First U.S. Patient Enrolled in Global Phase III Telitacicept Trial for Myasthenia Gravis

YANTAI, China, Aug. 6, 2024 – RemeGen Co. Ltd. has announced the commencement of the first patient enrollment in the United States for its global phase III clinical trial of telitacicept, a novel BLyS/APRIL dual targeting fusion protein drug, aimed at treating generalized myasthenia gravis (gMG). This significant milestone highlights the progression of telitacicept’s international clinical development, providing new hope for individuals affected by myasthenia gravis.

Telitacicept has previously received orphan drug and fast track designation for myasthenia gravis from the US Food and Drug Administration (FDA) and a breakthrough therapy designation from China’s National Medical Products Administration (NMPA). These recognitions underscore the drug’s potential and the urgent need for effective treatments in this therapeutic area.

The phase III clinical trial is designed as a global, multicenter, randomized, double-blind, placebo-controlled study. It aims to assess both the efficacy and safety of telitacicept in patients with gMG. The trial plans to enroll 180 participants across various countries and regions.

Myasthenia gravis is a rare and chronic autoimmune disorder that disrupts communication at neuromuscular junctions, leading to symptoms such as impaired eye movement, difficulty swallowing, speech challenges, general mobility issues, and compromised respiratory function. As per a Frost & Sullivan report, the global population of individuals with myasthenia gravis is projected to reach 1.15 million by 2025, including approximately 70,000 in the United States and 22,000 in China.

Current treatment options for myasthenia gravis include cholinesterase inhibitors, glucocorticoids, and immunosuppressants. However, many patients continue to experience unmet medical needs due to the inefficacy, poor tolerability, or contraindications of existing treatments.

Telitacicept is a unique antibody fusion protein that concurrently targets BLyS and APRIL, directly addressing the source of pathogenic antibodies by targeting B cells and plasma cells. This action reduces the production of harmful antibodies and fulfills its therapeutic purpose. Preliminary clinical studies have indicated that telitacicept effectively and consistently improves clinical outcomes for patients with generalized myasthenia gravis.

Since its approval in China in March 2021, telitacicept has treated over 40,000 patients, demonstrating notable efficacy and safety. In China, beyond its approved indications for systemic lupus erythematosus and rheumatoid arthritis, telitacicept is poised for potential approval in treating myasthenia gravis, Sjogren's syndrome, IgA nephritis, and neuromyelitis optica in the forthcoming years.

RemeGen Co. Ltd., established in 2008, is a premier biopharmaceutical firm in China focused on addressing unmet clinical needs for patients with severe diseases. The company has research facilities and offices in China and the United States. RemeGen is dedicated to the discovery, development, and commercialization of innovative and differentiated biologic drugs with substantial clinical value, particularly in autoimmune, oncology, and ophthalmic disease areas.

Telitacicept (RC18) is RemeGen’s innovative fusion protein specifically designed for the treatment of autoimmune diseases. It combines the extracellular domain of the human TACI receptor with the Fc domain of human IgG. This novel construction allows telitacicept to target two critical cell-signaling molecules involved in B-lymphocyte development: BLyS and APRIL, thereby effectively reducing B-cell mediated autoimmune responses implicated in various autoimmune diseases.