On February 9, the CDE website indicated that Trinmab’s Retavibart (TNM001) has been submitted for marketing approval for the prevention of lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in infants up to one year of age, including those at high risk for severe RSV infection. This is the second domestic RSV antibody to be considered for priority review, following Ruiyang Pharmaceutical’s Clesrovimab, which was granted priority review just last month.

Retavibart is a fully human monoclonal antibody that targets a highly conserved epitope on the pre-fusion (Pre-F) conformation of the RSV F protein, a differentiating feature compared to other known RSV antibodies.

In November 2025, Trinmab presented data from the Phase IIb TNM001-301 study evaluating Retavibart for the prevention of RSV-LRTI in infants at the IDWeek conference. Results showed a 66.2% reduction in the incidence of medically attended RSV-LRTI within 150 days after a single intramuscular injection, along with a significant 82.3% reduction in hospitalization rates. The TNM001-301 study includes Phase IIb and Phase III stages, with the Phase III portion having enrolled 1,500 subjects. Additionally, Trinmab is conducting another Phase III study to evaluate the efficacy and safety of Retavibart in high-risk infant populations.

RSV is one of the most common pathogens causing respiratory tract infections in children under five years old worldwide, posing a serious threat to children’s health. It is estimated that in 2019, RSV-associated acute LRTI (ALRTI) globally resulted in approximately 33 million episodes, 3.6 million hospitalizations, and 26,300 in-hospital deaths among children under five, with an estimated total of 101,400 attributable deaths from RSV.