Our Company
Pioneering Oncology Therapies that Expand What is Possible
We accelerate the delivery of innovative treatments that operate at the cutting edge of cancer research. Our teams have identified and are developing potential first-in-class medicines for the treatment of life-threatening conditions such as metastatic pancreatic cancer, locally advanced pancreatic cancer (LAPC), and chemotherapy-induced anemia (CIA). We are keenly focused on leveraging the body’s natural pathways to treat cancer and its related conditions.
OUR ONCOLOGY CANDIDATES:
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Roxadustat
Roxadustat, is an oral small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase, the enzyme that regulates HIF activity. By transiently inhibiting the enzyme, roxadustat induces the body’s natural coordinated process of producing red blood cells, increasing iron absorption, mobilization, and transport. Chemotherapy-induced anemia (CIA) is one of the most common side effects of chemotherapy, it is often not recognized and is frequently undertreated. Roxadustat is in late-stage development for the treatment of CIA in China. FibroGen and our partner AstraZeneca filed a supplemental new drug application with the China Health Authority for roxadustat in patients with chemotherapy-induced anemia and expect an approval decision in mid-2024. ​Roxadustat is approved in China, Europe, Japan, and over 40 other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and patients not on dialysis.
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FG-3246
FG-3246 is a potential first-in-class fully human antibody-drug conjugate (ADC), in-licensed from Fortis and being developed with FibroGen for metastatic castration-resistant prostate cancer and other tumor types. FG-3246 binds to a cell receptor target (CD46) that internalizes upon antibody binding and is present at high levels in prostate cancer and other tumor types, but that demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidate. FG-3246 is comprised of an anti-CD46 antibody, YS-5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. In both preclinical and Phase I clinical studies Fortis has reported initial clinical data to support additional clinical studies. FG-3246 is currently in two Phase I studies, being conducted by Fortis and UCSF, with initial data expected in the first half of 2024. We anticipate the initiation of the Phase II trial in metastatic castration-resistant prostate cancer in the second half of 2024. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.
