On June 11, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the Company has received a clinical trial notice approving the investigational new drug application for the its CLDN18.2-directed antibody-drug conjugate (ADC) SKB315 in combination of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody (mAb) tagitanlimab for the first-line treatment of gastric cancer / gastro-oesophageal junction cancer (GC/GEJC) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Press release, Kelun, JUN 11, 2025, View Source [SID1234653824]).
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SKB315 is a novel CLDN18.2-directed ADC for advanced solid tumors, configured with a proprietary, in-house developed humanized CLDN18.2 mAb and a differentiated payload-linker design. Building upon ongoing monotherapy studies in CLDN-expressing tumors such as GC/GEJC and pancreatic ductal adenocarcinoma, the Company is also initiating clinical studies of its combination therapy with immunotherapy for the first-line treatment of CLDN-positive GC/GEJC.
Tagitanlimab is the first PD-L1 mAb to receive authorization for the first-line treatment of nasopharyngeal carcinoma (NPC). It has been approved by the NMPA for marketing in China as a combination therapy with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic (R/M) NPC, as well as monotherapy for the treatment of patients with R/M NPC who have failed after prior 2L+ chemotherapy.
Previously, tagitanlimab in combination with TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) granted Breakthrough Therapy Designation by the CDE of the NMPA of China for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations.
Encouraging clinical development progress has been made in recent years with combination strategies based on PD-(L)1 antibodies. The innovative ADC SKB315 combined with the PD-L1 monoclonal antibody tagitanlimab is expected to generate synergistic effects through their distinct mechanisms of action, overcoming tumor heterogeneity among different patients and delivering greater survival benefits.