恒瑞医药(600276.SH)产品获得美国FDA孤儿药资格认定

Core Viewpoint - Heng Rui Medicine's product, injection of Rukang Trastuzumab combined with Atezolizumab and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma, has received orphan drug designation from the U.S. FDA, which will expedite clinical trials and market registration [1] Group 1 - The orphan drug designation allows for accelerated clinical trial and market registration processes [1] - The company will benefit from various policy supports, including tax credits for clinical trial costs and exemption from new drug application fees [1] - Upon approval, the product will enjoy a seven-year market exclusivity [1]