Shanghai Junshi Biosciences Co., Ltd. (688180.SH) announced that it recently received the "Acceptance Notice" issued by the National Medical Products Administration (NMPA). The new drug application for its product, Nuo Kao Qi Monoclonal Antibody Injection (recombinant humanized anti-IL-17A monoclonal antibody injection, product code: JS005), has been accepted for the treatment of moderate to severe plaque psoriasis in adult patients suitable for systemic therapy or phototherapy.
Nuo Kao Qi is a self-developed, highly specific anti-IL-17A monoclonal antibody. IL-17A (interleukin-17A) is a pleiotropic cytokine, and its dysregulated secretion is closely associated with the development of autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis. By binding with high affinity to IL-17A and selectively blocking its interaction with the IL-17RA/IL-17RC receptor, Nuo Kao Qi inhibits downstream signaling pathway activation and inflammatory cytokine release, effectively alleviating symptoms of autoimmune diseases.
As of the announcement date, in addition to this new drug application, all participants in the Phase II clinical study of Nuo Kao Qi for the treatment of active ankylosing spondylitis have completed treatment and entered the safety follow-up period.
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