{"id":35496,"date":"2025-06-18T18:07:45","date_gmt":"2025-06-18T10:07:45","guid":{"rendered":"https:\/\/flcube.com\/?p=35496"},"modified":"2025-06-18T18:07:46","modified_gmt":"2025-06-18T10:07:46","slug":"remegens-telitacicept-receives-orphan-drug-designation-for-myasthenia-gravis-in-europe","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35496","title":{"rendered":"RemeGen’s Telitacicept Receives Orphan Drug Designation for Myasthenia Gravis in Europe"},"content":{"rendered":"\n

China-based RemeGen Co., Ltd. (SHA: 688331<\/a>, HKG: 9995<\/a>) announced that it has received orphan drug designation (ODD) from the European Commission for its telitacicept (RC18) as a treatment for myasthenia gravis (MG).<\/p>\n\n\n\n

Myasthenia Gravis: Disease Overview<\/strong>
Myasthenia gravis is a rare autoimmune disorder that affects 15-25 individuals per 100,000 globally, meeting the EU’s definition of a rare disease. While existing treatments can partially control symptoms, many patients experience inadequate responses or are unable to tolerate long-term treatment side effects. Frequent disease relapses highlight the significant unmet clinical needs.<\/p>\n\n\n\n

Telitacicept Innovation<\/strong>
Telitacicept represents the world’s first approved BLyS\/APRIL dual-target fusion protein therapy for patients with myasthenia gravis. The therapy addresses the root cause of the disease by simultaneously blocking BLyS and APRIL signaling pathways, more effectively suppressing abnormally activated B cells and reducing the production of pathogenic autoantibodies.-Fineline Info & Tech<\/a><\/p>\n\n\n\n