Global Breakthrough: Siltartoxatug Injection Revolutionizing Tetanus Prevention

Tetanus is a life-threatening infectious disease caused by Clostridium tetani, a bacterium commonly found in soil, dust, and animal waste. When the bacterium enters the body through open wounds, burns, or puncture injuries, it produces a potent neurotoxin, which attacks the nervous system, leading to severe muscle stiffness, spasms, and respiratory failure.

Despite the availability of effective vaccines and prophylactic treatments, tetanus remains a global public health problem, particularly in regions with low immunization coverage and inadequate healthcare infrastructure.

Unlike many infectious diseases, recovering from tetanus does not provide immunity, meaning individuals remain vulnerable to reinfection. And in neonatal tetanus cases, the mortality rate can exceed 80%, particularly in developing regions.

Trinomab, founded in 2015, is a leading biotechnology company dedicated to the discovery and development of innovative monoclonal antibody therapies. With a mission to advance global health through cutting-edge biopharmaceutical solutions, Trinomab leverages its proprietary HitmAb® platform to develop next-generation treatments for infectious diseases and beyond. By integrating advanced antibody engineering, high-throughput screening, and large-scale biomanufacturing, Trinomab aims to reshape the future of biologic therapeutics.

February 11, 2025 – Trinomab Pharmaceuticals Co., Ltd. ("Trinomab") proudly announces the official approval of its groundbreaking, self-developed, first-in-class recombinant anti-tetanus toxin monoclonal antibody drug, Siltartoxatug Injection（新替妥®）, by the National Medical Products Administration (NMPA) of China. Representing a major leap forward in tetanus prophylaxis, Siltartoxatug Injection（新替妥®） offers a safer, more efficient, and accessible alternative for emergency tetanus prevention.

Siltartoxatug Injection（新替妥®） is designed for rapid and comprehensive tetanus protection with a single intramuscular injection. Unlike conventional treatments, it eliminates the need for pre-administration skin testing, extended post-dose observation (for outpatient cases), or adjustments based on patient weight or wound size. These advantages significantly improve patient experience and streamline clinical workflows.

By harnessing the power of recombinant monoclonal antibodies through our HitmAb® platform, we are transforming infectious disease management and paving the way for future innovations. We invite partners worldwide to explore the immense potential of HitmAb® in developing next-generation biologics.

Historically, tetanus prophylaxis has relied on two primary passive immune agents:

● Tetanus Antitoxin (TAT): Derived from horse serum, TAT poses a substantial risk of severe allergic reactions, including serum sickness and anaphylactic shock, affecting 5% to 30% of recipients[3]. Due to these safety concerns, it has been discontinued in many countries and removed from the WHO Essential Medicines List since 1991[4].

● Human Tetanus Immunoglobulin (HTIG): While HTIG is derived from human plasma and offers improved safety, its production is constrained by plasma supply limitations, resulting in frequent shortages and potential risks of blood-borne pathogen transmission.

These constraints hinder timely and effective tetanus prevention, particularly in regions with limited healthcare resources. Siltartoxatug Injection（新替妥®） directly addresses these limitations, ensuring a consistent, safe, and scalable solution.

As the world’s first recombinant anti-tetanus toxin monoclonal antibody, Siltartoxatug Injection（新替妥®） sets a new benchmark in tetanus prophylaxis with its exceptional safety, efficacy, stability, and accessibility. In clinical trials, zero cases of serum sickness were reported, eliminating the need for traditional pre-administration skin testing and reducing complexity in emergency care. Its "one-shot, walk-away" protocol simplifies administration, making it highly suitable for urgent situations. In terms of efficacy, 95.4% of patients achieve protective antibody levels within 12 hours, significantly outperforming HTIG (53.2%), while delivering 5–7 times higher neutralizing antibody. The median duration for neutralizing antibody titers to reach protective levels is 132 days, thereby reducing the risk of reinfection. Gene recombination technology ensures unmatched batch-to-batch consistency, surpassing industry standards. Additionally, Siltartoxatug Injection（新替妥®）'s cell-based production process eliminates reliance on human or equine plasma, overcoming global supply shortages. Its GMP-certified manufacturing enables stable distribution, ensuring broader accessibility and availability for patients in need.

Siltartoxatug Injection（新替妥®） is the flagship product developed through Trinomab's proprietary HitmAb® technology platform, which specializes in recombinant monoclonal antibody discovery. Leveraging this cutting-edge platform, Trinomab is advancing a robust pipeline of antibody-based therapies targeting infectious diseases, including respiratory syncytial virus (RSV) and human cytomegalovirus (HCMV).

Beyond Siltartoxatug Injection（新替妥®）, the HitmAb® platform, a fourth-generation natural human monoclonal antibody development platform enables creation of novel, proprietary, highly differentiated, and efficient monoclonal antibody therapies. This platform combines advanced molecular discovery technologies, allowing for the rapid and efficient identification and development of antibody drugs suited to various therapeutic areas, showcasing Trinomab's distinctive strengths in technological innovation and drug development.

Trinomab remains dedicated to developing clinically impactful therapies. The approval of Siltartoxatug Injection（新替妥®） highlights our commitment to advancing biotechnology and addressing public health needs. We will continue to drive innovation in biologics to enhance global health outcomes.

Trinomab welcomes collaborations with biotech and pharmaceutical companies seeking to develop novel monoclonal antibody therapies across various therapeutic areas. For more information or collaboration inquiries, please learn more at https://www.trinomab.com/en-us.

References

[1] Siltartoxatug Injection（新替妥®） Prescribing Information, NMPA Approval Document.
[2] Non-Neonatal Tetanus Diagnosis and Treatment Guidelines (2024 Edition), National Health Commission.
[3] Wang, C. Tetanus. People’s Medical Publishing House, 2022.
[4] MSF Medical Guidelines.