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Tagolizumab (formerly known as tagitanlimab, KL-A167) is a humanized IgG1κ monoclonal antibody targeting programmed cell death ligand 1 (PD-L1). Developed by Kelun-Biotech, tagolizumab blocks the interaction between PD-L1 and its receptor PD-1, thereby reversing T-cell suppression and enhancing anti-tumor immune responses. In December 2024, the National Medical Products Administration (NMPA) of China approved tagolizumab monotherapy (under the brand name Ketaile) for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed two or more lines of chemotherapy. In January 2025, the NMPA approved a second indication for tagolizumab in combination with cisplatin and gemcitabine for the first-line treatment of recurrent or metastatic NPC. Tagolizumab is also being evaluated in combination with other oncology assets, such as the TROP2-directed antibody-drug conjugate sacituzumab tirumotecan (sac-TMT) and the CLDN18.2-directed antibody-drug conjugate SKB315, for various solid tumors including non-small cell lung cancer, triple-negative breast cancer, and gastric cancer.
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