Shanghai Henlius Biotech Receives FDA Approval for IND Application of HLX13 Ipilimumab Biosimilar for First-Line Treatment of Unresectable Hepatocellular Carcinoma
Reuters
Sep 29
<a href="https://laohu8.com/S/SGBCF">Shanghai Henlius Biotech</a> Receives FDA Approval for IND Application of HLX13 Ipilimumab Biosimilar for First-Line Treatment of Unresectable Hepatocellular Carcinoma
**Shanghai Henlius Biotech Inc. Receives FDA Approval for Phase 1 Clinical Trial of Ipilimumab Biosimilar HLX13** Shanghai Henlius Biotech Inc. announced that its investigational new drug (IND) application for HLX13, a biosimilar of Ipilimumab (recombinant anti-CTLA-4 fully human monoclonal antibody injection), has been approved by the United States Food and Drug Administration (FDA). The approval allows the company to initiate a phase 1 clinical trial of HLX13 as a first-line treatment for patients with unresectable hepatocellular carcinoma $(HCC)$. In April 2025, Henlius also entered into a license agreement with Sandoz AG, granting Sandoz exclusive commercialization rights for HLX13 in the United States, selected European countries, Japan, Australia, and Canada. The company cautioned that successful development and commercialization are not guaranteed and advised investors to exercise caution. No grant or funding was reported to have been obtained by multiple organizations; the regulatory approval pertains specifically to Shanghai Henlius Biotech Inc.
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