GlobeNewswire Inc | Dec 2, 2020 07:00AM EST

December 02, 2020

New data show safety and efficacy of roxadustat in treating anemia secondary to lower-risk myelodysplastic syndromes (MDS) regardless of ring sideroblast (RS) or baseline erythropoietinlevel

Multiple analyses evaluate cardiovascular safety andefficacy of roxadustat in patients with anemia ofchronic kidney disease(CKD) regardless of dialysis status

SAN FRANCISCO, Dec. 02, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc.(Nasdaq: FGEN) and its partner,AstraZeneca(LSE/STO/Nasdaq: AZN), will present additional analyses of roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (MDS) and results from multiple roxadustat phase 3 studies. Roxadustat is a first-in-class oral small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in development for the treatment of patients with anemia of CKD and anemia secondary to lower-risk MDS. FibroGenand its partner will present eight abstracts at the 62ndAmerican Society of Hematology (ASH) Annual Meeting and Exposition, taking place virtually December 5-8, 2020.

We are pleased to share additional 52-week data from the open-label portion of our Phase 3 anemia of MDS trial with the medical community at ASH, saidEnrique Conterno, Chief Executive Officer,FibroGen. In addition, we are presenting Phase 3 cardiovascular safety and efficacy results of roxadustat, which highlight its potential in a broad range of CKD patients.

MDS is a group of blood disorders characterized by poorly formed or dysfunctional blood cells, resulting in chronic anemia.1 Exploratory analyses to be presented at ASH show the efficacy of roxadustat in transfusion-dependent lower-risk MDS patients regardless of ring sideroblast and baseline erythropoietin status - characteristics used to predict response to treatment.2 Patients with ring sideroblasts (RS+), without ring sideroblasts (RS-), baseline erythropoietin (BL EPO) 200 mIU/ml, and BL EPO > 200 mIU/ml achieved the primary endpoint of transfusion independence for 8 weeks during the first 28 treatment weeks (23% of MDS-RS+, 55% of MDS-RS-, 39% of BL EPO 200 mIU/ml, and 33% of BL EPO > 200 mIU/ml patients). Detailed results will be presented at the meeting.

Enrollment in the double-blind placebo-controlled portion of the Phase 3 roxadustat study of patients with anemia secondary to lower-risk MDS is ongoing (NCT03263091).

Roxadustat presentations during the62ndASHAnnual Meeting and Exposition

Presenter Presentation title Presentation details ePoster #1277 Oral Roxadustat Demonstrates Session 637:David Henry, Efficacy in Anemia Secondary to MyelodysplasticMD Lower-Risk Myelodysplastic Syndrome Syndromes?Clinical Studies Irrespective of Ring Sideroblasts (Poster I) and Baseline Erythropoietin Levels Sat., Dec. 5: 7:00 AM?3:30 PM PT ePoster #748 Session 101: Red Cells and Roxadustat Lowers Risk of RBC Erythropoiesis, StructureSteven Transfusion in Patients with Anemia and Function, Metabolism,Fishbane, MD of CKD and Survival, Excluding Iron (Poster I) Sat., Dec. 5: 7:00 AM?3:30 PM PT ePoster #749 Pooled Efficacy and Cardiovascular Session 101: Red Cells and Safety Results of Roxadustat Erythropoiesis, StructureSteven Compared with Epoetin Alfa in the and Function, Metabolism,Fishbane, MD Treatment of Anemia in Chronic and Survival, Excluding Kidney Disease Patients on Dialysis Iron (Poster I) Sat., Dec. 5: 7:00 AM?3:30 PM PT ePoster #757 Session 101: Red Cells and Roxadustat Increases Hemoglobin in Erythropoiesis, StructureCarol Pollock, Anemic Non-Dialysis-Dependent (NDD) and Function, Metabolism,MD Chronic Kidney Disease (CKD) and Survival, Excluding Patients Independent of Inflammation Iron (Poster I) Sat., Dec. 5: 7:00 AM?3:30 PM PT ePoster #758 Roxadustat Treatment Results in Session 101: Red Cells andRoberto Consistent Improvements in Erythropoiesis, StructurePecoits-Filho, Hemoglobin (Hb) Versus Placebo: An and Function, Metabolism,MD Analysis of 3 Multinational RCTs in and Survival, Excluding Patients with Non-Dialysis-Dependent Iron (Poster I) Chronic Kidney Disease (NDD-CKD) Sat., Dec. 5: 7:00 AM?3:30 PM PT ePoster #761 Roxadustat Treatment Corrects Anemia Session 101: Red Cells and to Hemoglobin (Hb) Values ?10 g/dL Erythropoiesis, StructureAnjay Rastogi, in the Majority of Patients with and Function, Metabolism,MD Non-Dialysis-Dependent Chronic and Survival, Excluding Kidney Disease (NDD-CKD) Iron (Poster I) Sat., Dec. 5: 7:00 AM?3:30 PM PT Hemoglobin (Hb) Correction with ePoster #766Steven Roxadustat is Associated with Session 102: Regulation ofFishbane, MD Improved Iron Homeostasis in Iron Metabolism (Poster I) Patients with Non-Dialysis-Dependent Sat., Dec. 5: 7:00 AM?3:30 Chronic Kidney Disease (NDD-CKD) PM PT ePoster #1671 Pooled Efficacy and Cardiovascular Session 101: Red Cells and Analysis of Roxadustat Compared with Erythropoiesis, StructureRobert Placebo in Anemia Correction in and Function, Metabolism,Provenzano, MD Chronic Kidney Disease Patients Not and Survival, Excluding on Dialysis Iron (Poster II) Sun., Dec. 6: 7:00 AM?3:30 PM PT

