On April 26, the inactivated vaccine of Omicron variant covid-19 virus of Sinopharm China biological won the clinical approval of the State Food and drug administration. The vaccine has previously obtained the clinical research approval from the Hong Kong Department of health, and is the first inactivated vaccine of Omicron strain in the world.
Affected by this, China National Medicines Corporation Ltd(600511) a shares rose sharply, with a closing price of 27.57 yuan / share and a total market value of 20.8 billion yuan. H-share Sinopharm holdings once soared by more than 5% and finally closed up 2.25%.
Almost at the same time, the State Food and drug administration also officially approved the inactivated covid-19 virus vaccine of Omicron variant of Kexing biology to enter clinical research.
With the approval of the clinical trials of these two covid-19 vaccines, the research and development of covid-19 vaccine of Chinese Omicron mutant will enter a critical stage. In the future, the listing of relevant vaccines will provide more options for the sequential booster vaccination of covid-19 vaccine, and may also open the prelude to the fourth booster vaccination of covid-19 vaccine in China.
the earliest in the world
Sinopharm China Bio introduced the Omicron variant strain from the University of Hong Kong for the first time on the basis of the prototype strain covid-19 inactivated vaccine listed in the early stage and the research and development of beta and delta variant inactivated vaccine. On December 9, 2021, Sinopharm China Bio quickly launched the research and development of Austrian strain inactivated vaccine.
According to its introduction, the inactivated vaccine of Omicron mutant covid-19 virus (hereinafter referred to as "Austrian covid-19 inactivated vaccine") can produce high titer neutralizing antibodies against Austrian strain and a variety of mutant strains.
On March 3 this year, Beijing Institute of biological products and Wuhan Institute of biological products determined the clinical scheme and relevant details with Hong Kong research institutions. On March 26 and 30, they obtained the verification qualification report of China Institute of drug and food certification respectively.
On April 1, it submitted clinical application materials to the Hong Kong Department of health. It obtained ethical approval on April 12 and clinical research approval on April 13, becoming the world's first inactivated vaccine of Omicron strain approved for clinical use.
At the same time, Sinopharm China biological began to submit Chinese clinical application materials to the drug evaluation center of the State Food and Drug Administration on a rolling basis from January 26 to start the technical review. On April 26, the inactivated vaccine of Austrian covid-19 virus obtained the clinical approval issued by the State Food and Drug Administration of China.
In the form of randomized, double-blind and cohort study, China biology will conduct a sequential immune clinical study among people aged 18 and over who have completed 2 or 3 doses of covid-19 vaccine to evaluate the safety and immunogenicity of inactivated Austrian covid-19 virus vaccine.
Kexing biology was also approved
On April 26, Kexing holding Biotechnology Co., Ltd. (hereinafter referred to as "Kexing biology") also announced that its covid-19 virus inactivated vaccine based on Omicron mutant was allowed to enter the clinical research to evaluate the safety and immunogenicity of covid-19 virus mutant vaccine in various populations.
On December 5, 2021, Kexing biology obtained nasopharyngeal swab samples from patients infected with covid-19 virus Omicron variant strain, and carried out virus isolation and whole gene sequencing in cooperation with Professor Qin Chuan of Institute of medical laboratory animals, Chinese Academy of Medical Sciences.
Four days later, Kexing biology introduced the sample of Omicron variant of covid-19 virus isolated from the University of Hong Kong.
The results of animal model study showed that the inactivated vaccine of Omicron variant of Kexing biology was safe and effective in experimental animals.
The paper version of the application for clinical trial and the electronic version of the application for clinical trial will be submitted to the CDE on January 15 of this year, and the full set of clinical trial registration materials will be submitted to the CDE.
At the same time, since the end of February, Sinovac has successively submitted clinical applications for inactivated vaccine of Omicron mutant strain to many countries and regions outside Chinese Mainland.
On April 14, the covid-19 virus inactivated vaccine developed by Kexing biology based on the Omicron mutant obtained clinical approval in the Hong Kong SAR.
multiple covid-19 vaccines under development
At present, covid-19 vaccination is still one of the important means of epidemic prevention and control in China. According to the official website of the Health Commission, as of April 25, 31 provinces (autonomous regions and municipalities directly under the central government) and Xinjiang production and Construction Corps had reported more than 3.3 billion doses of covid-19 virus vaccine.
Omicron mutant has the characteristics of rapid transmission and strong concealment, but vaccination is still effective in preventing Omicron infection.
According to statistics, as of April 15, China has approved a total of seven products to be listed, including Sinopharm Zhongsheng Wuhan Institute, Beijing Institute, Beijing Kexing, Chongqing Zhifei Biological Products Co.Ltd(300122) , Cansino Biologics Inc(688185) , Shenzhen Kangtai Biological Products Co.Ltd(300601) and Institute of medical biology, Chinese Academy of Medical Sciences, of which five are inactivated vaccines, one is recombinant protein vaccine and one is adenovirus vector vaccine.
China's inactivated vaccine technology is relatively mature, with the advantages of short research and development cycle, relatively mature preparation process, no infectious virulence and high safety. However, it usually requires multiple vaccinations to produce protective immunity.
At present, there are many covid-19 vaccines under development, mainly focusing on three technical paths: mRNA, recombinant protein and virus vector. The listed companies involved include Walvax Biotechnology Co.Ltd(300142) , Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , stone Pharmaceutical Group, Cansino Biologics Inc(688185) , Ruike biology, Livzon Pharmaceutical Group Inc(000513) , Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , etc.
