Ryzneuta® Highlights the 14× China–U.S. Drug Pricing Gap
Ryzneuta® (efbemalenograstim alfa) highlights a 13–14× U.S.–China pricing gap, illustrating the challenges and opportunities for Chinese biologics in global markets.
Yifan Pharmaceutical’s efbemalenograstim alfa—marketed as Ryzneuta® in the U.S. and Yilishu in China—offers a striking example of cross-border drug pricing disparity.
Approved by the China NMPA in May 2023 as the first third-generation long-acting granulocyte colony-stimulating factor (G-CSF) for reducing chemotherapy-induced neutropenia (CIN), Ryzneuta received FDA approval in November 2023. It launched in the U.S. at an estimated $4,600 per 20 mg vial (≈ RMB 33,000). In China, the NRDL-negotiated price is RMB 2,388 per vial, creating a 13–14× U.S. premium.
Drug Profile and Clinical Advantages
Ryzneuta is a recombinant human G-CSF-Fc fusion protein produced in CHO cells, featuring a dimeric Fc-fusion design to enhance receptor binding without PEGylation—reducing potential immunogenicity compared with second-generation PEGylated G-CSFs like pegfilgrastim (Neulasta).
Key advantages:
- Efficacy: Phase III trials demonstrated non-inferiority to pegfilgrastim and superior protection against grade 3-4 neutropenia in later chemotherapy cycles.
- Safety: Lower incidence of bone pain and musculoskeletal adverse events compared with filgrastim; discontinuation <6%.
- Convenience: Once-per-cycle SC injection, 24–48 h post-chemotherapy; EU approval for self-injection; shorter dosing intervals under study in Japan.
Ryzneuta has now entered 34 countries/regions, with U.S. commercialization via Acrotech Biopharma.
Pricing Disparities: U.S. vs. China
- United States: $4,600 per 20 mg vial, competitively below Amgen’s Neulasta (~$6,418), yet maintaining a premium margin.
- China: NRDL-negotiated price of RMB 2,388 per vial, reflecting domestic procurement pressures and competition.
The 13–14× price differential exemplifies structural differences between markets: China emphasizes volume-based procurement and accessibility, whereas the U.S. relies on innovation premiums, payer negotiations, and patent protection.
Comparative G-CSF Landscape
| Product | U.S. Price | China Price | Notes |
|---|---|---|---|
| Ryzneuta® (efbemalenograstim alfa) | $4,600 | RMB 2,388 | Third-gen long-acting G-CSF, China-developed |
| Pegfilgrastim (Neulasta®) | ~$6,327 | Limited availability | Second-gen PEGylated G-CSF |
| Tbo-filgrastim (Granix®) | ~$3,382 | Not widely available | Shorter-acting biosimilar/analogue |
| Filgrastim (Neupogen®) | ~$1,000 | ~RMB 300–500 | First-generation G-CSF, widely used |
These differences highlight global pricing dynamics and the opportunities for Chinese-origin biologics to achieve high U.S. margins.
Why the Gap Exists
- China: Centralized volume-based procurement and NRDL negotiations push prices low to expand patient access. Domestic market is highly competitive—nine long-acting G-CSFs battle for share, with leaders like Hengrui, Qilu, and CSPC.
- U.S.: Market rewards innovation premiums, with list prices shaped by patent protection, limited price controls, and payer negotiations. Ryzneuta undercuts Amgen’s Neulasta (~$6,418) by ~28% yet retains high-margin status.
This pattern mirrors other Chinese outbound drugs:
- BeiGene’s zanubrutinib — ~10× U.S. premium
- Junshi’s toripalimab — ~33×
- Hutchmed’s fruquintinib — > 20×
Business Implications for Yifan and Chinese Biotech
- Revenue upside: The U.S. market premium demonstrates strong ROI potential for out-licensed Chinese biologics.
- Strategic levers: Self-injection devices, real-world evidence, and EU/EMEA expansion can further boost adoption.
- Challenges: Navigating U.S. reimbursement, payer negotiations, and competition from established products remains critical.
Yifan’s H1 2025 report shows rapid adoption: over 220,000 Ryzneuta doses shipped globally, overseas revenue +6.5% to RMB 332 million. Domestic NRDL inclusion accelerated China sales (~RMB 640 million in 2024).
Ryzneuta exemplifies China’s transition from domestic generics to global innovative biologics, but bridging the U.S.–China pricing gap will require careful commercial and policy strategies.
Sources
- Zhou Y, et al. A randomized, multicenter Phase III study of once-per-cycle administration of efbemalenograstim alfa in breast cancer patients receiving myelosuppressive chemotherapy. BMC Cancer. 2024;24:12892. Available at: https://bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12892-5
- Evive Biotech. China Launch of Ryzneuta®. Evive Biotech News. 2023. Available at: https://www.evivebiotech.com/en/newsd/index?id=54
- U.S. Food and Drug Administration. Drug Trials Snapshots: Ryzneuta® (efbemalenograstim alfa). FDA. 2023. Available at: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-ryzneuta
- ResearchGate. Zhou Y, et al. Efbemalenograstim alfa, an Fc-fusion protein long-acting granulocyte-colony stimulating factor for reducing febrile neutropenia following chemotherapy: Results of a Phase III trial. 2024. Available at: https://www.researchgate.net/publication/376585151_Efbemalenograstim_alfa_an_Fc_fusion_protein_long-acting_granulocyte-colony_stimulating_factor_for_reducing_the_risk_of_febrile_neutropenia_following_chemotherapy_results_of_a_phase_III_trial
- BioWorld. China NMPA approves 40 innovative new drugs in 2023. 2023. Available at: https://www.bioworld.com/articles/706159-china-nmpa-approves-40-innovative-new-drugs-in-2023
- MedChemExpress. Efbemalenograstim alfa profile. 2023. Available at: https://www.medchemexpress.com/efbemalenograstim-alfa.html
- GoodRx. Pegfilgrastim (Neulasta®) U.S. pricing. 2023. Available at: https://www.goodrx.com/neulasta
- OncPracticeManagement.com. FDA Approved Ryzneuta®: A Novel G-CSF for Prevention and Treatment of Chemotherapy-Induced Febrile Neutropenia. 2024. Available at: https://oncpracticemanagement.com/issues/2024/february-2024-vol-14-no-2/fda-approved-ryzneuta-a-novel-g-csf-for-prevention-and-treatment-of-chemotherapy-induced-febrile-neutropenia
- Hematology Advisor. Ryzneuta approved for chemotherapy-induced neutropenia. 2024. Available at: https://www.hematologyadvisor.com/news/ryzneuta-approved-for-chemotherapy-induced-neutropenia/