The board of directors of RemeGen Co., Ltd. announced that the Company has completed the Phase III study on telitacicept (RC18, Brand Name: Tai Ai ®?) for the treatment of patients with rheumatoid arthritis (RA) in China and obtained the relevant data readout, and recently submitted a new drug application (NDA) to the Center for Drug Evaluation of the National Medical Products Administration of China (CDE). This was a randomised, double-blind, placebo-controlled, multicenter Phase III clinical trial that enrolled 479 patients. Results from the full analysis set (FAS) showed that at week 24, patients who received telitacicept (160mg) in combination with methotrexate achieved a significantly higher ACR20 response rate than those who received methotrexate alone, meeting the primary efficacy endpoint of the trial.

Based on the results, the Company recently submitted a NDA to the CDE. Rheumatoid arthritis (RA") is a chronic autoimmune disease characterised by erosive arthritis. The disease causes morning stiffness, swelling and pain in the joints at the onset and later deformities and even loss of normal function in the joints, which seriously affects the quality of life of patients.

The prevalence of RA in China ranges from 0.32% to 0.36%, marking a high incidence. The current standard treatment is mainly anti-inflammatory drugs, glucocorticoids, traditional immunosuppressants and TNF-a inhibitors and other drugs. There are unmet clinical needs for patients who do not respond to or are intolerant to the above therapies.