Core Viewpoint - Corning Jereh's Envafolimab has received Orphan Drug Designation from the FDA for the treatment of gastric cancer and gastroesophageal junction cancer, marking its third orphan drug designation after advanced biliary tract cancer and soft tissue sarcoma [1][2]. Group 1: Product Development - Envafolimab is a subcutaneously administered PD-L1 single-domain antibody Fc fusion protein developed by Corning Jereh [2][3]. - The product has been in collaboration with Sorrento Therapeutics since 2016, with a strategic partnership established in March 2020 involving Corning Jereh, Sorrento Therapeutics, and Ascletis Pharma [2][3]. - Envafolimab was approved for marketing in China in November 2021 for use in unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors [2][3]. Group 2: Regulatory Milestones - The FDA's Orphan Drug Designation for Envafolimab is significant as it provides incentives for the development of treatments for rare diseases [1]. - Prior to this designation, Envafolimab had already received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) for treating high tumor mutational burden (TMB-H) unresectable or metastatic solid tumors [2][3].
恩沃利单抗又一适应症获FDA孤儿药资格认定