In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November

2024/06/1518:41:36 hotcomm 1874

(Report Producer/Author: Northeast Securities, Liu Yuteng)

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews. A pioneer in the domestic vaccine industry with innovation-driven development

1.1. Company Profile

Kangtai Biotech is a pioneer in domestic vaccine companies. Kangtai Biotech was founded in 1992. Through cooperation with Merck, , Kangtai Biotech introduced a full set of production technology, production lines and production strains of recombinant hepatitis B vaccine ( Saccharomyces cerevisiae ), and subsequently successfully developed 10μg, 60μg and 20μg recombinant hepatitis B vaccine is the main manufacturer of hepatitis B vaccine in China. In 2008, Kangtai Biotech and Beijing Minhai strategically reorganized to form a strategic pattern of "North Minhai, South Kangtai". This has laid the foundation for the rapid development of the group’s vaccine research and development pipeline.

Innovation drives development, and Kangtai Biotech has many blockbuster products. After going public in 2017, the company entered a period of rapid growth through technology introduction and independent innovation capabilities. At present, in addition to hepatitis B vaccine, Kangtai 's product line also includes many blockbuster varieties such as DPT-Hib quadruple vaccine, 13-valent pneumonia polysaccharide conjugate vaccine, and 23-valent pneumonia polysaccharide vaccine. In addition, the company's new coronavirus inactivated vaccine has also received emergency use authorization in May 2021, and the adenovirus vector new coronavirus vaccine has received emergency use authorization from the Indonesian National Drug and Food Regulatory Authority in early November 2021.

The company's equity is highly concentrated and its operating conditions are stable. Kangtai Biotech’s equity is highly concentrated. As of the first quarter report of 2022, chairman Mr. Du Weimin and persons acting in concert controlled 45.72% of the equity. The company's equity is highly concentrated and its operating conditions are stable. The company has four subsidiaries with a clear business structure.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

1.2. Company Operations

Kangtai has nine products on sale and a rich product pipeline. Kangtai Biotech's products on the market include DPT-Hib quadruple vaccine, hepatitis B vaccine, Hib vaccine, leprosy double vaccine, 23-valent pneumococcal polysaccharide vaccine , 13-valent pneumococcal polysaccharide conjugate vaccine and COVID-19 inactivated vaccine. In addition, it absorbs Acellular diphtheria-tetanus-pertussis pertussis conjugate vaccine and freeze-dried Haemophilus influenzae type b conjugate vaccine have obtained drug registration approval documents. Among them, the 60 μg hepatitis B vaccine product and the diphtheria-tetanus-pertussis-Hib quadruple vaccine are exclusive products of Kangtai Biotech. They have high incidence rates of related indications and have a large potential market size in China. Kangtai's inactivated COVID-19 vaccine received emergency use authorization in May 2021. In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November 2021. The product is priced at around 458 yuan and is currently available in 21 provinces, and the bidding and acceptance work in other provinces and cities is also being actively promoted.

company has a rich pipeline of research and development, and many new products will be launched in the future. As of 2021Q4, the company has 12 vaccine pipelines in clinical stages. Among them, the inactivated COVID-19 vaccine received domestic emergency use authorization in May 2021 and is currently undergoing Phase III clinical trials. The adenovirus vector COVID-19 vaccine has completed pre-clinical research and submitted A clinical trial application has been submitted, and the product has received emergency use authorization from the National Drug and Food Regulatory Authority of Indonesia and emergency use authorization as a homologous booster shot. The freeze-dried human rabies vaccine (human diploid cells) has entered the production declaration stage, the freeze-dried attenuated chickenpox vaccine has obtained a clinical trial summary report, and the ACYW135 group meningococcal conjugate vaccine and hepatitis A inactivated vaccine are in clinical trials. Research summary stage. Six other vaccines, including the Sabin strain inactivated polio vaccine (Vero cell), have received clinical approval and are in the process of development.

