Core Viewpoint - The approval of BILDYOS and BILPREVDA by the FDA marks a significant milestone for the company, enhancing its international market presence and product recognition [1][2] Group 1: Product Approvals - The FDA has approved two products, BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL), for various indications related to osteoporosis and bone-related events in cancer patients [1] - BILDYOS is indicated for the treatment of osteoporosis in high-risk postmenopausal women and men, as well as for patients undergoing specific cancer treatments [1] - BILPREVDA is indicated for preventing bone-related events in multiple myeloma and solid tumor patients, and for treating certain bone tumors and refractory hypercalcemia [1] Group 2: Clinical Data and Comparisons - The FDA's approval was based on comprehensive reviews of comparative studies demonstrating the similarity of HLX14 (the active ingredient in BILDYOS) to its reference drug Prolia in terms of quality, safety, and efficacy [2] - The approval aligns with FDA guidelines on demonstrating biosimilarity to reference drugs, allowing HLX14 to be used for all indications approved for Prolia and XGEVA in the U.S. [2] Group 3: Market Impact - The global sales of denosumab (the active ingredient in Prolia) are projected to be approximately $7.462 billion in 2024, indicating a substantial market opportunity for the newly approved products [2] - With the approval of BILDYOS and BILPREVDA, the company now has six products approved for international markets, with three specifically approved in the U.S., further solidifying its international commercialization efforts [2]
复宏汉霖(02696.HK)：美国食品药品管理局(FDA)批准HLX14(地舒单抗，美国商品名：BILDYOS以及BILPREVDA)两个产品用于特定人...