FibroGen Inc. is focused on developing innovative therapies aimed at treating serious and life-threatening conditions, particularly in the fields of oncology and chronic kidney disease. Their research and development pipeline includes promising products such as Roxadustat, an oral HIF-PH inhibitor that enhances red blood cell production by increasing erythropoietin levels and improving iron metabolism. Additionally, the company is advancing a fully human antibody-drug conjugate (ADC) known as FG-3246, which targets CD46 and is being explored for its potential in treating metastatic castration-resistant prostate cancer and other cancers expressing CD46.

The company’s approach emphasizes the development of first-in-class medicines that not only address specific diseases but also serve as platforms for further research into various pathways and mediators involved in multiple conditions. FibroGen's commitment to innovation is evident in their ongoing clinical trials and their strategic efforts to introduce these groundbreaking therapies in markets such as China, where they aim to bring world-class medical advancements to patients in need.

United States

FibroGen, Inc., a biopharmaceutical company, discovers, develops, and commercializes therapeutics to treat serious unmet medical needs. It is developing Roxadustat, an oral small molecule inhibitor of hypoxia inducible factor prolyl hydroxylases that is in Phase III clinical development for the treatment of anemia in chronic kidney disease in the United States and Europe; and in Phase II/III development in China for anemia associated with myelodysplastic syndromes. The company is also developing Pamrevlumab, a human monoclonal antibody that inhibits the activity of connective tissue growth factor that is in Phase III clinical development for the treatment of idiopathic pulmonary fibrosis, pancreatic cancer, liver fibrosis, and diabetic kidney disease, as well as Phase II trial for the treatment of Duchenne muscular dystrophy. It has collaboration agreements with Astellas Pharma Inc. and AstraZeneca AB. The company was incorporated in 1993 and is headquartered in San Francisco, California.

Cancer

Endocrine System Diseases

Hematologic Diseases

Musculoskeletal Diseases

Urogenital Diseases

FibroGen Inc

Anemia

Chronic kidney disease

Roxadustat is a first-in-class orally administered inhibitor of HIF-PH, &nbsp;which increases hemoglobin levels through a mechanism of action that is &nbsp;different from that of traditional erythropoiesis-stimulating agents. As &nbsp;a HIF-PH inhibitor, roxadustat activates a response that occurs &nbsp;naturally when the body responds to reduced oxygen levels in the blood. &nbsp;Roxadustat promotes red blood cell production through increased &nbsp;endogenous production of erythropoietin; improved iron absorption, &nbsp;transport, and mobilization; and downregulation of hepcidin, which helps &nbsp;to overcome the negative impact of inflammation on hemoglobin synthesis &nbsp;and red blood cell production.
<a href="https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-present-safety-and-efficacy-analyses-roxadustat-global">Source</a>
 
In clinical trials, Roxa has shown certain advantages over current standard of care: &nbsp;Larger increase in hemoglobin than EPO in some key populations; lower transfusion in risk in key populations; possibly reduces LDL-C and less iron supplement is required than EPOs. Support is here: <a href="https://fibrogen.gcs-web.com/static-files/ff278473-c8f8-43cf-b55c-aa473dcf5245" target="_blank">https://fibrogen.gcs-web.com/static-files/ff278473-c8f8-43cf-b55c-aa473dcf5245</a>
 
More detailed biochem MOA:
Roxadustat (FG-4592) is a hypoxia-inducible factor prolyl hydroxylase inhibitor (PHI). The main mechanism of action is to inhibit the activity of prolyl hydroxylase domain protein (PHD) under the normoxia. Hypoxia-inducible factor α (HIF-α) has three subtypes 1, 2, and 3, and HIF-β has only one subtypes. In the case where PHD is inhibited, the HIF-α will be not hydroxylated by PHD, nor will it be ubiquitinated by the von Hippel-Lindau tumor suppressor (VHL), It will not be degraded by the proteasome. Therefore, more stable HIF-α enters the nucleus and forms heterodimers with HIF-β (<a href="https://www.frontiersin.org/articles/10.3389/fmed.2020.00393/full#B46">46</a>, <a href="https://www.frontiersin.org/articles/10.3389/fmed.2020.00393/full#B47">47</a>), which activates target gene expression, such as erythropoietin, glycolysis, and angiogenic factors (<a href="https://www.frontiersin.org/articles/10.3389/fmed.2020.00393/full#B48">48</a>, <a href="https://www.frontiersin.org/articles/10.3389/fmed.2020.00393/full#B49">49</a>). Therefore, besides being used to treat anemia, roxadustat may also be used to treat other diseases.
<a href="https://www.frontiersin.org/articles/10.3389/fmed.2020.00393/full">SOURCE - Frontiers in Medicine 2020</a>

