On Oct 17, RemeGen Co., Ltd. announced that the global multicenter phase 3 clinical trial of Telitacicept (Trade name: Tai’ai) for the treatment of systemic lupus erythematosus(SLE) was approved by the European Union and NMPA on September 26 and 28, which are two milestones of Telitacicept after the first patient enrolled in a global multicenter phase 3 clinical trial in the U.S. in the first half of this year.
To facilitate patients self-medication, improve the convenience of clinical application and compliance, RemeGen developed liquid preparation of Telitacicept, Telitacicept for Injection (Research code: RC18-L, prefilled injection), and started the global multicenter clinical trial of the liquid formulation for the treatment of systemic lupus erythematosus(SLE).
This is a multicenter, randomized, double-blind, placebo-controlled, two-stage trial to evaluate the efficacy and safety of Telitacicept in patients with moderately to severely active SLE, and more than 100 sites worldwide are expected to participate in this study, including North America, Central/South America, Europe, and Asia. The clinical trial was approved by the European Union and NMPA, marking the acceleration of the globalization of Telitacicept.
