entered September, and the temperature in various places gradually dropped, and it also entered the high incidence of flu . Pengpai News reporters found that Beijing, Shanghai, Guangzhou, Hangzhou, Ningbo , Zhengzhou and other cities have recently started influenza vaccination work, and some cities have also carried out free vaccination for people who meet the conditions.
Beijing has fully launched influenza vaccination from September 13. The free influenza vaccination population includes elderly people with the city’s resident identity certificate/ social security card , aged 60 years old (date of birth before December 31, 1962); all students in various primary and secondary schools in school; emergency support personnel for major activities identified by the health and health administrative departments of each district.
Shanghai Baoshan Road Street Community Health Service Center notice on influenza vaccine
Shanghai multiple Community Health Service Center notified the influenza vaccination work. For example, Baoshan Road Street Community Health Service Center began vaccination on September 15, and vaccinated people need to make an appointment online through the "Health Jing'an" WeChat official account; Jing'an District Pengpu Town Community Health Service Center also issued a similar notice on September 9; Songjiang District Jiuting Town Community Health Service Center announced on September 8 that influenza vaccination appointments can be made, and vaccinated people can make appointments based on the specific vaccine appointment channels on the health cloud of the vaccination clinic where they live.
For the public, getting influenza vaccination is a means of prevention. For the industry, behind it is a market of nearly 10 billion yuan. China Securities Research Report pointed out that China's influenza vaccine has just started and the market space is broad. The overall supply of influenza vaccines will continue to increase in the next two to three years, promoting the improvement of penetration rate and market expansion of the influenza vaccine industry. It is estimated that the domestic influenza vaccine market space will be 9.3 billion in 2025.
In this 10 billion track, companies are not only promoting the commercialization of approved influenza vaccine products, but also constantly developing new influenza vaccines, including mRNA technology that has become popular due to the new crown vaccine .
As of August 11, 11 manufacturers have supplied influenza vaccines
The full name of influenza is influenza , which is a respiratory infectious disease caused by influenza virus that is more harmful to human health. At the end of August this year, the latest "Technical Guidelines for the Prevention of Influenza Vaccination in China (2022-2023)" (hereinafter referred to as the "Technical Guidelines") released by the Chinese Center for Disease Control and Prevention pointed out that people are generally susceptible to influenza virus, and high-risk groups such as pregnant women, infants, the elderly and chronic disease patients have more serious harm after influenza infection. Getting influenza vaccinated every year is an effective means to prevent influenza and can significantly reduce the risk of influenza and serious complications in vaccinated people.
The influenza vaccines that have been launched worldwide are divided into inactivated influenza vaccine, live attenuated influenza vaccine and recombinant influenza vaccine. According to the components contained in the vaccine, influenza vaccines include trivalent and tetravalent; according to the production process, they can be divided into chicken embryo, cell culture and recombinant influenza vaccines. Foreign markets have also launched high antigen content inactivated influenza vaccines, adjuvant vaccines, and intradermal vaccination for specific populations.
Source: "Technical Guidelines for the Prevention of Influenza Vaccination in China (2022-2023)"
National Medical Products Administration database shows that there are currently more than 50 influenza vaccine-related approval documents in China. The above-mentioned "Technical Guidelines" show that as of August 11, 2022, 11 manufacturers have supplied influenza vaccines. According to the data disclosed on the official website of of the China National Procuratorate, in September, the companies that obtained the issuance of influenza vaccines mainly include Shenzhen Sanofi Pasteur Biotechnology Co., Ltd., Zhongyi Anke Biotechnology Co., Ltd., Guoguang Biotechnology Co., Ltd., Jiangsu Jindike Biotechnology Co., Ltd. (688670.SH), Dalian Yalifeng Biopharmaceutical Co., Ltd., Wuhan Biotechnology Research Co., Ltd., etc. The
3-valent vaccine component contains a line of A (H3N2) subtype, A (H1N1) pdm09 subtype and B strain, while the quadrivalent vaccine component contains A (H3N2) subtype, A (H1N1) pdm09 subtype, and B Victoria system, and Yamagata system. Innolux Securities research report introduces that there are many participants in the market for 4-valent influenza vaccines, and the proportion of Hualan Bio's batch issuance is close to 50%.According to data from the China Procuratorate, in 2021, five companies in my country's 4-valent influenza vaccines have issued data, of which Hualan Biotech's market share is the first, accounting for about 50%, and Changchun Institute, Jindike, and Sinovac account for nearly 15%-18%.
