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Amgen Receives National Medical Products Administration Approval For Prolia® (Denosumab) in China

News Releases
June 19, 2020

Amgen Receives National Medical Products Administration Approval For Prolia® (Denosumab) in China

Innovative Therapy Benefits Postmenopausal Women at High Risk of Fractures

Shanghai, China, June 19, 2020 -- Amgen today announced that the National Medical Products Administration (NMPA) in China has approved Prolia® (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk of fractures. This approval makes Prolia®the first and currently the only monoclonal antibody to target RANK-L for the treatment of osteoporosis in China. In postmenopausal women, Prolia® helps to significantly reduce the risk of vertebral, non-vertebral and hip fractures, providing an innovative therapy for improving Chinese patients’ bone health management and quality of life.

Osteoporosis is a disease characterized by excessive bone loss. Over the past decade, the number of adults 50 years and older with osteoporosis in China has nearly doubled1. Today, one in every three of Chinese women over the age of 50 is affected2. Osteoporosis is often seen as a "silent" disease, and its association with fractures has not yet been made widely aware to the general public. As a matter of fact, many women don’t know they have osteoporosis until they experience osteoporotic fractures including wrist fractures, spinal fractures and hip fractures. These women are also 5 times more likely to break another bone within the following year3.

"An osteoporotic fracture can be a life-changing event. It's one of the main causes of disability and death in seniors. Within 1 year of a hip fracture, 20 percent of patients would die of various complications4," said Prof. Zhang Zhenlin, Chairman of Chinese Medical Association Osteoporosis and Bone Mineral Disease Branch, Director of Department of Osteoporosis and Osteopathy, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University. "Regular exercise and proper nutrition can aide in disease management but may not be enough. We encourage patients to receive the right medications and treatments to help slow down or stop bone loss, build new bone, increase bone mineral density (BMD) and reduce the risk of fractures."

"Osteoporosis may pose a significant burden to China due to the aging population. The approval of Prolia®in China is a significant milestone for the millions of women suffering with osteoporosis in China, and an important step for Amgen as we continue to bring innovative medicines to Chinese patients.” said David M. Reese, M.D., executive vice president of Research and Development at Amgen.

Consistent efficacy and safety profile of Prolia®has been shown in a 3-year pivotal Phase 3 fracture study and its 7-year extension study which enrolled 7,808 postmenopausal women with osteoporosis. Subjects treated for 10 years with Prolia®continued to show gains in BMD; they achieved an average cumulative 10-year gain in BMD of 21.7 percent at the lumbar spine and 9.2 percent at the total hip, compared to baseline in the study5.

“The overwhelming process of population aging brings unprecedented public health challenges to China. Amgen is increasingly focused on establishing a strong presence in the treatment of chronic diseases that can support healthy longevity, an essential component of the Healthy China 2030 initiative,” said My Linh Kha, Vice President and General Manager at Amgen China. “We will work closely with the Chinese government to accelerate the launch of Prolia® to address the critical needs of patients who have been suffering from osteoporosis.”

About Prolia® (denosumab)

Prolia® is the first approved therapy that specifically targets RANKL. Prolia® is approved and marketed in over 80 countries worldwide.

Prolia® is approved in China for the treatment of postmenopausal women with osteoporosis at high risk of fractures.

Prolia® is administered as a single subcutaneous injection of 60 mg once every six months.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit http://www.amgen.comand follow us on http://www.twitter.com/amgen.

About Amgen China

Amgen entered China in 2012 on a mission to serve patients by using science and biotechnology to improve health for Chinese patients and societies. With its headquarters in Shanghai, Amgen China is present in approximately 80 cities across the country. In China, Amgen strives to bring innovative therapies to patients in a bid to address the huge unmet needs in chronic diseases including cardiovascular disease, bone health, Inflammation and Nephrology.

Amgen inaugurated the Asia Research and Development Center in Shanghai in 2014 as part of efforts to pursue the best in scientific innovation. With a biology-first approach, the center is committed to translating the promise of science and biotechnology into therapies that have the power to save lives and restore health.

For more information, visit http://www.amgen.cn, and follow us on Amgen China Corporate WeChat account.

  1. Chen et al. BMC Public Health (2016) 16:1039
  2. 中国疾病预防控制中心. 国家卫生健康委发布中国骨质疏松症流行病学调查结果. http://www.chinacdc.cn/gsywlswxx_9498/crbs/201812/t20181217_198289.html.Accessed October 8, 2019.
  3. van Geel TA, et al. Clinical subsequent fractures cluster in time after first fractures. Ann Rheum Dis. 2009;68:99-102.Kanis JA, Johnell O, De Laet C, et al. (2004) A meta-analysis of previous fracture and subsequent fracture risk. Bone. 35:375.
  4. 中华医学会骨质疏松和骨矿盐疾病分会. 原发性骨质疏松症诊疗指南(2017). 中华骨质疏松和骨矿盐疾病杂志, 2017, 10(5): 413-443. doi:10.3969/j.issn.1674-2591.2017.05.002
  5. Bone HG, Wagman RB, Brandi ML, et al. 10 years of denosumab treatment in postmenopausal women with osteoporosis: results from the phase 3 randomized FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017 ;5(7) : 513-523.https://www.ncbi.nlm.nih.gov/pubmed/28546097. Accessed April 20, 2020.