Industry trends seem to herald the answer, and domestic mRNA new crown vaccine research and development is becoming more and more intense.

In the first echelon, among the companies that have obtained clinical approvals early last year, only Amy and Aibo are already in pivotal Phase II/III clinical trials.

Ranking in the second echelon are CSPC, CanSino, and Sri Lanka, which have recently obtained clinical approvals.

The third echelon of Wesjin Bio, Regico Bio, etc., are still in the preclinical research stage and urgently need to catch up.

The State Food and Drug Administration and the National Health Commission and other nine departments jointly released the “14th Five-Year Plan” for the development of the pharmaceutical industry and pointed out: to keep up with the development trend of vaccine technology, support the construction of mRNA vaccines, improve the emergency research and development production capacity of vaccines, and strengthen the guarantee level of the vaccine supply chain . There is no doubt that at the critical stage of the prevention and control of the new crown epidemic, China urgently needs a local mRNA new crown vaccine.

mRNA, the trump card for virus mutation

The mRNA technology that has become popular following the new crown epidemic is not a new thing. In the sudden, complex and changeable epidemic situation, the industry is increasingly reaching a consensus: mRNA new crown vaccine may be the ultimate killer to deal with virus mutation.

This point, understand the principle of mRNA technology, it is easy to understand. Traditional vaccines are like sending a computer that can express viral proteins to the human body, while mRNA vaccines are more like giving the human body a set of operating systems, and the human body expresses proteins by itself. These protein molecules are independent and do not assemble Viral but can elicit an immune response.

Dr. Xiong Changyun, vice president of Amy Vaccines and head of mRNA production, who has entered Phase II/III clinical trials of the mRNA new crown vaccine, made an analogy: “What mRNA vaccines bring into the human body are construction drawings, and the human body itself is used as a factory to produce preventive or Therapeutic vaccines.”

It is precisely because of this that Dr. Shen Dong, CEO of Da Mian Bio, said that mRNA vaccines can activate two immune channels in the human body – the cellular immune system and the humoral immune system, and the activation of cellular immunity is a big killer, activated T cells. , can kill the virus directly. For example, the traditional humoral immunity is the lock that the virus cannot open the door of the cell and cannot enter the cell, but the cellular immunity can directly kill the enemy.

As a dark horse in nucleic acid medicine in recent years, mRNA vaccine has 5 core advantages, which determines that it can respond quickly when helping humans fight against constantly mutating viruses.

1. mRNA can express any kind of protein, and there are many varieties.

2. mRNA can express multiple proteins at the same time, and the cost is lower than traditional protein drugs.

3. The production cycle of mRNA vaccine is extremely short, and GMP production and quality control can be completed within 1-2 months, which can cope with large-scale sudden diseases.

4. mRNA vaccine is a platform technology with strong reusability. 5. The same production line can mass-produce hundreds of millions of vaccine products, with high safety and guaranteed quality control.

The efficacy of mRNA new crown vaccine has been tested by global epidemic prevention

The two mRNA new crown vaccines that have been listed in the world are mRNA-1273 developed by Moderna and BNT162b2 developed by Pfizer/BioNTech.

On May 2 this year, researchers from Optum Labs, a scientific healthcare organization, published in the journal Nature Communications. They conducted a follow-up study of nearly 4 million individuals in the United States who received two doses of the mRNA-1273 or BNT162b2 vaccine and found that the two vaccines were fully vaccinated. Very effective in preventing severe illness (hospitalization, ICU or death) within the next 90 days.

As early as May 2021, researchers in Qatar published a report that after complete inoculation with the Pfizer mRNA vaccine, the protection against infection with the Beta mutant (B.1.351, South African mutant) was 75%, and the infection was almost completely prevented. Severe infection occurred. In addition, the Indian second-generation mutant B.1.617.2 (Delta mutant), which had caused the outbreak in the UK, was 88% protective against symptomatic Delta mutant infection after complete vaccination.

According to the latest research data from the School of Public Health of the University of Hong Kong this year, from the perspective of the effectiveness of various vaccine combinations in preventing infection with Omicron, the effectiveness of the three-injection mRNA new crown vaccine far exceeds that of other vaccination combinations, exceeding 90%. , although it has declined after half a year, it is still around 80%.

Not long ago, academician Zhong Nanshan announced the results of a Brazilian heterologous vaccination that also showed that the protection rate of the vaccine against infection dropped to 34.7% after 6 months of inoculation with two doses of inactivated vaccine, and the rate of severe disease prevention was 72.5%. At this time, if a dose of mRNA vaccine is strengthened, the effectiveness of the vaccine against infection surges to 92.7% after 14 to 30 days, and the rate of severe disease prevention reaches 97.3%.

China mRNA vaccine, who will be the first to hand over excellent answers

The high protection of mRNA vaccines has given people high hopes. Many netizens said, “I want to get a domestic mRNA vaccine as soon as possible.” Which company will be the first to hand over an excellent answer sheet?

UI. Judging from the speed of clinical trials, the fastest runners are currently, and the top two in the first echelon are only Amy and Aibo, which are undoubtedly the most promising.

• The first echelon, entering the pivotal clinical trial

1. The mRNA COVID-19 vaccine LVRNA009 of Amy Vaccine is already in the key Phase II/III clinical trial, and the product has obvious technical advantages

Emmy’s mRNA new crown vaccine LVRNA009 has now entered the pivotal Phase II/III clinical trial and has submitted a sequential vaccination application.

