World's First Recombinant Anti-Tetanus Monoclonal Antibody Injected in Zhuhai, Marking Clinical Launch of Next-Gen Tetanus Prophylaxis

On March 13, a quiet revolution was underway in the Emergency Department of Zhuhai People’s Hospital. Dr. Chen Muqing, Secretary of the Emergency Department and Trauma Center, carefully clicked the confirmation button in the electronic prescription system, officially generating the first prescription for Xintituo® (Staidumab Injection), the world’s first recombinant anti-tetanus toxin monoclonal antibody drug. This seemingly ordinary electronic certificate marks a milestone in the history of tetanus prevention and treatment in China. Just 29 days after receiving approval from the National Medical Products Administration (NMPA) on February 11, this groundbreaking global first-in-class recombinant anti-tetanus toxin monoclonal antibody has been formally introduced into clinical practice, demonstrating “China speed.”

Even in the 21st century, the lethal threat of tetanus remains ever-present. As a highly severe and potentially fatal disease, tetanus has a case fatality rate approaching 100% in the absence of medical intervention. Even with aggressive comprehensive treatment, the global case fatality rate remains at 30%–50%.^【1】。

Although the widespread adoption of active immunization (vaccination) has significantly reduced the incidence rate, there remains a strong clinical demand for passive immunization against tetanus—commonly referred to as “tetanus shots.” The “tetanus shots” widely recognized by the public mainly include Tetanus Antitoxin (TAT) and Human Tetanus Immunoglobulin (HTIG).

As a representative of equine-derived blood products, TAT carries a high risk of allergic reactions, which may lead to anaphylactic shock, serum sickness, or even death.^【2】, it has long been phased out in many developed countries; due to the aforementioned adverse reactions, the World Health Organization (WHO) removed tetanus antitoxin (TAT) from its Model List of Essential Medicines as early as 1991.

HTIG relies entirely on human plasma as the raw material, resulting in limited production capacity and frequent shortages where doses are difficult to obtain. Moreover, it carries the risk of transmitting known or unknown blood-borne pathogens. Recently, the National Medical Products Administration (NMPA) has mandated revisions to the adverse reaction section of HTIG package inserts.^【3】。

Xintituo^®The advent of this product has completely transformed this landscape. By leveraging recombinant DNA technology, it entirely eliminates dependence on plasma-derived raw materials and eradicates the risk of transmitting blood-borne pathogens. Compared with traditional tetanus shots, Xintituo^®It offers significant advantages in terms of safety, superiority, controllability, and accessibility.

Phase III clinical data demonstrated rapid onset of action within 12 hours post-administration. Pharmacodynamic results indicated that the median duration for maintaining protective levels of tetanus-neutralizing antibodies was 132 days, providing more comprehensive coverage throughout the incubation period of tetanus. This means that patients can rapidly acquire effective protection within the critical 12-hour window following injury, while the median duration of 132 days for maintaining protective antibody levels is sufficient to cover the vast majority of tetanus incubation periods, significantly reducing the risk of infection.

 Figure. Time-course curve of the geometric mean (95% CI) of tetanus-neutralizing antibodies in Phase III clinical trials

At the point of initial prescription, Dr. Chen Muqing demonstrated Xin Tituo.^®...streamlined administration process, noting: “Traditional passive immunization agents for tetanus, such as Tetanus Antitoxin (TAT) and equine tetanus immunoglobulin F(ab')₂ fragments, require complex procedures including skin testing, desensitization injections, and post-administration observation. In contrast, Xintituo leverages recombinant DNA technology to enable precise antibody design, eliminating the need for skin testing or dose adjustments. This truly facilitates a ‘single-shot-and-go’ approach, fundamentally eradicating the risk of anaphylactic shock or even death following administration due to false-negative skin test results.”

Zhao Wengui, Vice President of Taizhaimab and General Manager of the Greater China Marketing Center, stated, “Clinical data demonstrate that a single intramuscular injection provides rapid immune protection. This one-dose regimen requires no skin test, no weight-based dosing stratification, and no wound assessment. Outpatients can leave immediately after injection without observation. Notably, for two categories of incubation periods that are difficult to cover with existing medications (approximately 10% of patients with <48 hours and 3% with >30 days), Xintituo offers comprehensive cycle protection. The company’s current annual production capacity has reached the tens of millions of doses level, which can effectively alleviate the supply pressure of passive immunization preparations in China.” The issuance of the first prescription marks Xintituo^®Officially Entering a New Era of Clinical Application.

When “China Acceleration” Becomes the Benchmark for Reshaping Global Public Health Governance. Behind this acceleration lies a triple resonance of policy innovation, technological breakthroughs, and industrial synergy, with its ripple effects spreading from the Pearl River Estuary to the rest of the world.

Xintituo^®Inaugural Shipment Ceremony Truck

Seizing the opportunity of its first prescription and first order, TnuoMab is accelerating its national online procurement listing and commercial channel strategy, while strengthening patient education initiatives, with the aim of expanding access to this innovative drug across more healthcare institutions in China and benefiting a broader patient population.

With the new replacement^®With regulatory approval for market launch and clinical application, China’s tetanus prevention and control system is undergoing three major strategic transformations: shifting from “high-risk passive defense” to “precision preemptive protection”; transitioning from “blood-derived dependency” to “recombinant DNA technology-driven production”; and optimizing from “complex processes” to “convenient services.” Meanwhile, Tnuo Biopharma will continue to uphold its corporate mission of “creating clinical value,” consistently driving innovation and development in biopharmaceutical technologies, and contributing more Chinese wisdom and strength to the upgrading and transformation of the global public health system.

Reference Article:

[1] Guidelines for the Diagnosis and Treatment of Non-Neonatal Tetanus (2024 Edition). General Office of the National Health Commission, 2024.

[2] Tetanus / edited by Wang Chuanlin. — Beijing: People's Medical Publishing House, 2022.2

[3] National Medical Products Administration. Announcement of the National Medical Products Administration on Revising the Package Insert for Human Tetanus Immunoglobulin (No. 153 of 2024) [EB/OL]. (2024-12-24)