Shanghai Henlius Biotech Inc. announced that its investigational new drug application for a phase 1 clinical trial of HLX18, a nivolumab biosimilar (recombinant anti-PD-1 humanized monoclonal antibody injection), has been approved by the United States Food and Drug Administration (FDA). HLX18 is independently developed by Henlius for the treatment of multiple solid tumors. The company plans to initiate the clinical trial in the United States when conditions permit. No other organizations are mentioned as recipients of this regulatory approval.
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