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Is it too late for China's Pharmaceutical company to launch the COVID mRNA vaccine?

Updated: Mar 24, 2023




On March 22, CSPC Pharmaceutical Group officially announced that its SARS-CoV-2 mRNA VACCINE (SYS6006) was included in emergency use in China, and China ushered in the first domestic mRNA COVID-19 vaccine.


Since the outbreak of the COVID-19, mRNA technology has attracted much attention due to its outstanding safety and short production cycle. According to incomplete statistics, about 16 mRNA COVID-19 vaccines are under development in China. When COVID-19 recedes globally, it is not yet known how much commercial value the subsequent vaccines will gain. Still, the deployment of mRNA vaccines is an important step in entering the emerging field of mRNA therapy for many Chinese big pharma companies.


CSPC Hit the Line


Among the companies deploying SARS-CoV-2 mRNA VACCINE, CSPC Pharmaceutical Group is the first to hit the line.


As China's first self-developed SARS-CoV-2 mRNA VACCINE that has obtained emergency authorization for use, SYS6006 is an mRNA vaccine covering the core mutation site of the OmicronBA. Clinical trials, phase I, II, and sequential booster immunization clinical trials have been completed in China. The clinical research results of more than 5,500 people have proved its safety, immunogenicity, and protective efficacy.


In addition to SYS6006, there are more than 10 mRNA COVID-19 vaccines under development in China, including Sinopharm, AIM Vaccine, Stemirna Therapeutics, Jiangsu Recbio Technology Co., Ltd, CanSinoBIO, Everest Medicines, Walvax Biotechnology Co., Ltd., and ABOGENBIO.


According to the announcement recently disclosed by Walvax Biotechnology Co., Ltd, the SARS-CoV-2 mutant mRNA vaccine (S protein chimera) RQ3013 phase IIIb clinical trial developed by the company in cooperation with Fudan University and Shanghai Lanque Biomedical Co., Ltd. has obtained safety, immunogenicity, and protective efficacy results.


Shrinking Market


The commercial value of SARS-CoV-2 mRNA VACCINE is obvious to all. With this vaccine product, Pfizer has returned to the top three pharmaceutical companies in the world.


Comirnaty is an mRNA vaccine jointly developed by Pfizer and BioNTech based on BioNTech's proprietary mRNA technology. It was first authorized by the European Union and the US FDA in December 2020 for the prevention of COVID-19 infection in people aged 16 and over.


In 2021, Comirnaty sales reached $36.781 billion. Thanks to this product, Pfizer achieved total revenue of 81.288 billion US dollars, with a revenue growth rate of 95%.


Although CSPC has taken the lead in the domestic SARS-CoV-2 mRNA VACCINE, the market has changed.

In 2022, Comirnaty's sales will only increase slightly by 3% to US$37.806 billion, and Pfizer expects that 2023 should be the trough of sales of COVID-19 products. In 2023, SARS-CoV-2 mRNA VACCINE Comirnaty revenue will be approximately US$13.5 billion, a year-on-year decrease of 64%.


Judging from the COVID-19 vaccine companies that have disclosed their annual reports, their performance has declined to vary degrees. A few days ago, Chongqing Zhifei Biological Products Co., Ltd disclosed its 2022 annual report. The company achieved an operating income of 38.264 billion yuan, a year-on-year increase of 24.83%, and realized a net profit of 7.539 billion yuan, a year-on-year decrease of 26.15%.


Regarding the decline in net profit, Zhifei Bio explained in its annual report that due to objective factors, the market demand and competition pattern of some of the company's products have undergone major changes, and its sales volume dropped significantly compared with last year.


Although the announcement did not specify specific products, Zhifei Bio mentioned in its previous semi-annual report that with the widespread vaccination of the COVID-19 vaccine in China, the formation of basic immunity has accelerated. According to public information in July this year, the full vaccination rate of China's COVID-19 vaccine reached nearly ninety percent. During the reporting period, sales of the company's first-generation COVID-19 vaccines dropped significantly compared to the same period last year.


Similarly, CanSino Bio's 2022 revenue dropped by 75.94% year-on-year to 1.035 billion yuan, with a loss of 902 million yuan, turning from profit to loss. According to CanSino Biological, during the reporting period, the market environment for COVID-19 vaccines at home and abroad has undergone major changes, the demand for COVID-19 vaccines showed a sharp decline compared with the same period last year, and the growth rate of global COVID-19 vaccinations has slowed down. Given the situation of oversupply and intensified market competition, the sales revenue of the company's COVID-19 vaccine products dropped significantly compared with the same period last year.


New Technology


It is unknown how much commercial value the vaccines that will be launched in the future will gain, but the layout of mRNA vaccines has become an entry ticket for mRNA therapy. In recent years, mRNA technology has been highly sought after by capital. The world's richest man, Tesla CEO Elon Musk, also posted on social platforms that "synthetic mRNA does have great potential to treat cancer."



"There is no protective agent in the mRNA production process, no antibiotics are added, and no adjuvant is required. Because of its own immunogenicity, it has no animal origin. The safety of this technology is outstanding. In addition, the preparation and production cycle of mRNA research and development is very short. Since it is a platform technology, it is easy to scale up. And because of the short R&D and production cycle, it is very suitable for emergency vaccines." Zhang Jiguo, the chief business officer of Stemirna Therapeutics, said when referring to the advantages of mRNA technology.


mRNA technology is expected to be applied to the field of cancer therapy. In February of this year, Moderna and Merck announced that their tumor neoantigen mRNA vaccine mRNA-4157, combined with PD-1 antibody in the adjuvant treatment of high-risk melanoma, was certified by the US Food and Drug Administration (FDA). It is the world's first mRNA tumor vaccine to receive this certification.


A research paper mentions the principle of mRNA technology: mRNA guides the production of proteins through "translation". 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 cell, thereby effectively stimulating cellular immunity and humoral immunity.


Applying mRNA technology to other fields is also a consideration for China domestic companies. In September 2021, Everest Medicines reached strategic cooperation with Canada's Providence to introduce its mRNA technology platform. According to Yang Wei, chief scientific officer of Everest Medicines, in terms of therapeutic vaccines, the company focuses on anti-tumor vaccines, and two projects are in the process of rapid advancement.


CanSino Biologics previously responded to investors’ research on mRNA vaccines and said, “We want to verify our mRNA platform technology through the COVID-19 vaccine product and accelerate the development of other candidate products, such as varicalla—zostervirus, herpes, flu, etc". Walvax Biotechnology Co., Ltd. also stated on the investor platform that the layout of the mRNA technology platform is a long-term research and development strategy for the company.


 


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