Siltartoxatug Injection (TNM002) is the world's first recombinant anti-tetanus toxin monoclonal antibody developed exclusively by Trinomab. It works by binding to tetanus toxin, thereby neutralizing the toxic effects that target the human neural system. Siltartoxatug Injection is intended for emergency tetanus prevention in adults. In March 2022, Siltartoxatug Injection was granted Breakthrough Therapy Designation by the China Center for Drug Evaluation (CDE). This was the first innovative biologic drug in the anti-infective field to receive the honrable designation in China.

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 and mammals, as well as on the skin. The bacterium infects humans through open wounds, lacerations, or 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 treatments, the global average mortality remains at 30%-50%. Such mortality is particularly high among neonates and the elderly, with the primary causes of death including asphyxia, atelectasis, heart failure, and pulmonary embolism. [Source: Chinese Expert Consensus on Tetanus Immunoprophylaxis]. Thus, tetanus is considered a serious global public health problem, particularly in developing countries.

Before the introduction of Siltartoxatug Injection, all clinical treatments for tetanus were provided by passive immunizing agents made from blood-derived products. Siltartoxatug Injection is made using recombinant biotechnology, thus effectively overcoming the safety concerns of blood-derived products while offering high specificity, high potency, and broad availability. These outstanding features position Siltartoxatug Injection as the next-generation innovative prophylaxis solution against tetanus infection.

TNM001 is a proprietary, fully human monoclonal antibody developed by Trinomab to target the Pre-F protein of respiratory syncytial virus (RSV), offering both prevention and treatment of RSV infections. If approved, TNM001 will be China’s first and the world’s third long-acting monoclonal antibody for RSV prophylaxis in healthy and high-risk infants. With rising RSV cases globally, the need for effective prevention and treatment options is growing.

Human Respiratory Syncytial Virus (RSV) is a single-stranded, negative-sense RNA virus from the Pneumoviridae family. As a leading cause of seasonal lower respiratory tract infections, RSV affects infants and young children, with peak infections occurring between 1 and 6 months of age. It is a major contributor to neonatal mortality from viral infections, particularly in high-risk children under 2 years old. Mild RSV cases typically present with coughing, low-grade fever, and wheezing. In severe cases, symptoms escalate to intense coughing, wheezing, shortness of breath, chest hyperinflation, and retractions. Without timely intervention, patients may develop lethargy or respiratory failure, posing a serious threat to health and, in extreme cases, leading to death.

TNM001 consists of a recombinant monoclonal antibody that binds specifically to a stable target on the RSV Pre-F protein, neutralizing the virus and preventing its fusion with human airway cells. This mechanism enables TNM001 to both prevent and treat RSV infections effectively. Preclinical and clinical studies demonstrate TNM001’s strong efficacy and favorable safety profile in RSV patients. Pending approval from the Center for Drug Evaluation (CDE), TNM001 is expected to provide a vital therapeutic option for infants and young children in China and globally, addressing the unmet need for RSV management.

TNM009 Injection is a fully human monoclonal antibody targeting nerve growth factor (NGF), developed exclusively by Trinomab for cancer pain management. In March 2023, China’s Center for Drug Evaluation (CDE) approved the TNM009 IND application in China.

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 thereby 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. Thus, NGF is considered an important mediator of pain in various pathological states, with its interaction with TrkA serving as a key link in the initiation, maintenance, and signaling of pain. By selectively inhibiting NGF, TNM009 helps block peripheral pain signaling to the brain.

Unlike widely used opioid analgesics, this NGF antibody selectively inhibits the NGF-TrkA signaling axis in the 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 could not only reduce cumulative opioid dosage and minimize addiction and dependence risks but also delay pain sensitization via complementary mechanisms. Additionally, due to the low immunogenicity of fully human monoclonal antibodies, TNM009 could theoretically mitigate the risk of reduced efficacy caused by immune responses during treatment in humans.

TNM005 Injection is a fully human monoclonal antibody developed exclusively by Trinomab for the treatment of varicella-zoster virus (VZV). In addition, TNM005 is considered the first-in-class anti-VZV mAb for global use. In April 2023, the FDA approved the TNM005 IND application, allowing clinical trials to proceed for post-exposure prophylaxis of VZV in high-risk populations in China.

High-risk patients for VZV infection primarily include immunocompromised individuals (such as those with HIV or receiving immunosuppressive therapy), pregnant women, newborns, and preterm infants. These populations can suffer severe complications from VZV infection, including pneumonia, encephalitis, extensive skin lesions, or even life-threatening conditions. Therefore, preventive measures using TNM005 are crucial for effectively reducing damage to patient health in these high-risk groups.

TNM005 is a monoclonal antibody that demonstrates unique potential in preventing VZV infection due to its highly specific interactions with the virus. Its ability to precisely recognize and neutralize VZV not only improves protective efficacy but also extends bioavailability in humans to prolong the duration of protection. 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, peripartum women, and immunocompromised individuals.

These characteristics of TNM005 could potentially offer a superior preventive solution for immunocompromised individuals and other high-risk populations.

TNM006 injection is a fully human monoclonal antibody developed exclusively by Trinomab against human cytomegalovirus (HCMV). The drug is administered to humans via intravenous injection. In May 2023, the CDE approved the TNM006 IND application in China. HCMV belongs to the Betaherpesvirinae subfamily and is also known as human herpesvirus 5 (HHV-5).

Human cytomegalovirus (HCMV) 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 bodily fluids, organ transplants, or hematopoietic stem cell transplantation, as well as vertically via the placenta or during childbirth. According to Frost & Sullivan's market research report, the HCMV infection rate is approximately 50% in developed countries and generally higher in developing countries, with prevalence increasing with age. In China, the HCMV infection rate 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.

Trinomab's TNM006 monoclonal antibody demonstrates high potency, effectiveness in viral neutralization, and low risk of resistance due to viral mutations. In fact, TNM006 could potentially become an excellent candidate for prophylactic treatment of high-risk HCMV populations, particularly transplant recipients. TNM006 is currently in clinical trial development.

TNM035 is a fully human monoclonal antibody developed exclusively by Trinomab. It was selected for its highly specific binding affinity to the dengue virus E protein, enabling the prevention and treatment of dengue virus infection by blocking viral propagation in humans.

Dengue fever is an acute infectious disease caused by the dengue virus (DENV) and transmitted through the bites of Aedes mosquitoes. The virus is primarily spread by vectors such as Aedes aegypti and Aedes albopictus. After replicating in the mosquito's salivary gland cells for 8-10 days, it can be transmitted to humans during subsequent blood-feeding. Infected mosquitoes remain capable of transmitting the virus throughout their lifespan and can pass it vertically to their offspring across generations. Aedes mosquito eggs are highly resistant to desiccation and can survive for extended periods in dry conditions. When humans are bitten by virus-carrying mosquitoes, a transmission cycle of mosquito-human-mosquito is established, leading to the continuous spread of the disease. Moreover, dengue fever outbreaks often result from mutations in the dengue virus RNA or the introduction of new external strains.

Global R&D pipelines for dengue prevention and treatment are advancing steadily. In prevention, vaccine development primarily focuses on tetravalent live-attenuated vaccines. For treatment, efforts mainly concentrate on chemical drugs, which inhibit viral replication through multiple mechanisms. Additionally, another monoclonal antibody therapy has entered Phase II clinical trials for dengue treatment, but its clinical effectiveness has not yet been revealed. Currently, global research on novel monoclonal antibody drugs for dengue prevention remains relatively underdeveloped."