Belgium-based biopharma UCB (EBR: UCB) announced the official market launch of Rystiggo (rozanolixizumab) in China. This chimeric monoclonal antibody received marketing approval in March of this year for use in combination with conventional therapy for adult generalized myasthenia gravis (gMG) patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
Rystiggo’s Mechanism and Innovation
Rystiggo is a neonatal Fc receptor blocker and stands as the world’s first and currently the only biological agent approved in China for both AChR-positive and MuSK-positive gMG patients. Clinical studies have confirmed that Rystiggo reduces total IgG levels by 50% in patients within the first week of treatment, leading to rapid symptom relief. By the sixth week of treatment, patients demonstrated a significant reduction of 3.4 points from baseline on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, with 72% of patients achieving a reduction of ≥2 points.
Dosage and Administration
Rystiggo also exhibits sustained efficacy within a single treatment cycle, enabling long-interval dosing. Among all treated patients, regardless of follow-up duration, the average annual treatment frequency was 2.9 cycles and 16.0 infusions. Administered via subcutaneous injection, Rystiggo offers simplified administration—a single treatment for patients weighing under 50 kg requires only approximately 6 minutes to complete.-Fineline Info & Tech
