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Innovent Biologics Reports Results of IBI303 (biosimilar- adalimumab) in P-III Studies for Ankylosing Spondylitis

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Innovent Biologics Reports Results of IBI303 (biosimilar- adalimumab) in P-III Studies for Ankylosing Spondylitis

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  • The P-III study involves assessing of IBI303 (SC- 40 mg/0.8 ml- q2w) vs the reference product- Humira (adalimiumab) in 438 patients with ankylosing spondylitis across 20 hospitals in China
  • The P-III study resulted in meeting its 1EPs- @24wks. ASAS20 response rate (75% vs 72%) & 2EPs i.e- ASAS20 @12wks.- ASAS40 @24wks; ASAS partial response rates- ASAS5/6 response rate- and BASDAI and were published in The Lancet Rheumatology
  •  IBI303 is a mAb of TNF-alpha having the same amino acid sequence- showing a high degree of biosimilarity data to the reference product- AbbVie’s Humira and has received NMPA’s Priority Review for its NDA

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Ref: Innovent Biologics | Image: Innovent


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