SinoMab BioScience Limited (SinoMab, or the Company, HKG: 3681), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 30 November 2021, SM03 (Suciraslimab) Phase III clinical trial for rheumatoid arthritis (RA) has completed its targeted enrollment of 510 patients. The patients currently in screening will be randomized by end of December 2021, given eligibility criteria are met.
SM03 (Suciraslimab), a potential global first-in-target anti-CD22 monoclonal antibody for the treatment of RA and potentially for the treatment of other immunological diseases, is currently in Phase III clinical trials in China. The Phase III clinical trial is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study to confirm the clinical efficacy and long-term safety in active RA patients receiving methotrexate (MTX).
The efficacy and safety of Suciraslimab was previously evaluated in phase II clinical study in moderate-to-severely active RA patients. The study results were published recently and shown that Suciraslimab at a dose of 600 mg with 4 and 6 infusions respectively, were both efficacious and well-tolerated throughout the 24 weeks of treatment when compared with the placebo group. Suciraslimab was effective in suppressing disease activity and alleviating symptoms of moderate-to-severely active RA patients receiving stable doses of background MTX.
Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of the Company, said, “After the Company announced the results of the flagship product, SM03, which is efficacious and well-tolerated earlier, the completion of enrolment in phase III clinical trial is a major milestone in the research and development process; with the smooth progression of the clinical trial, SM03 will soon step into commercialization officially.”
About SinoMab BioScience Limited
SinoMab BioScience Limited (HKG: 3681) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis, systemic lupus erythematosus, pemphigus vulgar, non-Hodgkin’s lymphoma, asthma, and other diseases with major unmet clinical needs.