FOSUN PHARMA's Biosimilar HLX05-N Receives FDA Clearance for US Clinical Trial

Stock News05-10

FOSUN PHARMA (600196.SH) has announced that its subsidiary, Shanghai Henlius Biotech, Inc., and its controlled subsidiaries (collectively referred to as "Henlius"), recently received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for HLX05-N (recombinant anti-EGFR chimeric human-mouse monoclonal antibody injection) for the treatment of metastatic colorectal cancer. Henlius plans to commence the related clinical studies for this drug in the United States once the necessary conditions are met. HLX05-N is a biosimilar of cetuximab injection independently developed by the Group (referring to the company and its controlled subsidiaries/units) and is intended for the treatment of metastatic colorectal cancer and head and neck squamous cell carcinoma. In April 2026, the application for a Phase I clinical trial of this drug for metastatic colorectal cancer treatment was approved by China's National Medical Products Administration. According to the latest IQVIA MIDAS™ data, global sales of cetuximab injection in 2025 were approximately $1.658 billion.

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