2025 年 7 月 8 日，北京大学人民医院 王传林 主任医师、 珠海泰诺麦博制药股份有限公 司 王 莞梅 博士作为共同通讯作者，在国际顶尖医学期刊 Nature Medicine 发表了题为： Recombinant monoclonal antibody siltartoxatug versus plasma-derived human tetanus immunoglobulin for tetanus: a randomized, double-blind, active-controlled, phase 3 trial 的临床研究论文。 这项随机、双盲、活性对照的 3 期临床试验结果显示， 全球首创的重组全人源抗破伤风毒素单克隆抗体新药—— 斯泰度塔单抗 （ Siltartoxatug ） ，相比当前 唯一推荐的抗破伤风被动免疫疗法 人破伤风免疫球蛋白 ，可提供更好的短期和长期防护效果。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 破伤风 是一种由破伤风梭菌 （ Clostridium tetani ） 产生的强效神经毒素所引发的危及生命的感染。在世界许多地区，尤其是在低收入国家或疫苗接种计划不完 ...

Group 1 - The documentary highlights a revolutionary breakthrough in the field of tetanus prevention, showcasing the innovative monoclonal antibody drug, New Tizhuo (generic name: Staidutata monoclonal antibody injection), developed by Zhuhai Tenomab Pharmaceutical Co., Ltd, which offers a new "Chinese solution" to longstanding clinical challenges in this area [1][2] - Approximately 50 million people in China use tetanus vaccines annually, indicating a significant public health concern, as traditional tetanus treatments derived from horse and human blood have notable safety and accessibility issues [1][2] - The approval of New Tizhuo by the National Medical Products Administration (NMPA) on February 11, 2025, marks a significant advancement in tetanus prevention, allowing for rapid intramuscular injection without the need for skin tests or routine observation [2][3] Group 2 - Traditional tetanus treatments, such as Tetanus Antitoxin (TAT), have a high allergic reaction rate of 5% to 30%, leading to safety concerns and their removal from the WHO's essential medicines list in 1991 [2] - The new drug utilizes fourth-generation monoclonal antibody technology, which has low immunogenicity and a significantly reduced incidence of allergic reactions, addressing the supply challenges of traditional human immunoglobulin [3] - The company emphasizes the importance of source innovation in drug development, highlighting the need for original research and development to meet domestic healthcare needs [3][4]