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Envafolimab is a humanized single-domain monoclonal antibody targeting programmed death-ligand 1 (PD-L1). It is the world’s first subcutaneously administered PD-(L)1 inhibitor approved for clinical use. Envafolimab blocks the interaction between PD-L1 and its receptor PD-1, thereby enhancing T-cell mediated immune responses against tumor cells. Developed by Alphamab Oncology (康宁杰瑞), in collaboration with 3D Medicines (思路迪医药) and Simcere Pharmaceutical (先声药业), envafolimab has demonstrated efficacy and safety in multiple cancer types, particularly in patients with advanced solid tumors characterized by high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). It was first approved in China for adult patients with unresectable or metastatic MSI-H/dMMR advanced solid tumors who have progressed following standard therapies. The drug has also received orphan drug designation from the US FDA for advanced biliary tract cancer and soft tissue sarcoma, and is being investigated globally across various indications including endometrial cancer, gastric cancer, colorectal cancer, non-small cell lung cancer, HIV infection cure research, chronic hepatitis B virus infection, among others[2][3][5][6][8].
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