About Anemia of CKDChronic kidney disease (CKD) is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant. CKD is estimated to occur in approximately 10-12% of adults worldwide and is predicted to become the fifth most common cause of premature death globally by 2040.

Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is a common early complication of CKD, affecting approximately 20% of CKD patients. Anemia of CKD is associated with an increased risk of hospitalization, cardiovascular complications, and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life. Blood transfusions are used for treating severe anemia, however, they may reduce a patients opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.

About MDSMDS develops because the bone marrow cells do not develop into mature blood cells. Instead, these blood cells stay within the bone marrow in an immature state. There are many subtypes of MDS. Some cases are mild, while others are more severe, and carry a high risk of becoming acute myelogenous leukemia (AML). It is estimated that more than 10,000 patients are diagnosed with MDS each year in the U.S.,3 and overall prevalence is estimated to be between 60,000 170,000 in the country.4

About RoxadustatRoxadustat is a first-in-class orally administered inhibitor of HIF-PH, which increases hemoglobin levels through a mechanism of action that is different from that of traditional erythropoiesis-stimulating agents. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. Roxadustat promotes red blood cell production through increased endogenous production of erythropoietin; improved iron absorption, transport, and mobilization; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production.

Roxadustat is approved and launched for the treatment of anemia of CKD in Japan and China in adult patients on dialysis (DD) and not on dialysis (NDD). A New Drug Application for the treatment of anemia of CKD in patients both DD and NDD is under review by the U.S. Food and Drug Administration with a decision expected in December 2020. The marketing authorization application for roxadustat for the treatment of anemia of CKD in patients both DD and NDD was accepted by the European Medicines Agency for review on May 21, 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, which are currently in review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

AboutFibroGenFibroGen, Inc.is a biopharmaceutical company committed to discovering, developing and commercializing 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 to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visitwww.fibrogen.com.

Forward-Looking StatementsThis release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the companys product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, 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 endedDecember 31, 2019and our Quarterly Report on Form 10-Q for quarter endedSeptember 30, 2020filed with theSecurities 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.

Contacts:FibroGen, Inc.

Investors:Michael Tung, M.D.Investor Relations+1.415.978.1434mtung@fibrogen.com

Media:Jennifer Harrington+1.610.574.9196Jennifer.Harrington@gcihealth.com

1 American Cancer Society. What Are Myelodysplastic Syndromes? Available at https://www.cancer.org/cancer/myelodysplastic-syndrome/about/what-is-mds.html. Accessed November 2020.2 Abu-Zeinah G, DeSancho MT. Understanding Sideroblastic Anemia: An Overview of Genetics, Epidemiology, Pathophysiology and Current Therapeutic Options.J Blood Med. 2020;11:305-318. Published 2020 Sep 25. doi:10.2147/JBM.S2326443 Ma X, Does M, Raza A, Mayne ST. Myelodysplastic syndromes: incidence and survival in the United States. Cancer. 2007;109(8):1536.4 Cogle CR. Incidence and Burden of the Myelodysplastic Syndromes. Curr Hematol Malig Rep. 2015;10(3):272-281.