RemeGen's Telitaccept Marketing Application for Myasthenia Gravis Approved in China

YANTAI, China, Oct. 29, 2024 -- RemeGen Co. Ltd. ("RemeGen"), a biotechnology company operating at a commercial stage, has made an important announcement regarding its product Taicercept®. The Center for Drug Evaluation (CDE) of the China National Food and Drug Administration has accepted its marketing application for the treatment of generalized myasthenia gravis (gMG) and prioritized it for review and approval.

Myasthenia gravis (MG) is a chronic autoimmune disorder marked by muscle weakness. The disease interferes with the synaptic transmission between nerves and muscles through immunoglobulin G (IgG) antibodies. This disruption leads to severe muscle fatigue and can cause life-threatening complications. Approximately 85% of MG patients develop the generalized form of the condition within two years of its onset. These patients experience extreme tiredness and find it difficult to perform basic functions like facial expressions, speech, swallowing, and movement.

Current treatments for myasthenia gravis have not proven entirely satisfactory, highlighting the growing interest in precise, targeted biological agents. B-cell targeted therapies have emerged as a promising area in the treatment of MG, significantly reducing the recurrence rate compared to traditional immunotherapies. Taicercept is a dual-target antibody fusion protein that targets BLyS and APRIL, attacking the source of pathogenic antibodies by focusing on B cells and plasma cells. This approach reduces the production of harmful antibodies, offering a therapeutic benefit for MG patients.

In August 2024, RemeGen completed a domestic phase III clinical trial for the treatment of generalized myasthenia gravis with Taicercept. The clinical study results revealed that Taicercept could continuously and effectively improve the condition of patients with generalized MG. On an international scale, the global phase III clinical trial has begun, with the first patient enrolled in the United States in August 2024. Taicercept has received orphan drug designation and fast track status from the U.S. Food and Drug Administration (FDA), as well as breakthrough therapy status from China's National Medical Products Administration (NMPA).

About Telitacicept (RC18):
Telitacicept (RC18) is a proprietary fusion protein developed by RemeGen for treating autoimmune diseases. It combines the extracellular domain of the human TACI receptor with the Fc domain of human immunoglobulin G (IgG). This fusion protein targets BLyS and APRIL, key molecules in B-lymphocyte development, effectively reducing B-cell mediated autoimmune responses implicated in several autoimmune conditions. Telitacicept received complete marketing approval for systemic lupus erythematosus (SLE) from NMPA in November 2023, and for rheumatoid arthritis (RA) in July 2024.

About RemeGen Co. Ltd.:
Founded in 2008, RemeGen is a leading biopharmaceutical company in China focused on addressing unmet clinical needs for patients with life-threatening diseases. The company has research facilities and offices in both China and the United States. RemeGen is dedicated to discovering, developing, and commercializing innovative biologic drugs with significant clinical value, particularly in the fields of autoimmune, oncology, and ophthalmic diseases.