’s R&D investment continues to increase, and its R&D team continues to expand, ensuring rapid advancement of the R&D pipeline. Innovation and research and development are the core elements of the vaccine industry. In terms of R&D investment, the company continues to increase investment to ensure the smooth progress of the R&D pipeline. The CAGR of R&D investment from 2016 to 2021 is nearly 50%. The company's R&D investment in 2021 will reach 738 million yuan, mainly due to the high investment in the phase III clinical trial of new crown vaccine in 2021. The overall proportion of R&D investment in revenue has been maintained at a reasonable level, ensuring net profit margins.Many of the company's core technical personnel are responsible for and participate in a number of "863" national key research projects and major projects of the Ministry of Science and Technology, and have rich experience in research and development in the vaccine industry. From 2016 to 2020, the company's number of R&D personnel has rapidly expanded from 88 to 460, with those with master's and doctorate degrees accounting for as high as 24%. It is expected that the number of R&D personnel will be further expanded.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

The resumption of hepatitis B production and inactivation of and the new crown in 2021 will contribute to the main revenue increase. In 2019-2020, affected by the relocation of the Shenzhen factory, the suspension of hepatitis B production and the launch of the 23-valent pneumonia vaccine, the company's revenue growth in 2019 and 2020 was stable. Hepatitis B vaccine production will resume in 2021, and the new coronavirus inactivated vaccine was approved in May 2021, and sales began in June to contribute to performance growth. The profit growth rate in 2020 is significantly higher than the revenue growth rate, mainly due to the rapid increase in the volume of high-margin second-class vaccines such as 23-price pneumonia and quadruple vaccine. In 2021, the company's regular products will be greatly affected by epidemic prevention work, but the company's two new crown vaccines made outstanding contributions, and the company's overall annual revenue was 3.652 billion. In terms of net profit attributable to the parent company, the company's net profit in 2021 is 1.263 billion. The CAGR of net profit attributable to the parent company from 2016 to 2021 is as high as 71.1%, maintaining rapid growth.

company's revenue and profits mainly come from second-class seedlings with larger profit margins. From the perspective of batch issuance structure, from 2016 to 2021, the proportion of batches of first-class vaccines such as hepatitis B (some specifications are second-class vaccines), leprosy, etc. has gradually declined. The batches of Hib, quadruple vaccine, 23-valent pneumonia vaccine, etc. accounted for The ratio is gradually rising; from the perspective of revenue structure, the revenue from second-category seedlings accounts for as high as 98.62% of the company's overall revenue. We believe that as the company's new Class II vaccine products continue to increase in volume after they are launched, the increase in Class II vaccine batches will further increase the company's operating income and net profit.

With the blessing of the new crown epidemic, new channels for overseas markets of vaccines have opened up. From January to November 2020, my country's human vaccine exports totaled 630 million yuan. In December 2020, the export volume of human vaccines reached 1.25 billion, mainly due to the approved export contribution of new crown vaccine . The quantity and value of my country's human vaccine exports have grown strongly throughout 2021, with cumulative exports totaling RMB 101 billion throughout the year. The main export destinations are countries participating in the "Belt and Road" initiative. We believe that the huge growth in COVID-19 vaccine exports will help China’s vaccines open up foreign markets and drive the export of other vaccine products. Kangtai Biotech is currently actively exploring international market cooperation and sales channels, strengthening overseas product registration, exploring diversified product sales channels, and is committed to becoming a world-renowned biological vaccine supplier. Kangtai has obtained foreign registration certificates for many of its products. Compared with foreign vaccine multinational companies, Kangtai's products are more cost-effective and have a larger market space in developing countries.

insists on combining "bringing in" and "going out" to strengthen overseas cooperation and accelerate product research and development. While steadily advancing R&D projects, the company actively introduces international advanced R&D technologies. The company has reached cooperation with Sanofi Pasteur , INTRAVACC, IMUNA PHARM, A.S., DESMONS CONSULTING SPRL, Jean Didelez, AstraZeneca and other companies to introduce It has acquired a variety of vaccine R&D and production-related technologies to further enhance the company’s R&D strength. (Report source: Future Think Tank)

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews. Blockbuster products have entered the harvest period and are expected to usher in high performance elasticity

