Core Viewpoint - Fosun Pharma's subsidiary Henlius Europe GmbH has received orphan drug designation from the European Commission for HLX22, a humanized anti-HER2 monoclonal antibody injection for gastric cancer treatment [1] Group 1: Product Development - HLX22 is developed by the company under a license from AbClon, Inc. and is intended for the treatment of solid tumors such as gastric and breast cancer [1] - As of April 2025, the company has invested approximately 310 million yuan in the research and development of HLX22 [1] Group 2: Market Potential - According to IQVIA MIDAS data, the global sales of targeted HER2 monoclonal antibody products are projected to be approximately 9.029 billion USD in 2024 [1] - The orphan drug designation will facilitate HLX22's subsequent research, registration, and commercialization in the European Union by providing policy support [1]
复星医药:HLX22获欧盟孤儿药资格认定