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On November 23, Xinda Bio announced that its recombinant human anti-tumor necrosis cause - α (TNF-α) monoclonal antibody drug Su Lixin ® (Adamo monoantigen injection, English trademark: SULINNO®) was officially approved by the State Drug Administration for the treatment of polyarthritis in young children, which is the fourth adaptation approved by Suleyn ®.
previously, Su Lixin ® was approved for listing by NMPA on September 2, 2020, and the three adaptations approved were rheumatoid arthritis, strong straight spina bifida, and psoriasis.
idiopathic arthritis (JIA) in childhood refers to unexplained arthritis that is unexplained at or under the age of 16 and has a course of 6 weeks or more.
arthritis is divided into less arthritis (< 5 joints) and multiple arthritis.
can be divided into two subtypes: rheumatoid factor (RF) negative multi-joint type JIA and RF-positive multi-joint type JIA.
estimated that RF-negative multi-joint JIA affects 1-4/100,000 children per year.
the less common RF-positive multi-joint type JIA is estimated at 0.3-0.7/100,000 children/year.
JIA occurs in children's special age group, and accompanied by more symptoms, if not treated, it will lead to higher teratogenic, disabling, fatality rate, seriously affecting the quality of life of children.
early positive treatment can improve outcomes and prevent potential complications. since its launch, the
original drug Adamo single anti-injection has been approved worldwide for the treatment of 17 diseases including rheumatoid arthritis, hyperthyroiditis, psoriasis, psoriasis arthritis, early-onset idiopathic arthritis, Crohn's disease (including children's Crohn's disease), ulcerative colitis, septic sweating gout, and staphylococcitis.
the drug has been widely used in North America and Europe to treat idiolytitis in young children.
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