2.1. Pneumonia and Pneumonia vaccine :

Pneumonia is the main cause of death due to infection in children around the world. In 2017, pneumonia killed approximately 800,000 children under the age of five globally, accounting for 15% of all deaths among children under the age of five. Pneumonia can be caused by a variety of infectious agents, including viruses, bacteria, and fungi. Among them, Streptococcus pneumoniae infection is the most common cause of bacterial pneumonia in children. Pneumonia can be spread in many ways. Viruses and bacteria usually lurk in the patient's nasal cavity or throat. If inhaled, they can infect the lungs and can also be spread through droplets. In addition, pneumonia can be spread through blood, especially in During delivery and subsequent stages. Currently, the main treatment for pneumonia caused by bacteria is antibiotics. Additionally, immunization is the most effective way to prevent pneumonia. Judging from the death toll statistics, people aged 0-5 and people over 50 are the main susceptible groups.

PPV23 is significantly different from PCV13 in many aspects.There are currently two types of vaccines on the market that can be used to prevent Streptococcus pneumoniae infection , namely Streptococcus pneumoniae polysaccharide vaccines (PPVs) and Streptococcus pneumoniae glycoconjugate vaccines (PCVs). The 23-valent pneumococcal polysaccharide vaccine (PPV23) has been on the market for many years and is prepared from a mixture of capsular polysaccharides (CPS) of 23 common serotype strains. However, the bacterial capsular polysaccharide belongs to the non-thymus-dependent antigen and is only It can produce a response by stimulating mature B cells , but cannot activate T cells, cannot form immune memory, and has a short immune effect. Therefore, PPV is not suitable for children under 2 years of age whose immune systems are not fully developed, but is mainly used for people over 50 years of age. PCVs overcome the shortcomings of PPVs by conjugating polysaccharide antigens with protein carriers, and can effectively stimulate T cells to form immune memory, making the immune effect longer-lasting. Up to now, my country's Pfizer , Watson and Kangtai PCV13 have been put on the market one after another, and Pfizer PCV20 and Merck PCV15 have been approved for adult vaccination in the United States. It is expected that the vaccination population will further expand to teenagers and infants in the future; domestically, Zhifei 15 The 20-valent pneumonia polysaccharide conjugate vaccine is under development, and the IND application for Pfizer's 20-valent pneumonia vaccine has been accepted. We expect that the PCV series of products will further expand the scope of CPS serotypes in the future.

Pneumococcal polysaccharide conjugate vaccine has a significantly enhanced preventive effect on pneumococcal-related diseases, and multiple related products have been launched. Pneumococcal infection-related diseases are the leading cause of mortality in children under 5 years of age worldwide, including pneumonia, meningitis, febrile bacteremia, otitis media, sinusitis, and bronchitis, among which invasive pneumococcal infection ( IPD), pneumonia, acute otitis media mainly. Pfizer's 13-valent pneumococcal conjugate vaccine has completed admission in 149 countries. Affected by the global epidemic, sales in 2020 were US$5.85 billion. Revenue in 2021 has declined, mainly due to the impact of other competing products on the market. Pfizer's 20-valent pneumonia polysaccharide conjugate vaccine was approved for marketing in the United States in June 2021 and is suitable for people over 18 years old; Merck's 15-valent pneumonia polysaccharide conjugate vaccine is expected to be approved for marketing in the United States in July 2021 and in Europe in December 2021. Batch launch, suitable for people over 18 years old; after the 13-valent pneumonia vaccine of Watson Bio was launched in China in 2020, the sales revenue that year was 1.658 billion. According to the current selling price, the domestic PCV13 batch release value in 2020 is about 7.1 billion. In 2021, 104 batches of domestic 13-valent pneumonia vaccine were issued throughout the year, reaching a record high. We expect continued growth in batch releases in 2022 as Kangtai products join the track.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

