恒瑞医药(01276):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
智通财经网·2025-08-06 09:19

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