By Fineline Cube 
Zhuhai Trinomab Biopharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for Retavibart Injection (formerly TNM001 Injection), a recombinant long‑acting fully human monoclonal antibody targeting respiratory syncytial virus (RSV). The product is specifically designed for infants under one year old, including high‑risk populations prone to severe RSV infections, for the prevention of lower respiratory tract infections caused by the virus.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Zhuhai Trinomab Biopharmaceutical Co., Ltd. |
| Product | Retavibart Injection (formerly TNM001 Injection) |
| Regulatory Action | NDA accepted by NMPA |
| Application Date | 13 Feb 2026 |
| Drug Class | Recombinant long‑acting fully human anti‑RSV monoclonal antibody |
| Target Population | Infants under 1 year old (including high‑risk groups) |
| Indication | Prevention of RSV lower respiratory tract infections |
| Administration | Single intramuscular injection |
Clinical Evidence – Phase III Study
| Endpoint | Retavibart Result | Clinical Significance |
|---|---|---|
| Primary Efficacy | Significant reduction in RSV lower respiratory tract infections within 150 days | Demonstrates robust seasonal protection |
| Severe Disease Prevention | Particularly outstanding protection against severe RSV lower respiratory tract infections | Addresses highest unmet medical need in infant population |
| Duration of Protection | Full RSV epidemic season coverage from single dose | Eliminates need for repeat dosing during season |
| Administration Convenience | Single intramuscular injection | Aligns with infant care workflows and compliance needs |
Product Profile – Retavibart
- Mechanism: Long‑acting fully human anti‑RSV monoclonal antibody providing passive immunization
- Target: Respiratory syncytial virus (RSV) – leading cause of infant hospitalization globally
- Differentiation: Single‑dose seasonal protection vs. multi‑dose regimens or monthly injections required by competing products
- Clinical Convenience: One intramuscular injection covers entire RSV epidemic season, reducing healthcare burden and improving parental compliance
Market Impact & Outlook
- China RSV Prevention Market: RSV is the leading cause of lower respiratory tract infections in infants under one year, with significant hospitalization burden. Current prevention options in China are limited, creating substantial market opportunity.
- Competitive Positioning: Retavibart’s long‑acting profile and single‑dose convenience differentiate it from existing monoclonal antibody therapies requiring monthly administration, potentially capturing significant market share upon approval.
- Public Health Value: The product addresses a critical pediatric unmet need, with potential for inclusion in national immunization programs or seasonal prophylaxis guidelines for high‑risk infants.
- Pipeline Validation: NDA acceptance validates Trinomab’s independent R&D capabilities and positions the company as an emerging player in the infectious disease biologics space.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding NMPA review timelines, approval expectations, and commercial potential for Retavibart. Actual results may differ due to risks including regulatory review outcomes, manufacturing scale‑up, and competitive market dynamics.-Fineline Info & Tech