The domestically produced 13-valent pneumonia vaccine was launched for the first time, and its efficacy is comparable to that of imported products, stimulating the rapid growth of market demand. In 2016 and 2019, Pfizer and Watson Biotech PCV13 were successively approved in China, and the number of batches issued increased from 710,000 to 10.88 million. Watson Bio began sales in the second quarter of 2020, and the number of batches issued in 2020 was 4.46 million, accounting for 41%. Kangtai's 13-valent pneumonia vaccine is the world's first dual-vector 13-valent pneumococcal polysaccharide conjugate vaccine. It was approved for marketing in September 2021. The phase 3 head-to-head clinical results of Kangtai Biotech's PCV13 and Pfizer's PCV13 showed that all serotypes were non-inferior to imported ones. Products, some serotypes are better than imported products, and the product performance is excellent. It obtained the batch release certificate for the first time in October 2021 and will be launched for sale in China in November 2021. The product is priced at 458 yuan, and a total of 3 batches will be issued in 2021, with a total of 417,600 pieces. As of March 2022, the company's products have been approved in 21 provinces, and the bidding and admission work in other provinces and cities is also actively advancing. Kangtai Biological's 13-valent pneumonia vaccine is expected to achieve rapid mass production in 2022.

Many companies have deployed 13-valent pneumonia vaccines, and their research and development pipelines have evolved towards higher prices.At present, from the pipeline of research and development, Zhifei Biotech 15-price, CanSino and Lanshengsuo 13-price pneumonia have all entered the clinical phase III. Among them, CanSino’s clinical phase III will be launched in April 2021, and Zhifei Biotech 15-price pneumonia The Phase III clinical trial of the polysaccharide conjugate vaccine was launched in December 2020. The Phase III clinical trial is expected to take 3-4 years, and it will take about 1 year to apply for production approval. Therefore, we predict that before 2025, Kangtai’s 13-valent pneumococcal polysaccharide conjugate vaccine will mainly The competitors are Pfizer and Watson, and the market competition is good.

PCV13 The domestic market share growth potential is huge, and the penetration rate of and is expected to continue to increase. The number of newborns nationwide in 2021 will be approximately 10.63 million. With the full liberalization of the three-child policy, the country’s policy direction of promoting the improvement of the population structure and delaying the aging process has become very obvious. At present, my country's urbanization rate is 63.89%, and it is expected to further increase to 65.50% in 2025. Residents' living standards continue to improve, sanitary conditions have further improved, residents affected by the COVID-19 epidemic have further improved their awareness of epidemic prevention, and the vaccination penetration rate has also continued to increase.

The current 13-valent pneumonia vaccine market is still in a state of rapid expansion, and each company has different market focus. Pfizer’s products mainly target the first- and second-tier urban markets with their years of reputation advantage and high price strategy. Kangtai uses its own price and sales network advantages. , in addition to focusing on developing markets in first- and second-tier cities, it also covers third- and fourth-tier cities as well as county and township markets. Kangtai’s new product is priced at about 458 yuan, which is significantly lower than Pfizer and Watson. We expect that the number of newborns will remain stable at 9-11 million from 2021 to 2025, and the penetration rate of PCV13 will increase from 13% to 36%. The sales volume of Kangtai products from 2022 to 2025 is expected to be 375/480/550/6.1 million units, domestically produced The price is 458 yuan/piece. Sales are: 1.7.2/22.0/25.2/2.79 billion yuan respectively.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

2.2. WHO "gold standard", human diploid rabies vaccine is expected to be launched

human diploid rabies vaccine replaces rabies vaccine derived from animal cells is the general trend. The fatality rate of rabies virus infection is as high as 100%. There is a lack of clinically effective treatment and dependence on rabies vaccination before and after virus exposure. In addition to the nerve tissue vaccine that has been basically eliminated, the rabies vaccines used globally are mainly divided into animal cells. There are two types of cultured and human diploid cell culture:

(1) Human diploid cell vaccine: using human cells, such as human embryonic lung fibroblasts (MRC-5), which has the strongest immune response and good safety It is the gold standard reference vaccine recommended by WHO and is currently mainly used in developed countries in Europe and the United States.

(2) Animal cell cell matrix vaccine: The vaccine is made by using Vero cells, hamster kidney cells, chicken embryo cells and other animal cells as the culture matrix to propagate the virus and then inactivate it. It is the main variety in the domestic rabies vaccine market. China has stopped issuing batches of chicken embryo cell vaccines since 2018.

