Core Viewpoint - Sidley Pharmaceuticals (01244) announced that its commercial product Envita (generic name: Envafolimab injection, original research code: KN035) has officially received orphan drug designation for the indications of gastric cancer and gastroesophageal junction cancer, marking the third orphan drug indication approval following cholangiocarcinoma and soft tissue sarcoma [1] Group 1 - The approval is based on the results of the Phase II clinical study of Envita in patients with advanced gastric/gastroesophageal junction adenocarcinoma, which demonstrated clear antitumor efficacy [1] - The objective response rate of the combination with the FOLFOX regimen reached 60%, and the disease control rate was as high as 100% [1] - The safety and tolerability of the treatment were good, with no adverse events leading to treatment discontinuation or death reported [1]
思路迪医药股份：恩维达 胃癌和胃食管结合部癌适应症获孤儿药资格认定