Kelun-Biotech's Novel CLDN18.2 ADC SKB315 IND in Combination with Tagolizumab Receives NMPA Approval for the First-Line Treatment of Gastric/Gastro-oesophageal Junction Cancer

CHENGDU, China, June 12, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") today announced 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).

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.

About Kelun-Biotech
Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit .

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