From "Catching Up" To "Surpassing": China'S Vaccine Industry Has Entered The "Golden Decade"

"In 2021, China's new crown vaccine will become the world's best and" go out "on an unprecedented scale. Emerging research and development paths such as nucleic acid vaccine will also leap from" prevention "to" treatment ", giving us endless space for imagination." Recently, Yu Wenxin, chief analyst of Haitong Securities pharmaceutical industry, said at the third bio medicine bio 50 person forum.

It's no exaggeration to describe China's vaccine this year as "the world's best". In response to the epidemic, China has a number of new coronal vaccines put into use at home and abroad, and took the lead in entering the international market.

Martin, academician of the Chinese Academy of engineering and director of dongfanglue, said that vaccination has made great contributions to human health in human history. The vaccine industry is a part of the biomedical industry. As one of the most effective ways to prevent infectious diseases, it is a key link in the national medical system. In the international arena, China's vaccines are on the road from catching up to surpassing. During the epidemic period, the emergence of new vaccine technologies breeds numerous possibilities for innovation.

The next ten years will be the decade when China's biomedical industry will be transformed into a super market, and it will also be a golden decade for China's vaccines. "The application of new technologies and the investment of new enterprises will inevitably lead to the formation and even prosperity of new markets," the white paper on Chinese vaccines released at the forum pointed out. Considering various factors, it is expected that China's vaccine industry will show an annual growth rate of more than 12%, higher than the average growth rate of GDP and the overall pharmaceutical industry, and the vaccine industry will enter the golden decade. "

Five stages of vaccine development in China

Since 1950, vaccination in China has been developing for 70 years.

Wang Huaqing, chairman of the vaccine and Immunization Branch of the Chinese Preventive Medicine Association and chief expert of the immunization program of the China CDC, pointed out that China's vaccination has gone through five stages“ The first is the advance of surprise vaccination; The second is the late stage of the shock vaccination. In our country, vaccination was conducted at a time when the temperature was low. There was no cold chain at that time, relying on the natural environment. At the beginning of EPI in 1978, it was carried out simultaneously with China; The third is pre EPI, from 1978 to 1987; The fourth is the late period of EPI, from 1988 to 2007; 2008 is the period of expanded immunization. "

Every stage of vaccination has achievements and contributions“ In the early stage of the shock vaccination, the biggest use is the realization of smallpox free state in China. In the late stage of sudden vaccination, there is vaccination network, and in the early stage of EPI, there is a sound cold chain system. The latter stage of planned immunization is to popularize children's immunization, and the vaccination is mainly for children, so as to achieve its effect. In the later stage, our country will continue to expand the vaccine. " Wang Huaqing further introduced that.

Vaccines have always been an important means for human beings to control infectious diseases. In Wang Huaqing's view, without vaccines, these infectious diseases will cause great harm, because the mortality rate is high, many of them are more than 2% of Xinguan.

Previously, the target of vaccination has been children. However, under the influence of the new epidemic situation, China's vaccine will enter a new adult age.

"China vaccine white paper" also stressed the new crown epidemic situation on the concept of great change“ After the outbreak, adults, healthy people and sub-health people have also become the target of vaccination. A nationwide and global education on vaccine awareness is being conducted to urge people to understand and examine vaccines from a new perspective. The medicine is taken by the sick. After all, the patients are very few, and the vaccine is given by healthy people. In this sense, the chance of vaccine is much greater than that of medicine. "

Golden decade of "from rush to super"

"China's vaccine industry in 2021 is a bit like China's Internet in 2011. Before 2011, China's Internet was "copying homework". Google was in the United States, baidu was in China, Yahoo was in the United States, and Sohu was in China. In 2011, an innovative Internet product - wechat appeared. The birth of wechat is a sign of China's Internet from "copy operation" to surpass. Today's tremolo, byte jitter, has also dumped several streets of the same product in the United States. " Chen Mingjian believes that the next ten years will be the decade when China's biomedical industry has been promoted to the super market, and even more will be the golden decade for China's vaccines.

However, compared with the pharmaceutical industry, the vaccine industry has five advantages:

First, the R & D cycle is longer. On average, it takes 8-10 years for a drug to be developed, and a longer time for vaccine development. It took 13 years for children to develop influenza vaccine, 23 years for HPV vaccine and 38 years for hepatitis B vaccine.

Second, more stringent policy supervision. In the field of vaccine R & D and use, there is a "no fault principle", that is, as long as "can not be excluded" is the side effect of vaccine, vaccine enterprises or related insurance companies will bear the consequences.

Third, mass production is more difficult. Vaccine batch stability requirements are very high, each batch of products before marketing or import, need to appoint drug inspection institutions to conduct data review, on-site verification, sample inspection. Batch issuance system is the "sword of Damocles" hanging over the head of vaccine enterprises.

Fourth, the investment cost is higher. The long R & D cycle and the particularity of production and supervision increase the investment risk and the order of magnitude of investment cost.

Fifth, the market concentration is higher. The high barriers to R & D and production mean that the vaccine circle is a field of high status and few people. The "no admittance" feature is obvious.

Chen Mingjian believes that it is precisely because of the characteristics of the "five shifts" that the approval and marketing of new varieties of vaccines and new technology vaccines in the past has been slow and requires enough patience. However, the outbreak of new crown pneumonia has profoundly changed this rule.

