Reporter : He Liping
Publisher : The Paper
Translation, editing : Gan Yung Chyan
/ KUCINTA SETIA
Image courtesy : CanSino / via Fierce Pharma
In the morning of 29 June 2020, CanSino Bio Co., Ltd. (Kang Xinuo Biological-B, 06185.HK) announced that the recombinant SARS-CoV-2 vaccine (adenoviral vector) received the People's Republic of China (PRC) military special drug approval.
The announcement stated that the recombinant novel coronavirus vaccine (adenovirus vector) (Ad5-nCoV) jointly developed by the company and the Institute of Bioengineering of the Academy of Military Medical Sciences of the Military Academy of Sciences has been awarded the Health Bureau of the Logistics Support Department of the Central Military Commission on 25 June 2020. (Hereinafter referred to as the "Military Commission Post-Defense Department") issued military special needs drug approval, valid for one year.
The Phase I and Phase II clinical trials of Ad5-nCoV have been launched in PRC, and the blinding of Phase II clinical trials was completed on June 11, 2020. Kang Xinuo said that the clinical trial data confirmed that it has good safety and a high level of humoral immunity and cellular immune response. The overall test results show that Ad5-nCoV has the potential to prevent diseases caused by SARS-CoV-2.
The announcement mentions that, according to the relevant provisions of the Measures of the People’s Liberation Army for the Implementation of the “Law of the People’s Republic of China on Drug Administration”, Ad5-nCoV is currently limited to internal use by the military, and the scope of vaccination may not be expanded without the approval of the Ministry of Military Affairs and Security.
CanSino Bio also reminded: We cannot guarantee that we will be able to successfully commercialize Ad5-nCoV in the end.
This Ad5-nCoV vaccine was jointly developed by the team of academician Chen Wei from the Institute of Bioengineering of the Academy of Military Medical Sciences of the Academy of Biological and Military Sciences. The vaccine is a replication-defective Ad5 vector vaccine expressing SARS-CoV-2 spike glycoprotein (S protein). The vaccine uses an attenuated common cold virus (adenovirus, susceptible to human cells but not pathogenic) to deliver genetic material encoding the SARS-CoV-2 spike (S) protein to the cells. These cells then produce S protein and reach the lymph nodes, the immune system produces antibodies, recognizes the S protein and repels coronavirus.
Prior to the evening of 22 May, the top medical journal The Lancet published a paper entitled "The safety, tolerability and immunogenicity of the recombinant adenovirus type 5 vector COVID-19 vaccine : Increasing dose, open label, non-random, first human trial". Researchers such as Chen Wei reported the Phase 1 clinical data of the Ad5 carrier COVID-19 vaccine used in Chinese healthy adults within 28 days after vaccination to initially assess the safety, tolerability and immunogenicity of the vaccine.
Chen Wei said at the time, "These results are an important milestone. Tests have shown that a single vaccination of the replication-deficient human adenovirus type 5 (Ad5) vector new crown vaccine can induce the production of virus-specific antibodies and T cell responses within 14 days. This makes it a potential vaccine candidate for further research."
Chen Wei also said, "We should interpret these results with caution. The challenge of developing the COVID-19 vaccine is unprecedented, and the ability to induce an immune response does not necessarily indicate that the vaccine can completely protect humans from SARS-CoV-2 infection. These results provide positive prospects for the development of the new crown vaccine, but we still have a lot of work to do before the vaccine is launched."
CanSino Bio was registered in Tianjin Binhai New Area in 2009. It specializes in the research, development, production and commercialization of high-quality human vaccines. It has established research and development pipelines for 16 innovative vaccine products in 13 disease areas, including covid, Ebola virus disease, tuberculosis, meningitis, leucorrhea, herpes zoster, etc. In March 2019, it was listed on the H shares of the main board of the Hong Kong Stock Exchange; in January 2020, the company formally submitted the application for the listing of the science and technology board and was accepted. It plans to raise funds for the expansion of new vaccine production capacity and the development of new vaccine products.
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