Zhifei Initiated Phase II Clinical Trials of Recombinant 2019-nCoV Vaccine

On July 10, the Phase II clinical trials of recombinant 2019-nCoV vaccine jointly developed by Zhifei Longcom, a wholly-owned subsidiary of Zhifei, and the Institute of Microbiology of the Chinese Academy of Sciences (IMCAS) was initiated at Xiangtan County Center for Disease Control and Prevention in Hunan Province, to evaluate the safety and immunogenicity of vaccine.

This vaccine is developed using recombinant DNA technology, where the unique dimer of receptor binding region (RBD) of novel coronavirus spike glycoprotein (S protein) is employed as the antigen, supplemented with traditional adjuvant. The vaccine, without foreign tags of any form, is characterized with unique conformation, high immunogenicity and high safety. After obtaining the drug clinical trial approval from National Medical Products Administration, the Phase I clinical trials were conducted in the Second Affiliated Hospital of Chongqing Medical University and Beijing Chao-Yang Hospital of Capital Medical University to evaluate the safety and tolerance of the vaccine.

As the R&D partner of the vaccine, IMCAS has long been committed to the basic research on molecular epidemiology of emerging infectious diseases, cross species transmission of animal-derived viruses, and pathogen structure biology. As a state-level research institute with complete specialties and highest level in the field of microbiology research in China, it is at the forefront in participating in major domestic and international projects related to infectious diseases and sharing international research resources. IMCAS’s long-term research results and rich experience in commercialization lay a solid foundation for the rapid development of recombinant subunit 2019-nCoV vaccine.

As a high-tech corporation covering the whole process from research, development, production, sales, distribution to import and export of vaccines and biological products, Zhifei, since its establishment, has been committed to the R&D and production of new vaccines for human use on basis of independent research and development. Moreover, Zhifei has actively introduced international leading technologies and successively rolled out over ten categories of vaccines, contributing to the national health. Zhifei Longcom, a national high-tech enterprise and a wholly-owned subsidiary of Zhifei, has been committed to the R&D and production of new vaccines for human use mainly including tuberculosis prevention and control products and virus vaccines. At the beginning of COVID-19 outbreak, under the guidance of Zhifei, Zhifei Longcom took rapid actions and started the scientific research on a 2019-nCoV vaccine by taking advantage of its experience and advantages of more than ten years in the field of vaccine research and development. The vaccine became the first recombinant subunit 2019-nCoV vaccine approved for clinical trials in China. At present, the construction of production workshop and quality assurance system specially for the 2019-nCoV vaccine is speeding up.

As a special product for healthy people, vaccines are very important for pandemic prevention and control. As a biopharmaceutical enterprise, we will continue to earnestly fulfill our social responsibility, speed up the vaccine research and development, ensure safety in production, and contribute to the pandemic prevention and control.