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Hexaell Biotech was founded in 2015. It has established production base and R & D center in the core area of Jiading Industrial Park and Zhangjiang High Tech Park of Shanghai. The company possesses internationally leading cell differentiation and production technology and is focusing on developing novel cell therapies and regenerative medicines for severe liver diseases.
All the founders of the company are from international renowned scientific research institutes and top pharmaceutical companies, committed to developing the world’s leading innovative biomedical technology and products and providing better clinical solutions for patients.
In July 2017, the domestic first production line for clinical research and development of human hepatocyte-derived bioartificial liver was established by Hexaell Biotech in Jiading district, Shanghai. Academician Gang Pei and top officials from Shanghai Municipal Science and Technology Commission and Jiading district government attended the opening ceremony of the company. Currently, the company is vigorously conducting IND application in both China and US, and strive to benefit more patients as soon as possible.
China has a large population that is affected by liver diseases. There are about 500,000 new cases of liver failure each year. The 28-day mortality is as high as 50% in patients with acute liver failure. Currently, the most effective therapeutic regimen is liver transplantation, however, the high cost of treatment and shortage of liver sources make only around 5,000 patients able to receive liver transplantation per year in China. Other traditional therapies, including standard medical care and non-bioartificial liver, can neither effectively remove the toxins in blood, nor promote the recovery of liver function.
Through international-wised collaboration with institutions and hospitals, Dr. Lijian Hui’s team from Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences, made a breakthrough in in vitro culture technology of hepatocyte-like cells and generated expandable human hepatocytes (hiHep cells) using internationally leading direct transdifferentiation technology. This technology also won the honor of “The Ten Major Advances in Chinese Science” in 2011. Taking this as the core, Hexaell Biotech who acquires the globally exclusive authorization for use of this technology set up a brand new HepaCure bioartificial liver support system, providing a new effective therapeutic regimen for patients with liver failure resulted from severe liver disease.
Hexaell HepaCure-BAL with hiHeps as working cells is a liver support system which could partially replace liver functions. Its main mechanisms include removal of toxic substances in patient plasma; secretion of liver-specific proteins such as ALB, AAT and TRF; reduction of inflammatory responses and promotion of liver regeneration. During treatment, the patient’s plasma progresses through the surface of implanted hiHeps in the bioreactor. The material exchange between plasma and hiHeps may eliminate toxic substances generated after liver failure and return liver-specific proteins to the body.
The advanced technology utilized by HepaCure system has won a number of national honors. Following the completion of treatment for the first patient with severe liver disease in 2016, ten patients have received treatment with this system and achieved significant response by far. The condition of patients after HepaCure treatment is significantly improved. And the major breakthrough in the clinical translation of the technology also won the award of “2017 China’s Ten Major Advances in Medical Sciences”.