Wantai Biotech 20-valent pneumonia vaccine started clinical trials, how far is domestic substitution?

Recently, Wantai Biotech announced that its 20-valent pneumococcal polysaccharide conjugate vaccine (20-valent pneumonia vaccine) has launched a phase 1 clinical trial and completed the enrollment of the first subject.

As of December 2022, 12, a total of three 31-valent pneumococcal polysaccharide conjugate vaccines and five 3-valent pneumococcal polysaccharide vaccines have been approved for marketing in China.

The entry of Wantai Biotech is destined to add a strong stroke to the domestic pneumonia vaccine.

With the clinical launch of the 20-valent pneumonia vaccine and the development of domestic pneumococcal vaccines, a wave of domestic substitution quietly began.

13 vs 23 price,

How is the pneumococcal vaccine different?

Wantai Biotech mentioned in the announcement that "at present, Pfizer's 13-valent pneumococcal conjugate vaccine (Peier), Watson Biotech's 13-valent pneumococcal conjugate vaccine (Wao'anxin), and Minhai Biotechnology's 13-valent pneumococcal polysaccharide conjugate vaccine (Weimin Feibao) have been approved for marketing in China."

Seeing this announcement, some people may wonder: China also has 5 23-valent pneumococcal vaccines on the market, and the 23-valent virus that can be protected has more types, why not mention it? This is because their technical routes are different.

13-valent vaccine can resist 13 types of pneumococcus, while 23-valent vaccine can resist 23 types of pneumonia, but the higher the "price", the better, because the two vaccines have different technical routes and different prevention principles.

At present, there are two technical routes for pneumococcal vaccines, polysaccharide vaccine and polysaccharide protein conjugate vaccine.

Pneumococcus is a conditionally pathogenic bacterium that colonizes the nasopharyngeal area of healthy people. The antigens of pneumococcus mainly include capsular polysaccharides and C polysaccharides (ie M proteins), of which capsular polysaccharides are important virulence factors.

Polysaccharide vaccine is to extract capsular polysaccharides on bacteria as antigens, which are T-cell non-dependent antigens, which can stimulate mature B lymphocytes, but do not stimulate T lymphocytes, and infants under 2 years old have imperfect immune function and poor response to T cells-independent antigens. Therefore, polysaccharide vaccines can only be used for people over 2 years old, but embarrassingly the biggest harm group of pneumococcus happens to be children under 2 years old, so the batch issuance of 23-valent pneumonia vaccine is growing slowly.

Polysaccharide conjugate vaccine is to combine bacterial capsular polysaccharides with specific proteins, after binding to become T cell-dependent antigens, after vaccination to form immune memory, long duration of immunity, suitable for people of any age, especially for infants under 2 years old has a good protective effect, so 13-valent pneumococcal vaccine occupies the main market.

Wantai Biotech's 20-valent pneumonia vaccine is jointly developed with Jiangsu Kunli Biopharmaceutical, and is a 1-valent pneumonia vaccine that uses pneumococcal 3, 4, 5, 6, 6A, 7A, 8F, 9, 10V, 11A, 12A, 14F, 15, 18B, 19C, 19A, 22F, 23F, 33F and 20F capsular polysaccharides to form polysaccharide protein conjugates with recombinant pneumonia hemolysis, respectively, and then configures 20 polysaccharide protein conjugates in a certain proportion. Therefore, the vaccine is a polysaccharide conjugate vaccine.

Pfizer occupies the main market,

But domestic substitution quietly began

According to reports, as of December 2022, 12, a total of 31 3-valent pneumococcal polysaccharide conjugate vaccines and 13 5-valent pneumococcal polysaccharide vaccines have been approved for marketing in China.

In 2021, the batch issuance volume of pneumococcal vaccines in China was 2820.137 million, the market size was about 13.116 billion yuan according to sales revenue, and the 2017-valent pneumococcal vaccine accounted for about 2021.74 billion yuan in the main market. From 13 to 13, the compound growth rate of pneumococcal vaccine reached 2020%, the main reason is that after the domestic pneumococcal vaccine Watson and Kangtai domestic 38-valent vaccine for infants and young children were launched, the proportion of these two 5-valent pneumococcal vaccines showed a rapid upward trend, accounting for only 2021.54% in 04 and <>.<>% in <>, and the future domestic substitution + market penetration rate will promote the continuous growth of the pneumococcal vaccine market.

China's 13-valent pneumococcal vaccine batch issuance enterprises are mainly Pfizer, Watson Biotech and Kangtai Biotechnology (Minhai Biotechnology), with a batch issuance volume of about 2021.1760 million doses in 13, which is still growing rapidly. Pfizer's pneumococcal vaccine "Peier-2022" had global sales of US$63.37 billion in <>, occupying an absolute global market share.

The batch issuance enterprises of 23-valent pneumococcal vaccine are mainly Watson Biotechnology, Kangtai Biotechnology (Minhai Biotechnology), Sinovac Biotechnology, Merck Sharp & Dohme, and Chengdu Institute of Biological Products, with a batch issuance volume of about 2021.1060 million doses in 2020, a decrease of 41% compared with 13, with the release of domestic 23-valent pneumonia vaccine production capacity may further squeeze the <>-valent pneumonia vaccine market.

As of December 2022, 12, there are 31 23-valent pneumococcal vaccines in the clinical research stage in China, of which the 4-valent pneumonia vaccine of Zhifei Luzhu has completed all clinical trials and is in the marketing application stage, and the 23-valent pneumonia vaccine of Lanzhou Institute of Biology has also entered phase III clinical trials.

A total of 13 9-valent pneumococcal vaccines are in the clinical stage, of which 4 product vaccines from Embienvision, Fosun Antkin, CanSino and Lanzhou Institute of Biology are in phase III clinical stage, and the other 5 are in early clinical trials.

On the one hand, the listing of these pneumonia vaccines increases the accessibility of pneumonia vaccines, and on the other hand, it breaks Pfizer's long-term import monopoly on the pneumonia conjugate vaccine market and gradually realizes domestic substitution.

brief summary

Although the domestic public has little awareness of pneumococcal and the vaccine coverage rate is low, as the relevant domestic departments formulate corresponding rules, local centers for disease control and prevention have successively issued documents to give guidance on the vaccination of pneumococcal vaccine.

In addition, with the impact of the new crown epidemic, the public's health awareness has been significantly improved, especially the rapid popularization of the new crown vaccine, so that everyone's awareness of vaccine disease prevention has been qualitatively improved, and capital is also entering the vaccine field in a steady stream.