The batch issuance volume of rabies vaccine is growing steadily, and the market space is huge. Due to the nearly 100% mortality rate of rabies and the increased risk of exposure (the number of domestic pets is increasing), the sales of rabies vaccine have grown steadily in recent years. Since 2013, the number of batches issued has been approximately 45 to 65 million doses, and the number of batches issued has been approximately 15 million. The number of rabies vaccine batches issued in 2020 reached 78.6 million, a significant increase of 34% from the batch issued in 2019.

The human diploid rabies vaccine market is expected to open up space after the industry’s production capacity is released. At present, Vero cell rabies vaccine is the mainstream product in the market, and the proportion of human diploid rabies vaccine is relatively low, only about 5%. Only Chengdu Kanghua's human diploid rabies vaccine has been put on the market in China, and there are no similar products from other manufacturers. In recent years, the number of batches of human diploid rabies vaccines has been gradually increasing, reaching 4.8 million in 2021. Under the impact of the epidemic Compared with the batch issuance volume in 2020, it increased by nearly 29%, and the compound growth rate from 2014 to 2020 reached 48%. It is expected that further increase in production capacity will lead to further substitution and open up market space.

Kangtai Biological Human Diploid Wild Vaccine has entered the production site inspection stage and is expected to become the second similar product to be launched in China. In 2010, Kangtai Biotech developed a complete set of production technologies for the human diploid vaccine from Sanofi Pasteur, and completed a clinical trial summary in 2019.The traditional static culture process (single-layer adherent culture) limits production capacity. The company has improved the process and changed the traditional way of cultivating human diploid cells in square flasks and spinner bottles. It uses bioreactors and Using microcarrier technology, the microcarrier concentration of 5 μg/ml can reach a culture area of ​​30CM2. With the improvement of culture medium parameters and other measures, the production capacity of viral vaccines has been greatly improved. The traditional 24-hour formaldehyde inactivation process will reduce the effectiveness of the vaccine due to continued inactivation. Kangtai Biotech uses β-propiolactone, and the inactivation time only takes 10 hours. Combined with the characteristics of microcarrier technology, which has higher yield and is easier to expand production, The company's wild seedling production process is suitable for large-scale application.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

From the perspective of the R&D pipeline, Kangtai Biotech has completed the production site inspection. If it goes well, it is expected to be registered in the second half of 2022. The product is expected to be officially launched in 2023, becoming the second related product to be put on the market. Some domestic vaccine manufacturers have made important progress in clinical trial pipelines related to human diploid rabies vaccines. The relevant vaccine pipelines of Zhifei Biotech, Chengdu Institute of Biological Products (Chengdu Institute) and Liaoning Chengda are all in the process of Phase III clinical trials, targeting people aged 10-60 years.

It is expected that Kangtai Biological's human diploid rabies vaccine will be approved at the end of 2022 and officially launched in 2023. The number of people vaccinated with rabies vaccine every year is 15 million. Referring to Kanghua Biological's pricing, it is assumed that the company's human diploid rabies vaccine is 300 yuan. / dose, the vaccinator has received a total of 4 injections (the company's products have both 4-needle and 5-needle methods, and the calculation is conservatively based on the 4-needle method). Kangtai Biotech's sales volume is expected to be 2.5 million units in 2023, and is expected to increase significantly after the release of production capacity, reaching 5 million units in 2025, with sales approaching 1.25 billion yuan.

2.3. Live attenuated varicella vaccine

my country has a high vaccine incidence rate and low vaccination rate, and the market is expected to continue to expand. Chickenpox is an acute infectious disease caused by primary infection with varicella-zoster virus (VZV). It occurs frequently in winter and spring. It is highly contagious. Chickenpox patients are the only source of infection. 1-2 days before onset of illness The rash is contagious until the scab stage. It can be transmitted through contact or droplet inhalation. The incidence rate in susceptible children can reach more than 95%. Varicella vaccine is currently the only means of preventing chickenpox infection. Since 2011, various provinces and cities in my country have begun to promote the two-shot chickenpox vaccine. The vaccination rate of children with chickenpox vaccine in China varies greatly among regions and is overall lower than the average level of developed countries. At present, the average vaccination rate of varicella vaccine among children in China is 61.1% (95% confidence interval is 55.7%-66.5%). The rates in the eastern and central and western regions are 97.3% and 40.8% respectively. The regional vaccination rates vary greatly. Compared with Germany, Italy, and the United States, Compared with the average vaccination rate of more than 80% in developed countries, there is still some room for improvement.

