Original title: Cangxinuo COVID-19 Vaccine was approved for internal use in the army, completing clinical blindness detection in phase II.
(article / Observer Network Lu Dong) before the Hong Kong stock market on June 29th, 06185.HK announced that the Recombinant novel coronavirus Vaccine (adenovirus Vector) (Ad5-nCoV) developed jointly with the Institute of Biological Engineering of the Institute of military Medicine of the Academy of military Sciences had been approved by the Health Bureau of the Logistics support Department of the Central military Commission (hereinafter referred to as: the Department of Post Security of the Central military Commission) on June 25. It is valid for 1 year.
According to the announcement, phase I and II clinical trials of Ad5-nCoV have been carried out in China, and phase II clinical trials were completed on June 11. Clinical trial data confirmed that it has good safety and high level of humoral and cellular immune response.
The overall trial results show that Ad5-nCoV has the potential to prevent diseases caused by SARS-CoV-2 (severe respiratory syndrome type 2 coronavirus), Kangxinuo said. According to the relevant provisions of the measures of the people's Liberation Army for the implementation of the Drug Administration Law of the people's Republic of ChinaAt this stage, Ad5-nCoV can only be used within the army.The scope of vaccination shall not be expanded without the approval of the Ministry of Security after the Central military Commission.
The announcement also reminds investors that there is no guarantee that Kangxinuo will eventually succeed in commercializing Ad5-nCoV.
Hong Kong stocks opened today, Kangxinuo Bio-B opened 4.2% higher, with the highest intraday rise of 8%. As of press time, the increase fell back to 3.2%, with a market capitalization of HK $50.5 billion. Its shares have risen 284 per cent so far this year.
In 2009, Kangxinuo Bio was registered in Tianjin Binhai New area and listed in Hong Kong in March last year, engaged in the research, development, production and commercialization of human vaccines. In January this year, it formally submitted and accepted the application for listing on the pioneer board of the company, and proposed to raise funds for the expansion of new vaccine production capacity and product research and development.
The Ad5-nCoV vaccine was jointly developed by a team of Chen Wei academicians of the Cancino Academy of Biology 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 that infects human cells but does not cause disease) to pass genetic material that encodes the SARS-CoV-2 spike (S) protein to the cells. These cells then produce the S protein and reach the lymph nodes, where the immune system produces antibodies that recognize the S protein and repel the coronavirus.
On May 22nd, the international academic journal the Lancet published online the results of the world's first phase I clinical trial of recombinant adenovirus type 5 vector COVID-19 vaccine. Its editor-in-chief Richard Horton commented: "the first human trial of this novel coronavirus vaccine has found that it has good safety and tolerance, and can induce a rapid immune response." These results represent an important milestone. "
As for the experimental results, Academician Chen Wei pointed out: "these results make it a potential candidate for further research."
At the same time, however, she stressed, "We should interpret these results carefully." The challenge of developing a COVID-19 vaccine is unprecedented, and the ability to induce an immune response does not necessarily mean that the vaccine completely protects humans from SARS-CoV-2 infection. These results provide a positive prospect for COVID-19 vaccine research and development, but we still have a lot of work to do before the vaccine is put on the market. "
In fact, at the beginning of the epidemic, China's scientific research team took vaccine research and development as one of the main directions. A total of 12 R & D tasks were arranged according to five technical routes, such as inactivated vaccine, genetically engineered recombinant subunit vaccine, adenovirus vector vaccine, attenuated influenza virus vector vaccine and nucleic acid vaccine. At present, clinical trials have been carried out on one adenovirus vector vaccine and four inactivated vaccines, accounting for 40% of the total number of clinical trial vaccines in the world.
Wang Junzhi, deputy head of the expert group on vaccine research and development of the joint prevention and control mechanism, said on June 19 that at present, five research institutes of COVID-19 vaccine in our country have entered the clinical trial stage, and three of them have completed phase II clinical trials. All the research process, research and development process, evaluation standards, and technical guidelines to ensure safety and effectiveness are all in line with international standards.
"the next step is to actively conduct clinical phase III trials to obtain data on the effective protection rate of the real vaccine population, which is extremely important for the ultimate success of our vaccine." He said.
On the evening of June 23, Sinopharmaceutical Group China Biological announced that the world's first international clinical trial of a new inactivated crown vaccine (Phase III) was launched in the United Arab Emirates. This is also the first clinical trial of China's COVID-19 vaccine overseas.
Why do Phase III clinical trials of vaccines go abroad?
According to Duan Kai, director of Wuhan Institute of Biological products, clinical research is usually divided into three phases. The safety was mainly evaluated in the first phase. Phase II mainly evaluated the safety and immunogenicity of the vaccine and explored the immune procedure. Phase III mainly evaluated the safety and effectiveness of the vaccine in a larger population.
"in view of the fact that the domestic epidemic situation has been effectively controlled and does not have the conditions for phase III clinical trials, if COVID-19 vaccine wants to do clinical research, it should be done in foreign places where the epidemic is relatively high. Safety evaluation runs through the whole process of clinical research. If the phase III clinical trial is successful, it shows that these vaccines are safe, effective and can protect vaccinated people from novel coronavirus infection. " He said.
(editor: Zhou Yuanyuan)