Green Cross, a South Korean biopharmaceutical company, announced on July 9 that its phase I clinical trial plan of “Hepabig-gene” to extend the indications for treatment of the chronic hepatitis B virus (HBV) infection has received approval from the Ministry of Food and Drug Safety (MFDS). Hepabig-gene is a new genetically-recombined hepatitis B antibiotic medicine.
The company carried out Phase II clinical trials last year to evaluate the safety and efficacy of the Hepabig-gene on liver transplant patients who have underlying medical conditions of HBV infection for preventing the recurrence of HBV infection following a liver transplant.
The product has higher purity levels than existing plasma-based products and is more capable of neutralizing HBV. Therefore smaller doses are required over a shorter period compared with previous plasma-based products. Based on the advantages, the final goal of the Hepabig-gene is the complete recovery of chronic hepatitis B patients, according to the Green Cross.
HBV infection remains a major global issue, affecting up to 350 million people worldwide. Chronic hepatitis B patients are at considerably higher risk for the development of cirrhosis and hepatocellular carcinoma. Liver transplants are the only treatment option for such patients. In particular, there are more than 100 million chronic hepatitis B patients in China, so the demand for both a hepatitis B immunoglobulin and liver transplants is expected to grow in the future.
An official from the Green Cross said, “Until now, no country or company in the world has succeeded in the commercialization of a gene recombinant hepatitis B antibody treatment. So, Hepabig-gene is highly likely to be the world’s first gene recombinant hepatitis B antibiotic medicine, if it is proven safe and effective.”
Meanwhile, both the U.S Food and Drug Administration (FDA) and the European Medicine Agency (EMA) granted orphan drug status for Hepabig-gene in 2013, since the product can significantly improve safety, effectiveness, and convenience compared to existing plasma-based products. Therefore, Green Cross will receive the benefits, including tax cuts and quick evaluation, when conducting clinical trials of the product in the U.S. and Europe. The company now has a plan to assess the safety and effectiveness of Hepabig-gene through global clinical trials.