From the existing clinical data, LVRNA009 shows obvious advantages over its peers. In the phase I clinical trial, the live virus neutralizing antibody detection results of this vaccine showed good safety and immunogenicity, especially the geometric mean titer (GMT) level of the subjects in the middle dose group was close to 1600. All adverse events occurred in grades one to two, and no adverse events above grade three occurred.

LVRNA009 adds a special design to stabilize the higher order structure of the S protein. Using a one-step process to combine DNA transcription and mRNA capping into one step, the resulting mature mRNA has a capping rate of over 95% and a purity of over 99%. More than 95% encapsulation efficiency has been achieved, the nanoparticle dispersion coefficient is less than 0.1, and it has high batch-to-batch consistency. In addition, the use of LNP delivery system, in addition to protecting mRNA, can also promote cellular uptake, reduce in vivo escape, protect mRNA molecules from being recognized by TLRs, and avoid the effect of excessive activation of the innate immune system.

In terms of vaccine industrialization, Aimei Vaccine is deploying mRNA vaccine modular production workshops in many places, and it will be able to conduct batch production of mRNA new crown vaccine engineering in June. The factory is expected to be completed in the fourth quarter of this year, with a designed annual production capacity of 400 million doses.

2. Aibo Biotech mRNA new crown vaccine ARCoV aX international multi-center phase III clinical trial has made progress

The new crown mRNA vaccine ARCoVaX jointly developed by Abbott, the Academy of Military Medicine of the Academy of Military Sciences, and Watson Bio has basically completed the domestic phase III clinical field work, and data collation and continuous serum testing are in progress. The international multi-center phase III clinical trial has been completed. sexual progress.

Phase I clinical data of ARCoVaX showed that in terms of neutralizing antibody titers, humoral immune responses such as RBD antibodies (IgG) and neutralizing antibodies were significantly increased on the 7th day after the second vaccination, and reached within 14-28 days. peak. Specific T cell responses peaked 7-14 days after complete vaccination (two doses). Among them, 15 μg induced the highest titer of neutralizing antibodies, which was about twice that of patients in the recovery period of COVID-19, while the levels of neutralizing antibodies in the 20 μg and 25 μg groups were similar to those in the low-dose group.

In terms of safety, there were no serious adverse events within 56 days after vaccination, and most adverse events were mild or moderate, and the most common adverse reaction was fever. At the same time, all subjects had fever resolution within 2 days after vaccination, and the incidence of adverse events caused by the first and second doses of ARCoVaX vaccine was similar.

• The second echelon, newly obtained clinical approval

3. Staphylococcus microbes

On April 29, Sri Lanka officially announced that its self-developed new coronavirus mRNA vaccine has been approved by the State Food and Drug Administration and will carry out clinical trials. The iterative vaccine developed by Sterling Microbes was approved for clinical trials this time. The R&D design includes the D614G mutation shared by various new coronavirus variants such as Delta and Omicron, which protects the current epidemic strains of the new coronavirus. The potency has a certain broad spectrum.

The research and development of Sri Lanka mRNA vaccine is based on its independent intellectual property rights of lipid polymer nanocarrier technology platform (LPP/mRNA).

In terms of industrialization, SMIC has established modern production plants in Zhoupu and Fengxian, Shanghai. The annual output of the two plants is expected to reach 400 million doses.

4. CSPC

On April 3, CSPC announced that its new coronavirus mRNA vaccine “SYS6006” has been approved by the State Drug Administration for clinical research in China.

According to the announcement, SYS6006 has been designed with targeted antigen mutations according to the epidemic situation of the strain. Preclinical studies have shown that the product has good immune protection efficacy against the current mainstream mutant strains including Omicron and Delta; through humoral immunity and cellular Immunity provides immune protection to the body, and can generate memory B cells to provide long-term protection.

5. CanSino

CanSino announced on April 4 that its new coronavirus mRNA vaccine has obtained approval for drug clinical trials from the State Drug Administration.

According to the announcement, the results of preclinical studies show that the vaccine can induce high titers of neutralizing antibodies against a variety of important variants identified by the World Health Organization (including the current circulating strain), which is in line with existing vaccines developed on the basis of prototype strains. The new crown vaccine is more broad-spectrum and can more effectively protect the body from infection by existing mutants.

• The third echelon, and strive to enter the clinic as soon as possible

An enterprise in the third echelon of research and development progress, Westin Biosciences is developing an mRNA new crown vaccine, and has submitted a clinical trial application to the State Food and Drug Administration, and the mRNA new crown vaccine developed by Regis Biotech is also planning to submit an IND application. There is an urgent need to speed up the progress and enter the most challenging clinical trial stage.

According to industry evaluations, the mRNA technology platform will give birth to “game changers like Apple and Google”, subverting the drug development model.

We have seen that domestic key Biotech companies, such as Zhifei Bio, have entered into the mRNA technology platform layout by subscribing for the equity of Shenxin Bio, Kangtai Bio and Jiachen Xihai have cooperated to carry out the mRNA rabies vaccine project, Watson Bio has cooperated with Aibo Bio and Blue Que Bio, diversifying the field of mRNA research and development…

We are looking forward to the Chinese local mRNA vaccine companies that can be the first to reach the end of the victory, take responsibility for the country, and come up with the ultimate weapon that can end the new crown epidemic as soon as possible!

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