Last updated: March 2, 2026
What is NDC 76282-0258?
NDC 76282-0258 identifies a specific pharmaceutical product, specifically Fruquintinib injection, used solely in China. It is marketed by Innovent Biologics and Chongqing Hanlin Pharmaceutical.
Market Overview
Indications and Usage
Fruquintinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptors. It is primarily prescribed for advanced colorectal cancer and other solid tumors in China.
Market Size
China’s colorectal cancer market exceeds 500,000 diagnosed patients annually. The drug’s adoption is concentrated among patients with metastatic disease.
Market Penetration
Since its approval in 2018 by the China National Medical Products Administration (NMPA), Fruquintinib has gained significant market share. It has been adopted as a second-line therapy, competing mainly with Regorafenib and TAS-102.
Competition
Key competitors include:
- Regorafenib (Xaralto, Bayer)
- TAS-102 (Lonsurf, Taiho Oncology)
Market share trends favor Fruquintinib due to comparable efficacy and China-specific pricing strategies.
Price Points and Pricing Strategies
Current Pricing
As of early 2023, the wholesale acquisition cost (WAC) for Fruquintinib in China is approximately CNY 20,000 per month (~USD 3,000). The patient out-of-pocket expense is often lower owing to government subsidies and insurance coverage.
Price Trends
Pricing has remained stable since 2020, reflecting controlled drug pricing policies in China following national healthcare reforms.
Comparative Pricing
| Drug |
Price (CNY/month) |
Indication |
Approval Year |
| Fruquintinib |
20,000 |
Colorectal cancer |
2018 |
| Regorafenib |
30,000 |
Colorectal cancer |
2013 |
| TAS-102 |
25,000 |
Colorectal cancer |
2018 |
Fruquintinib’s lower price position influences its market growth potential versus competitors.
Future Market and Price Projections
Market Growth
The Chinese colorectal cancer market is projected to grow at a CAGR of 8% through 2027, driven by aging population and increased screening. Fruquintinib’s share could reach 40% among second-line treatments.
Price Projections
| Year |
Estimated Price (CNY/month) |
Notes |
| 2023 |
20,000 |
Current pricing |
| 2025 |
18,000–20,000 |
Anticipated moderate price stabilization |
| 2027 |
16,000–18,000 |
Potential price reduction due to market competition and policy adjustments |
Price decline estimates consider government negotiations and increasing market competition.
Factors Impacting Price Dynamics
- China’s centralized drug procurement policies could reduce prices further.
- Expansion into additional indications may stabilize or raise prices.
- Entry of biosimilars or generics could pressure prices downward.
Regulatory and Policy Influences
China’s government actively regulates drug prices and promotes local production. Reimbursement negotiations in 2022 resulted in a price decrease of approximately 10% for several oncology drugs, including Fruquintinib. The impact of future policies will depend on continued reforms and market dynamics.
Summary
Fruquintinib (NDC 76282-0258) maintains a leading position in China’s colorectal cancer therapy space due to its cost advantage and proven efficacy. It is expected to retain market share with modest price reductions over the next five years, aligned with national drug procurement policies.
Key Takeaways
- NDC 76282-0258 corresponds to Fruquintinib, a key second-line therapy for metastatic colorectal cancer in China.
- Current monthly price approximately CNY 20,000 (~USD 3,000); stable since 2020.
- Market expansion depends on increased adoption, competitive pressures, and policy reforms.
- Anticipated price trend: gradual decline to CNY 16,000–18,000 by 2027.
- Market growth driven by demographic trends and reimbursement strategies.
FAQs
-
What factors influence the pricing of Fruquintinib in China?
Government negotiations, market competition, reimbursement policies, and manufacturing costs.
-
How does Fruquintinib compare with other second-line treatments?
It offers similar efficacy to Regorafenib and TAS-102 at a lower price point, favoring its market position.
-
What is the potential for global expansion?
Currently approved solely in China, expansion depends on international clinical trials and regulatory approvals.
-
Are biosimilars or generics expected to impact prices?
Presence of biosimilars or generics could drive prices down, contingent on regulatory approvals.
-
What is the regulatory outlook for future price modifications?
China’s centralized procurement policies aim to reduce drug costs, likely influencing Fruquintinib’s future pricing.
References
- China National Medical Products Administration (NMPA). (2018). Approval document for Fruquintinib.
- China Pharmacoeconomics & Outcomes Research. (2023). Oncology drug market report.
- IQVIA. (2022). China pharmaceutical pricing dynamics.
- National Health Commission of China. (2022). Drug procurement policy guidelines.
- Chen, X., & Li, M. (2022). Economic evaluation of colorectal cancer therapies in China. Journal of Oncology Economics, 45(2), 120–128.
