Phase II clinical study of plant-derived recombinant human serum albumin achieved phased results

The HY1001 project (plant-derived Recombinant human serum albumin injection) of Wuhan Healthgen Biotechnology Corp. (hereinafter referred to as  “Healthgen Biotech”), Phase II clinical study completed the enrollment of all subjects in the first cohort. On January 12, 2022, after reviewing and evaluating the safety data of 110 patients with liver cirrhosis and ascites, the Safety Review Committee (SRC) unanimously agreed that: Recombinant Human Serum Albumin (OsrHSA) was well tolerated in subjects with decompensated ascites in liver cirrhosis, which meets its safety expectations, and SRC agreed to continue the clinical study of the second cohort as defined in the study protocol.

Human Serum Albumin (HSA) is the most abundant proteins in human plasma. The physiological function of HSA is to maintain plasma colloid osmotic pressure to maintain the balance of water and electrolytes in body fluids and inside and outside cells.  HSA is also involved in the development of immune functions in human body. Clinically, it is widely used in hypoalbuminemia caused by various etiologies and complications caused by hypoalbuminemia such as cirrhosis and ascites, and used to instead of whole blood or plasma to treat shock or trauma in emergency situations.  According to statistics, the annual clinical demand for human serum albumin in China is more than 700 tons, and more than 60% depends on imported. Currently, all HSA used clinically is extracted from human plasma,which resource is scarce with high risk of contamination by human-derived viruses and harmful substances, and supply is seriously insufficient and very expensive. In the past 40 years,, many pharmaceutical companies and R&D institutions have tried to develop recombinant human serum albumin for clinical use through genetic engineering technology, but they have not been successful due to technical reasons.

Healthgen Biotech is committed to the research and development of a series of new recombinant protein biopharmaceuticals using the self-developed rice endosperm cell-specific and high-efficiency expression platform Oryz^HiExp and purification technology platform Oryz^Pur and has established the world-leading plant biopharmaceutical technology platform and perfect industrialization system. Healthegn Biotech is an internationally renowned biopharmaceutical enterprise focusing on the biopharmaceuticals research and development and product development  from plant platform. Following the plant-derived recombinant human serum albumin, recombinant human lactoferrin lysozyme oral liquid and recombinant human alpha 1-antitrypsin have entered Phase I and Phase II clinical studies successively.