恒瑞医药：注射用瑞康曲妥珠单抗联合阿得贝利单抗注射液和化疗用于胃癌或胃食管结合部腺癌适应症获得美国 FDA孤儿药资格认定

Core Viewpoint - Heng Rui Medicine has received orphan drug designation from the FDA for its product, injection of Rukang Qutuzumab combined with Adebali monoclonal antibody and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma, which will provide opportunities for policy support in product development, registration, and commercialization [1] Group 1 - The product received orphan drug designation, which is aimed at drugs for rare diseases [1] - This designation will accelerate the clinical trial and market registration process [1] - The company will benefit from various policy supports, including tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [1]