Roxadustat (ROW)

Chemotherapy Induced Anemia

Roxadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, promotes coordinated erythropoiesis through increasing endogenous erythropoietin, improving iron availability, and reducing hepcidin.

Roxadustat

Myelodysplastic syndrome

Roxadustat is a first-in-class orally administered inhibitor of HIF-PH, &nbsp;which increases hemoglobin levels through a mechanism of action that is &nbsp;different from that of traditional erythropoiesis-stimulating agents. As &nbsp;a HIF-PH inhibitor, roxadustat activates a response that occurs &nbsp;naturally when the body responds to reduced oxygen levels in the blood. &nbsp;Roxadustat promotes red blood cell production through increased &nbsp;endogenous production of erythropoietin; improved iron absorption, &nbsp;transport, and mobilization; and downregulation of hepcidin, which helps &nbsp;to overcome the negative impact of inflammation on hemoglobin synthesis &nbsp;and red blood cell production.
<a href="https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-present-safety-and-efficacy-analyses-roxadustat-global">Source</a>

Castration-resistant prostate cancer

FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting a novel epitope on CD46 for metastatic castration-resistant prostate cancer (mCRPC).

FG-3246 (ADC)

FG-3246+ enzalutamide

Solid tumor/s

FG-3165 is a galectin-9 (“Gal9”) targeted antibody under development for treatment of solid tumors and potentially hematologic malignancies characterized by high Gal9 levels of expression. Gal9 has been reported to signal through multiple immune checkpoints on lymphocytes, including TIM3, VISTA, and PD-1, suppressing T and natural killer cell activation. FG-3165 selectively binds to Gal9 with high affinity and inhibits its ability to induce lymphocyte cell death, resulting in enhanced tumor cell killing.

FG-3165

Duchenne muscular dystrophy

Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a &nbsp;common factor in fibrotic and proliferative disorders. Pamrevlumab is &nbsp;in Phase 3 clinical development for the treatment of idiopathic &nbsp;pulmonary fibrosis (IPF), locally advanced unresectable pancreatic &nbsp;cancer (LAPC), and Duchenne muscular dystrophy (DMD); and in Phase 2 &nbsp;clinical development for coronavirus (COVID-19).&nbsp;
<a href="https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-announces-first-patient-enrolled-pamrevlumab-phase-3">Source</a>

Pamrevlumab

Pancreatic cancer

Pamrevlumab 

COVID-19

Infectious disease

Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a &nbsp;common factor in fibrotic and proliferative disorders. Pamrevlumab is &nbsp;in Phase 3 clinical development for the treatment of idiopathic &nbsp;pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic &nbsp;cancer (LAPC), and in Phase 2 clinical development for the treatment of &nbsp;Duchenne muscular dystrophy (DMD) and coronavirus (COVID-19).&nbsp;
<a href="https://fibrogen.gcs-web.com/news-releases/news-release-details/fibrogen-announces-first-patient-enrolled-pamrevlumab-clinical">Source</a>

Idiopathic pulmonary fibrosis

Roxadustat (U.S.) 

Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a &nbsp;common factor in fibrotic and proliferative disorders. Pamrevlumab is &nbsp;in Phase 3 clinical development for the treatment of idiopathic &nbsp;pulmonary fibrosis (IPF), locally advanced unresectable pancreatic &nbsp;cancer (LAPC), and Duchenne muscular dystrophy (DMD); and in Phase 2 &nbsp;clinical development for coronavirus (COVID-19).

FibroGen Inc

Company Details