根据ClinicalTrials官网，武田已经于今年12月启动了mezagitamab治疗成人慢性ITP患者的国际多中心3期临床研究。在中国，武田已经完成该产品治疗持续性/慢性原发性免疫性血小板减少症的2期临床研究。本次该产品再次获得临床试验默示许可，意味着在中国迎来新的进展。Takeda Pharmaceutical (TAK.US) CD38 monoclonal antibody has been approved for clinical trials in China.
According to Zhito Finance APP, on December 16, the State Drug Administration of China CDE website announced that Takeda Pharmaceutical (TAK.US) has received a new clinical trial implied approval for the Class 1 new drug mezagitamab injection, which is intended to develop treatment for primary immune thrombocytopenia (ITP). Public information shows that mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody (mAb) with high affinity for cells expressing CD38 (including plasma cells, plasma cells, and natural killer cells), leading to their depletion. The aim of mezagitamab treatment is to provide rapid and sustained improvement in platelet response and restore platelet counts to functional levels.
Screenshot source: CDE official website.
According to ClinicalTrials official website, Takeda has launched an international multicenter Phase 3 clinical study of mezagitamab for adult patients with chronic ITP in December this year. In China, Takeda has completed the Phase 2 clinical study of the product for the treatment of persistent/chronic primary immune thrombocytopenia. The recent clinical trial implied approval for this product means new progress in China.