SinoMab’s SM03 Meets Primary Endpoint in Phase III Rheumatoid Arthritis Trial

Hong Kong-based biopharmaceutical company SinoMab BioScience Ltd (HKG: 3681) has announced that its Phase III clinical study for the CD22 monoclonal antibody (mAb) SM03, also known as suciraslimab, has successfully reached the primary endpoint in patients with rheumatoid arthritis (RA).

Study Design and Efficacy of Suciraslimab
The randomized, double-blind, multi-center, placebo-controlled study aimed to assess the clinical efficacy and safety of suciraslimab when combined with methotrexate (MTX) in active RA. The primary endpoint was the proportion of subjects who achieved an American College of Rheumatology 20% response (ACR20) at week 24. Top-line results indicated that the combination of SM03 with MTX effectively reduced disease activity and alleviated symptoms in patients with active rheumatoid arthritis.

Innovative Mechanism of Suciraslimab
Suciraslimab is noted as the world’s first CD22 monoclonal antibody developed to treat RA and other autoimmune diseases. It offers a unique mechanism of action that differs significantly from existing products on the market, potentially providing a new treatment option for patients with RA.-Fineline Info & Tech

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