RemeGen Co. Ltd. has announced that the marketing application for Taicercept® (telitacicept) for the treatment of generalized myasthenia gravis (gMG) has been officially accepted by the Center for Drug Evaluation (CDE) of the China National Food and Drug Administration and has been included in the priority review and approval process.
Myasthenia gravis (MG) is a rare chronic autoimmune disease affecting approximately 217,000 people in China and is characterized by immunoglobulin G (IgG) antibodies disrupting synaptic transmission between nerves and muscles, leading to muscle weakness. More than 85% of patients develop generalized myasthenia gravis within 24 months of disease onset, characterized by extreme fatigue and significant difficulty with facial expression, speech, swallowing, and mobility.
Targeting B-Cells for gMG Treatment
Currently, effective, safe, and precise targeted biological agents are a focal point in myasthenia gravis drug development. B-cell targeted therapies have demonstrated therapeutic potential, significantly reducing the recurrence rate of myasthenia gravis compared to traditional immunotherapy. Telitacicept is a dual target antibody fusion protein, which can target BLyS and APRIL at the same time, and directly attack the source of pathogenic antibodies -- B cells and plasma cells, thereby reducing the production of pathogenic antibodies and resulting in therapeutic effect.
Clinical Trial Success and Regulatory Designations
The company announced the completion of the domestic phase II clinical trial of telitacept in the treatment of generalized myasthenia gravis in August 2024. The results of the clinical study showed that telitacept can continuously and effectively improve the clinical status of patients with generalized myasthenia gravis. Internationally, the global multicenter phase II clinical trial of gMG has achieved the first patient enrollment in the United States in August 2024. Telitacicept has been granted orphan drug and fast track status by the Food and Drug Administration (FDA) of the United States, and breakthrough therapy status by National Medical Products Administration (NMPA) of China.
About Telitacicept
Telitacicept (RC18) is RemeGen's novel fusion protein designed for autoimmune diseases. It comprises the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept targets B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), reducing B-cell mediated autoimmune responses. It was granted complete marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in November 2023 and rheumatoid arthritis (RA) in July 2024.
