Prnewswireยท2025-09-18 01:00Core Viewpoint - RemeGen's telitacicept has shown promising results in treating generalized myasthenia gravis (gMG), with data from a 48-week open-label extension of a Phase III clinical study to be presented at the upcoming AANEM Annual Meeting, indicating its potential as a best-in-class therapy in this field [1][3]. Group 1: Clinical Study Results - The 24-week data from the Phase III study of telitacicept revealed that 98.1% of patients experienced a 3-point improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score, while 87% achieved a 5-point improvement in the Quantitative Myasthenia Gravis (QMG) score [3]. - The complete 48-week data presentation is expected to further emphasize telitacicept's efficacy and safety in treating gMG [3]. Group 2: Licensing and Development - In June 2025, RemeGen out-licensed telitacicept to Vor Bio, which is currently advancing a global multicenter Phase III clinical trial for gMG, with patient recruitment ongoing across multiple regions including the US, Europe, South America, and Asia-Pacific [4]. Group 3: Product Information - Telitacicept is the first-in-class injectable recombinant dual-target fusion protein that inhibits the binding of BLyS and APRIL cytokines to B cell receptors, addressing autoimmune diseases [5]. - The drug has already received approval in China for treating systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG) [5]. Group 4: Market Context - Generalized myasthenia gravis is a rare autoimmune disorder affecting approximately 90,000 patients in the US, 140,000 in Europe, and 29,000 in Japan, highlighting a significant unmet clinical need for effective therapies [7].