RemeGen Co., Ltd. (688331.SH/ 9995.HK) (“RemeGen”) announced on November 22nd that Telitacicept for Injection, a novel fusion protein targeting both B lymphocyte stimulator (BlyS) and a proliferation-inducing ligand (APRIL), has been granted full approval by China’s National Medial Product Administration (NMPA).
Telitacicept had been conditionally approved by NMPA for marketing in China before. The full approval means the drug has been proven safe and effective for most of the target population by all the necessary clinical trials, and can be widely used for the treatment of Systemic Lupus Erythematosus (SLE). The newly granted approval is based on a multicenter, randomized, double-blind and placebo-controlled Phase 3 confirmatory clinical study, the results of which showed that all the pre-defined clinical endpoints were achieved and Telitacicept demonstrated good safety profile.
Telitacicept is an antibody fusion protein, which can inhibit overexpression of two cell factors, namely BlyS and APRIL, simultaneously and inhibit B cells proliferation and maturation. Therefore, it could be a treatment for a variety of autoimmune diseases such as B cell-mediated SLE. Now, the biologics license application of Telitacicept for treatment of rheumatoid arthritis (RA) has been received by Center of Drug Evaluation (CDE), NMPA in China. Phase 2/3 clinical trials in other indications of autoimmune diseases are underway in China and the rest of the world