China-based Yiming (Beijing) Cell Biotechnology Co., Ltd (also known as Ubrigene) and its partner Shanghai Hexaell Biotech Co., Ltd have received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for their in-house developed HepaCure Biocolumn. This bioartificial liver product is designed to treat chronic acute liver failure caused by the hepatitis B virus (HBV) and represents a significant advancement in the field.
HepaCure Biocolumn: A Pioneering Bioartificial Liver Product
HepaCure Biocolumn is a combination product of medicine and device, primarily based on cell therapy, and serves as a core component of the bioartificial liver system. It is the first of its kind to receive clinical approval in China. The product is composed of human induced hepatocytes (hiHep cells) and cell filler. The main active ingredient, hiHep cells, exhibits a gene expression profile similar to that of human primary hepatocytes and has demonstrated liver functions in vitro, including liver-specific protein secretion and drug metabolism.
Mechanism and Clinical Application
In clinical use, hiHep cells within the plasma biological purification column exchange substances with human plasma through in vitro dialysis. This process purifies the plasma of patients with liver failure, thereby playing a therapeutic role. The hiHep cells maintain the expression of liver genes and liver functions even after expansion, making HepaCure Biocolumn a promising treatment option for patients with chronic acute liver failure caused by HBV.-Fineline Info & Tech
