The time when roselixizumab was approved for marketing in China

On May 24, 2025, Rozanolixizumab was officially approved for marketing in China. The trade name is “Udige” and it was introduced by UCB. This approval not only brings a new treatment option to the vast number of myasthenia gravis (gMG; rare disease) patients in China, but also symbolizes an important step in the domestic neuroimmunotherapy field to integrate with international standards. What is particularly critical is that roselixizumab is the first in the world and the only targeted biological agent in China approved to cover both AChR antibody-positive and MuSK antibody-positive gMG patients, breaking the limitations of traditional treatment options in target coverage.

Behind this approval, clinical studies recognized its rapid onset of action, good tolerability and significantIgG antibody clearance capabilities. Rozelixizumabis administered by subcutaneous injection once a week, which is convenient for patients to use at home or outpatient, greatly improving compliance and quality of life. As a new mechanism drug, it blocks the recycling process of IgG antibodies by targeting the neonatal Fc receptor (FcRn), reducing the concentration of pathogenic antibodies from the source, and its onset of effect is significantly faster than traditional immunosuppressive drugs.

Although roselixizumab has not yet been included in the national medical insurance directory, as an important innovative drug that fills the gap in the treatment of gMG, it has attracted great attention from academics and clinicians. As the country gradually tilts its policy toward rare diseases and neuroimmune diseases, the prospect of including this drug in the medical insurance or auxiliary drug catalog is promising.

This listing also shows that the domestic regulatory system has significantly improved the efficiency of new drug review. It took less than two years from the initiation of clinical trials to official approval, demonstrating China's accelerated strategy in introducing cutting-edge international drugs. In the future, roselixizumab may provide new treatment ideas for more autoimmune diseases, and research on its expanded indications also deserves continued attention.

Reference materials:https://www.drugs.com/rystiggo.html