全球首创：国产破伤风新药登上医学顶刊Nature Medicine

Core Viewpoint - The article discusses the urgent need for a safe, effective, and more accessible alternative to current tetanus immunization therapies, highlighting the promising results of the recombinant monoclonal antibody Siltartoxatug compared to human tetanus immunoglobulin (HTIG) [3][15]. Group 1: Tetanus Overview - Tetanus is a life-threatening infection caused by the neurotoxin produced by Clostridium tetani, with an estimated 34,684 deaths globally in 2019 [1]. - Vaccination coverage for tetanus is inadequate, with 14.3 million infants not receiving the first dose of the DTP vaccine in 2022 [1]. Group 2: Current Treatments and Limitations - WHO recommends passive immunization for tetanus prevention and treatment, but current therapies like equine tetanus antitoxin are associated with allergic reactions occurring in 5%-30% of cases [2]. - HTIG, the replacement for equine antitoxin in developed countries, has issues such as supply shortages, high costs, and risks of infectious disease transmission [2]. Group 3: Siltartoxatug Development - Siltartoxatug, a recombinant fully human IgG1 monoclonal antibody, targets the AB fragment of tetanus toxin, blocking its transport and enzymatic activity [7]. - The monoclonal antibody can be produced on a large scale through standardized industrial processes, offering a viable alternative to plasma-derived therapies [6]. Group 4: Clinical Trial Results - A phase 3 clinical trial demonstrated that Siltartoxatug significantly outperformed HTIG in providing both short-term and long-term protection against tetanus [10][11]. - In the trial, 95.4% of participants receiving Siltartoxatug had a significant increase in neutralizing antibody titers within 12 hours compared to 53.2% for HTIG [10]. Group 5: Safety and Efficacy - The safety profile of Siltartoxatug was comparable to HTIG, with adverse event rates of 38.2% for Siltartoxatug and 33.9% for HTIG [14]. - Allergic reactions were lower in the Siltartoxatug group at 0.2% compared to 0.9% in the HTIG group [14]. Group 6: Regulatory Approval - Siltartoxatug received approval from the National Medical Products Administration (NMPA) in China in February for emergency prevention of tetanus in adults [16].