Shenzhen Regi Biotechnology Co., Ltd. announced that its lyophilized novel coronavirus Omicron strain mRNA vaccine RH109, ​​developed by its joint venture company Wuhan Regi Biotechnology Co., Ltd., has obtained clinical approval in New Zealand and the Philippines. . This approva

The world's first freeze-dried COVID-19 Omicron strain mRNA vaccine enters the clinical stage

Shenzhen Regis Biotechnology Co., Ltd. announced that it developed freeze-dried Novel coronavirus Omicron strain mRNA vaccine RH109, ​​which was developed by The joint venture company, Wuhan Ruikeji Biotechnology Co., Ltd., has obtained clinical approvals in New Zealand and the Philippines. This approval marks the world's first freeze-dried COVID-19 Omicron strain mRNA vaccine entering the clinical stage, which is a milestone. RH109 adopts freeze-drying technology independently developed by Regis Biotech, which can effectively maintain the physical and chemical properties and biological activity of mRNA-LNP and achieve long-term storage at 2-8°C. Preclinical studies have shown that this product can produce effective protection against the Omicron variant virus, and can induce a broad-spectrum cross-neutralizing reaction when used as a booster shot, showing its good immunogenicity characteristics. Relevant research results have been released on the preprint platform bioRvix. What is

mRNA?

mRNA directs protein production through "translation." mRNA (messenger ribonucleic acid) is transcribed from the DNA template, carrying genetic information and instructing cells to produce intracellular proteins, membrane protein and extracellular proteins. Taking the mRNA vaccine as an example, the core principle is to deliver the mRNA encoding the antigen into human cells through different delivery methods, and produce the corresponding antigen protein after translation in the cells, thereby effectively stimulating cellular immunity and humoral immunity .

mRNA can be widely used in many fields such as preventive vaccines, therapeutic vaccines, and therapeutic drugs due to its technical advantages. In theory, mRNA can express any protein and can prevent and treat a variety of diseases. Therefore, mRNA can be used as a universal technology platform with great potential. At present, mRNA can be used in infectious disease prevention, tumor immunotherapy, protein replacement, CAR-T, gene editing, etc. It can be generally divided into three categories: preventive vaccines, therapeutic vaccines, and therapeutic drugs. Among them, the field of preventive vaccines has the most abundant layout, followed by the field of therapeutic drugs.

mRNA vaccine has the advantages of short development cycle, simple production process and high effectiveness. Compared with traditional inactivated/attenuated vaccines, subunit vaccine and genetically engineered vaccines, mRNA vaccines have the following advantages: short development cycle; simple production process and easy expansion; no need for adjuvants, high effectiveness; no entry cell nucleus , better security, etc. Compared with DNA vaccines, it does not enter the cell nucleus, is safer, has faster onset of action and is more effective. The development history of

mRNA: Breakthroughs were achieved in key technologies such as molecular modification and delivery, and the commercialization era began.

mRNA took about 60 years from its discovery to its first launch as a commercial product. The development of the technology went through the following stages:

1961-1990: mRNA from theory into reality. From the discovery of mRNA in 1961 to the world's first report of transcribing mRNA in mice in vivo and in vitro in 1990, the specific mechanism and role of mRNA and its development potential as a "commander" were clarified.

1990-2009: Key technologies such as molecular modification made human applications possible. From the 1990s to 2009, in order to achieve breakthroughs from animals to humans, mRNA technology was in a continuous breakthrough stage. In 2005, it was discovered that chemical modification can reduce the immunogenicity of mRNA. In 2009, cancer immunotherapy was first applied to humans.

2009-2020: Advances in delivery technology drive large-scale human clinical trials. In 2009, the LNP delivery system applied for a patent for the first time. In 2010, Moderna, the global leader in mRNA, was established. In 2015, the first LNP-delivered mRNA vaccine entered the clinic. From 2015 to 2019, the gradual maturity of LNP delivery technology and sequence modification technology brought great changes to the development of the mRNA industry. With sufficient motivation, a number of mRNA vaccines have been launched into clinical trials.

2020-present: The era of commercialization has officially begun. In 2020, the world's first commercialized mRNA product, mRNA-1273, was launched and quickly gained popularity in the capital market. my country's mRNA technology industry has also begun to flourish since then. As the early technology accumulation gradually matures and with the help of the capital market, mRNA technology will enter a golden decade of rapid development.

Advantages of mRNA vaccine

Compared with traditional inactivated/attenuated vaccines, subunit vaccines and genetic engineering vaccines, mRNA vaccines have the following advantages: short research and development cycle; simple production process and easy expansion; no need for adjuvants and high effectiveness ;Does not enter the cell nucleus, has good safety, etc. Compared with DNA vaccines, it does not enter the cell nucleus, is safer, and works faster and more effectively.

