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Another milestone! Xinkanghe XKH001 has received approval for clinical trials from the China National Medical Products Administration.
Release time:
2021-11-17 09:40
2021Year11Month15Day, Xinkanghe Biopharmaceutical'sXKH001injection clinical trial application has been approved by the China National Medical Products Administration for the treatment of moderate to severe asthma. This is another milestone event following the approval in2021Year7monthFDAapproved the initiation ofPhase Iclinical trials.
XKH001It is the first monoclonal antibody independently developed by Xinkanghe with global intellectual property rights.IL-25Currently, drugs targetingIL-25are all in the preclinical development stage, and no drugs have entered clinical trials.IL-25Also known asIL-17E, isIL-17a member of the family of cytokines, mainly produced by epithelial cells and innate immune cells. When it binds to its receptor, it activates2immune cells, thereby initiating, amplifying, and maintainingTh2immune responses. Research shows thatIL-25is expressed at elevated levels in tissues of2inflammatory diseases, closely related to allergic asthma, atopic dermatitis, and other inflammatory diseases.XKH001It can specifically neutralize humanIL-25, blocking its binding to the receptor, thereby inhibiting the inflammatory response caused byTh2.
This project will conduct clinical Phase Iatrials in the United States by the end of the year. The Xinkanghe team will rapidly advance clinical research, hoping to provide patients with original Chinese drugs through good clinical results.
IL-25 monoclonal antibody
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