Fosun is determined to win the "first domestic MNA vaccine", but with the entry of Watson, things become delicate.
Wen 丨 Niacinamide
Universal vaccination of the COVID-19 vaccine is nearing completion, but the competition for the MNA vaccine has only just begun.
On July 21, the China Clinical Trials Registry disclosed a clinical registration information. Watson BiomRNA Covid-19 Vaccine plans to conduct Phase III clinical trials in Guangxi.
This is an interventional study, mainly implemented by the CDC of Yongfu, Liujiang and Yunxian counties in Guangxi, with an estimated total enrollment of 2,000 people, of which 1,500 are in the experimental group and 500 in the control group. Trial recruitment has not yet begun.
Zhang Li, secretary of the board of directors of Watson Biology, told the Health Bureau that the phase III clinical trial of the Watson mna new crown vaccine is carried out simultaneously around the world, and "the domestic one is part of the entire phase III program." The entire phase III clinical trial should achieve a sample size of 26,000 to 30,000. ”
The reason why this test has aroused market attention is because on July 14, Fosun Pharma revealed to the outside world through the shareholders' meeting that Fosun's expert review of the mna new crown vaccine "Fubitai" has been passed and administrative approval is being stepped up.
The outside world interprets Fosun's statement as "the first domestic MNA vaccine will be approved soon". Now, the situation is delicate again.
Theoretically, the phase III clinic can only be started after the drug completes the phase II clinical trial.
At present, many of the new crown vaccines that have been listed in China are applied for "emergency use" after the completion of phase II clinical trials, and phase III clinical trials are carried out simultaneously. Watson MNA has now launched a global phase III clinical trial, which means that phase II has been completed, and theoretically has the same opportunity to be approved for "emergency use".
No MRA vaccine has been approved for listing in China, but there are already many companies in the layout. Among them, Abo Biology invested by Watson, as well as Si Microorganism, Livanda, and Deeply Believed Biology are among them. Of course, the most well-known participant is Fosun Pharma.
On July 14, Fosun Pharma only revealed that its mna-covid-19 vaccine in cooperation with Biontech had entered the administrative approval stage, stirring up thousands of waves in the market. As of the close of trading on July 22, Fosun Pharma's stock price has risen by more than 20% in one week.
It is reported that the Watson MRA vaccine is also applying for marketing, will it become a spoiler?
Watson Biotech's latest disclosure of the "mrna new coronavirus vaccine arcovax phase III clinical trial" program clearly mentions that the product is developed in cooperation with Suzhou Aibo Biologics, and plans to evaluate the protective efficacy, safety and immunity of vaccination in people aged 18 years and older.
Watson Biology said that the phase III clinical trial carried out by Watson Biology this time is a part of the global phase III clinical trial, and the progress is normal. And "there is no contradiction between opening phase III clinical trials and applying for emergency use." This may mean that the listing application and phase III clinical trials are in parallel.
Obviously, whoever can become the first company in China to list a MNA new crown vaccine will be able to seize the opportunity.
At the aforementioned shareholders' meeting, Fosun Pharma said that it is expected to achieve an annual production capacity of 1 billion doses of mra vaccine stock solution by the end of the year, and the monthly production may be expanded to 100-200 million doses.
On April 2, 2021, Watson said at the performance briefing: The mrna vaccine production workshop was opened in December 2020 in Yunnan Yuxi Watson Industrial Park, with a design capacity of 120 million doses. On July 2 this year, Watson revealed on the interactive platform that the relevant plant has been capped.
Is there still a market for COVID-19 vaccines? This is the biggest question in the industry and the public.
As of July 2021, seven COVID-19 vaccines have been approved for market in China, namely Beijing Sinopharm Vaccine, Kexing Vaccine, Wuhan Sinopharm Vaccine, Kangtai Biological Vaccine, CanSino Vaccine and Chinese Academy of Medical Sciences Vaccine. It involves three technical pathways of inactivation, adenovirus and recombinant protein.
In the case of six vaccines being supplied at the same time, the latest data released by the National Health Commission on July 22 shows that as of July 21, the country has reported a cumulative total of 1.4916 billion doses of COVID-19 vaccines.
The source of the picture is the official website of the National Health Commission
Wu Zunyou, chief expert in epidemiology at the Chinese Center for Disease Control and Prevention, said at an event on April 15 this year: "China has achieved herd immunity through vaccination, and the number of people who need to be vaccinated has reached 1 billion. Academician Zhong Nanshan also said that by the end of 2021, the coverage rate of China's new crown virus vaccine can reach 80%.
At present, the largest amount of domestic vaccination is the two-shot inactivated vaccine, and according to the standard of "1 billion people", there are still about 500 million doses left in this round of group vaccination.
This market size is more than enough for an unmarketed MNA vaccine. Moreover, the new crown vaccine manufacturers also shoulder the responsibility of delivering vaccines to the world, and the production capacity cannot be fully released to the country, so there is still a certain market for the MNA vaccine that is on the last step.
If it involves a second or third round of vaccination or immunization booster injections, the demand for vaccines will undoubtedly increase. The principle of mrna vaccine is to inject part of the mrrna fragment of the virus into human cells to produce antigens, which in turn stimulates a specific immune response and forms an immune memory.
According to data released in June this year by the New England Journal of Medicine, the results of real-world studies conducted by Pfizer/biontech's MRA vaccine and Modena's MNA vaccine in 6 states in the United States showed that the effectiveness of the vaccine was 91% in the case of full vaccination; the effectiveness of the vaccine was 81% in the case of incomplete vaccination.
This may be the reason why Fosun, Watson and other companies are still diligently pursuing. Even if there is only a market capacity of 100 million doses, its sales may be close to the scale of 10 billion.
In addition, after the completion of the production hall, the mrna technology route can continue to be applied to other related products in the future.
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