ZHUHAI, China, September 3, 2026 — Zhuhai Trinomab Pharmaceutical Co., Ltd. (stock code: 688806 ; hereafter referred to as "Trinomab"), announced that Retavibart Injection(previously known as TNM001), a recombinant fully human monoclonal antibody against respiratory syncytial virus (RSV), has been approved for marketing by the National Medical Products Administration (NMPA) of China. Retavibart is the first long-acting anti-RSV monoclonal antibody worldwide with protection data extending up to 9 months from a single dose. The approval marks Trinomab’s second commercialized product, following the anti-tetanus monoclonal antibody Siltartoxatug Injection.

Retavibart is indicated for the prevention of RSV-associated lower respiratory tract infection (LRTI) in neonates and infants who are entering or are born during their first RSV season. With a single intramuscular injection and no weight-based dose adjustment, Retavibart provides protection throughout the RSV season, offering a new passive immunization option for all newborns and infants.

Source: Official website of the NMPA

Addressing an Urgent Unmet Need

RSV is the most common viral cause of lower respiratory tract infection in children under five years of age worldwide and is highly contagious. According to surveillance data from the Chinese Center for Disease Control and Prevention and clinical studies,1 more than 60% of infants are infected with RSV within their first year of life. High-risk infants with RSV infection, which include those born before 35 weeks of gestation and those with congenital heart disease (CHD), chronic lung disease of prematurity (CLD, also known as BPD), or immunocompromising conditions,  face markedly higher rates of acute bronchiolitis, pneumonia, and hospitalization. RSV therefore not only threatens the lives and health of young infants but also places a heavy socioeconomic burden on families and healthcare systems.

With therapeutic options limited, prevention remains the cornerstone of RSV control. China, however, has long lacked a domestically developed innovative preventive product, leaving clinical supply dependent on costly imported products. Retavibart offers Chinese infants a safe, effective and accessible home-grown alternative, and is expected to reduce the market’s reliance on imports.

Four Advantages in a Single dose of Retarvibart

Developed on HitmAb, Trinomab’s proprietary, fully integrated high-throughput platform for fully human monoclonal antibody discovery, Retavibart is derived entirely from naturally occurring human immune cells and offers four distinctive advantages:

•  Long-acting protection covering a full RSV season. 

As seasonal epidemic of RSV infection lasts for about 5 months from late autumn through winter to the next spring in temperate climates, while outbreaks in tropical and subtropical zones coincide with seasonal rainy seasons and may last longer than 5 months. A single injection provides continuous protection for up to 270 days (9 months), a substantial improvement over the roughly 150 days (nearly 5 months) offered by comparable products on the market. One shot covers an entire RSV season, delivering meaningful clinical benefit even in regions without well-defined seasonality where the virus circulates year-round. No follow-up booster is required, sparing infants repeated injections and giving families a more convenient and reassuring experience.

•  A favorable safety profile for all infants under one year of age. 

As a recombinant, fully human monoclonal antibody derived from a human B cell, Retavibart carries intrinsically low risk of immunogenicity. It is suitable for all neonates and infants under one year of age, including full-term infants and those in high-risk categories.

•  Stronger protection with excellent clinical efficacy. 

Phase 3 results show that a single intramuscular injection (administered in the anterolateral thigh) significantly reduced the risk of RSV-related LRTI in healthy full-term and late preterm infants, with particularly effectiveness against severe RSV LRTI.

•  A single fixed dosage for simple, efficient administration.

 Retavibart is supplied in a single fixed 120 mg dosage. No body-weight calculation or adjustment is required — one vial suits all, simplifying clinical administration.

End-to-End Independent Innovation, from Discovery to Manufacturing

From target discovery and antibody screening to process development, clinical trials, and commercial manufacturing, Retavibart is the second independently originated innovative drug that Trinomab has brought to market, after Siltartoxatug Injection. Like its predecessor, it is developed with end-to-end independent control — a China-originated innovative biologic developed through independent innovation.

The innovative value of Retavibart has been well recognized at the national level in China:

⭐️ February 2026: the New Drug Application (NDA) was accepted by the NMPA;

⭐️ March 2026: the product was included in the priority review and approval procedure, substantially accelerating its review;

⭐️ May 2026: it was selected for a National Science and Technology Major Project;

⭐️ September 2026: it was officially approved for marketing by the NMPA.

These milestones reflect the China-originated innovation, and the role of high-quality, efficient review in supporting a “Healthy China.”

Dr. Larry LIAO, Chairman and Chief Technology Officer of Trinomab, said:

“Retavibart is another successful translation of source-level innovation relying on our HitmAb fully human antibody platform, following Siltartoxatug Injection, a first-in-class anti-tetanus monoclonal antibody. There has long been an enormous unmet need for RSV prevention in infants worldwide, and China previously had no domestically developed long-acting preventive option. We hope this fully human monoclonal antibody, offering up to 9 months of protection, will provide a safe, efficacious and accessible homegrown choice for infants in China and around the world to reduce the burden of severe RSV disease.

“Looking ahead, we will continue to leverage our fully human antibody platform and remain guided by our commitment to creating clinical value, delivering more China-originated innovative medicines to patients in China and beyond.”

Weihong ZHENG, Vice Chairman and General Manager of Trinomab, added:

“Every newborn represents a family’s hope and the future of society. With Retavibart's approval, infants in China and worldwide now have a better option for RSV prevention. A single injection providing 9 months of long-lasting protection safeguards not only a child’s safe passage through the first RSV season, but also the peace of mind of countless families. 

“Rooted in local innovation, Trinomab is committed to safeguarding the health of the next generation through source-level innovation and to living up to the nation’s expectations. We will continue to identify genuine clinical value, accelerate the development and commercialization of more China-originated innovative medicines, and bring the benefits of Chinese innovation to patients worldwide.”

Disclaimer

1.Trinomab does not recommend any drugs that have not been approved for listing or indications that have not been approved.

2.The medical information in this press release is for informational popularization and news reporting purposes only. It does not constitute medical advertising, nor does it constitute any form of diagnosis and treatment advice, medication guidance, or doctor-patient communication. No individual or institution shall use it for commercial promotion or medical decision-making.

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