RemeGen’s Telitacicept (RC18) Received Orphan Drug Designation from EMA for Myasthenia Gravis
On June 16, 2025, RemeGen Co., Ltd. („RemeGen“, stock symbols: 688331.SH/09995.HK) announced that telitacicept (RC18; brand name: ??®) has received Orphan Drug Designation (ODD) from European Medicines Agency (EMA) for the treatment of Myasthenia Gravis (MG), marking a key milestone achieved in its global development. Telitacicept now is the first dual-target biologic drug for MG with ODD from both FDA and EMA worldwide. The designation, granted based on telitacicept’s significant benefits in treating the life-threatening rare disease of MG, will provide advantages to this novel agent on protocol assistance, regulatory fee reductions/waivers and up to 10 years of market exclusivity, thereby accelerating the clinical development, registration and drug approval process in Europe and its availability among MG patients. MG is an acquired antibody-mediated rare autoimmune disorder affecting the neuromuscular junction. According to the Myasthenia Gravis Foundation of America (MGFA) and…
