Up to now, two mRNA vaccines have been released worldwide, and there have been more than 60 vaccines worldwide.countryAnd the region is approved for listing or emergency use, respectively, GermanyBioNTech(Byntec) BNT162b2 developed in cooperation with Pfizer, and the United StatesModerna(Modena) mRNA-1273 developed by the company, both inIIIThe protection rates shown in phase clinical trials exceeded 90%.
At the Fosun Pharma’s shareholders’ meeting held last week, Fosun Pharma stated thatBioNTechThe co-developed new crown mRNA vaccine Fubitai is still waiting for approval. At present, the approval process for pharmacy is basically completed, and the approval requirements and materials to be carried out in the follow-up have basically been sorted out.
Fosun Pharma: mRNA Covid-19vaccineAwaiting approval, the localized production line will be completed in August
Wu Yifang, Chairman of Fosun Pharma, revealed that “mRNA is a brand-new technical route. Under approval,countryThe Food and Drug Administration has some groundbreaking things to do, and we conducted in-depth exchanges throughout the process.countryThe Food and Drug Administration has given a lot of guidance and feedback is very fast. “It is understood that the matters required for the pharmacy-related conditional approval have been basically completed, and the subsequent conditional research and clinical requirements to be carried out are basically clear.
At the general meeting of shareholders, Fosun Pharma revealed thatBioNTechTechnology transfer and equipment ordering are already underway.BioNTechDispatchedexpertI have gone to the Jinshan plant in Shanghai to work with the Fosun Pharma team. Both parties have a daily meeting on various professional working groups. The localized production line is expected to be completed in August,beginnormal production.
Source: Network
Some people in the industry have put forward a point of view that Fosun Pharma and Germany’sBioNTechIt belongs to the joint venture agency model, and its essence is to exchange technology for the market.
As early as May 9, Fosun Pharma issued a major announcement stating that its holding subsidiary Fosun PharmaBioNTechInvest in the establishment of a joint venture company to realize the new mRNA crownvaccineLocalized production and commercialization of products.
At the beginning of last year, the two parties signed a license agreement, agreed to pay a license fee and pay a sales commission based on a certain percentage of the product’s annual gross profit.forGuaranteeChinese market mRNA Covid-19vaccineSupply, Fosun Pharmaceutical Industry andBioNTechSigned the “License Agreement Amendment One” on December 15, 2020, to promote mRNA COVID-19 in stages such as the import of finished products, the import of large-package preparations in China (excluding Hong Kong, Macao and Taiwan), and localized production.vaccineChina sales and supply reached an agreement.In order to further implement the relevant mRNA new crown in the “License Agreement Amendment One”vaccineArrangements for localized production, both partiesup to dateThe announcement announced the signing of the “Terms”, the establishment of a joint venture company, and an agreement that Fosun Pharmaceutical Industry should provide an annual production capacity of up to 1 billion doses of mRNA.vaccineProduction facilities and injected the facility as part of the capital contribution into the joint venture company.
onvaccineFor subsequent commercialization issues, the two parties agreed that the joint venture company will hire an affiliate of Fosun Pharmaceutical Industry as the CSO to provide mRNA new crowns in China (excluding Hong Kong, Macao and Taiwan)vaccineMarket and sales services, and pay corresponding fees to the CSO in accordance with the contract.
Subsequently, at the beginning of 2021, the BNT162b2 vaccine (Fobitai) was approved for emergency use in the Hong Kong Special Administrative Region and Macau Special Administrative Region respectively, and was used in the vaccination programs of the above-mentioned two regional governments in March.
According to CCTV News, as of June 14th, 31 provinces, municipalities (including the Corps) across the country had cumulatively reported vaccination against the new crownvaccineThe number of doses exceeded 900 million, even if Fosun Pharma’svaccineWhen approved, how much market will be left to it is a question of great concern to many investors.
There are barriers to the production technology of mRNA vaccines entering the sprint stage
At present, the domestic competition for the approval and listing of mRNA vaccines has entered a fierce stage.In addition to Fosun Pharma, the mRNA vaccines that Abbio is responsible for research and development, and Watson Bio is responsible for the production and promotion of mRNA vaccines are the current domesticthe firstA mRNA vaccine that has entered clinical phase III. On May 11, the Mexican Foreign Minister announced that the mRNA new crown vaccine developed by a Chinese companyARCoVWill start in Mexico on the 30th of this monthIIIPhase trial, it is estimated that 6000 volunteers will participate, thisvaccineIt is the joint research and development of the Military Academy of Sciences, Aibo Biology, Watson Biology, and the three parties.
Different from the cooperation model of Fosun Pharma, the research and development of Aibo Biological and Watson BiologicalARCoVThe vaccine has independent intellectual property rights, and itscoreThe raw materials and key equipment have been made domestically. In December 2020, Watson builds China’s first mRNA new crownvaccineProduction workshop,ARCoVThe vaccine is expected to be completed and put into production within 8 months, with a production capacity of 120 million doses per year in the first phase.
It has always been a concern in the industry that the domestically produced mRNA vaccines of Watson Biologics and Fosun Pharma will be the first to cross the line in China.Former Shanghai Center for Disease ControlvaccineExpert Tao Lina believes that Fubitai is an imported product after all. If it is successfully approved for listing in the future, it is most likely to be listed conditionally.He told Ao Yi News reporter that, in comparison, the local company Watson Biotech may have an advantage in production. “After all, it is our local Chinese company, and Fosun andBioNTechBecause of the cooperation model, it may be slower in production. ”
Regarding the localized production of Fubitai, Fosun Pharma stated that the company hasBioNTechTechnology transfer and equipment ordering are already underway.BioNTechDispatchedexpertI have gone to the Jinshan plant in Shanghai to work with the Fosun Pharma team. Both parties have a daily meeting on various professional working groups. Fosun Pharma expects that the joint venture agreement will be implemented in June 2021 and the localized production line will be completed in August.beginnormal production. According to Wu Yifang, in terms of production capacity design, considering that the production line will be transferred to other mRNA vaccines and global demand, production capacity will retain the possibility of growth.
