China’s Center for Drug Evaluation (CDE) has accepted Trinomab Biotech Co., Ltd.’s market approval filing for its antitetanus toxin monoclonal antibody (mAb) injection, TNM002, for review.
TNM002, developed using Trinomab’s proprietary HitmAb technology platform, has demonstrated strong drug specificity, favorable safety profiles, and exceptional efficacy in neutralizing tetanus toxin in pre-clinical studies. This next-generation mAb, produced through gene recombination technology, has the potential to surpass traditional treatments, including anti-toxin TAT and human tetanus immunoglobulin (hTIG), positioning it as the world’s first fully humanized anti-tetanus toxin mAb. The product received breakthrough therapy designation in China in March 2022, following its fast-track status from the FDA in August.- Flcube.com
