Drug name
Last update: Aug 2026Retavibart (TNM-001) (mAb)
Developer(s)
Drug information
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Retabivart (TNM-001)
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Biotherapeutic
Monoclonal Antibody
Retavibart is a recombinant long-acting fully human monoclonal antibody against respiratory syncytial virus (RSV), specifically designed for infants under one year old (including high-risk groups prone to severe RSV infections). It is intended for the prevention of lower respiratory tract infections caused by RSV. Phase 3 clinical studies have demonstrated that, among infants under one year old entering the RSV epidemic season, Retavibart significantly reduces the incidence of RSV lower respiratory tract infections within 150 days after administration, with particularly outstanding preventive protection against severe RSV lower respiratory tract infections. A single intramuscular injection can provide coverage throughout the entire RSV epidemic season.
In Feb.2026, Trinomab announced that the New Drug Application (NDA) for its independently developed Retavibart Injection (formerly known as TNM001 Injection) has been accepted by China’s National Medical Products Administration (NMPA).
Pending
Therapeutic area(s)
- Respiratory syncytial virus (RSV)
- Prevention
Administration route
Intramuscular
Associated long-acting platforms
Monoclonal antibodies and antibody drug conjugates
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Once
Dosage
120mg
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Single dose to at risk infants under 1 year of age who are entering their first RSV season.
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Associated compounds, formulations and regimens
Not provided
Associated technologies
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Additional information
source: https://source.gbihealth.com.cn/news/detail?id=2057944&utm_source=official
Developer(s)
Trinomab
Zhuhai Trinomab Pharmaceutical Co., Ltd. is a global biopharmaceutical company established in 2015 and headquartered in Zhuhai, China. Focusing on R&D, production, and sales, their proprietary technology, HitmAb®, is a fourth-generation antibody platform for discovering fully human monoclonal antibodies against infectious diseases, autoimmune disorders, malignant tumors, and other human diseases.
Drug structure
Scale-up and manufacturing prospects
General manufacturing requirements and production scale-up for therapeutic monoclonal antibody (mAb) products is primarily focused on pharmacokinetic suitability, formulation stability and the overall maintenance of product quality. Industrial bioprocessing steps can also potentially introduce additional challenges regarding mAb formulation viscosity and aggregation propensity.
Industrial bioreactor vessel with a production volume capacity of between 5-25kL. Continuous disc stack centrifuges for bioreactor harvesting with subsequent membrane and depth filtration for supernatant clarification. Recombinant protein-A chromatography or other suitable affinity capture apparatus followed by two chromatographic polishing steps such as cation- and anion-exchange. Ultrafiltration membrane system to concentrate and formulate the final product.
MAbs are highly dependent on their structural, chemical and conformational stability for biological activity. Chemical degradation of mAbs during manufacture can lead to the generation of product variants and complex impurity profiles resulting from a wide range of processes, including: N-linked glycosylation, isomerisation, fragmentation, deamidation, oxidation and C-terminal lysine clipping. Additionally prior to packaging, the final product requires close monitoring for the presence of residual contaminants such as endotoxins and pro-inflammatory peptidoglycans.
Formulation characterisation steps for therapeutic mAb products include (but are not limited to): (1) Identification of post-translational modifications using ion-exchange chromatography and capillary isoelectric focusing, (2) Measurement of concentration dependent aggregation rates via thermal differential scanning calorimetry, sub-visible particle quantitation and size-exclusion chromatography, and (3) Antibody clipping and fragmentation detection by capillary electrophoresis.
Excipients & delivery device(s)
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No delivery device
Safety, Efficacy and Evidence Summary
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