November 28, 2022

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2nd mRNA COVID-19 Vaccine Kick-off in China

2nd mRNA COVID-19 Vaccine Kick-off in China



 

2nd mRNA COVID-19 Vaccine Kick-off in China. 

 

China’s second independently developed mRNA COVID-19 vaccine was approved for clinical use. 

China Tibet Pharmaceuticals announced that on January 4, 2021, the company was informed that Sri Microbiology had received the “Drug Clinical Trial Approval Document” for the mRNA novel coronavirus pneumonia vaccine approved and issued by the China National Medical Products Administration. This is China’s second independently developed mRNA COVID-19 vaccine approved for clinical trials.

 

2nd mRNA COVID-19 Vaccine Kick-off in China

 

In response to this new type of coronavirus pneumonia, Sri Microbiology urgently launched the new coronavirus mRNA vaccine research and development project in January 2020, and completed the pharmacodynamic research of all candidate vaccines.

At present, the vaccine has obtained clinical approval in China, and clinical trials will be carried out as planned; related overseas work has not yet started, and overseas application, registration, review, and product listing must comply with local laws and regulations.

 

According to the agreement, Tibet Pharmaceuticals has paid an advance payment of 35 million yuan (including tax) after the agreement was signed.

After obtaining the “Approval for Clinical Trials of Drugs” this time, the corresponding milestone payment of 35 million yuan (including tax) must be paid to Sri Microbiology .

 

 

An amazing breakthrough in mRNA vaccines

Nucleic acid vaccine is known as the third-generation vaccine technology. Its principle is to introduce the nucleic acid sequence (DNA or mRNA) encoding the antigen into the body, and use the human autogenous cells as the “cell factory” to synthesize protein antigens to stimulate the immune response.

The main focus this time is the mRNA vaccine using mRNA molecules. The reason is also easy to understand: from the internal principle, first of all, mRNA does not enter the nucleus, theoretically there is no risk of integration, and the safety is better.

Second, compared with traditional antigens (such as proteins, inactivated virus particles) without increasing, the mRNA molecules delivered into the human body can amplify more protein antigens.

From the perspective of external influence, mRNA vaccines do not require live virus research, the research site is flexible, the research and development speed is fast, and it is suitable for rapid construction.

Moreover, the mRNA vaccine production process is highly versatile, does not involve cell culture or animal-derived substrates, and has low cost.

 

 

In the past, the difficulties of mRNA vaccines focused on three parts: synthetic modification, delivery system and scale-up production. With technological advancement, synthesis modification and process scale-up are no longer difficult at present, and the barriers are mainly focused on the research of delivery technology.

From research and development to clinical trials to final production and use, mRNA vaccines only took about three quarters, completely breaking the traditional timetable of the vaccine industry.

 

MRNA vaccine approved for large-scale use

In this COVID-19 epidemic, mRNA vaccines performed brilliantly. Two mRNA vaccines worldwide have announced the results of phase III clinical analysis, namely Morderna’s COVID-19 mRNA vaccine mRNA-1273 and BioNTech/Pfizer’s COVID-19 mRNA vaccine BNT162b2. In addition, the COVID-19 mRNA vaccine CvnCoV from CureVac has also entered the phase III clinical stage (for details, please click: What should we expect about the COVID-19 vaccine?).

 

As the leading representatives of vaccine technology-the three mRNA vaccine giants Moderna, BioNTech and CureVac shined in this epidemic.

 

In terms of immune data, according to relevant clinical studies, both BNT162b2 and mRNA-1273 measured the plasma data of convalescent patients in the study. Although they are not scientifically comparable, they also have certain reference value (the numbers in parentheses below are the level of vaccine-induced antibodies Relative to the multiple of convalescent patients’ plasma):

For BNT162b2, in the two groups of subjects aged 18-55 and 65-85 who received two doses of 30-μg, the binding antibody GMT was 9136 (14.5 times) and 7985 (12.7 times), and the neutralizing antibody GMT They are 361 (3.8 times) and 149 (1.6 times) respectively.

For mRNA-1273, in the three groups of subjects 18-55, 56-70 and ≥71 years old who received two doses of 100-μg inoculation, the binding antibody GMT was 558905 (14.8 times) and 1005639 (27.0 times), respectively And 694471 (18.65 times), neutralizing antibody GMT were 654 (4.1 times), 878 (5.6 times) and 317 (2.0 times), respectively.

It can be seen that, compared with other types of vaccines, the level of humoral immunity induced is mostly inferior to or equivalent to that of convalescent patients, and the level of antibody induction of mRNA vaccines that is several times or even more than ten times is really amazing. In addition, mRNA vaccines can also induce Th1 biased CD4+ T cell responses and CD8+ T cell responses.

In terms of vaccine effectiveness, Root Company published documents and FDA emergency authorization review materials. The effectiveness of BioNTech/Pfizer’s nCOVID-19 mRNA vaccine is 95.0%; the effectiveness of Moderna’s COVID-19 mRNA vaccine mRNA-1273 is 94.1%.

 

 

 

China’s mRNA vaccine development status

Although China has a COVID-19 vaccine on the market, this does not mean the end of the COVID-19 vaccine development. In China, there are also related companies represented by Essex Microbiology and Abbio Biotech are engaged in the technical research of mRNA vaccines.

 

SMIC

Was founded in 2016 in Shanghai Zhangjiang Medicine Valley, focusing on the research and development of innovative mRNA drugs using the lipid polymer nanocarrier technology platform (LPP/mRNA®) with independent intellectual property rights. The therapeutic areas include cancer, Infectious diseases, protein defect diseases and genetic diseases and other therapeutic areas.

