Chongqing - Recently, the world's first industrialized production base for the bioartificial liver, the HepAssis2® Bioartificial Liver, designed for the clinical treatment of liver failure, has officially opened in Chongqing Banan.

"All diseases that harm the liver can lead to liver failure," said Wang Wei, Executive GM of Chongqing Togo Medical Technology Ltd. (Chongqing Togo), in an interview with Bridging News. Conditions such as hepatitis viruses, liver cancer, drugs, and alcohol can cause liver failure, severely damaging the liver and disrupting essential functions like synthesis, detoxification, metabolism, and biotransformation.

Wang explained that the HepAssis2® operates by cultivating liver cells in a bioreactor. An extracorporeal circulation device directs the plasma of liver failure patients into the bioreactor, allowing it to exchange substances and undergo biological processes with the liver cells through a semipermeable membrane. This system is not a literal implantable artificial liver.

As developed by Zhejiang Togo Medical Technology Co., Ltd., the HepAssis2® received approval from Hubei Province and the National Healthcare Security Administration in 2023. Its wholly-owned subsidiary, Chongqing Togo, handles production.

Technological advantages drive overseas market expansion

Chongqing Togo's upcoming production and research workshop. (Photo/Chongqing Togo)

"Currently, we are in preliminary discussions with markets in Saudi Arabia and Indonesia to explore overseas opportunities," Wang stated. 

According to the WHO's Global Hepatitis Report 2024, released in April, an estimated 254 million people are living with hepatitis B, 50 million people are living with hepatitis C worldwide, and 6000 people are newly infected with viral hepatitis each day, which indicates significant potential in the international liver failure market.

Additionally, the HepAssis2® holds a competitive edge internationally. According to Wang, it is the world's first bioartificial liver to have clinically applied fee-based treatment. Due to clinical trial failures, its American competitor, Vital Therapies, had to discontinue its Extracorporeal Liver Assist Device (ELAD) project.

Despite being the world's first company dedicated to artificial liver technology, with the longest R&D history, advanced technology, and the highest number of clinical trial cases, Vital Therapies faced clinical trial failures that led to a significant drop in stock prices, ultimately resulting in its acquisition by Immunic Therapeutics.

Specifically, the advantage of the HepAssis2® over ELAD lies in the type of cells used. "The technical challenge of this project is finding liver cells that can self-proliferate in vitro," Wang stated. To ensure cell self-proliferation, ELAD uses hepatocellular carcinoma cells (CA3), while human liver cells have poor liver function due to their cancerous nature.

“In another liver cell project, we discovered human-derived liver stem cells (HL2), suitable for bioartificial liver applications,” Wang introduced. HL2, as normal liver cells, ensures both normal liver function and proliferation capability.

HepAssis2® is beneficial in China's liver disease treatment market

The exterior of Chongqing Togo's upcoming production base. (Photo/Huxin Luo)

The HepAssis2® has technological advantages enabling it to address China's liver disease market more effectively than traditional non-bioartificial liver treatments.

"China is a major country for HBV and liver failure, largely due to its HBV patient population, making its data particularly representative," Wang expressed. 

According to Expert Consensus on Viral Hepatitis Health Management (2021), there are approximately 70 million chronic HBV infections and 10 million HCV infections in China. It is estimated that 500,000 to 1 million new liver failure cases arise annually, with a mortality rate as high as 50% to 80% under conventional medical treatment.

Wang highlighted that the high incidence of liver disease and liver failure in China makes traditional treatments, such as liver transplantation and Plasma Adsorption (PA), ineffective. 

For liver transplantation, there is a severe shortage of donors, with only over 5,000 surgeries performed annually. Additionally, PA not only removes bilirubin but also significantly absorbs proteins and clotting factors, impairing coagulation and causing considerable side effects.

"The key to bioartificial liver treatment is allowing the liver time to rest and regenerate," Wang stated. Through the use of human-derived liver cells HL2 in the bioreactor, the HepAssis2® can replicate the liver's environment and functions while delivering liver regeneration factors to the body, promoting liver self-renewal without side effects.