On December 30, 2020, the new crown inactivated vaccine of Beijing Institute of biological products was approved for marketing, only eight months after the clinical application. Subsequently, the vaccines produced by Chinese enterprises such as Kexing biology, Wuhan Institute of Chinese medicine Zhongsheng, kangxinuo and Zhifei biology were approved for emergency application or listed on the market. On December 2 of the same year, the first nucleic acid vaccine developed and produced by biontech / Pfizer was approved for marketing, only 7.5 months after the clinical application.

Never in human history has a vaccine been approved so quickly. In Chen Mingjian's view, this is a milestone revolution in the vaccine industry“ The number of the first clinical sample is greatly reduced; Second, the approval time has been greatly reduced. This is a major breakthrough for China's drug administration. " Although the interval between clinical application and approval for marketing has been greatly reduced, the efficacy of the vaccine has not been compromised. A set of data can be used as an example. From the beginning of 2021 to the end of April, the coverage rate of new crown vaccine in the United States increased from 2% to nearly 70%, and accordingly, the number of infected people per 10000 people dropped from 25 to less than 4.

MRNA vaccine is emerging

Yu Wenxin believes that, looking forward to the next decade, China's vaccines are entering the fast lane without mentioning the new crown“ Today, China's pharmaceutical industry has an output value of more than 1 trillion yuan, and the vaccine industry has an output value of more than 40 billion yuan. It feels like a small market. However, in 2020, China's 13 price pneumonia vaccine and 2-price HPV vaccine will enter the market, including Kangtai biological, Zhifei biological, including Wulian vaccine. It is believed that in two years, more Chinese enterprises will appear in the top ten list of Chinese vaccines. Among the listed vaccine enterprises, many companies are now laying out new products. "

"China vaccine white paper" pointed out that the outbreak of the new crown epidemic, China's vaccine industry to obtain a new growth point“ The leapfrog development of the vaccine industry, especially the new technologies, new enterprises and new markets related to vaccines, has been widely concerned by all countries in the world, and has also set off an ideological emancipation that can be called a cognitive renewal revolution in the industry. "

First of all, from the perspective of new technology, vaccines are high-tech products. According to the research and development technology, vaccines can be divided into traditional vaccines and new vaccines. Traditional vaccines include inactivated vaccines and live attenuated vaccines. New vaccines include nucleic acid vaccine and recombinant vaccine. In the face of the impact of the epidemic, nucleic acid vaccine, recombinant vaccine and other vaccines developed by using new technology of genetic engineering have been fully developed. They have strong immunogenicity, high safety, controllable technology, short R & D cycle, low cost, easy scale production and other characteristics, which have been fully released and demonstrated.

At present, there are mainly seven technical routes for the development of new coronal vaccines in the world, which are inactivated vaccine, attenuated live vaccine, protein subunit vaccine, virus like particle vaccine, virus vector vaccine, mRNA vaccine and DNA vaccine. In addition to virus like particle vaccine and live attenuated vaccine, China has a vaccine R & D layout for the other five technical routes.

Secondly, from the perspective of new enterprises, the application of genetic engineering technology in the field of vaccine has promoted a large number of vaccine enterprises to shift their research and development focus from traditional technology to new technology, and at the same time, it has also spawned a number of new enterprises.

With the rapid development of mRNA vaccine, major pharmaceutical enterprises are competing for the best. There are many enterprises in the world engaged in the research and development of mRNA vaccine. The leading ones are "the three giants of mRNA" (Moderna, biontech, and curevac). Domestic enterprises, including Sinochem and Abbott biology, also have their own core advantages and characteristics in the design and modification of mRNA molecules and the key delivery system technology; In the field of DNA vaccine, the most representative enterprise in the world is inovio company in the United States. Dongfanglue and adivichin in China have also shown a good development trend, and DNA vaccine is likely to become the next hot spot of R & D and investment.

In addition, emerging vaccine enterprises are in the "test of ice and fire", one side is the hot track, the other is the solid ice of the market pattern. For emerging enterprises, they should avoid competing with leading companies on the traditional technology platform, because there is no first mover advantage from the perspective of technology accumulation. A better way is to use new technology platforms, such as mRNA vaccine technology, DNA vaccine technology, new virus vector technology, new genetic engineering recombination technology, new adjuvant technology, etc; Or it is more difficult to develop new vaccine varieties, including multi vaccine, multivalent vaccine, vaccine products that have not yet met the clinical needs.

Finally, the application of new technologies and the investment of new enterprises will inevitably lead to the formation and prosperity of new markets. The iteration, support and integration of new technologies, new enterprises and new products will rapidly enhance the market scale, industrial upgrading and global influence of China's vaccines.

In the future, the vaccine market will present the following major investment trends: first, new gene vaccine technology will be applied on a large scale, mRNA vaccine has ignited the hot spot of investment at home and abroad, DNA vaccine has the potential to become the next hot spot, and the research and development of new adjuvants has accumulated a lot, and it is also expected to become a new investment hotspot; Second, the new market is further explored, and the growth rate and space of adult vaccine market will be far greater than the planned vaccination market scale; Third, local vaccine enterprises continue to expand, and more new vaccines and multi valent vaccines are listed in the market, which will replace foreign-funded enterprises and low-cost vaccines; Fourth, the leading team of domestic emerging vaccine enterprises is growing vigorously, and more core backbone teams with cross academic background at home and abroad and senior management experience of vaccine head enterprises are emerging.