ATLANTA – From October 19 to 22, 2025, IDWeek – a premier global infectious disease conference jointly organized by leading international professional associations – took place in Atlanta, USA. The event convened top experts to share the latest advances in research and clinical practice.
Among the highlights, Zhuhai Trinomab Pharmaceutical Co., Ltd. (“Trinomab”), an innovative biopharmaceutical company from China, showcased two key assets: TNM001, a novel recombinant fully human monoclonal antibody targeting respiratory syncytial virus (RSV), and siltartoxatug (Sintetol ®) that already obtained marketing approval for tetanus prevention in Feb., 2025. TNM001 was featured in an oral presentation revealing its phase 2b clinical results. The high-quality data garnered broad interest from the international scientific community, underscoring a major milestone for China’s homegrown biopharmaceutical innovation on the global stage.
Dr. Daiyin TIAN, a representative of the team of investigators responsible for the TNM001 phase 2b trial (professor at the Chongqing Medical University Children’s Hospital), presented the results of trial at IDWeek.
The phase IIb trial enrolled 751 infants including healthy and high‑risk infants who were entering their first RSV season. Results demonstrated that a single intramuscular dose of TNM001 provided significant clinical protection throughout the typical five-month RSV epidemic. Compared to placebo, TNM001 reduced the incidence of medically attended RSV-associated lower respiratory tract infections (LRTIs) by 66.2% (95% CI: 41.5–80.5) and lowered hospitalization rates by 82.3% (95% CI: 57.6–92.6). These findings indicate that a single dose of TNM001 can confer long enough protection across the entire RSV epidemic season. The antibody was well-tolerated, with a safety profile comparable to placebo.
TNM001 exhibits significant innovative advantages underpinned by its unique mechanism of action. Developed by using Trinomab’s proprietary HitmAb® platform, it is a fully human monoclonal antibody that specifically binds to a highly conserved epitope on the pre-fusion (Pre-F) conformation of the RSV F protein – a site distinct from those targeted by other known anti-RSV monoclonal antibodies. This distinctive targeting strategy underscores the molecule’s originality and proprietary nature, positioning it as a promising candidate with the strong potential to deliver clinical benefits in preventing RSV-associated LRTIs.
Extensive preclinical and clinical data support TNM001 as a promising candidate to address the unmet need in RSV prevention. Its ongoing development aims to provide China and the global community with a next-generation prophylactic option, with the potential to significantly reduce the worldwide burden of RSV-associated disease.
RSV is a leading cause of seasonal LRTIs in infants and young children and a major contributor to virus-related neonatal mortality. Epidemiological studies indicate that susceptibility peaks between 1 and 6 months of age, and most children experience RSV infection within 2 years of age. While primary infection often manifests mild symptoms such as cough, fever, and wheezing, severe cases can progress to respiratory distress, marked by pronounced cough, dyspnea, intercostal and subcostal retractions, and chest hyperinflation. In critical instances, the disease may lead to lethargy and respiratory failure, posing serious threats to survival and long-term pulmonary health. These realities underscore the persistent and urgent global need for effective prophylactic interventions against RSV.
“We are honored to present the phase 2b clinical data for TNM001 Injection at IDWeek, a top-tier global forum in infectious disease. This not only marks the international debut of China’s biopharmaceutical innovation capabilities but also represents a pivotal milestone in introducing a novel RSV prevention strategy to the global community. Moving forward, Trinomab will accelerate commercialization efforts while actively expanding our global footprint and exploring the full therapeutic potential of our pipeline. Rooted in proprietary innovation, we remain committed to delivering a high-value ‘Chinese Solution’ for RSV prevention and control, with the goal of improving health outcomes for infants worldwide.”
(Sintetol Trademark Registration Number: 74174546)
