Zhuhai, Guangdong, July 8, 2025 – Zhuhai Trinomab Pharmaceutical Co., Ltd. (hereinafter referred to as "Trinomab") announced that the results of the Phase III clinical trial of Siltartoxatug Injection (brand name: Sintetol), a first-in-class anti-tetanus monoclonal antibody developed by Trinomab, have been published in the top-tier international journal Nature Medicine (Impact Factor: 50.0) [1].
The publication of the results of the Phase III clinical trial as an Article in Nature Medicine signifies global academic recognition of the outstanding clinical value of Siltartoxatug Injection and its significant implications for addressing tetanus prophylaxis, an important global public health issue.
（Source：Nature Medicine Published online: 08 July 2025）
Siltartoxatug Injection is the first China-developed innovative biologic drug in the field of anti-infectives to be designated as a Breakthrough Therapy by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The trial results were also orally presented at the American College of Emergency Physicians (ACEP) Annual Meeting in Las Vegas, USA (2024), and the European Emergency Medicine Congress (EUSEM) in Copenhagen, Denmark, garnering widespread attention and recognition from the global academic community [2].
This high-evidence-level, multicenter, randomized, double-blind, active-controlled Phase III clinical trial demonstrated that:
Compared to the conventional standard treatment—human tetanus immunoglobulin (a blood-derived product), Siltartoxatug Injection:
· Achieved protective levels of tetanus-neutralizing antibodies more rapidly
· Induced higher titers of neutralizing antibodies
· Provided longer-lasting protective neutralizing antibodies, covering extended incubation periods
· May have a reduced impact on active immunization with tetanus vaccines
Siltartoxatug Injection was approved for marketing in China in February 2025 for urgent prophylaxis against tetanus in adults. As the world's first monoclonal antibody targeting tetanus toxin, Siltartoxatug Injection is produced using genetic engineering technology, enabling large-scale manufacturing and eliminating reliance on human- or horse-blood-derived products. This innovation represents a significant advancement in safety, efficacy, accessibility, and quality control - fully aligned with WHO's initiative to develop monoclonal antibodies for infectious disease prevention and treatment, while overcoming the limitations of traditional blood-derived therapies [3].
Wanmei Wang
Chief Medical Officer and Senior Vice President
Tetanus is a life-threatening infectious disease and remains a significant public health concern in many parts of the world. In China, the burden of tetanus prophylaxis in wounded patients remains substantial. As the sponsor of this Phase III clinical trial, we are delighted to see that Siltartoxatug Injection, the first-in-class anti-tetanus monoclonal antibody, has demonstrated significant advantages over traditional passive immunizing agents in wounded patients. It is highly encouraging that this independently developed innovative drug by Trinomab, along with its high-level clinical evidence, has gained recognition from a leading international journal and the global academic community. The approval of Siltartoxatug Injection offers a more effective, safer, and more accessible clinical option for tetanus prophylaxis.
HUAXIN LIAO
Chairman & Chief Technology Officer
Siltartoxatug Injection—the world’s first anti-tetanus monoclonal antibody—was developed using Trinomab’s proprietary HitmAb® platform, a globally leading technology for fully native human monoclonal antibody discovery. The results of its Phase III confirmatory clinical trial underwent rigorous international peer review and were published as a full-length original article in a top-tier medical journal, demonstrating that its meticulous trial design, robust clinical data, and significant public health value have earned global academic recognition. This achievement also marks a major success for the company's proprietary technology platform in developing China-originated innovative biologics.
The series of R&D achievements of Siltartoxatug not only demonstrate the innovation capability and strength of China's biopharmaceutical enterprises, but also showcase China's wisdom and contributions to global health, particularly in advancing worldwide tetanus prevention and control efforts.
Reference:
[1] Nature Medicine 2025.https://www.nature.com/articles/s41591-025-03791-8.
[2] Liu X, Wang C, Liang Z, et al. 201 A Recombinant Native Human Anti-Tetanus Monoclonal Antibody Versus Human Tetanus Immunoglobulin for Passive Immunization Against Tetanus: A Double-Blind, Randomized, Phase 3 Trial. Annals of Emergency Medicine 2024; 84(4): S94.
[3] WHO (2023). "Guidelines on the nonclinical and clinical evaluation of monoclonal antibodies and related products intended for the prevention or treatment of infectious diseases. Available at: https://cdn.who.int/media/docs/default-source/biologicals/who-ecbs-mar-2023---annex-2---mab-evaluation-guidelines---clean-for-posting---1-may-2023.pdf?sfvrsn=11d4de14_1&download=true.
（Sintetol Trademark Registration Number: Class 5 - 74174546）
