Retavibart NDA Submission Accepted

On February 13, 2026, the National Medical Products Administration (NMPA) formally accepted the New Drug Application (NDA) for retavibart (formerly known as TNM001). Retavibart is a long-acting recombinant human monoclonal antibody targeting fusion protein (F) of respiratory syncytial virus (RSV) for prevention of RSV infection in infants, developed by Zhuhai Trinomab Pharmaceutical Co., Ltd. (hereinafter referred to as "Trinomab"). This milestone marks significant progress in China's domestic innovation in RSV prevention. It is expected to fill the clinical gap for locally developed long-acting anti-RSV monoclonal antibodies and to help build a stronger line of protection for health of children in China as well as world-wide.

（origin：CENTER FOR DRUG EVALUATION, NMPA）

01 Respiratory Syncytial Virus (RSV)

Globally, RSV is the leading cause of lower respiratory tract infections in children under five. In northern China, the virus typically circulates from November to May, while in the south, transmission persists year-round. According to surveillance data from the Chinese Center for Disease Control and Prevention [1], nearly all children experience at least one RSV infection by age two, with over 60% of infections occurring in infants under one year. High-risk groups—including preterm and low birth weight infants—face significantly higher rates of bronchiolitis, pneumonia, and hospitalization following infection. Beyond its threat to infant health, RSV infection imposes a considerable socioeconomic burden.

Epidemiological models and high-quality clinical research [2] estimate that acute lower respiratory tract infections caused by RSV in infants result in an annual economic burden of approximately RMB 7 billion in China, of which RMB 2.74 billion is attributed to hospitalized children. The high hospitalization rate strains medical resources and challenges the broader healthcare system. Additionally, parents often miss work to care for hospitalized children, compounding financial stress on families. Currently, effective clinical treatments for RSV infection remain limited, making prevention the cornerstone of disease control. However, the domestic market currently relies on imported products that are costly and in short supply, leaving significant clinical needs unmet.

02 Retavibart: Developed to Address Clinical Needs

Retavibart is indicated for the prevention of RSV-caused lower respiratory tract infections in infants, including those at highest risk for severe disease. Clinical trials have demonstrated that retavibart offers strong efficacy and a safety profile comparable to placebo. In Phase 3 trials, a single dose of retavibart significantly reduced the incidence of RSV-associated lower respiratory tract infections, with sustained protection extending up to 270 days-substantially longer than the typical 150-day RSV season. Even greater efficacy was observed against severe infections. With a single injection that covers the full RSV season and extends well beyond it, retavibart offers a convenient and effective option for protecting infants from RSV.

03 Domestic Milestone in Anti-RSV Antibody Development

The NDA acceptance of retavibart represents a pivotal milestone in China's development of prophylactic monoclonal antibodies against RSV. It signals a transition from "following" to "leading" in the field of passive immunization against respiratory viruses. As the potential first homegrown long-acting anti-RSV monoclonal antibody, retavibart is poised to significantly improve the accessibility and affordability of RSV preventive therapies, benefiting more infants across China. It will also strengthen China's contribution to global innovation in infectious disease prevention.

Innovation endures; protection lasts. Trinomab remains committed to advancing innovative antibody drug research and development and leveraging its proprietary human antibody discovery platform to expand its pipeline.

Reference：

[1]中国疾控中心哨点监测、《人呼吸道合胞病毒下呼吸道感染治疗及预防指南(2024版)》及儿童呼吸道疾病临床研究.

[2]《呼吸道合胞病毒感染防治医防协同专家共识》及相关临床经济负担研究.

（All images above are generated by AI.)