Short development cycle : The development of mRNA vaccines only requires the replacement of antigen sequences on a mature technology platform. Therefore, it has outstanding advantages in dealing with virus mutations and can be updated in 4-6 weeks;

The production process is simple : Using DNA templates in vitro Transcription production, simple manufacturing process, easy for mass production;

has high effectiveness : can induce humoral immunity and cellular immunity, has strong immunogenicity and does not require adjuvants;

has good safety : mRNA does not enter the nucleus and has no exogenous Risk of DNA infection.

Data Interpretation

According to PubMed, the overall size of the mRNA market in 2035 is 23 billion US dollars, and the GAGR from 2025 to 2035 will reach 68%.

4. Analysis of the mRNA industry chain and related enterprises

4.1 Production process of mRNA vaccine

The production of mRNA vaccine can be divided into three major stages, one is the production of DNA plasmid, the other is the preparation of mRNA stock solution, and the third is the production of mRNA-LNP preparation. From DNA template production to final mRNA vaccine filling, the entire production process takes about one month. (Report source: Future Think Tank)

4.2. Relevant companies analyze

mRNA technology commercialization prospects are unlimited, is expected to usher in a golden decade , and is optimistic about the early layout of mRNA technology-related targets and industrial chains. Pay attention to Watson Bio /Aibo Bio/Lanque Bio, Fosun Pharma , Aimei Vaccine/Livanda Biotech, etc., which are in the forefront of the progress of the new crown mRNA vaccine. At the same time, CanSino , CSPC Pharmaceutical Group, Kangtai Bio/Jiachen Xihai, Zhifei Bio/Shenxin Bio, Ruike Bio/Rigi Bio, Anke Bio, Anke Bio, etc. are also actively deploying and are in the early clinical stage.

1, GenScript Biotech

GenScript Biotech is a biopharmaceutical contract development and production organization (CDMO) under Nanjing GenScript Biotechnology Co., Ltd. . It has a one-stop biopharmaceutical R&D and production platform and actively provides customers with comprehensive services. End-to-end services from target development to commercial production. On October 22, GenScript Biotech, Abbot Biotech and Watson Biotech reached a cooperation on the BLA (Biological Products License Application) application and commercial production of the mRNA vaccine project (ABO028M). It is reported that Watson Biotech is the applicant for the ABO-028M project, and GenScript Biotech will exclusively provide services related to the commercial production of plasmid in the ABO-028M project.

2, Novozant

Novozant was established in 2001. It is a biotechnology company that conducts technology research and product development around enzymes, antigens, antibodies and other functional proteins and polymer organic materials. Relying on the independently developed functional protein common technology platform and taking advantage of the opportunity of vaccine CRO services, the company began to get involved in the mRNA vaccine raw material supply chain, and can provide enzyme raw materials needed for the production of mRNA vaccines, including capping enzymes, transcriptases and Tailing enzymes, etc., assist in the research and development and industrialization of mRNA vaccines.

3, Nearshore Protein

Nearshore Protein Technology Co., Ltd. was established in 2004. It is the first domestic high-tech enterprise specializing in the development and production of recombinant protein preparation processes. The current mature expression systems include Escherichia coli , yeast , insect cells and mammalian cell expression systems. Each expression system has a production capacity of more than gram level. Nearshore Protein has the production capacity of 5 billion copies of mRNA raw material enzymes, and can supply all enzyme raw materials required for mRNA synthesis and modification that comply with GMP specifications and are free of animal sources and other high standards.It has promptly solved the problem of supply of raw materials for new crown vaccine clinical application for domestic mRNA vaccine companies, laying the foundation for the rapid advancement of China's mRNA vaccine.

4, Aibo Biotechnology

Aibo Biotechnology was established in January 2019. It is an innovative biological company focusing on the research and development of nucleic acid drugs. The founding team of is experienced. The founder, Dr. Yingbo, served as a senior scientist and project leader at Moderna and invented the innovative Lipid Nano Particle (LNP) technology. The new coronavirus vaccine is the first to be verified. The company's mRNA COVID-19 vaccine ARCoV, developed in cooperation with Watson Biotech and the Academy of Military Medical Sciences, has entered the Phase III clinical stage and is currently the fastest-growing mRNA COVID-19 vaccine in China.

5, Watson Bio : The company’s Phase III clinical trial of the new coronavirus mRNA vaccine is in progress. The new coronavirus variant mRNA vaccine developed by the company in cooperation with Shanghai Lanque Biopharmaceutical Co., Ltd. is in the pre-clinical research stage and is applying for clinical trials.

6, Anke Biotechnology cooperates with Afana to develop mRNA vaccines for new coronavirus Omicron and other mutant strains

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