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SAN FRANCISCO, Sept. 30, 2019 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that roxadustat received the 2019 Dushu Lake Prize 独墅湖杯in China for “On-Market Innovative Drug with Highest Clinical Value.” The award was received by its subsidiary FibroGen (China) Medical Technology Development Company, Ltd., of Beijing.
The Dushu Lake Prize is one of the highest honors awarded each year within the China’s pharmaceutical industry. It recognizes achievements by companies, researchers, and individuals in the advancement of innovative drug development, and supports the country’s strategy to transform its key industries from “Made in China” to “Innovated in China.” This is the fourth year the award was presented by the China Pharmaceutical Innovation and Research Development Association (PhIRDA 中国医药创新促进会 or 药促会), a national level non-profit organization registered under the Ministry of Civil Affairs. An expert panel composed of 56 members, including 17 members from the Chinese Academy of Science and Chinese Academy of Engineering Sciences representing the fields of medicine, pharmacy, pharmacology, pharmaco-economics and other fields of expertise oversaw three rounds of nomination, review, and final ranking. The award ceremony was held in Suzhou, China.
Roxadustat was approved in China in December 2018 for the treatment of anemia in dialysis-dependent chronic kidney disease patients, and in August 2019 for non-dialysis-dependent patients.
"FibroGen recognized over a decade ago the unmet medical need in the treatment of anemia in chronic kidney disease in China,” said Ms. Chris Chung, Managing Director, FibroGen China. “With the recent marketing approvals in China, we are pleased to be able to begin delivering this therapeutic to patients. It is gratifying to see our commitment to innovation recognized with a national level award of the caliber of the Dushu Lake Prize.”
“The selection of roxadustat among a highly competitive group of candidates underscores the merits of roxadustat as an innovative therapeutic with meaningful clinical value to patients,” said Mr. Song Ruilin, President of PhIRDA. “The approval of roxadustat as a first-in-class drug in China at the end of 2018, before any other country, is a milestone achievement for the National Medical and Products Administration (“NMPA”). It is consistent with the country’s commitment to accelerating access to innovative medicines, and illustrates the post-reform capability of the agency.”
Founded in 1988, China Pharmaceutical Innovation and Research Development Association (PhIRDA) is a national level non-profit organization registered under the Ministry of Civil Affairs. Its mission is to serve as a platform to foster pharmaceutical innovation and address unmet medical needs, centered on the principles of innovation, industrialization and internationalization. Its 144 members are comprised of biomedical companies, academics institutions and investment funds.
About Anemia Associated with CKD in China
Anemia commonly develops in association with chronic kidney disease and is linked to significant morbidity and mortality in both the dialysis and non-dialysis populations. Although CKD may occur at any age, it is more common in aging populations, and its prevalence is increasing. CKD can be both a cause and a consequence of cardiovascular disease and is a critical healthcare issue. There is no treatment available that is curative or can stop kidney deterioration.
In China, 120 million people have chronic kidney disease. 1 Anemia is a complication of chronic kidney disease, is associated with morbidity and mortality 2, 3 and remains undertreated in non-dialysis chronic kidney disease patients worldwide due to delayed nephrology referral 7 and concerns over erythropoiesis stimulating agent safety. 4-6
Roxadustat (China Approved Drug Name: 罗沙司他; Chinese brand name: 爱瑞卓®) is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl-hydroxylase that has been approved by the National Medical Products Agency in China for treatment of anemia associated with chronic kidney disease.
Roxadustat (FG-4592) is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron. Roxadustat is currently approved in China, and is also approved in Japan for the treatment of anemia in CKD patients on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia.
Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.
About FibroGen China
FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China) is collaborating with FibroGen’s partner AstraZeneca on the development and commercialization of roxadustat in China. FibroGen China, a Beijing-based subsidiary of FibroGen, Inc., sponsored the development and registration of roxadustat as a Domestic Class 1 Innovative Drug. FibroGen China conducted the China Phase 3 clinical trials and submitted the New Drug Application for registration of roxadustat to the Chinese regulatory authorities. Following approval, AstraZeneca now manages commercialization activities in China, and FibroGen China manages commercial manufacturing and medical affairs, as well as clinical development and regulatory affairs.
FibroGen, Inc., headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China, is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase (HIF-PH) activity, completing worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), and is approved by the National Medical Products Administration (NMPA) in China, and by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com.
This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development of the company’s product candidates, the potential safety and efficacy profile of our product candidates, and our clinical, regulatory plans, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and our quarterly report on 10-Q for the fiscal quarter ended June 30, 2019 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
Karen L. Bergman
Investor Relations and Corporate Communications
1 (415) 978-1433
1Hörl WH. Anaemia management and mortality risk in chronic kidney disease. Nat Rev Nephrol 2013; 9:291-301.
2Collins AJ, Ma JZ, Xia A, Ebben J. Trends in anemia treatment with erythropoietin usage and patient outcomes. Am J Kidney Dis 1998; 32: Suppl 4: S133-S141.
3Coresh J, Selvin E, Stevens LA, et al. Prevalence of chronic kidney disease in the United States. JAMA 2007; 298: 2038-47.
4Drüeke TB, Locatelli F, Clyne N, et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006; 355: 2071-84.
5Pfeffer MA, Burdmann EA, Chen C-Y, et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 2009; 361: 2019-32.
6Singh AK, Szczech L, Tang KL, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006; 355: 2085-98.