According to the guideline of Provisions of Drug Registration (China Food and Drug Administration order No.28, 2007) for clinical trials, Healthgen Biotechnology Co., Ltd. completed the Pre-Clinical Safety Assessment Studies for plant-derived recombinant human serum albumin (OsrHSA), including general pharmacological test, acute dermal toxicity test, long-term toxicity test, pharmacokinetic studies, reproductive toxicity test, immunotoxicity and immunogenicity test, hemolytic test, and dependence studies, which were performed by JOINN laboratories, Inc. and Chinese PLA Academy of Military Medical Sciences (AMMS), respectively. The results show that the OsrHSA has no significant differencewith plasma-derived human serum albuminin market preparations for toxicological reaction and pharmacokinetics of rats and cynomolgus monkeys. It is the first plant-derived drug in the world to enter into pre-clinic trial. The results provide the evidence to show plant-derived recombinant human serum albumin is safe based on the pre-clinical trial.










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