In addition to traditional injection vaccines, influenza vaccines have also been approved for nasal spray forms in the country. In February 2020, the freeze-dried live nasal spray influenza live vaccine developed by 100G bio (688276), a subsidiary of Changchun Hi-Tech (000661), was approved for the launch of the market, becoming the first domestic nasal spray influenza vaccine, but the vaccine is trivalent.
The flu vaccine contributed different performance in the first half of the year
Generally speaking, autumn and winter are the peak seasons for influenza vaccination, and it is also the peak of influenza vaccination. However, this summer, some provinces in southern my country experienced a peak in the summer influenza epidemic. Not only were the sales of anti-influenza drugs hot, but some cities also started influenza vaccination in advance. Therefore, some influenza vaccine companies also obtained the batch issuance of influenza vaccines in advance, and were reflected in their performance.
Hualan Vaccine (301207), a subsidiary of Hualan Bio, is a leading domestic influenza vaccine company and was listed on the Shenzhen Stock Exchange in February this year. The 2021 annual report shows that according to the biological product batch issuance data released by of the China Food and Drug Inspection Institute of , the Hualan vaccine's influenza vaccine was approved in 2021, of which 96 batches of quadrivalent influenza vaccines were 4 batches of trivalent influenza vaccines, and the number of batches of quadrivalent influenza vaccines and influenza vaccines remained the first in China.
2022 semi-annual report shows that Hualan Vaccine achieved revenue of 1.061 billion yuan, a year-on-year increase of 9624%, and a net profit of 298 million yuan, a year-on-year increase of 1128%. Hualan Vaccine said that the company obtained the first batch of influenza vaccine batch issuance in late May. As of the end of June, a total of 64 batches of quadrivalent influenza vaccine were approved for issuance, including 52 batches of adult dosage forms and 12 batches of children dosage forms.
Hualan vaccine also mentioned on the interactive platform on September 15 that the company has the production capacity of 100 million doses of influenza vaccine in 2022. Thanks to this, the company has basically completed its annual production plan. As of now, the company has issued a total of 103 batches of influenza vaccines.
also benefited from the advance issuance of influenza vaccines. Baike Biotech, a subsidiary of Changchun Hi-Tech. The 2022 semi-annual report mentioned that after the nasal jet influenza vaccine was approved in June, sales promotion work was quickly launched, and publicity efforts were strengthened during the southern summer influenza epidemic season to promote product vaccination. In terms of performance, Baike Biologics achieved revenue of 441 million yuan in the first half of the year and net profit attributable to shareholders of 74 million yuan.
Jindik (688670), who also produced influenza vaccines, did not catch up with the positive news of early batch issuance. The semi-annual report shows that the operating income was 16.3954 million yuan, a year-on-year decrease of 48.91%; the net profit attributable to shareholders of listed companies was 17.258 million yuan.
Source: Jindik Semi-annual report
Jindik mentioned in the semi-annual report that the influenza virus strain may mutate every year, so influenza vaccines are required every year, and the influenza vaccine is effective for one year. For the northern hemisphere in which China is located, the flu season refers to the high incidence period of the influenza virus epidemic every year, mainly from September to May of the following year. The tropical and subtropical areas may occur throughout the year. The corresponding influenza vaccine sales cycle is from August to June of the following year. The peak sales season is concentrated in September to December, and January to June of the following year is the off-season. Influenza vaccine companies in the northern hemisphere receive the possible prevalence of the current influenza season predicted by WHO at the end of February and early March each year and organize production. They mainly carry out product production in the first half of the year. After production, inspection, and batch issuance, the products generally start mass-marketing and sales in August of that year. Therefore, the operating performance of major influenza vaccine companies also showed obvious seasonal fluctuations, that is, performance is mainly reflected in the second half of the year.
