Core Viewpoint - Heng Rui Medicine has received orphan drug designation from the FDA for its product, injection of Rukang Qutuzumab combined with Adebeli monoclonal antibody and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma, which will provide significant support in product development and commercialization [1] Group 1 - The product has been granted orphan drug status, which is aimed at drugs for rare diseases, allowing the company to benefit from U.S. policy support in various aspects [1] - The orphan drug designation will expedite the clinical trial and market registration process for the product [1] - The company will enjoy several policy benefits, including tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [1]
恒瑞医药(01276.HK)胃癌联合疗法获得美国FDA孤儿药资格认定