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<p>Retlirafusp alfa (艾泽利<sup>®</sup>), a bifunctional antibody fusion protein combining a PD-L1-targeting antibody with a truncated form of the TGF-β receptor&#xa0;II (TGF-βRII) extracellular domain, is being developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd for the treatment of solid malignant tumours. In January 2026, retlirafusp alfa was approved for use in combination with fluorouracil and platinum-based drugs as a first-line treatment for locally advanced, unresectable, recurrent, or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJA) with a PD-L1 positive CPS ≥&#xa0;1, as assessed by a well-validated assay in China. This article summarizes the milestones in the development of retlirafusp alfa leading to this first approval for the treatment of advanced PD-L1 positive GC/GEJA.</p>

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Retlirafusp Alfa: First Approval

  • 期刊论文

  • 发表日期：

    2026年3月21日

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  • Susan J. Keam

摘要

Retlirafusp alfa (艾泽利®), a bifunctional antibody fusion protein combining a PD-L1-targeting antibody with a truncated form of the TGF-β receptor II (TGF-βRII) extracellular domain, is being developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd for the treatment of solid malignant tumours. In January 2026, retlirafusp alfa was approved for use in combination with fluorouracil and platinum-based drugs as a first-line treatment for locally advanced, unresectable, recurrent, or metastatic gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJA) with a PD-L1 positive CPS ≥ 1, as assessed by a well-validated assay in China. This article summarizes the milestones in the development of retlirafusp alfa leading to this first approval for the treatment of advanced PD-L1 positive GC/GEJA.