Drug name
Last update: Apr 2026Retavibart (TNM-001) (mAb)
Developer(s)
Drug information
Not provided
Retabivart (TNM-001)
Not provided
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
Not provided
Dosage
investigated doses are not disclosed
Not provided
Single dose to at risk infants under 1 year of age who are entering their first RSV season.
Not provided
Not provided
Associated technologies
Not provided
Comment & Information
Developer(s)
Zhuhai Trinomab Pharmaceutical Co., Ltd.
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
Not provided
Not provided
Not provided
Delivery device(s)
No delivery device
Retavibart (TNM-001) antibody compound and CDRs
The present disclosure relates to a respiratory syncytial virus (RSV)-specific binding molecule and an application thereof. Further provided in the present disclosure are a method for preparing the molecule, and an application of the molecule in the preparation of a product that specifically binds to an RSV surface glycoprotein fusion protein and in the preparation of an RSV vaccine, and other such aspects.
WO2022127793
Compound
Zhuhai Trinomab Biotechnology Co Ltd
Not provided
December 14, 2041
Granted: AU, BR, CN, JP Filed: CN, EP, JP, US
Publications
Li Y, Tian D, Pan L, et al. Efficacy and Safety of Retavibart, a Long-acting Monoclonal Antibody, for the Prevention of Respiratory Syncytial Virus-Induced Lower Respiratory Tract Infection: A Phase 2b Trial in Infants Entering Their First Epidemic Season. Open Forum Infect Dis. 2026;13(Suppl 1):ofaf695.169. Published 2026 Jan 11. doi:10.1093/ofid/ofaf695.169
Background
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection in young children. Retavibart (formerly known as TNM001) is a recombinant human monoclonal antibody (mAb) targeting the prefusion protein of RSV.
Methods
This was a randomized, double-blind, placebo-controlled phase 2b trial. Eligible participants included term and preterm infants, with or without congenital heart disease (CHD) or chronic lung disease (CLD) of prematurity, who were entering their first RSV season. Participants were randomized in a 2:1 ratio to receive a single intramuscular injection of retavibart 120 mg or placebo. Efficacy endpoints included incidence of medically attended lower respiratory tract infection (MALRTI) and hospitalization due to RT-PCR confirmed RSV infection through Day 151. Safety assessments included the collection of adverse events (AEs) and serious adverse events (SAEs) and monitoring of vital signs within 240 days post-dose.
Results
A total of 760 participants were randomized and 751 received treatment: 500 received retavibart and 251 received placebo. The median age of participants was 2.50 months (range: 0-8.1 months) with a slight male predominance. Ninety-two participants were classified as high-risk, including 65 healthy preterm infants (gestation age < 35 weeks) and 28 with CHD. No infants with CLD were enrolled.
Retavibart reduced the incidence of MALRTI by 66.2% (95% CI: 41.5, 80.5) and RSV-related hospitalization by 82.3% (95% CI: 57.6, 92.6) compared to placebo. Greater efficacy was observed in the high-risk population. In this subgroup, the reduction in RSV-related MALRTIs and hospitalization reached 91.1% and 93.5%, respectively.
The incidences of any AEs and SAEs were comparable between the two groups. No participants died or were early withdrawn from the trial due to AE.
Conclusion
A single dose injection of retavibart 120 mg was well tolerated and had a safety profile comparable to that of placebo. Retavibart showed effective protection against RSV infection in infants during their first season. This was the first clinical trial that compared a long-acting anti-RSV mAb with placebo in the high-risk population. Results showed that retavibart had greater efficacy in this population.
Additional documents
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