HIF-117 (SSS17): A Comprehensive Analysis of a Novel HIF Prolyl Hydroxylase Inhibitor

Section 1: Executive Summary

This report provides a comprehensive analysis of HIF-117, an investigational small-molecule drug also identified by the development code SSS17. HIF-117 is an orally administered Hypoxia-Inducible Factor Prolyl Hydroxylase (HIF-PH) inhibitor developed by the Chinese biopharmaceutical company 3SBio Inc., through its subsidiary Shenyang Sunshine Pharmaceutical. The primary therapeutic indication for HIF-117 is the treatment of anemia associated with Chronic Kidney Disease (CKD), a common and serious complication of renal impairment.

The mechanism of action of HIF-117 is centered on the inhibition of PHD enzymes, which are key regulators of the body's natural response to changes in oxygen availability. By inhibiting these enzymes, HIF-117 stabilizes Hypoxia-Inducible Factor-alpha (HIF-α), a transcription factor that is normally degraded in the presence of oxygen. This stabilization mimics a physiological state of hypoxia, leading to a coordinated upregulation of genes involved in erythropoiesis. The principal outcomes are an increase in endogenous erythropoietin (EPO) production and an improvement in iron metabolism through the suppression of hepcidin. This dual action on both red blood cell production and the iron supply chain required for hemoglobin synthesis represents a more integrated physiological approach compared to the current standard of care, injectable Erythropoiesis-Stimulating Agents (ESAs).