On Oct 17, RemeGen Co., Ltd. (688331.SH/09995.HK) announced that the global multicenter Phase III clinical IND of Telitacicept for the treatment of adults with active primary Sjögren's syndrome has been approved by the U.S. FDA. Clinical studies will be carried out in many countries and regions around the world.

This is a multicenter, randomized, double-blind, placebo-controlled phase III trial to evaluate the efficacy and safety of Telitacicept in the treatment of adults with active primary Sjögren's syndrome (pSS), and the evaluation of pharmacokinetic characteristics, pharmacodynamics and immunogenicity will also be conducted.

In a series of previous non-clinical projects and clinical trials, the efficacy and safety of Telitacicept in adult patients with pSS have been confirmed. In a phase II study (18C012) involving 42 adult pSS patients in China, both the 240 mg and 160 mg dosage regimens of Telitacicept for Injection showed good efficacy and tolerability. This 48-week global phase III clinical study selected the 160 mg dosage regimen to evaluate the optimal benefit-risk ratio of Telitacicept for Injection in patients with pSS worldwide.

Primary Sjögren's syndrome (pSS) is a common rheumatic disease characterized by autoimmune exocrinopathy. The main clinical features are dry eyes and mouth caused by glandular dysfunction caused by autoimmune damage. Multiple organ systems may also be involved. Studies have shown that B cells are key immune cells involved in the pathogenesis of pSS, and excessive activation of B cells is a pathogenic sign of pSS and has long been regarded as a key target for intervention.

Telitacicept is an innovative BLyS/APRIL dual-target fusion protein drug independently developed by Rongchang Biotechnology. By simultaneously inhibiting the overexpression of two cytokines, BLyS and APRIL, it prevents abnormal differentiation and maturation of B cells through a "two-pronged approach". Thereby treating various autoimmune diseases mediated by B cells. At present, in China, Telitacicept has been fully approved for marketing by the NMPA for systemic lupus erythematosus, and the marketing application for rheumatoid arthritis has been accepted by the NMPA. The Phase III clinical trial for the indications of myasthenia gravis, primary Sjögren's syndrome, and IgA nephropathy neuromyelitis optica and neuromyelitis optica spectrum diseases are in progress. Overseas, the Phase III clinical trials of Telitacicept for systemic lupus erythematosus are progressing smoothly, and the Phase III clinical trials for primary Sjögren's syndrome and myasthenia gravis have been approved by the FDA.

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