Qyuns Therapeutics (HKG: 2509) announced that the New Drug Application (NDA) for QX002N, its first innovative drug, has been officially accepted by China’s National Medical Products Administration (NMPA) (Acceptance No.: CXSS2600039) for the treatment of active ankylosing spondylitis (AS) in adults. The high-affinity IL-17A monoclonal antibody, independently developed by Qyuns, positions the company to enter the competitive autoimmune market with a biosimilar-like innovator targeting the validated IL-17 pathway that drives axial spondyloarthritis pathogenesis.
Forward‑Looking Statements This brief contains forward‑looking statements regarding NDA review timelines, regulatory approval, and commercial positioning for QX002N. Actual results may differ due to NMPA review delays, competitive dynamics with established IL-17A inhibitors, and pricing negotiations.-Fineline Info & Tech
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