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

The Drug Safety Evaluation Research Center of Shandong Xinbo Pharmaceutical Research Co., Ltd. undertook the non clinical safety research of this variety, including species screening, pharmacokinetic studies, establishment and validation of relevant methodologies, and safety evaluation research. The relevant research data provides support for the clinical trial approval of this variety.
Tetanus is an acute infectious diseases caused by Clostridium tetanus, and there is a great need for preventive medicine.
Whole human monoclonal antibodies are one of the important directions for the development of monoclonal antibody drugs. As of now, there are no monoclonal antibody products against tetanus toxin approved for market in China.
The company has accumulated project experience in the field of non clinical safety evaluation of biological products, and has provided evaluation services for more than 30 innovative non clinical studies of biological products so far, helping them obtain clinical trial licenses. The company will continue to improve its technology platform and service capabilities.