Biopharmaceutical company RemeGen Co. Ltd. (9995.HK) (SHA:688331) announced on Tuesday the first patient enrollment in the US for its global phase III clinical trial of telitacicept for generalized myasthenia gravis (gMG).

This milestone advances the global clinical development of telitacicept, offering new hope to gMG patients worldwide. Telitacicept has previously received orphan drug and fast track status from the FDA and breakthrough therapy designation from China's NMPA for myasthenia gravis.

The phase III trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating telitacicept's efficacy and safety in treating gMG. It aims to recruit 180 patients across multiple countries and regions. Myasthenia gravis is a rare autoimmune disease impairing neuromuscular junctions, affecting eye movement, swallowing, speech, general movement, and respiratory function. Current treatments include cholinesterase inhibitors, glucocorticoids, and immunosuppressants, but unmet medical needs persist due to efficacy, tolerability and contraindication issues.

Telitacicept is a dual targeting fusion protein attacking BLyS and APRIL, reducing pathogenic antibody production by targeting B cells and plasma cells. Preliminary studies indicate telitacicept's potential to continuously and effectively improve the clinical status of gMG patients.