恒瑞医药产品获得美国FDA孤儿药资格认定

Core Viewpoint - Heng Rui Medicine (600276.SH) has received orphan drug designation from the U.S. FDA for its product, injection of Rukang Qutuzumab combined with Adebali injection and chemotherapy for the treatment of gastric cancer or gastroesophageal junction adenocarcinoma [1] Group 1 - The orphan drug designation allows for expedited clinical trials 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 seven years of market exclusivity [1]