New Force Of Domestic Vaccine

According to "evaluate Pharma world preview 2020", the global vaccine market size will be about 32.5 billion US dollars in 2019. It is predicted that the global vaccine market will reach 56.1 billion US dollars in 2026, with an annual compound growth rate of about 8.1%.

In 2020, the new crown pneumonia epidemic will spread all over the world. In the absence of specific drugs, vaccines have become the ultimate weapon for human beings to deal with infectious diseases.

In recent years, China's vaccine industry has developed rapidly, and the level of comprehensive technology research and development has been greatly improved. After SARS, H1N1 and other epidemics, the awareness of vaccines from the government to the public has been improved to varying degrees. Especially this year, in the face of the sudden new coronavirus, China's vaccine research and development force quickly launched, a number of technical routes went hand in hand, and successfully ranked in the "first echelon" of global new crown vaccine research and development.

At present, China is the world's largest producer of human vaccines. According to the data disclosed by the Chinese people's Procuratorate, China issues 500 million to 1 billion bottles (bottles) of vaccines every year, ranking first in the world. In 2020, the new crown pneumonia swept the world, causing a great impact on all walks of life. However, the approval and issuance of vaccines in China did not stop. In the first half of the year, 28.62 million vaccines were approved, up 22.03% year-on-year.

AI kunwei pointed out that after experiencing the stages of rapid development, adjustment and transformation, the development mode of China's vaccine market tends to be healthy. The year 2020 is also known as "the first year of domestic new vaccines". Domestic innovative vaccines will continue to improve in terms of product strength and marketing power, as well as the volume of batch issuance. In the future, with the gradual introduction of heavy domestic innovative vaccines, a new era of large varieties of domestic vaccines will be ushered in, and domestic substitutes will be gradually realized, and the road of advancement will be opened.

Since the outbreak of new crown pneumonia, the world's major pharmaceutical companies and research institutions have been involved in the research and development of vaccines. Xinhua News Agency

Advanced domestic vaccines

Since 2000, the global vaccine market has been in a state of rapid growth, and then gradually flattened around 2010. According to "evaluate Pharma world preview 2020", the global vaccine market size will be about 32.5 billion US dollars in 2019. It is predicted that the global vaccine market will reach 56.1 billion US dollars in 2026, with an annual compound growth rate of about 8.1%.

The global vaccine market has formed an oligopoly competition pattern. In 2019, GSK, MSD, Pfizer and Sanofi achieved revenue of 8.481 billion US dollars, 7.967 billion US dollars, 6.716 billion US dollars and 6.504 billion US dollars respectively, accounting for more than 90% of the global vaccine market.

Different from the high concentration of global vaccine market, China's vaccine industry has only entered the market for less than 20 years, and the vaccine market pattern is relatively scattered. At present, according to China's policy, vaccines are generally divided into category I vaccine and class II vaccine (referred to as "vaccines included in the national immunization program" and "vaccines not included in the national immunization program" in the new version of the vaccine law in 2019).

The first type of vaccine is a kind of compulsory vaccination stipulated by the state, which is free of charge by the government. It includes 11 kinds of routine vaccination for children, including hepatitis B vaccine, BCG vaccine, poliomyelitis vaccine and acellular pertussis vaccine, and three kinds of vaccines for key groups including hemorrhagic fever vaccine, Leptospira vaccine and anthrax vaccine, which can prevent hepatitis B, tuberculosis, poliomyelitis and pertussis Five kinds of infectious diseases; the second type vaccine is a kind of voluntary vaccination by citizens at their own expense, which adopts a complete market-oriented pricing model and has strong profitability.

According to the statistics from January 1, 2007 to November 30, 2020, there are 58 vaccine enterprises in China (9 state-owned enterprises, 42 private enterprises and 7 foreign enterprises), 32 kinds of vaccines (subject to pathogens / diseases) and 339 vaccine products. Among them, 12 enterprises, including andI, Borna, Fuer, Haiwang, waldun, Puxin, Tianyuan, Weike, Xiangrui, Abbott, Yanshen and Zerun, have no approval and issuance records in recent three years.

The market share of multinational pharmaceutical enterprises in China is not high. According to AI kunwei's consulting statistics, state-owned vaccine enterprises account for more than 70% of the first-class vaccine market (sales volume), while the market share of multinational vaccine enterprises is only 2%; the competition in the second category vaccine market is relatively scattered, with local private enterprises accounting for more than 60% and multinational enterprises accounting for nearly 10%.

However, the quantity of overseas mainstream vaccines, such as 13 valent pneumonia vaccine, HPV vaccine and herpes zoster vaccine, is relatively small in China. However, with the continuous development and accumulation of domestic enterprises, domestic large varieties of vaccines are gradually on the market. In January 2020, Xiamen Wantai Canghai bivalent human papillomavirus vaccine (trade name: Xinkening) and Watson biological 13 valent pneumococcal polysaccharide conjugate vaccine (commodity name: Xinkening) It is an important step for the advancement of domestic vaccines.

Pacific Securities analyst Sheng Lihua pointed out that the vaccine research and development time is long and the investment cost is large. For example, it usually takes 10-15 years and 500-800 million yuan for domestic cervical cancer vaccine from early research and development to commercial production.

In addition, according to the domestic Watson biological disclosure, its subsidiary Shanghai Zerun HPV industrialization investment of 340 million yuan; Wantai bio's prospectus disclosed that the investment in the production line was 580 million yuan, and the R & D cost was 280 million yuan, with an estimated total investment of more than 800 million yuan. The research and development cycle is long. Wantai biological started the project of HPV vaccine in 2002 and has been on the market for 18 years.

