The Recombinant 2019-nCoV Vaccine Approved for Clinical Trials

Recently, National Medical Products Administration has officially released the clinical trial notification for the recombinant 2019-nCoV vaccine co-developed by Zhifei Longcom, a wholly-owned subsidiary of Zhifei, and the Institute of Microbiology of the Chinese Academy of Sciences (IMCAS). It is the first recombinant subunit 2019-nCoV vaccine approved for clinical trials in China.

On January 29, Zhifei Longcom signed a Framework Agreement on Cooperation with IMCAS for joint research and development of a recombinant subunit 2019-nCoV vaccine, which has been included in one of the key special projects of “Technical Equipment for Public Safety Risk Prevention and Emergency Response” of National Special Emergency-Key R&D Program of China. With unremitting efforts, researchers from both parties have completed the design of vaccine antigen sequence, the construction of engineering cell lines, and the development of production process. At the same time, Zhifei Longcom carried out the construction of vaccine production workshop and the establishment of quality assurance system to pave the way for the vaccine’s early launch.

This recombinant subunit 2019-nCoV vaccine is co-developed by Zhifei Longcom and IMCAS using recombinant DNA technology, where the 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. The significant protective effect of the vaccine was proved by the challenge experiment in transgenic mice. The challenge experiment in rhesus monkeys showed, the vaccine could induce high level of neutralizing antibody, significantly reduce the viral load of lung tissue, and mitigate the lung injury caused by virus infection, presenting significant protective effects. The vaccine can be put into commercial production based on engineering cell lines, featuring high yield, low cost and strong accessibility. In future, we will carry out human clinical trials to further verify the safety and effectiveness of the vaccine. The Phase I clinical trials will be conducted in the Second Affiliated Hospital of Chongqing Medical University and Beijing Chao-Yang Hospital of Capital Medical University.

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. Since the outbreak of COVID-19, Zhifei, while paying close attention to the pandemic situation, gave full play to its professional advantages, organize competent R&D personnel to actively participate in the research and development of 2019-nCoV vaccine day and night, contributing to the efforts in pandemic prevention and control of the country.

In the global fight against COVID-19, vaccines are the most powerful weapon to overcome the pandemic. We will continue to adhere to the tenet of “Social benefits go before corporate profits”, spare no effort to accelerate the research and development of 2019-nCoV vaccine to protect lives and health of people and make unremitting efforts for the cause of human health.