Northeast Securities research report pointed out that due to the impact of the southern influenza outbreak, the influenza vaccine batch issuance cycle is advanced. Under the low base effect of weak influenza vaccine sales in 2021, it is expected to usher in considerable growth in 2022. CITIC Securities research report predicts that domestic influenza vaccination demand in the second half of the year is expected to continue to recover compared with the same period last year, and is expected to maintain rapid growth throughout the year.
Many companies have increased their investment in the influenza vaccine market
In fact, in China, the vaccination rate of influenza vaccine is not high.Huatai Securities Research Report pointed out that the overall vaccination rate of influenza vaccine in my country is about 5%, which is far from the 48.4% in the United States, among which preschool children with the highest vaccination rate are only 12.35%. Compared with the 75% target vaccination rate recommended by the World Health Organization (WHO), there is still a lot of room for improvement.
The huge room for improvement in the influenza vaccine market has also become an important background for companies to increase their influenza vaccines. The ways to increase the bid are different. Some companies have added different dosage forms of influenza vaccines, while others have targeted new technology routes such as mRNA.
htmlOn September 7, Jindik announced that the company's pre-filled dosage form of the quadrivalent influenza virus cleavage vaccine was approved. The company's current sales network of tetravalent influenza virus cleavage vaccine covers more than 2,000 CDC in 30 provinces in Hong Kong, Macao and Taiwan. Since Beijing only allows pre-filled influenza vaccines to enter, it has not yet entered. This supplementary application has been approved, giving the company's tetravalent influenza virus cleavage vaccine products the opportunity to enter the Beijing market in the future by participating in bidding; at the same time, with the abundant dosage forms, different dosage forms can better meet the diverse vaccination needs of the people.In addition to the approved influenza vaccine, Jindik is also in-depth development of a series of quadrivalent influenza vaccine products. The semi-annual report mentioned that the company is developing a high-dose quadrivalent influenza vaccine focused on vaccination of children between June and under 3 years old and a high-dose quadrivalent influenza vaccine focused on vaccination of elderly people over 65 years old. Among them, the quadrivalent influenza virus lysis vaccine (children) has completed the first phase of clinical trials, and the quadrivalent influenza virus lysis vaccine (high dose) is in the preclinical research stage.
0 billion vaccine giant Zhifei Bio (300122) relies on the proxy for HPV vaccine and other independent products to make great sales revenue, and has also targeted the influenza vaccine track. The 2022 semi-annual report also disclosed that its quadrivalent influenza virus lysis vaccine and influenza virus lysis vaccine have completed clinical trials.
Hualan Vaccine In addition to the existing influenza vaccine products, the semi-annual report also mentioned that the company has gradually established an mRNA vaccine research and development platform and actively carried out the preliminary research and development of mRNA influenza vaccine. From a global perspective, vaccine giants such as Sanofi and Pfizer have also targeted mRNA flu vaccines. In mid-September, Pfizer announced that its Phase 3 clinical trial of the quadrivalent modified RNA influenza vaccine under development has completed the first patient's administration. Pfizer said that despite the use of existing seasonal influenza vaccines, it still needs to better cope with the burden of influenza. An mRNA-based influenza vaccine may provide an improved influenza vaccine.
It is worth noting that in addition to actively laying out for the domestic market, various domestic influenza vaccine companies are also exploring the way to go overseas.
Recently, the Bangladesh State Administration of Drug Administration approved the launch of the quadrivalent influenza vaccine produced by Sinovac in cooperation with local vaccine companies in Bangladesh. This is the first time that the Sinovac quadrivalent influenza vaccine was approved overseas after it was approved for marketing in China by the State Food and Drug Administration in June 2020. In addition, Hualan Bio also interacted with the platform on June 29 that the company's influenza vaccine has passed the WHO pre-certification and can be exported abroad.
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