Shanghai Henlius Biotech Doses First Patient in International Phase 1 Trial of Pembrolizumab Biosimilar HLX17 for Solid Tumours

Reuters
Sep 26
<a href="https://laohu8.com/S/SGBCF">Shanghai Henlius Biotech</a> Doses First Patient in International Phase 1 Trial of Pembrolizumab Biosimilar HLX17 for Solid Tumours

Shanghai Henlius Biotech Inc. has announced the initiation of an international multi-center phase 1 clinical trial for HLX17, a biosimilar of pembrolizumab (recombinant humanised anti-PD-1 monoclonal antibody injection), in patients with multiple resected solid tumors in mainland China. The study is designed as a randomized, double-blind, parallel-controlled trial to evaluate the similarity of pharmacokinetic profiles, efficacy, safety, and immunogenicity between HLX17 and US-sourced KEYTRUDA® in patients with conditions such as non-small cell lung cancer, melanoma, or renal cell carcinoma. The trial is currently underway, with the first patient already dosed, and results have not yet been presented. The company also plans to extend the clinical trial to the United States, Europe, Australia, and other regions when conditions allow. According to IQVIA MIDAS, global sales of pembrolizumab in 2024 reached approximately USD 32.056 billion.

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