On March 2, 2026, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Priority Review designation to retavibart (formerly TNM001), a long-acting recombinant human monoclonal antibody developed by Zhuhai Trinomab Pharmaceutical Co., Ltd. (hereinafter referred to as "Trinomab") for the prevention of respiratory syncytial virus (RSV) infection in infants.

（origin：CENTER FOR DRUG EVALUATION, NMPA）

This marks the second CDE Priority Review designation for Trinomab's pipeline, following Siltartoxatug Injection, the company's first marketed asset and a global first-in-class tetanus antibody. The achievement highlights Trinomab’s growing strength and continued momentum in developing innovative antibody therapeutics.

The Priority Review status is expected to expedite the New Drug Application (NDA) process for retavibart, paving the way for faster market availability and earlier protection against RSV for healthy and high-risk infants, both in China and globally.

RSV Remains a Leading Threat to Infant Health

Respiratory syncytial virus (RSV) is the leading viral cause of lower respiratory tract infections (LRTI) in children under five years of age. Globally, RSV-associated LRTI results in approximately 33 million cases, 3.6 million hospitalizations, and more than 100,000 deaths each year. Studies suggest that the mortality rate among infants under one year infected with RSV is roughly 2.5 times higher than that of influenza. Preterm infants, low-birth-weight infants, and those with congenital heart disease are at elevated risk for severe RSV disease. Moreover, infants infected with RSV face a two- to three-fold increased risk of developing asthma later in childhood compared to those who are not infected [1]. 

Four Features: Advancing Infant Health Protection

01 Enhanced Efficacy

In the Phase 3 clinical trial, a single intramuscular dose of retavibart significantly reduced the incidence of RSV-associated LRTI in healthy full-term and late preterm infants, with sustained protection for up to 270 days post-dose—substantially exceeding the typical 150-day RSV season. In addition, greater efficacy was observed against severe RSV-associated LRTI, offering robust coverage that spans and extends well beyond an entire RSV season - a convenient and effective solution aligned with the practical needs of infant care.

02 Innovative Targeting

Retavibart binds specifically to a conserved epitope on the prefusion (pre-F) conformation of the RSV F protein. This targeted approach enhances neutralizing potency and supports long-lasting protection, contributing to its potential clinical advantages.

03 Favorable Safety Profile

As a recombinant long-acting fully human monoclonal antibody, retavibart is derived entirely from human source, minimizing the risk of immunogenicity. This feature is especially important for infants, whose immune systems are still developing.

04 Single-Dose Convenience

A single injection offers protection throughout the RSV season, reducing the need for repeated doses and minimizing discomfort for infants, offering families a more convenient and reassuring preventive option.

Regulatory Pathways Accelerating Innovation

The Priority Review designation for retavibart reflects China’s ongoing commitment to regulatory reform aimed at encouraging pharmaceutical innovation and protecting public health. The recently updated Implementing Regulations of the Drug Administration Law of the People’s Republic of China [2] formalized four expedited pathways—Breakthrough Therapy Designation, Conditional Approval, Priority Review, and Special Approval—establishing a modern, clinically driven framework for efficient drug evaluation.

Priority Review is expected to fast-track the market availability of retavibart. This milestone not only underscores Trinomab’s R&D capabilities and innovation strength but also highlights the broader progress of China’s biopharmaceutical industry toward high-quality development. Retavibart has the potential to offer safe, convenient, and durable immune protection for infants across China and beyond throughout the RSV season, contributing to improved pediatric health outcomes globally.

Reference：

[1]上海市卫生健康委员会 上海市中医药管理局《重视预防，避免呼吸道合胞病毒感染》.https://wsjkw.sh.gov.cn/crbfz/20230918/f6d65f94cbf747f4a69620e0e5db38c5.html.2023.9.18

[2]中华人民共和国中央人民政府《中华人民共和国药品管理法实施条例》（以下简称《条例》）.https://www.gov.cn/zhengce/zhengceku/202601/content_7056256.htm.2026.1.16.

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