Core Viewpoint - Sihuan Pharmaceutical Holdings Group Ltd. (01244) shares rose nearly 7%, reaching HKD 4.73 with a trading volume of HKD 911,200, following the announcement of its product Envidat receiving orphan drug designation for gastric cancer and gastroesophageal junction cancer indications [1] Group 1: Product Development - Envidat (generic name: Envafolimab injection, original research code: KN035) has officially received orphan drug status for its third indication, following approvals for cholangiocarcinoma and soft tissue sarcoma [1] - The approval is based on the results of a Phase II clinical study demonstrating significant antitumor efficacy, with an objective response rate of 60% and a disease control rate of 100% when combined with the FOLFOX regimen [1] Group 2: Safety and Tolerability - The clinical study indicated that Envidat has good safety and tolerability, with no adverse events leading to treatment discontinuation or death reported [1]
思路迪医药股份涨近7% 恩维达针对胃癌和胃食管结合部癌适应症获孤儿药资格认定