The "two-pin method" is gradually becoming popular, and the market size is expected to continue to expand. The domestic chickenpox vaccine initially adopts the "one-shot" immunization schedule (that is, children receive one shot of chickenpox vaccine after they reach 1 year old). However, due to the large regional differences in vaccination rates across the country, chickenpox epidemics still occur and are far from being able to effectively prevent them. communication purpose. Foreign studies have shown that after healthy children receive a single dose of chickenpox vaccine, their antibody protection rate averages 70%, and after receiving two doses of chickenpox vaccine, the antibody protection rate rises to more than 95%. Since 2011, many places in my country have also launched the "two-shot" varicella vaccine immunization program by issuing guidance on varicella vaccination. So far, it has been implemented in some cities or municipalities in 21 provinces. After the implementation of the "two-shot method", on the one hand, newborns need to receive two doses of varicella vaccine; on the other hand, children who have received one dose of varicella vaccine in previous years still need to receive a second dose of varicella vaccine . As the two-shot varicella vaccine immunization program is gradually promoted across the country, the market demand for varicella vaccine will further increase.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

The chickenpox market continues to expand, and competition is becoming increasingly fierce. In recent years, the volume of domestic chickenpox batches has continued to expand. In 2020, the batch volume was as high as 27.58 million. The winning bid price of my country's chickenpox vaccine products is generally between 130-160 yuan/dose. If calculated based on 136 yuan per dose, China's chickenpox vaccine in 2019 The value of batch signed shipments reached 3.75 billion yuan.At present, domestic varicella vaccines are all live attenuated vaccines . Among them, hundred grams of biological , Shanghai Research Institute and Changchun Qijian are the main varicella vaccine manufacturers in my country. The chickenpox vaccine specifications and immunization procedures of the above-mentioned major manufacturers are basically the same. The specifications are 0.5ml per bottle after reconstitution, and the vaccination procedures are similar.

After the chickenpox vaccine is incorporated into local immunization plans, the unit price will decrease and the vaccination rate is expected to increase. Chickenpox vaccine is currently a non-immunization program vaccine, but due to its high incidence rate and rapid contagion, some cities have included it in local immunization programs for free vaccination, and the scope of adjustment is expected to be further expanded in the future. Currently, the company's chickenpox vaccine is included in local immunization plans in areas including Beijing, Shanghai, Tianjin, and some provincial cities (Guangdong Province, Jiangsu Province, and Shandong Province). The winning bid price for the vaccine that is included in the local immunization plan will be reduced, and the local finance will bear the procurement cost, and free vaccination will be given to people of appropriate age locally. If a vaccine product is included in the local immunization plan, the local vaccination rate of the relevant vaccine product will usually increase, and the overall vaccine sales will increase accordingly.

Kangtai Chickenpox Vaccine Phase III clinical trial has been completed and is expected to be launched in the near future. The clinical research phase of the freeze-dried live attenuated varicella vaccine developed by the company has been successfully completed, and a clinical trial summary report has been obtained, which meets the necessary conditions for applying for production. Research results show that the freeze-dried live attenuated chickenpox vaccine developed by the company has good immunogenicity and safety for healthy chickenpox-susceptible people aged 1 to 55 years old. We believe that with the company's strong sales capabilities, the chickenpox vaccine is expected to increase in volume rapidly after it is launched and contribute to the company's performance growth. (Report source: Future Think Tank)

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews. Traditional products remain strong, and their main revenue contribution is growing steadily at the same time