In the early stage of the outbreak of the COVID-19 pneumonia epidemic, Sri Lanka was in danger of being ordered, and after obtaining the new coronavirus antigen provided by the Chinese Centers for Disease Control and Prevention, he initiated the establishment of the COVID-19 mRNA vaccine project.

 

Aibo Bio

Established in 2019, Aibo Biosciences is committed to the research and development of new drugs based on nucleic acids (siRNA, mRNA, DNA). Target diseases include cancer and infectious diseases. The founder of the company has many years of experience in the field of nucleic acid drug research and development, and many of his drugs have entered clinical trials in the United States. In May 2020, it cooperated with the listed company Watson Bio to carry out pre-clinical research, clinical research and commercial production of the new coronavirus mRNA vaccine.

The new coronavirus mRNA vaccine candidate ARCoV developed by the Academy of Military Medicine of the Chinese Academy of Military Sciences, Abbio and Watson Biosciences, has officially passed the clinical trial approval of the National Medical Products Administration on June 19. This is the first mRNA vaccine approved for clinical trials in China.

On December 14, 2020, the ARCoV production workshop was laid in Yuxi City, Yunnan Province. It was the first mRNA COVID-19 vaccine production workshop in China. The workshop relies on Watson’s existing vaccine production facilities and a mature and stable production quality management system. It is expected to be completed and put into operation within 8 months after the start of construction. The mRNA COVID-19 vaccine industrialization construction project invested 280 million yuan, and the first-phase production capacity was 120 million doses/year.

 

Fosun Pharma

In March of this year, Fosun Pharma and BioNTech reached a strategic cooperation to jointly develop and commercialize vaccine products against the new coronavirus based on its proprietary mRNA technology platform in mainland China, Hong Kong, Macau and Taiwan. At present, in addition to discussing research and development plans with its partner BioNTech and completing clinical trials in China, Fosun Pharma has also designed and completed animal challenge trials for multiple mRNA-selected vaccines including BNT162b2 with Chinese research units.

On November 25, 2020, BioNTech and Fosun Pharma jointly announced that their preferred novel coronavirus mRNA vaccine BNT162b2 will start phase II clinical trials in Taizhou and Lianshui, Jiangsu, China.

The two companies stated that the Phase II clinical trial of the BNT162b2 vaccine in China was carried out by the Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Institute of Public Health). The trial sites were located at the China Medical City Vaccine Engineering Center in Taizhou and the Lianshui County CDC, Taizhou Municipal People’s Hospital, Lianshui County People’s Hospital and other units jointly participated.

The Phase II clinical trial plans to recruit 960 healthy subjects, aged 18 to 85 years old, through online, to evaluate the safety and immunogenicity of the candidate vaccine to support the future application of the vaccine in China.

 

CanSino Bio

On May 21, 2020, CanSinoBio and Canada’s Precision NanoSystems (PNI) jointly announced that the two parties have reached an agreement to use PNI’s unique RNA vaccine technology platform to develop mRNA-based lipid nanoparticles (mRNA-LNP) Technical vaccine.

According to the agreement, PNI will be responsible for the development of the mRNA-LNP vaccine, and CanSinoBIO will be responsible for preclinical testing, human clinical trials, regulatory approvals and commercialization. CanSinoBIO has the right to commercialize the vaccine product in Asia (except Japan). PNI reserves the right to other parts of the world. The financial details of the cooperation have not been disclosed.

PNI is a global leader in nano-drug development and manufacturing technologies and solutions. PNI has installed more than 400 NanoAssemblr(R) systems to support its customers in drug development and manufacturing in the fields of oncology, infectious diseases and rare diseases. In order to provide drug developers with a complete solution, PNI has developed a library of lipid preparations for nucleic acid delivery.

 

Guanhao Bio

Guanhao Bio is a high-tech enterprise based in the regenerative medicine industry, expanding life and health-related fields, and grafting global high-end technical resources and achievements.

It continues to deploy in the fields of biomaterials, cells\stem cells, pharmaceuticals, and advanced medical technology and products. The core business forms a “3+1” pattern, namely the three major business sectors of materials, cells, and pharmaceuticals and a technology incubation platform.

On February 2, 2020, Guanhao Biotech and ZY Company, a shareholding company, signed the “Framework Agreement on Cooperation Intention for Nucleic Acid Vaccine Projects.”

According to the agreement, both parties agreed through friendly negotiation that Party A would invest the first phase of R&D funds and Party B would be responsible Method of R&D The target project: “ZY Nucleic Acid Vaccine Project” is planned to carry out research and clinical projects on the new pneumonia coronavirus mRNA vaccine (Z-VacciRNA). The total R&D cost of the project is estimated at 3 million US dollars.

 

Zhuhai Livanda Bio

Established in 2019, Livanda Zhuhai has an independent mRNA production and drug delivery platform, and has applied for a number of invention patents in drug design, production and formulation delivery. The company has accumulated a lot of vaccine development experience in the early stage, and its fastest-developing mRNA rabies vaccine project is currently in the preclinical research stage.

In February 2020, Livanda announced that the first batch of mRNA new coronavirus vaccine standard samples developed during the Spring Festival have detected the production of target antibodies, and they have been delivered to relevant national authorities on February 1 for animal testing and drug efficacy verification. .

 

Shanghai Lanque Biomedical Co., Ltd.

Blue Magpie Bio was established in 2019, focusing on early innovative research on mRNA drugs. The founder team comes from Harvard University and Yale University.

In February 2020, it, together with the Lin Jinzhong team of the School of Life Sciences of Fudan University and the affiliated Zhongshan Hospital, and the Xu Yingjie team of Shanghai Jiaotong University, claimed an important breakthrough in the research of the new coronavirus mRNA vaccine, and achieved the new coronavirus (SARS-CoV-2) virus sample for the first time The expression of particles.

 

(source:qq, reference only)

 


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