(SHANGHAI, China, June 27, 2022) – Fosun Pharma and Amgen today jointly announced a collaboration and license agreement for Fosun Pharma for the commercialization of Amgen’s Otezla® and Parsabiv® in the Chinese Mainland. The collaboration will enable Amgen to bring the two innovative medicines to Chinese patients with psoriasis and chronic kidney disease more quickly by leveraging Fosun Pharma’s commercial capabilities within China.
Wu Yifang, Chairman of Fosun Pharma said: “We are very pleased to enter into this partnership with Amgen to bring two innovative medicines, Otezla® and Parsabiv®, to Chinese patients. With Fosun Pharma's experience in the areas of autoimmune diseases, including psoriasis, and chronic kidney diseases over the years, we are well aware of Chinese patients’ urgent needs for better treatment options. Going forward, we will work together with Amgen to leverage our presence in these areas to make the medicines accessible to patients, enabling them to benefit from these innovative medicines as soon as possible, control diseases and improve quality of life.”
“This decision - to enter into a collaboration with a local partner - is consistent with our determined focus to bring our innovative medicines to more Chinese patients more quickly," said Irene Hsu, Vice President & General Manager of Amgen China, " By out-licensing these two products to a partner with the presence, expertise and credibility of Fosun Pharma in these therapeutic areas, we can give full play to both companies’ advantages to ensure more patients are able to benefit from these innovative medicines, while enabling Amgen to focus on our core general medicines business in cardiovascular disease and bone health in China.”
Otezla® (apremilast tablets) was approved by the National Medical Products Administration of China (NMPA) in August 2021 for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This approval makes Otezla® the first and currently the only oral phosphodiesterase 4 (PDE4) inhibitor for the treatment of plaque psoriasis in China, providing an additional choice for Chinese patients to manage disease and improve quality of life. China has about 6.5 million patients with psoriasis[1], and 57.3% of them are moderate-to-severe cases[2].
Parsabiv® has been approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in November 2016 and February 2017 respectively for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Currently Parsabiv® is in the process of market authorization approval (MAA) in China. SHPT is one of the common complications of CKD patients on hemodialysis. The prevalence of adult CKD in China is 10.8%[3]. Data show that by the end of 2019, the number of dialysis patients in China has increased to 735,000[4], among which hemodialysis is the main therapy for dialysis patients in China. The incidence of SHPT in hemodialysis patients is 47%-58%[4].
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About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.
Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, and central nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, oncolytic viruses, gene therapy and PROTAC, to enhance its innovation capabilities.
Guided by the 4IN strategy (Innovation, Internationalization, Integration, and Intelligentization), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth", with the mission of creating shareholder values as well as promoting the global networks through strengthening its innovative R&D and in-licensing ability and enriching its product pipelines. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global mainstream medical and health market.
Fosun Pharma Forward-looking statements:
This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including, without limitation, the discussions of Fosun Pharma’s business strategies and expectations concerning future operations, margins, profitability, liquidity and capital resources, the future development of Fosun Pharma’s industry and the future development of the general economy of Fosun Pharma’s key markets and any statements preceded by, followed by or that include words and expressions such as “expect”, “seek”, “believe”, “plan”, “intend”, “estimate”, “project”, “anticipate”, “may”, “will”, “would” and “could” or similar words or statements, as they relate to Fosun Pharma’s or its management, are intended to identify forward-looking statements. These statements are subject to certain known and unknown risks, uncertainties and assumptions, which may cause Fosun Pharma’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Accordingly, you should not place undue reliance on any forward-looking information. Subject to the requirements of applicable laws, rules and regulations, Fosun Pharma does not have any and undertakes no obligation to update or otherwise revise the forward- looking statements in this press release, whether as a result of new information, future events or developments or otherwise. In this press release, statements of or references to Fosun Pharma’s intentions are made as of the date of this press release. Any such intentions may change in light of future developments. All forward-looking statements contained in this press release are qualified by reference to the cautionary statements set out above.
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.
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 more than 100 cities across the country. In China, Amgen strives to bring innovative therapies to patients in a bid to address the huge unmet needs in in our priority therapeutic areas including cardiovascular disease, bone health, inflammation, and hematology/oncology.
For more information, visit
www.amgen.cn and follow us on Amgen China Corporate WeChat account “安进Amgen”.
Reference:
1.中华医学会皮肤性病学分会银屑病专业委员会.中国银屑病诊疗指南(2018简版)[J].中华皮肤科杂志,2019,52(4):223-230.
2. Chen, K., Wang, G., Jin, H., Xu, J., Zhu, X., Zheng, M., & Gu, H. (2017). Clinic characteristics of psoriasis in China: a nationwide survey in over 12000 patients. Oncotarget, 8(28), 46381–46389.
3. Zhang, L., Wang, F., Wang L, et al. Prevalence of chronic kidney disease in China: a cross-sectional survey[J]. Lancet, 2012, 379(9818): 815-822.
4.全国血液净化病例信息登记系统, 2020.