The Center for Drug Evaluation (CDE) website indicates that China-based RemeGen Co., Ltd’s (HKG: 9995, SHA: 688331) novel fusion protein telitacicept is set to receive breakthrough therapy designation (BTD) status for the treatment of myasthenia gravis (MG). This marks a significant step forward in addressing a rare and challenging autoimmune disease.
Myasthenia Gravis Overview
Myasthenia gravis is a rare and chronic autoimmune disease caused by the dysfunction of nerve muscle junction transmission. Characterized by a long course and difficulty in achieving a cure, patients often experience relapses. Current treatments, including cholinesterase inhibitors, glucocorticoids, and immunosuppressants, have shown unsatisfactory clinical outcomes over long-term use, highlighting the need for more effective therapies.
Telitacicept Profile
Telitacicept is a novel recombinant fusion protein targeting both B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). The drug received conditional approval in China in March 2021 for the treatment of systemic lupus erythematosus (SLE) and was included in the National Reimbursement Drug List (NRDL) at the end of 2021. Telitacicept is also undergoing clinical studies for multiple autoimmune diseases, positioning it as a potential breakthrough therapy for myasthenia gravis.-Fineline Info & Tech
