Siltartoxatug Injection is the world's first recombinant anti-tetanus toxin monoclonal antibody drug independently developed by Trimomab. It works by targeting tetanus toxin to neutralize its effects and prevent disease onset, and is intended for emergency tetanus prevention in adults. In March 2022, the Siltartoxatug Injection was included in the Breakthrough Therapy Designation list by the China Center for Drug Evaluation (CDE), becoming the first domestically developed innovative biologic drug in the anti-infective field to receive this designation. In August 2022, it was granted Fast Track designation by the U.S. FDA, followed by inclusion in the Priority Review program by the CDE in December 2023. The Phase III clinical trial results of Siltartoxatug Injection were featured in live presentations at both the 2024 American College of Emergency Physicians (ACEP) Annual Meeting and the 18th European Emergency Medicine Congress (EUSEM) in 2024, bringing disruptive changes to global tetanus prophylaxis regimens.
In February 2025, Siltartoxatug Injection successfully obtained approval for marketing in China, providing a safer, more effective, and more accessible solution for tetanus prevention to exposed populations both domestically and globally in the future.
Clostridium tetani is the pathogenic bacterium that causes tetanus. It is widely distributed in nature and can be found in various environments such as soil, dust, the intestines and feces of humans or mammals, as well as on the skin. The bacterium infects humans through open wounds or lacerations during childbirth, leading to the disease. Once symptoms appear, the prognosis for tetanus patients is poor, with a high mortality rate. Severe cases may lead to complications such as laryngospasm, asphyxia, pulmonary infections, and organ failure. Without medical intervention, the fatality rate approaches 100%. Even with aggressive comprehensive treatment, the global average mortality remains at 30%-50%, particularly high among neonates and the elderly [Source: Chinese Expert Consensus on Tetanus Immunoprophylaxis]. It is an extremely severe and potentially fatal disease. The primary causes of death include asphyxia, atelectasis, heart failure, and pulmonary embolism. Globally, particularly in developing countries, tetanus remains a serious public health challenge.
Before the advent of Siltartoxatug Injection, all passive immunizing agents used clinically for the prevention and treatment of tetanus were blood-derived products. Siltartoxatug Injection effectively overcomes the limitations of blood-derived products while offering high specificity, high potency, superior safety, and enhanced accessibility, representing a next-generation innovation in prophylaxis.
Drug Name/Code | Indication | Target | Pre-clinical study | IND | Phase I Clinical Trial | Phase II clinical Trial | Phase III Clinical Trial | NDA | Marketed |
Siltartoxatug TNM002 |
Prevention of tetanus | Tetanus toxin |
TNM001 injection is the company's proprietary fully human monoclonal antibody targeting the Pre-F protein of respiratory syncytial virus (RSV) for immunization. it represents the potential third globally and first in China for long-term RSV prophylaxis in both healthy and high-risk infants, Currently, there is a significant unmet clinical need for RSV infection prevention globally.
Human Respiratory Syncytial Virus (RSV) is a single-stranded negative-sense RNA virus belonging to the Orthopneumovirus genus of the Pneumoviridae family. As a common viral pathogen of respiratory infections, RSV exhibits a range of epidemiological patterns, from sporadic cases to outbreaks, as well as localized or widespread epidemics. RSV is a major cause of seasonal lower respiratory tract infections in infants and young children, imposing a significant disease burden on this population. It is also a major contributor to neonatal deaths caused by viral infections. The peak incidence of RSV infection in children occurs between 1 and 6 months of age, with those under 2 years old being at particularly high risk. Mild cases of initial RSV infection typically present with coughing, low-grade fever, and wheezing. In severe cases, symptoms escalate to intensified coughing and wheezing accompanied by dyspnea, chest hyperinflation, intercostal and subcostal retractions. If the condition worsens, patients may develop lethargy and respiratory failure, posing serious threats to their health and life.
