Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443), a biopharmaceutical company based in China, has submitted a new indication filing for its innovative biologic product xeligekimab, which has now been accepted for review by the National Medical Products Administration (NMPA). This latest filing seeks approval for xeligekimab to treat radiologically positive axial spondyloarthritis (ax-SpA), adding a significant potential indication for the drug in China.
Xeligekimab, an anti-IL-17 antibody developed entirely by Genrix, has yet to receive market authorization. The first NDA for the molecule was filed in March 2023 for use in moderate-to-severe plaque psoriasis. If approved, xeligekimab will be the first domestically developed anti-IL-17 therapy available in China. The biologic works by selectively targeting IL-17A, inhibiting IL-17RA signal transduction, and reducing IL-17A-induced inflammation.- Flcube.com
