#China #Yantai #RemeGen #Myasthenia Gravis #Telitacicept

Results of Phase III Clinical Study of Telitacicept for Generalized Myasthenia Gravis

On September 17, 2025, RemeGen Co., Ltd. announced the findings from the 48-week open-label extension of its Phase III clinical study of telitacicept, a novel treatment for generalized myasthenia gravis (gMG). This groundbreaking study is notable for its selection as an oral presentation at the upcoming 2025 American Association of Neuromuscular Electrodiagnostic Medicine (AANEM) Annual Meeting, scheduled to take place from October 29 to November 1 in San Francisco, California.

Presentation Overview

The presentation titled "Efficacy and Safety of Telitacicept in Patients with Generalized Myasthenia Gravis: Results from a Phase 3 Study" is set to occur on October 29, 2025, at 10:50 AM Pacific Standard Time. This session, which has been specifically invited by the Myasthenia Gravis Foundation of America, aims to disseminate crucial findings from the study amidst some of the leading experts in neuromuscular medicine.

Previously, RemeGen had shared 24-week data at the 2025 American Academy of Neurology (AAN) Annual Meeting earlier this year. The results revealed that an impressive 98.1% of patients demonstrated an improvement of at least three points on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, while 87% attained a minimum five-point enhancement in the Quantitative Myasthenia Gravis (QMG) scoring metric. The outcomes have positioned telitacicept as exhibiting the highest MG-ADL response rate amongst drugs that have completed Phase III studies for gMG.

The Significance of Telitacicept

Telitacicept, also known as RC18 and marketed under the brand name 泰爱®, is distinctive as the world's first injectable recombinant dual-target protein that inhibits the B-lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL). Through its dual-action mechanism, telitacicept obstructs the binding of these crucial cytokines, preventing unfavourable B cell maturation tied to autoimmune diseases like gMG. Approved in China for gMG, systemic lupus erythematosus, and rheumatoid arthritis, telitacicept holds immense promise as a potential best-in-class therapy for gMG.

In a significant strategic move, RemeGen out-licensed telitacicept to Vor Bio, a clinical-stage biotech entity pursuing the progressive advancement of telitacicept in a global multicenter Phase III clinical trial for gMG. Recruitment efforts are currently moving ahead swiftly across the United States, Europe, South America, and the Asia-Pacific region.

Understanding Generalized Myasthenia Gravis (gMG)

Generalized myasthenia gravis is a rare and chronic autoimmune disorder that severely disrupts the communication pathways between nerves and muscles, leading to debilitating muscle weakness. This condition can compromise vital functions such as mobility, vision, swallowing, and even breathing. The disorder primarily affects individuals through autoantibodies that obstruct neuromuscular transmission. Currently, there is a pressing demand for innovative therapies to provide sustainable efficacy while ensuring patient safety and ease of use. In the United States alone, approximately 90,000 patients grapple with gMG, underscoring the urgent need for effective treatments.

In summary, as RemeGen prepares to present its pivotal findings at the AANEM Annual Meeting, the data surrounding telitacicept’s efficacy could signify a transformative shift in the management of generalized myasthenia gravis, opening doors for broader therapeutic options and enhanced patient outcomes.

For more information, visit RemeGen's official website.