The two domestic vaccines (hk-8193 mRNA) and (hk-8185 cosh mRNA) have entered the clinical trial, and they have entered the clinical trial successively.
Boosted by the above news, the Hong Kong stock prices of the two companies rose more than 5% on the morning of April 4.
Interestingly, the above two covid-19 mRNAs under development have a certain broad spectrum, trying to fight a variety of covid-19 variants. The continuous variation of covid-19 virus weakens the anti infection effect of the existing vaccines on the market, and there is an urgent need for a new generation of vaccines to be put into use. At present, many domestic mRNA vaccines are turning to the development of broad-spectrum vaccines.
How effective is the broad-spectrum mRNA vaccine against covid-19 virus? What new breakthroughs have domestic mRNA vaccine enterprises made?
explore and develop broad-spectrum mRNA Vaccine
In the morning of April 4th, Cansino Biologics Inc(688185) bio announced that the New Coronavirus mRNA vaccine developed by the company has been approved by the National Drug Administration clinical trial. The results of preclinical studies show that the vaccine can induce high titer neutralizing antibodies against a variety of important variants (including current strains) identified by WHO. Compared with the existing covid-19 vaccine developed based on the prototype strain, it has a wider spectrum and can more effectively protect the body from the infection of the existing mutant strain.
Coincidentally, the night before, another enterprise Shiyao group also announced that the New Coronavirus mRNA vaccine developed by the company ("SYS6006") has been approved by the State Administration of drug supervision and administration, and can be launched in China.
According to the bulletin of the stone drug group, SYS6006 is the mRNA vaccine developed by the company for New Coronavirus variant strain. The product has targeted antigen mutation design according to the epidemic situation of the virus strain. Preclinical research shows that the product has good immune protection against the current mainstream mutant strains including Omicron and delta; It provides immune protection to the body through humoral immunity and cellular immunity, and can produce memory B cells to provide long-term protective effect. In addition, the preclinical safety evaluation data also fully proved the safety of the product.
From the above, both covid-19 vaccines have a certain broad spectrum.
In addition to the above two enterprises, on March 31, the first financial reporter also learned from Jiachen Xihai (Hangzhou) Biotechnology Co., Ltd. that the mRNA covid-19 vaccine jointly developed by the company and minhai biology has completed the verification and evaluation of the immune effect of Omicron vaccine and multivalent vaccine. The prepared Omicron variant mRNA vaccine can induce high titer neutralizing antibody in mice.
The continuous variation of covid-19 virus weakens the preventive effect of the existing vaccines on the market. The highly infectious Omicron mutant has spread to more than 20 provinces in China since it first appeared in Tianjin in January this year. In order to fight the Omicron mutant more effectively, many pharmaceutical companies are trying to carry out multivalent vaccine research for different vaccine technology routes. One of the advantages of developing multivalent vaccine is that it can deal with a variety of mutated viruses at the same time and has a certain broad spectrum.
Recently, Jiang Shibo, director of the Institute of pathogenic microorganisms of Fudan University, said in an interview with the first financial reporter that the covid-19 vaccine development routes of different technology platforms have different strategies for developing broad-spectrum. For example, the technical route of mRNA vaccine can improve the immune response and broad-spectrum by appropriately changing the vaccine antigen or adding intramolecular immune adjuvant.
challenges and breakthroughs
However, the effectiveness of broad-spectrum mRNA vaccine against Omicron variant and whether it can really solve the breakthrough infection of covid-19 virus still need to be verified by clinical research and real-world research.
It is worth noting that there is no absolute standard on the relationship between the antibody level, cellular immunity level and the preventive efficacy of covid-19 vaccine, which also leads to difficulties in the development of covid-19 vaccine.
"If there are absolute indicators, the road of vaccine development will become smoother. Because of the lack of relevant standards, the current development of covid-19 vaccine needs to carry out large-scale phase III clinical trials, which must be judged by effectiveness indicators, which not only greatly increases the difficulty of vaccine development, but also increases the development cost." Recently, Zhang Lunan, executive director and vice chairman of the board of directors of AI diweixin biology, told the first financial reporter.
The Cansino Biologics Inc(688185) bio warned in the announcement that the safety and efficacy of New Coronavirus mRNA vaccine must be confirmed by clinical research. The company can not guarantee that New Coronavirus mRNA vaccine will eventually be successfully developed or commercialized.
Since the emergence of covid-19 epidemic in 2020, as a new vaccine technology route, covid-19 mRNA vaccine has been valued by the industry and sought after by capital due to its short R & D cycle.
As a kind of nucleic acid vaccine, the principle of mRNA vaccine is to inject the mRNA encoding antigen protein directly into human cells, use human cells to produce protein antigen and activate immune response. The vaccine will not integrate with human DNA and has no risk of exogenous virus infection. The following steps are required for mRNA vaccine to work: mRNA is wrapped by various delivery vectors; Injection into the human body; Liposomes encapsulating mRNA endocytosis into cells; MRNA is released in cells, and the antigen protein is translated and expressed by human organelles to stimulate the human body to produce immune response.
For the development of covid-19 mRNA vaccine, in addition to solving the vaccine efficacy, how to solve the delivery system, production process and storage and transportation of this vaccine need to be explored. Among them, how to specifically deliver mRNA into target cells is a big problem. The bottleneck in production lies in raw materials and large-scale production.
It is worth mentioning that at present, domestic mRNA vaccine enterprises have been trying to make some breakthroughs.
According to the first financial reporter, before developing mRNA vaccine, the company has built a liposome technology platform with independent intellectual property rights and produced four new drug products. Today, the company also applies the technology platform to mRNA vaccine research and development.
Stone Pharmaceutical Group said in the announcement that the company's mRNA vaccine sys6006 uses advanced production technology, the process is highly controllable, the consistency between batches is good, and it is easy to realize amplification and industrialization; Moreover, it has good stability and can be stored for a long time in 2-8 days. In addition, the company has realized internalized production and domestic substitution for the key production raw materials and auxiliary materials of mRNA technology, which can meet the demand of large-scale production capacity supply.
Cansino Biologics Inc(688185) bio also said that the company has been distributing mRNA synthesis and delivery technology for many years on the official WeChat official account. It has developed and stored patents, processes and mRNA sequence design in various fields, such as talent, platform and industrialization, and has applied for a number of patents on mRNA vaccine design and new delivery system design. The mRNA technology platform established by the company has independently designed and developed sequence optimization software, which can obtain the key sites affecting stability and the optimal sequence that can effectively improve the expression of antigen. In addition, the company's mRNA vaccine production plant will be delivered by the end of 2021 and will have the conditions for large-scale industrialization by the end of this year.
