Henlius’ biosimilar HLX17 receives FDA approval for clinical trials, entering the over $30 billion market
September 10, 2025
Source: drugdu
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On September 8, Henlius Biosciences (02696) announced that it received approval from the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial of its independently developed pembrolizumab biosimilar, HLX17, in patients with various resected solid tumors. The company plans to conduct this international, multicenter clinical trial in the United States once conditions permit.
The potential indications of HLX17 include melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair gene-deficient tumors and gastric cancer.
According to relevant information, in 2024, the global sales of pembrolizumab will be approximately US$32.056 billion.
Source：https://finance.eastmoney.com/a/202509083507721654.html
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