Core Viewpoint - The company has received FDA approval for two products, BILDYOS and BILPREVDA, which enhances its international market presence and product recognition [1][2]. Product Approvals - BILDYOS (60 mg/mL) is approved for treating osteoporosis in high-risk postmenopausal women, increasing bone mass in high-risk men, and treating osteoporosis caused by glucocorticoids in both men and women [1]. - BILPREVDA (120 mg/1.7 mL) is approved for preventing bone-related events in multiple myeloma and solid tumor patients, treating giant cell tumors of bone, and managing refractory hypercalcemia in malignancies after bisphosphonate treatment [1]. FDA Review Process - The FDA's approval was based on comprehensive reviews of comparative studies between HLX14 (the active ingredient in BILDYOS and BILPREVDA) and its reference drug Prolia, demonstrating high similarity in quality, safety, and efficacy [2]. - The production facilities for HLX14 have passed FDA pre-license inspections, confirming compliance with cGMP requirements [2]. Market Impact - With the approval of BILDYOS and BILPREVDA, the company now has six products approved overseas and three in the U.S., indicating a deepening of global commercialization efforts [2]. - This approval signifies further recognition of the company's products in international markets, enhancing their global influence [2].
复宏汉霖：美国食品药品管理局批准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