Amgen China announced that Evonik® (romoxozimab injection) has been approved by the National Medical Products Administration of China for the treatment of osteoporosis in postmenopausal women at high risk of fracture. As the world's first and only dual-action biologic that simultaneously promotes bone formation and inhibits bone resorption, the approval of Evonik® provides a new treatment option for osteoporosis patients in China, especially those at very high fracture risk.

Studies show that the risk of refracture is highest within 1-2 years after a fracture, and women with a history of fracture have an 86% increased risk of refracture. One in five postmenopausal women with vertebral fractures will experience a new fracture within one year, and 45% of women with hip fractures have reported fragility fractures .

The approval of Evonik® is based on the results of several pivotal clinical studies, including the pivotal Phase III clinical trials FRAME and ARCH. The FRAME study showed that after 12 months of Evonik® treatment , compared to placebo, the risk of new vertebral fractures was significantly reduced by 73%, and bone mineral density in the lumbar spine, total hip, and femoral neck increased by 13.3%, 6.8%, and 5.2%, respectively. The ARCH study showed that compared to alendronate sodium monotherapy, one year of Evonik® followed by one year of alendronate sodium treatment significantly reduced the risk of vertebral fractures by approximately 50% . Furthermore, the STRUCTURE study showed that compared to the bone-forming drug teriparatide, 12 months of Evonik® treatment resulted in approximately twice the increase in bone mineral density in the lumbar spine, total hip, and lumbar spine .These results demonstrate that Evonik® is significantly effective in reducing fracture risk and increasing bone mineral density, with good overall tolerability.

Based on its innovative mechanism and clinical value, romosuzumab was named No. 1 of the Top 10 Medical Innovations of 2020 by the Cleveland Clinic . Currently, romosuzumab® has been approved for marketing in multiple countries and regions worldwide and has been included in several authoritative clinical guidelines. In the future, Amgen will continue to collaborate with the Chinese medical community to promote the clinical application of innovative treatment options and make sustained contributions to the prevention and treatment of osteoporosis in China.

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