
UB653
ProductTocilizumab injection
Strength80mg(4ml)/vial
IndicationsRheumatoid arthritis; Systemic juvenile idiopathic arthritis; Cytokine release syndrome
TherapeuticsImmunology & Inflammation; Rheumatology
GMPCN - NMPA
RegistrationChina
ModalitiesAntibody
Exclusive Summary
- · Similar to the original primary structure and advanced structure, and similar to the original purity
- · The proportion of non-glycosylated heavy chains was low, suggesting better stability and activity
- · Using a breakthrough purification process, the impurity residue is much lower than that of the original research
- · A total of 669 patients were included in the phase III clinical study, and the efficacy, pharmacokinetics, immunogenicity, and safety were comprehensively evaluated, and the results of the study were comparable to the original study
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