The main active ingredient of TNM001 injection is a recombinant fully human monoclonal antibody targeting RSV. Its primary mechanism of action involvesspecific binding of the TNM001 antibody to a conserved epitope on the prefusion conformation (Pre-F) of the RSV F protein, thereby neutralizing RSV and blocking the fusion process between the virus and host cells. This prevents viral entry into cells, enabling both prevention and treatment of RSV infection in humans. Preclinical and clinical data have shown that TNM001 demonstrates exhibits strong efficacy and good safety in preventing RSV infection. Following its market launch, TNM001 is expected to provide a rational therapeutic option for preventing RSV infections in infants and young children nationwide and globally, helping to reduce the associated disease burden.
Drug Name/Code | Indication | Target | Pre-clinical study | IND | Phase I Clinical Trial | Phase II clinical Trial | Phase III Clinical Trial | NDA | Marketed |
TNM001 | Prevention of RSV infection | RSV Pre-F protein |
TNM009 Injection is a fully human monoclonal antibody targeting nerve growth factor (NGF) independently developed by the company for pain management. In March 2023, the CDE approved the Investigational New Drug (IND) application for TNM009.
NGF, a prototypical member of the neurotrophin family, is a pleiotropic cytokine widely present in various tissues and organs throughout the body, exerting stage-specific biological effects during human development. During growth phases, NGF promotes neuronal survival, proliferation, and differentiation, while also repairing and regenerating damaged nerve cells. In adulthood, NGF primarily functions to modulate the activity of nociceptive neurons and pain responses. Research indicates that NGF levels increase in conditions such as trauma, inflammation, and chronic pain, where it activates intracellular signaling via TrkA receptors on nociceptors, triggering pain pathways. Therefore, it is considered to be an important mediator of pain in various pathological states, and the interaction of NGF with its receptor TrkA is an important link in the initiation and maintenance of pain, therefore playing an important function in pain signaling. By selectively inhibiting NGF, it helps block peripheral pain signaling to the brain.
Unlike widely used opioid analgesics, the NGF antibody selectively inhibits the NGF-TrkA signaling axis in peripheral nervous system without interfering with central neurotransmitter release, theoretically eliminating addiction risks. Meanwhile, As a monoclonal antibody, TNM009 offers extended dosing intervals—particularly advantageous for chronic pain patients requiring long-term management, such as those with bone metastasis-induced cancer pain or chemotherapy-induced neuropathic pain. NGF antibodies show promise for combination therapy with low-dose opioids, enhancing analgesic efficacy through multi-pathway synergy.. This strategy not only reduces cumulative opioid dosage and minimizes addiction and dependence risks, but also delays pain sensitization via complementary mechanisms. Additionally, thanks to the low immunogenicity of fully human monoclonal antibodies, TNM009 theoretically mitigating the risk of immunogenicity-driven efficacy reduction.
Drug Name/Code | Indication | Target | Pre-clinical study | IND | Phase I Clinical Trial | Phase II clinical Trial | Phase III Clinical Trial | NDA | Marketed |
TNM009 | cancer pain, joint pain | NGF |
TNM005 Injection is a fully human monoclonal antibody independently developed by the company targeting the varicella-zoster virus (VZV), representing a recombinant anti-VZV monoclonal antibody drug, it holds first-in-class potential globally. In April 2023, the FDA approved the Investigational New Drug (IND) application for TNM005, with an indication for post-exposure prophylaxis of varicella-zoster virus (VZV) in high-risk populations.
High-risk groups for VZV infection mainly include immunocompromised individuals (such as HIV patients or those receiving immunosuppressive therapy), pregnant women, newborns, and preterm infants. These populations may face more severe complications if infected with VZV, such as pneumonia, encephalitis, extensive skin lesions, or even life-threatening conditions. Therefore, preventive measures for high-risk groups are crucial to effectively reduce infection risks and mitigate severe disease outcomes.
