May 13th, 2020, Wuhan Healthgen Biotechnology Corp.( hereinafter referred to as Healthgen Biotech) received the Clinical Trial Notice of its new bio-innovative drug - Recombinant Human Lactoferrin and Lysozyme Oral Liquid (Project No. HY1002) from the Center for Drug Evaluation of the National Medical Products Administration (namely "CDE"). The notice showed that Healthgen Biotech had been approved to carry out clinical trials of the recombinant human lactoferrin and lysozyme oral liquid used for infectious diarrhea in children caused by rotavirus in accordance with the submitted clinical trials protocol.
Infectious diarrhea, an intestinal infectious disease caused by pathogens such as virus and bacteria mainly with diarrhea, is an infectious disease with a high incidence and widespread epidemic in the world, and it is a serious health hazard to humans, especially children. According to the survey, the incidence rate of children under 5 years old is 2.50～3.38 times per child every year. A clinical survey in 2014 showed that viral diarrhea accounted for 92.4% of infectious diarrhea, bacterial diarrhea accounted for 7.4%, and among viral diarrhea, 95.7% were rotavirus infections. At present, there is a lack of clinically safe and effective drugs for children with viral infectious diarrhea, but only adjunctive treatment by microecological preparations and intestinal absorption protectants, which have problems with its effectiveness and safety, and greatly affect the safe medication and healthy growth of children.
Studies have shown that human lactoferrin and human lysozyme have a good therapeutic effect on infectious diarrhea. Both human lactoferrin and lysozyme are biologically active proteins with high abundance in human breast milk. As a non-specific immune factor of the human body, human lactoferrin has multiple pharmacological effects such as promoting the absorption of intestinal iron, broad-spectrum antibacterial, anti-viral, anti-cancer, immune regulation, and promoting the proliferation of beneficial bacteria in the intestinal tract. Human lysozyme also has pharmacological effects of anti-bacterial, anti-viral, anti-tumor and immune regulation, furthermore, it has synergistic effect with human lactoferrin. However, human derived lactoferrin and lysozyme are shortage supply due to the extremely scarce resource of human breast milk. There are also commercially available bovine lactoferrin and chicken lysozyme, but they have certain safety risks of heterologous proteins.
Now, using its core patented technological platforms: rice endosperm specific expression platform(OryzHiExp) and protein high purification platform(OryzPur), Healthgen Biotech has respectively developed high-efficiency and high-purity recombinant human lactoferrin and recombinant human lysozyme, which have been confirmed has the identical structure as the natural proteins. Moreover, simulating the concentration of them in human breast milk, combined with their drug efficacy tests in vitro, Healthgen Biotech has developed the best formula of recombinant human lactoferrin and recombinant human lysozyme and made them to be the recombinant human lactoferrin and lysozyme oral liquid. In vivo pharmacodynamic studies showed that the oral liquid has a significant therapeutic effect on mouse infectious diarrhea caused by rotavirus or/and pathogenic Escherichia coli., while the systematic non-clinical studies in animals had proved that the oral liquid has excellent safety. The recombinant human lactoferrin and recombinant human lysozyme are both derived from rice(Oryza Sativa) and have advantages of high capacity and stable supply, which can solve the problem of shortage supply of human lactoferrin and lysozyme derived from breast milk, and can eliminate the risk of heterologous proteins from bovine lactoferrin and chicken lysozyme.
Healthgen Biotech, specialized in developing and manufacturing a series of recombinant protein bio-pharmaceuticals by its State-of-the-Art technological platforms: rice endosperm specific expression platform OryzHiExp and protein high purification platform OryzPur, has established an internationally leading plant biopharmaceutical technology and a complete industrialization system, and become an internationally famous bio-pharmaceutical company focusing on R&D of plant derived new drugs.
The project HY1002 Recombinant Human Lactoferrin and Lysozyme Oral Liquid, is a recombinant protein drug used for the treatment of infectious diarrhea in children caused by rotavirus and accompanied by bacterial infection, and it is also the first innovative bio-pharmaceutical for the treatment of viral diarrhea. Moreover, the project HY1002 is the second original innovative drug of Healthgen Biotech approved for clinical trials after the recombinant human serum albumin (Project HY1001) being approved for clinical trials, which showed that Healthgen Biotech have a huge advantage in technology platforms for developing recombinant protein bio-pharmaceuticals.