复星医药控股子公司药品获欧盟注册批准
Ge Long Hui·2025-09-19 10:12

Group 1 - The core point of the news is that Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA®, in the European Union and certain EEA countries [1][2] Group 2 - The biosimilar HLX14 is developed for the treatment of osteoporosis in postmenopausal women at high risk of fractures, along with other indications consistent with the reference drug label [2] - The product is expected to receive approval in the United States by August 2025 for eight indications related to osteoporosis treatment, covering all indications approved for the reference product in the U.S. [2] - As of July 2025, the cumulative R&D investment for HLX14 is approximately RMB 323 million (unaudited) [2]