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 portfolio [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 [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 [2] Group 3: Market Impact - According to IQVIA data, the global sales of denosumab (the active ingredient in Prolia) are projected to be approximately $7.462 billion in 2024 [2] - With the approval of BILDYOS and BILPREVDA, the company has now achieved a total of six products approved for overseas markets, with three specifically approved in the U.S., indicating a deepening of its global commercialization efforts [2] - This approval is seen as a recognition from international markets, which will further advance the company's internationalization strategy and enhance the global influence of its products [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群骨质疏松症治疗等8项适应症