enlonstobart

Enlonstobart (also known as enlongsubimab, SG-001, or SYSA1802) is a recombinant, fully humanized IgG4-kappa monoclonal antibody directed against the immune checkpoint receptor programmed cell death protein 1 (PD-1). By binding to PD-1, enlonstobart blocks its interaction with its ligands, PD-L1 and PD-L2, thereby reversing PD-1 pathway-mediated immunosuppression and reactivating T-cell-mediated anti-tumor immune responses. Originally developed by Hangzhou Sumgen Biotech and subsequently co-developed and commercialized by CSPC Pharmaceutical Group (including its subsidiaries CSPC Megalith Biopharmaceutical and CSPC Zhongqi Pharmaceutical Technology), enlonstobart was approved in China in June 2024 under the brand name Enshuxing for the treatment of PD-L1-positive recurrent or metastatic cervical cancer in patients who have failed platinum-based chemotherapy. It is also undergoing clinical evaluation for various other oncology indications, including a Phase 3 trial in combination with the EGFR-targeting antibody-drug conjugate SYS6010 for first-line treatment of PD-L1-positive advanced non-small cell lung cancer (NSCLC), as well as Phase 2 trials for esophageal squamous cell carcinoma and colorectal cancer.

Brand names

Enshuxing

Other names

enlongsubimab恩朗苏拜单抗