3.1. The series of multi-combination vaccines against diphtheria-tetanus and pertussis

can reduce the number of vaccination needles, greatly improve vaccination efficiency, and improve patient compliance. . According to the immunization schedule, newborns need intensive vaccination programs before the age of 2 years. In recent years, new children's vaccines have been continuously launched on the market, resulting in some overlap in vaccination windows. However, the multi-combination vaccine reduces the discomfort of young children, saves parents' time, effectively utilizes the vaccination window, and is conducive to alleviating the resource shortage of grassroots vaccination clinics under the current epidemic. Therefore, the joint vaccine market has received widespread attention.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

Comprehensive vaccination compliance and price, the quadruple vaccine vaccination program is more cost-effective. According to the current immunization plan, there are currently three options for parents to choose from for newborns to receive , DPT, , Hib and poliovirus vaccines, including a single vaccine program, a quadruple vaccine program and a five-combination vaccine program. Compared with the single vaccine, the number of vaccinations for the quadruple vaccine and the pentavalent vaccine is 4 fewer and 6 shots + 2 doses respectively. The quadruple vaccine has a higher comprehensive cost performance. The replacement rate of Hib single vaccine by

multiple vaccine has exceeded 50%, and there is still a trend of further improvement. The proportion of Hib single vaccine batches issued dropped from 78% in 2016 to 35% in 2019. From 2020 to 2021, due to the suspension of production of Zhifei Bio's ACHib triple vaccine, the Hib single vaccine batches issued has rebounded. The replacement rate of Hib single vaccine by AC-Hib, DTaP-Hib, DTaPIPV/Hib and other combined vaccines has exceeded 50%. With the promotion of combined vaccines, we expect that the market share of Hib single vaccines will be further replaced by combined vaccines. The replacement rate of

multi-combination vaccine for diphtheria-tetanus pertussis vaccine is less than 20%, and there is huge room for improvement. Compared with the Hib single vaccine, the replacement rate of the combined vaccine for the DPT single vaccine is relatively weak. The main reason is that the Hib single vaccine is a second-class vaccine (non-immunization program vaccine), and its substitutability is lower than that of the combined vaccine, which is also a second-class vaccine. Strong, while DTP triple vaccine is a first-class vaccine and its price substitutability is weak. However, looking at the DPT series, the total number of batches of quadruple and pentavalent vaccines increased from 4.116 million in 2016 to 11.866 million in 2020, with a CAGR of 30.3%, and the substitution trend of multiple vaccines is obvious. The proportion of quadruple vaccine + pentavirus vaccine in the batch release of , DPT and series vaccines increased from 6% in 2016 to 19% in 2020, and the replacement rate was less than 20%. We judge that with the improvement of residents’ living standards, the pharmaceutical industry will The willingness to consume in the health field has increased, and there is still a lot of room for improvement in the replacement rate of quadruple and five-unit vaccines for DTP. The performance of

quadruple vaccine has increased year by year, contributing important results to the company.From 2016 to 2020, the batch release volume and sales revenue of Kangtai Quadruple Vaccine products showed an obvious year-by-year growth trend. Since 2019, due to the impact of the COVID-19 epidemic, the growth rate of batch issuance and sales revenue has slowed down significantly. In 2021, due to the change of packaging and re-hanging of the company's products and the demand for grassroots epidemic prevention, the sales volume has declined. The full-year sales of Quadruple Vaccine in 2021 are expected to be 2 million, with revenue lower than in 2020. It is expected that the epidemic will be effectively controlled by the end of 2022 and sales of the quadruple vaccine will return to normal growth.

