also reaching an all‑time high.
Record‑Setting Performance
| Metric | 2025 | 2024 | Change |
|---|---|---|---|
| Innovative Drug Approvals | 76 | 48 | +58% |
| First‑in‑Class (FIC) Approvals | 11 | Not disclosed | Record high |
| Domestically Developed FIC | 4 | Not disclosed | Significant milestone |
| Out‑Licensing Value | >USD 130 billion | ~USD 65 billion | ~+100% |
| Transaction Count | 150+ | Not disclosed | Unprecedented volume |
Strategic Milestones
Innovation Pipeline Leadership
China’s pipeline of new drugs under development now accounts for ~30% of the global total, ranking second worldwide behind the United States. The 4 domestically developed first‑in‑class drugs approved in 2025 underscore China’s maturing R&D capabilities.
Global Licensing Surge
The USD 130+ billion in out‑licensing deals reflects strong global appetite for Chinese innovation:
- Average deal size: ~USD 867 million per transaction
- Key therapeutic areas: Oncology, immunology, rare diseases
- Major partners: Global pharma seeking China‑origin assets
Policy Catalyst
These achievements are the direct result of China’s continued deepening of drug review and approval reforms and implementation of innovation‑encouraging policies, including:
- Priority review pathways for breakthrough therapies
- Accelerated IND approval timelines (now 60 days for most drugs)
- Regulatory harmonization with ICH standards
Market Implications
Investment Surge: The record licensing values are expected to drive an additional ¥80‑100 billion in venture capital and corporate R&D investment in 2026.
Competitive Positioning: Chinese companies are now preferred partners for global co‑development, with out‑licensing deals growing 45% annually since 2022.
Revenue Transformation: Domestic innovators are projected to capture 25% of China’s pharmaceutical market (currently ¥1.8 trillion) by 2028, up from 15% in 2024.
Future Policy Measures
The NMPA stated that starting in 2026, it will introduce further measures to boost high‑speed development of innovative drugs, including:
- Expanded breakthrough therapy designation for rare diseases
- Conditional approval pathways for regenerative medicines
- Streamlined global multi‑center trial acceptance
- Enhanced IP protection for biologics and cell therapies
Forward‑Looking Statements
This brief contains forward‑looking statements regarding China’s drug approval volumes, out‑licensing market size, and policy impact. Actual results may differ due to regulatory changes, competitive dynamics, and global market conditions.-Fineline Info & Tech