JW THERAP-B: The clinical phase I study of Regiokalon for the treatment of moderate to severe active SLE shows good safety and significant efficacy

JW THERAP-B announced that the company has submitted Phase I study data of Ruijiaolun's injection for adult patients with active systemic lupus erythematosus to the National Medical Products Administration of China. As of July 2025, the study has enrolled 12 subjects and completed the infusion of Ruijiaolun injection, preliminarily completing the exploration of safety, efficacy, pharmacokinetics, and pharmacodynamics in low, medium, and high dose groups. All subjects were female, with a median age of 27 years and a median disease history of 9.5 years, all being moderate to severe active SLE patients. Preliminary results showed that among the 12 patients with assessable efficacy at 6 months, 100% met the SRI-4 criteria, 50% met the LLDAS criteria, and 100% were Drug-Free. Disease activity scale scores showed a downward trend, indicating significant efficacy. Safety results showed that 11 patients experienced CRS, all of which were Grade 1, and 1 patient experienced Grade 2 ICANS, which resolved after symptomatic treatment, with no DLT. The Phase I clinical study of Ruijiaolun for moderate to severe active SLE demonstrated good safety and significant efficacy