The addition of domestic vaccines will better alleviate the situation of "one shot is difficult to obtain" for some vaccines in China, so that more people can be vaccinated. For example, cervical cancer can be prevented and controlled, but because of the low vaccination rate, not only one third of the world's new cases are reported every year, but more than 50000 people lose their lives. Consulting Xie Yang, who is in charge of health economy and real world research in Greater China, AI kunwei pointed out that if HPV vaccine is included in the immunization program and vaccinated to people aged 9 to 15, it is roughly estimated that about 53 million people will be involved. From the age of 16 to 45, our Congress involves about 280 million people.

"In the face of such a large demand, production capacity has become the threshold for mass vaccination of HPV vaccine. In China, from 2017 to now, only about 30 million HPV vaccines have been issued. " Xie Yang pointed out to the 21st century economic reporter.

Tao Lina pointed out that the domestic 2-valent HPV vaccine will sink into the market of girls aged 9-14 years after it comes into the market, so as to alleviate the situation that it is difficult to get a single injection.

New crown vaccine "kill"

Since the outbreak of new crown pneumonia, the world's major pharmaceutical companies and research institutions have been involved in the research and development of vaccines. At the beginning of the epidemic, a research team was set up in China, and the research and development of vaccine was included in the priority work for priority support.

Zheng Zhongwei, head of the vaccine research and development team of the joint prevention and control mechanism research team of the State Council and director of the medical and health science and technology development research center of the National Health Commission, said that at present, five new coronavirus vaccines have been in phase III clinical trials in China, ranking first in the world. "Evaluation of a vaccine requires a number of comprehensive indicators, of which safety, effectiveness, accessibility and affordability are the most important. We are preparing for mass production. "

The vaccines that have entered phase III clinical trials include two inactivated vaccines from Sinopharm Group China biology, one inactivated vaccine from Beijing Kexing Zhongwei company, adenovirus vector vaccine jointly developed by Military Medical Research Institute and kangxinuo company, and recombinant protein vaccine jointly developed by Institute of Microbiology of Chinese Academy of Sciences and Zhifei biological company.

On December 27, 2020, there was also news that the Watson biological new crown vaccine base was settled in Beijing Daxing biomedical industrial park, which was also the first industrialization base of new crown vaccine of chimpanzee adenovirus vector in China. Relying on Watson biological's innovative vaccine industrialization advantages and mature production quality management system, the new coronavirus vaccine developed by Professor Zhang Linqi of Tsinghua University and Professor Zhou Dongming of Tianjin Medical University has entered the preparation stage of industrialization.

So far, a number of adenovirus vaccines have entered the clinical stage. Among them, the new crown vaccine (azd1222) developed by Oxford University and AstraZeneca uses chimpanzee adenovirus vector. The vaccine was approved for emergency use in the UK on December 30, 2020.

On December 30, China biological Beijing company of national pharmaceutical group released the interim analysis data of phase III clinical trial of new coronavirus inactivated vaccine. The protective effect of the vaccine against diseases caused by new coronavirus infection (covid-19) was 79.34%, and the data met the relevant technical standards of the World Health Organization and the relevant standards of the State Food and drug administration. At present, Sinopharm Group China biology Beijing company has formally submitted a conditional listing application to SFDA.

It is also understood that the new crown vaccine of national medicine can be transported at 2-8 ℃ under normal conditions. By 2021, the vaccine production will reach one billion doses. At present, the cold storage of Sinopharm holdings can store more than 7 million vaccines, and each vaccine can be scanned and traced throughout the whole process.

In addition, the phase III clinical trial of the new coronal vaccine of kangxinuo biological is also in progress. Due to the use of adenovirus vector technology route, kangxinuo vaccine can be stably stored between 2 ℃ and 8 ℃ as the Ebola virus disease vaccine developed by the same technical route. It has stability, is easier to transport and store normally, and the vaccine has higher accessibility. At the same time, the vaccine can be administered by multiple routes, including intramuscular injection or mucosal immunization.

Based on the above-mentioned vaccine progress in China, emergency vaccination of new coronal vaccine has been carried out for some key population at the time of winter and spring. Zheng Zhongwei said that more than 1 million doses of the new crown vaccine had been given to high-risk exposed people. After strict adverse reaction monitoring and follow-up observation, no serious adverse reactions were found. Among them, more than 60000 people went to high-risk areas abroad, and no serious cases of infection were reported. It is based on this to start vaccination of key populations.

It is worth noting that while the global vaccine is urgently launched, vaccine fairness has also been put on the agenda.

According to the data from the global health research center of Duke University in the United States, 7.7 billion doses of new crown vaccines have been "pre purchased" by countries around the world, and another 3.9 billion doses are currently under negotiation. According to the center's prediction, vaccine capacity will not cover the world's population until 2023 or 2024.

Gong Wenfeng, a Senior Strategic Officer of the China Office of the Gates Foundation and an epidemiologist, pointed out to the 21st century economic reporter that fairness should be taken into account in the distribution of vaccines. The people who need priority vaccination may not have a high payment ability, while low - and middle-income countries may be more affected by the epidemic situation, so they need to be given priority consideration and establish a multilateral cooperation mechanism.

To this end, 189 countries including China have actively joined the covax. The plan was created by the global alliance for vaccine and immunization, the World Health Organization and the Innovation Alliance for epidemic prevention in April 2020. It aims to improve the efficiency of vaccine development and lay the foundation for rapid production and global popularization of vaccines. It is expected to provide at least 2 billion doses of safe and effective new coronapneumonia vaccine to the world by the end of 2021.

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