National New Drug Creation Project “Human Pickup Rabies Vaccine” Received Clinical Approval from the Food and Drug Administration

Medical Network October 9th, October 8th, the national major new drug creation project "human pickup rabies vaccine" has recently made progress in stages, and won the clinical approval of the China National Drug Administration. The human rickshaw rabies vaccine is a new generation of rabies vaccine independently developed by Chinese scientists. The development process has been going through ten years. Since 2013, it has been listed as a major new drug creation project by the Ministry of Science and Technology. It has received special state fund support and won the United States in 2016. The FDA grants orphan drug qualifications for the prevention and treatment of rabies infections were written in official documents by the World Health Organization (WHO) rabies expert group in 2017. At present, the product has successfully completed clinical Phase I and Phase II studies overseas. The products show good safety and immunogenicity, and the clinical results have been published in international authoritative magazines. According to the project sponsor of the rabies vaccine, the project has started the international multi-center phase III clinical trial and prepared for the large-scale production of the product.

Rabies is a 100% infectious disease with an annual mortality rate of about 60,000 people worldwide due to rabies, spread over 100 countries and regions. As a new generation of rabies vaccine, the pickup rabies vaccine uses a new immune regulation activation technology to rapidly induce strong cellular and humoral immunity by activating pathways such as Toll-like receptor 3 (TLR-3) to protect the body from rabies virus infection. , greatly improve the protection rate of vaccines. Compared with the existing commercial rabies vaccine, which requires multiple injections of standard immunizations for four weeks, the immunization protocol of the vaccine three times a week will greatly improve the compliance of the immunized population. The product and related technologies have obtained more than 60 patents in more than 30 countries, covering major countries such as the United States, China, and the European Union.

Mr. Zhang Yi, Chairman and Project Leader of Yisheng Bio, said: “We are very grateful to the State Food and Drug Administration for granting clinical approvals to ensure that the product will open large-scale clinical research in China. As a biopharmaceutical deep-working in the field of rabies prevention. Enterprises , we have carried out a large number of pre-clinical and clinical studies on this project. Compared with the existing commercial vaccines, the pickup rabies vaccine has the characteristics of early antibody production and high antibody titer. This product can produce better exposure. The protective effect, while at the same time, induces a stronger non-specific immune and specific cellular immune response, significantly improving the protective effect after exposure."

Dr. Shao Hui, President and CEO of Essence Biotech, pointed out: "First of all, we would like to congratulate our R&D team and partners for their unremitting efforts for more than ten years, and successfully complete the clinical Phase I and Phase II studies abroad. In recent years, the international use of TLR The development of a new generation of vaccines by the receptor agonist platform has become an important development trend, and the pickup immune modulation activation technology is at the forefront of this field. The 2011 Nobel Prize in Medicine was awarded to the three experts who contributed to TLR receptor-related immunity research. The scholars, Bruce A Beutler, Jules A Hoffmann and Ralph M Steinman, in their awards, specifically mentioned the significance of the study to improve vaccines against infection."

Dr. Shi Zhongkai, the chief medical officer of Yisheng Biotechnology, pointed out that the World Health Organization (WHO) rabies expert advisory committee proposed new ideas for further shortening the vaccine immunization program and implementing new immunization protocols worldwide in 2017. And the four weeks of commercial vaccines. Compared to the immunization protocol, our first-ever accelerated immunization protocol for the pickup rabies vaccine has demonstrated excellent protective and clinical advantages in clinical trials. The pickup rabies vaccine is very likely to be the first to comply with the WHO Expert Committee's global rabies immunization protocol. To reform the guiding vaccine products, we look forward to the successful completion of clinical trials in China and the successful completion of international multi-center clinical trials of more than 5,000 subjects in several countries in Southeast Asia, so that this innovative vaccine will benefit humans as soon as possible. It is in line with the strategic direction of the national 'Belt and Road' and 'Made in China'."

　　 Source: China Yisheng Bio-Pharmaceutical Co., Ltd.