Preliminary data of the preliminary data of SLE III confirmed research in Thai Sepupa

On September 19, Rongchang Biopharmaceutical (Yantai) Co., Ltd. (688331.SH/09995.HK) announced that it has completed the patients with RC18 (product name: Taiai®) for the treatment of systemic lupus erythematosus (SLE) patients (SLE) patients (SLE) patients (SLE) patients (SLE) patients (SLE) patient The domestic phase III confirmed research and obtained preliminary data results.

This is a clinical study of multi -centered, random, double -blindness, and placebo control. A total of 335 SLE patients were included in the group. The patient was randomly assigned to the Thai Sip (160 mg) group or the placebo group. , Combined with standard treatment for 52 weeks. The preliminary results show that this study has reached the preset clinical end point. The 52nd week SRI-4 response rate was 82.6%in the Thai Sip group, and the placebo group was 38.1%. The results of all sensitive analysis show that the SRI-4 reaction rate of the Thai Sip group is significantly higher than that of the placebo group. Thai Sip also shows good security.

Taipu is an antibody fusion protein drug molecules inventing and designed by the company's CEO and chief scientific official House, and the excessive expression of the two cytokines of Blys and April by simultaneously inhibiting the abnormal differentiation and maturity of B cells from the "two -pronged approach" to prevent B cells from abnormal differentiation and maturity , Thereby treating a series of autoimmune diseases such as systemic lupus erythematosus in B cells. On March 9, 2021, Thai Sip's systemic lupus erythematosus indications officially obtained the domestic listing approval of the State Drug Administration, and entered the national medical insurance category at the end of the same year.

When the domestic confirmation clinical study was completed, the global multi -centered phase III clinical trials of patients with systemic lupus erythematosus were promoted smoothly, and the first subject to the United States in the first half of this year was administered in the United States. Essence This study is a multi -centered, random, double -blind, and placebo -controlled two -stage test in patients with severe activity and systemic lupus erythematosus. More than 100 research centers in South America, Europe, Asia, and the world will participate in this study.

Except for systemic lupus erythematosus adaptation, Thai Sippi treats rheumatoid arthritis, IgA nephritis, primary drying syndrome, optic neuritis spectrum disease, intensive muscle weakness, multiple sclerosis and other indications Period clinical research is also being promoted. Among them, Phase II clinical trials for the treatment of IgA nephropathy have completed the first patient administration last year.

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