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HL-TOF is a generic formulation of tofacitinib developed by Hanlim Pharm. Co., Ltd. for the treatment of moderate to severe rheumatoid arthritis. It is formulated as tofacitinib freebase, distinguishing it from the reference product Xeljanz, which contains tofacitinib citrate. As a small molecule Janus kinase (JAK) inhibitor, HL-TOF targets JAK1, JAK2, and JAK3, and to a lesser extent TYK2, thereby inhibiting the signaling of multiple cytokines involved in the inflammatory cascade. The drug has undergone Phase 1 clinical evaluation in healthy volunteers to establish bioequivalence, safety, and pharmacokinetic profiles comparable to the branded reference product.
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