FDA Approves Shanghai Henlius Biotech's IND Application for Nivolumab Biosimilar HLX18 Phase 1 Trial
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Shanghai Henlius Biotech Inc. has received FDA approval for its investigational new drug application for a phase 1 clinical trial of HLX18, a nivolumab biosimilar. HLX18 is developed for treating multiple solid tumors, and the trial will commence in the U.S. when conditions allow. This approval marks a significant milestone for Henlius in advancing its biosimilar drug development.
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