Monoclonal antibodies demonstrate unique potential in preventing VZV infection due to their highly targeted characteristics. Their ability to precisely identify and neutralize virusesmay not only improve protective efficacy but also extend the duration of protection, potentially offering superior preventive options for immunocompromised individuals and other high-risk populations. TNM005 achieves viral neutralization by specifically binding to the VZV gH/gL glycoprotein, serving as a preventive measure against varicella exposure in special populations including newborns, preterm infants, women during delivery, and immunocompromised individuals.
Drug Name/Code | Indication | Target | Pre-clinical study | IND | Phase I Clinical Trial | Phase II clinical Trial | Phase III Clinical Trial | NDA | Marketed |
TNM005 | Prevention and treatment of VZV infection | VZV gH/gL protein |
TNM006 injection is a fully human monoclonal antibody independently developed by the company for intravenous administration against human cytomegalovirus (HCMV). In May 2023, the CDE approved Investigational New Drug (IND) application for TNM006. Human cytomegalovirus, also known as human herpesvirus 5 (HHV-5), belongs to the betaherpesvirinae subfamily.
Human cytomegalovirus infection is one of the most prevalent infectious diseases worldwide. HCMV is present in bodily fluids such as saliva, semen, urine, and blood. It can be transmitted through blood, bodily fluids, organ transplants, or hematopoietic stem cell transplantation, as well as vertically via the placenta or during childbirth. According to Frost & Sullivan's report, the infection rate of HCMV is approximately 50% in developed countries and generally higher in developing countries, with prevalence increasing with age. The HCMV infection rate in China exceeds 90%, with antibody positivity rates of 86%-96% in the general population, approximately 95% in pregnant women, and 60%-80% in infants and young children.
In contrast, monoclonal antibody drugs demonstrate higher potency, more effective viral neutralization, and lower resistance risks, potentially becoming a superior prophylactic option for high-risk HCMV populations, particularly transplant recipients. TNM006 is expected to fill the gap in domestically developed prophylactic antibody biologics for HCMV infection prevention.
Drug Name/Code | Indication | Target | Pre-clinical study | IND | Phase I Clinical Trial | Phase II clinical Trial | Phase III Clinical Trial | NDA | Marketed |
TNM006 | hCMV infection (prevention) | human cytomegalovirus |
TNM035 is a fully human monoclonal antibody independently developed by our company that specifically binds to the dengue virus E proteinfor the prevention and treatment of dengue virus infection.
Dengue fever is an acute infectious disease caused by the Dengue Virus (DENV) and transmitted through the bite of vector Aedes mosquitoes. The dengue virus is primarily transmitted by vector insects such as Aedes aegypti and Aedes albopictus. After replicating in the mosquito's salivary gland cells for 8-10 days, the virus can spread through subsequent blood-feeding. Infected mosquitoes retain the ability to transmit the virus throughout their lifespan and can pass it vertically to their offspring. Aedes mosquito eggs are highly resistant to desiccation and can survive externally for extended periods outside the body. When humans are bitten by dengue virus-carrying mosquitoes, a mosquito-human-mosquito transmission cycle is established, leading to disease spread. Moreover, dengue fever outbreaks often occur due to mutations in dengue virus RNA or the introduction of new exogenous strains.
Global R&D pipelines for dengue prevention and treatment are continuously advancing. In dengue prevention, vaccine development primarily focuses on tetravalent live-attenuated vaccines. For dengue treatment, pipelines mainly concentrate on small-molecule drugs, which offer the advantage of inhibiting viral replication through multiple mechanisms. Additionally, a monoclonal antibody therapy has entered Phase II clinical trials for dengue treatment. Globally, research on monoclonal antibody drugs fordengue prevention remains relatively underdeveloped.
Drug Name/Code | Indication | Target | Pre-clinical study | IND | Phase I Clinical Trial | Phase II clinical Trial | Phase III Clinical Trial | NDA | Marketed |
TNM035 | Bacterial infectious shock | Hla toxin |