On October 30, 2023, Changchun Baike Biotechnology Co., Ltd. independently developed a Class 1 new drug - a combination of fully human anti tetanus toxin monoclonal antibody A82/B86 injection, which received the "Drug Clinical Trial Approval Notice" (acceptance number CXSL2300536) issued by the National Medical Products Administration. It is mainly used for the prevention of tetanus in clinical practice.

The Drug Safety Evaluation Research Center of Shandong Xinbo Pharmaceutical Research Co., Ltd. has undertaken preclinical safety studies for a Class 1 new drug - a combination of fully human anti tetanus toxin monoclonal antibodies A82/B86 injection, including preclinical species screening, pharmacokinetic studies, methodological establishment and validation, and comprehensive safety evaluation studies. The results show that this product has good safety and has helped it obtain clinical trial approval.

Tetanus is an acute traumatic infectious diseases caused by the invasion of Clostridium tetanus (Tetanus). The population susceptible to tetanus includes newborns, unvaccinated individuals, drug users, and immunocompromised individuals. The average mortality rate of tetanus worldwide is 30-50%. Without medical intervention, the mortality rate of critically ill patients is close to 100%, especially elderly and infant patients.

Among them, monoclonal antibodies are widely used in the development of specific target drugs due to their unique advantages, and have great potential in tumor treatment and prevention and treatment of infectious diseases. With the development and iteration of monoclonal antibody drug development technology, it has evolved from mouse antibodies to fully human monoclonal antibodies. Compared to heterologous serum, mouse derived antibodies, humanized antibodies, and chimeric antibodies, fully humanized antibodies can minimize host heterogeneity to ensure product safety, while also having excellent production capacity to meet market demand. As of now, there are no monoclonal antibodies against tetanus toxin approved for sale in China.

Shandong Xinbo Pharmaceutical Research Co., Ltd. has rich experience in preclinical safety evaluation of biological products, and has helped more than 30 fully innovative biological products obtain clinical approvals. At the same time, Shandong Xinbo Pharmaceutical Research Co., Ltd. will continue to explore and accumulate relevant experimental technologies, improve service capabilities, in order to provide high-quality and efficient services to more customers around the world, and help new drugs be approved quickly.

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