FDA Approves Shanghai Henlius Biotech's IND Application for Nivolumab Biosimilar HLX18 Phase 1 Trial

Reuters12-19 17:03

FDA Approves <a href="https://laohu8.com/S/SGBCF">Shanghai Henlius Biotech</a>'s IND Application for Nivolumab Biosimilar HLX18 Phase 1 Trial

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Shanghai Henlius Biotech Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20251219-11961499), on December 19, 2025, and is solely responsible for the information contained therein.

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