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F012 is a pegylated recombinant urate oxidase (uricase) developed by Shandong New Era Pharmaceutical, a subsidiary of Lunan Pharmaceutical Group, for the treatment of refractory gout. In humans, the absence of functional urate oxidase leads to high levels of uric acid, which can crystallize in joints and tissues. F012 acts as an enzyme replacement therapy, converting uric acid into allantoin, which is highly soluble and easily eliminated by the kidneys. The attachment of polyethylene glycol (PEG) to the recombinant enzyme is designed to extend its half-life and reduce the risk of immunogenic reactions, which are common with non-modified uricase treatments. It is currently in Phase 2 clinical development for patients with chronic gout who have not responded to standard therapies.
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