In February 8th, Walvax Biotechnology Co.Ltd(300142) (hereinafter referred to as ” Walvax Biotechnology Co.Ltd(300142) “, 300142) announced that its self controlled recombinant New Coronavirus variant vaccine (CHO cell), a subsidiary of Shanghai Ze run Biotechnology Co., Ltd. (hereinafter referred to as “Shanghai Ze run”), was awarded the ethical approval of phase I / II clinical trials approved by the ethics committee of Ma Riba Marco University of science and technology recently.
The announcement said that after confirmation by the ethics committee, it was agreed to carry out phase I / II clinical trials of the vaccine in Mali to evaluate the safety, immunogenicity and immunogenicity of the vaccine in healthy adults aged 18 to 60.
Meanwhile, the epidemic prevention Innovation Alliance (CEPI) announced that it would provide us $8.15 million to Shanghai Zerun to support the phase I / II clinical trial to be carried out in Mali. Up to now, CEPI’s financial support for covid-19 candidate vaccine of Shanghai Zerun has reached US $25.1 million.
Previously, Shanghai Ze Ran has developed a vaccine against New Coronavirus prototype strain. Historical announcement shows that the recombinant New Coronavirus vaccine (CHO cell) for the prototype strain is in phase II clinical trial. Prior to August 28, 2021, Walvax Biotechnology Co.Ltd(300142) issued a notice. The Board agreed that Shanghai Ze ran set up its wholly owned subsidiary, Beijing zrun, in Daxing District, Beijing, and invested in the construction of the New Coronavirus vaccine (CHO cell) industrialization project with Beijing zrun as the investment entity. The total investment of the project is 520 million yuan.
The recombinant New Coronavirus vaccine approved for clinical trials is a vaccine against New Coronavirus variants.
Walvax Biotechnology Co.Ltd(300142) said recently that the European Drug Administration (EMA) has approved the development of the New Coronavirus recombinant protein vaccine NVX-CoV2373, which is developed by the US Novavax company, with the conditions listed. The WHO (WHO), India, Indonesia, Philippines, Korea, Australia and other countries have approved the emergency use authorization of Novavax, the China Chongqing Zhifei Biological Products Co.Ltd(300122) . Sinopharm China biological recombinant protein covid-19 vaccine has also been authorized for emergency use. The global recombinant protein vaccine against New Coronavirus mutant is currently in the research stage.
Walvax Biotechnology Co.Ltd(300142) at the same time, it is reminded that with the continuous improvement of global covid-19 vaccination rate and the continuous variation of covid-19 virus, the implementation of vaccine clinical trial faces many challenges, and there are still some uncertainties in the progress and results of phase I / II clinical trial of this vaccine.
It is noteworthy that Walvax Biotechnology Co.Ltd(300142) has a lot of vaccine layout during covid-19 pandemic. The candidate mRNA vaccine arcov jointly developed by the Chinese Academy of Military Medical Sciences (AMMS), Aibo biology and Walvax Biotechnology Co.Ltd(300142) is currently in phase III clinical trials. Arcov encodes the receptor binding domain (RBD) of sars-cov-2 spike protein as antigen. This is also the first mRNA vaccine approved for clinical trials in China.
In January this year, the lancet microbe, an open access journal of the lancet, disclosed the data of the first phase of clinical trial of the vaccine. According to the research team, arcov showed safety, good tolerance and immunogenicity at all doses of 5 μ g, 10 μ g, 15 μ g, 20 μ g and 25 μ G. No serious adverse events were reported within 56 days after vaccination, and most adverse events were mild or moderate. Fever is the most common systemic adverse reaction, and its frequency increases with the increase of dose. However, the grade 3 systemic adverse event fever and effectiveness of the vaccine have been controversial.
In addition, prior to the Walvax Biotechnology Co.Ltd(300142) announcement in May 29, 2021, the joint New Coronavirus vaccine (chimpanzee adenovirus vector) jointly developed by Tsinghua University and Medical University Of Tianjin was approved by the drug clinical trial.
Recently, on January 29, Walvax Biotechnology Co.Ltd(300142) announcement showed that it also had another layout in mRNA vaccine. The company signed the “New Coronavirus mutant mRNA vaccine technology development and commercial integration agreement” with Shanghai Blue Magpie bio Pharmaceutical Co., Ltd. (hereinafter referred to as “Blue Magpie creature”), and jointly launched the New Coronavirus mutant mRNA vaccine product development and commercial cooperation.
