The RSV Threat · Prevention in Urgent Need
RSV is the leading viral cause of LRTI in children under five and is highly contagious. Chinese data show that approximately 60% of infections occur in infants under one year of age. High-risk infants — including those born before 35 weeks of gestation and those with congenital heart disease (CHD), chronic lung disease of prematurity (CLD), or immunosuppression — face significantly elevated hospitalization rates after infection, placing a heavy disease burden on families and healthcare systems.Four Key Advantages · A New RSV Solution
Xinduotuo was developed on Trinomab’s proprietary high-throughput fully human monoclonal antibody discovery platform, HitmAb. Its antibody molecules are screened entirely from naturally occurring human immune cells, delivering four distinct advantages:One Injection, Season-Long Protection
A single dose provides continuous protection for up to 270 days (9 months) — a substantial improvement over the approximately 150 days (nearly 5 months) offered by comparable products on the market. One injection covers a complete RSV season and delivers meaningful clinical benefit even in regions without a distinct season, where RSV circulates year-round. With no booster needed, babies are spared the distress of repeated injections, giving families a more convenient and reassuring experience.
Favorable Safety for All Neonates and Infants Under 12 Months
As a recombinant fully human monoclonal antibody with human-derived sequences, Xinduotuo minimizes immunogenicity risk. It is suitable for all neonates and infants under 12 months of age — including full-term babies and high-risk infants such as those born before 35 weeks of gestation, or those with CHD, CLD (also known as bronchopulmonary dysplasia, BPD), or immunosuppression.
Stronger Protection with Excellent Clinical Efficacy
Phase III clinical results showed that a single intramuscular injection (recommended at the anterolateral thigh) significantly reduced the risk of RSV-associated LRTI in healthy full-term and late preterm infants, with outstanding preventive protection against severe RSV-associated LRTI.
Fixed Dose for Simple, Efficient Administration
Xinduotuo is supplied in a single fixed dose of 120 mg, requiring no weight-based adjustment — one vial for all infants, making administration simple and convenient.
Xinduotuo is Trinomab’s second self-developed innovative drug to reach commercialization, following its anti-tetanus monoclonal antibody Xintituo. From target discovery and antibody screening to process development, clinical trials and commercial manufacturing, Trinomab controls the entire value chain in-house — a testament to its strength in source innovation and full-chain integration. This approval is not only a vivid illustration of China’s source-driven biopharmaceutical innovation, but also a “China solution” contributing to global RSV prevention.
Medicilon’s Antibody Preclinical Platform · Sustaining Breakthroughs in Antibody Source Innovation
Throughout Xinduotuo’s development, Medicilon fully leveraged its one-stop preclinical R&D service platform, which spans antibody drug discovery, pharmaceutical research and preclinical evaluation:- Antibody discovery: hybridoma, single B-cell and anti-drug antibody (ADA) technologies deliver efficient, precise antibody development solutions;
- CMC: process development and formulation R&D for antibody drugs, with active expansion into novel formulation areas such as nanobody formulations;
- Preclinical studies: GLP compliance aligned with China’s NMPA, the US FDA and the EU OECD, and AAALAC International accreditation, supporting PD,PK and safety evaluation across a wide range of antibody drug modalities.
Medicilon congratulates Trinomab on the approval of Xinduotuo, and looks forward to this world-first long-acting anti-RSV monoclonal antibody benefiting countless families and building a robust RSV immune shield for infants. Going forward, Medicilon will continue to deepen its one-stop preclinical R&D service platform, partnering with innovative pharma companies worldwide to accelerate the journey of more original drugs from laboratory to clinic to market.