Earlier, Abbio and its partner institutions introduced its mRNA COVID-19 vaccine in a paper published in the journal Cell in September 2020.ARCoVProduction process. The paper introduces that the aqueous solution of mRNA and the ethanol solution of lipid molecules are quickly mixed, so that the lipid molecules form LNP that encapsulates the mRNA, and then the ethanol is removed by tangential flow filtration and concentrated to obtain the original solution.
Although the above process seems simple, the founder andchiefIn an interview with the media, executive InBev pointed out that it involved the determination of a large number of process parameters.coreTechnology”. The determination of these parameters fundamentally determines the performance of the product, and only a few companies have it.
Tao Lina introduced to Ao Yi reporters that the two domestically producedvaccineThere are two differences in the technical details: Fubitel uses all the S protein of the virus asvaccineTarget ingredient, WatsonvaccineUse the RBD region on the viral S protein asvaccineTarget component. RBD is the key to the virus being able to attach to human cells. The mutation is not large. If the mutation is large, it may not be able to infect the human body.vaccineIt may be more effective in dealing with virus mutations; in addition, there are other areas on the S protein that can stimulate the body to produce antibodies. These antibodies may not have the effect of neutralizing the virus, and theoretically may also lead to ADEeffect, Which helps the virus infect the human body.So, theoretically, the RBD vaccine may be moreSafetysome.The lipid carrier used in both is LNP, but Fubitai must be cryopreserved, WatsonvaccineIt is announced that it can be stored at 2-8 degrees.
HaitongInternationalAccording to the research report, there are many difficulties in mRNA production. One is that the carrier used is usually nanometer-sized, with a diameter of usually less than 200 nanometers, so the production process is more demanding; in addition, the capping rate will also affect the activity and side effects of the product. However, the preparation process has a great influence on the stability of the product, and how to maintain the purity of the product is also a challenge. “Capping” is the process of modifying mRNA molecules.
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With the outbreak of the new crown epidemic in 2020, mRNA vaccines became famous in the first battle.
Former Shanghai Center for Disease ControlvaccineExpert Tao Lina told Ao Yi news reporter that in the new crownvaccinePreviously, most of the early work on mRNA vaccines focused onTumoraspect.cancerThe vaccine istreatmentSexual, not preventive, aimed atTumorPreferentially expressed by cellsTumorRelated antigens, therefore, stimulating cell-mediated immune responses can reduceTumorburden.
In this new crown epidemic, the unprecedented cooperation environment and government investment have prompted effective data and large-scale applications tovaccineProvides a conceptualverification.Government support helps manufacturers scale up at risk while gainingthe firstBatch validity data. Two foreign companies that first developed mRNA vaccines——BioNTech(Bintech),Moderna(Modena) Announced separatelyIIIClinical data,ModernaIn the clinical data of (Modena), among 30,000 vaccinators,vaccineThe effective rate is 94.5%, and the critical illness protection is 100%. November 9, 2020BioNTechofIIIPhase clinical data released, mRNA vaccineThe effective rate exceeds 90%.
Tao Lina believes that the mRNA vaccine is effective, and the corresponding vaccinators should also receive a “greater response.” “ThisvaccineTo stimulate antibody immunity and cellular immunity at the same time, and cellular immunity will release a lot of cytokines, leading to adverse reactions in the vaccinated person. “He thinks that because there are other less reactivevaccineFor reference, it is not ruled out that the people will inoculate different types of vaccines according to their own acceptance.vaccine.
Since the outbreak of the new crown epidemic, there have been many cases of cooperation between domestic pharmaceutical companies and mRNA companies:
On May 20, 2020, CanSino and Precision Canada NanoSystems(PNI) companies jointly developed a technology based on mRNA lipid nanoparticles (mRNA-LNP)vaccine；
On December 7, 2020, Zhifei Biological announced that it plans to subscribe for 10.189% of the shares of Shenxin Biological with its own funds of 35 million yuan to deploy the third-generation mRNA vaccine technology platform.
On May 9, 2021, Fosun Pharma invested 100 million U.S. dollars to cooperate with a German biotech companyBioNTechSet up a joint venture company to realize the new mRNA crownvaccineLocalized production and commercialization.
It can be said that the outbreak of the new crown epidemic has pushed the mRNA pharmaceutical industry to an unprecedented climax, and the domestic mRNA pharmaceutical industry has finally ushered in the spring of development.
Large-scale financing of mRNA technology companies has also received attention. Just at the beginning of June, Si Microbiology announced that it has officially completed a new round of financing of 200 million US dollars, breaking the record of a single financing for domestic mRNA companies.At the “2021 Pujiang Innovation Forum” held recently, Li Hangwen, founder, chairman and CEO of Sri Microbiology, stated that mRNA vaccines should have become the world’s most frequently administered vaccine.vaccine, Both in clinical trial results and in the real world have shown good results, suchvaccineIt can also be adjusted quickly to deal with virus mutations. In addition, unlike many traditionalvaccineCompared with the development route, mRNA vaccines can activate stronger cellular immunity.
Gao Fu, director of the Chinese Center for Disease Control and Prevention, once stated at an industry conference that mRNA technology is effective for infectious diseases,AIDS, Genetic diseases, rare diseases,TumorWill provide various opportunities, hoping to develop classic traditionsvaccineWhen considering the benefits that mRNA vaccines may bring to humans.
Ao Yi News reporter Lin Shiyan
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