Kangtai's R&D pipeline has a clear advantage of being the first to launch, and no competing products will be launched in the short term. There are only three domestic companies currently researching DPT series polycombination vaccine: Wuhan Institute, Kunming Institute (Institute of Medical Biology, Academy of Medical Sciences) and Watson Biotechnology. The Wuhan Institute is making the fastest progress and is in the clinical phase I. The competitive landscape of the DTP multi-combination vaccine series is relatively good, and Kangtai's five-combination vaccine is expected to be launched after 2025, which is expected to further expand the company's advantages in the field of poly-combination vaccines.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

The penetration rate is steadily increasing, and the revenue contributed by Quadruple Vaccine is expected to continue to increase. Due to the impact of the COVID-19 epidemic and packaging changes, Kangtai Quadruple Vaccine has seen a decline in batch issuance and sales in 2021, and is expected to resume growth in 2022. Based on the calculation based on the number of newborns, the price of quadruple vaccine is 368 yuan/dose, and the sales volume from 2022 to 2025 is expected to be 350/425/500/5.5 million respectively. We judge that the company's DTaP-Hib penetration rate will gradually increase and show a steady growth trend, with revenue of 1.29/15.6/18.4/2.02 billion in 2022-2025. The higher-priced Wulian vaccine will be launched after 2025, contributing to new performance increases for the company.

3.2. Aging is accelerating, and the 23-valent pneumococcal vaccine market is growing steadily

Under the aging trend, the domestic 23-valent pneumococcal polysaccharide vaccine market will continue to grow. WHO recommends that healthy elderly people over 65 years old (especially those living in public institutions), all people aged 50 years and above, and patients with chronic diseases between 2 and 50 years old (the frail, chronic lung disease, diabetes , high blood pressure , etc.) vaccinate with 23-valent pneumococcal polysaccharide vaccine . The domestic 23-valent pneumococcal polysaccharide vaccine is mainly used to vaccinate high-risk groups over 2 years old to prevent pneumococcal pneumonia, and for routine vaccination of people over 50 years old (inclusive). For people at high risk of pneumococcal infection, the 23-valent pneumococcal polysaccharide vaccine can be revaccined after an interval of 5 years. According to the forecast of Zhuoshi Consulting in the Oulin Bio prospectus, the market size of the 23-valent pneumonia polysaccharide vaccine will increase from 1.89 billion yuan in 2019 to about 4.47 billion yuan in 2030.

23 The price of pneumonia vaccines is increasing rapidly, and there is an obvious trend of domestically produced vaccines replacing imported vaccines. Currently, a total of 5 23-valent pneumonia polysaccharide vaccines are on the market in China, respectively from Kangtai Biologics, Merck (agent of Zhifei Biotech), Chengdu Institute, Watson Biotech, and Sinovac Biotech. The total number of batches issued increased from 3.69 million in 2016 to 17.39 million in 2020, with a compound growth rate of 47%, indicating an extremely rapid increase in volume. Based on the number of batches issued in 2020, the market shares of Chengdu Institute, Watson Biotech, Kangtai Biotech and Merck are 41%, 34%, 23% and 2% respectively. Affected by the epidemic in 2021, the batch releases of 23-valent pneumonia vaccines from Chengdu Institute, Watson and Kangtai, which have a large market share, have all decreased, while the batch releases of Sinovac and Merck products have not increased significantly. We expect that the batch releases of 23-valent pneumonia vaccines in 2021 Vaccine batches issued have decreased.

Many companies are investing in the elderly vaccine market, and the competition for the 23-valent pneumonia vaccine is becoming increasingly fierce. Judging from the ongoing research pipeline, Zhifei Luzhu (a wholly-owned subsidiary of Zhifei Biotechnology) has applied for production registration and has been accepted. The Lanzhou Institute has completed clinical phase III trials. It is expected that in 2025, there will be 6-7 domestic companies producing PPV23 at the same time. Competition for 23-valent pneumococcal polysaccharide vaccine has become increasingly fierce. Kangtai is expected to seize more markets with its strong sales network and cost-effective products.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

With the blessing of aging, there is still room for improvement in the market size of the 23-valent pneumonia vaccine. According to data from the National Bureau of Statistics, the number of elderly people will continue to grow in the next five years. People’s awareness of pneumonia prevention will continue to increase after the COVID-19 epidemic. Superimposed on national policies to promote vaccination among the elderly with reduced immunity, the market space for the 23-valent pneumonia polysaccharide vaccine is expected to continue to change. big.The current domestic population aged 65 and over is 190.64 million (2020 data), with an average growth rate of 4.68% in the past five years. Considering that the average life expectancy in China has reached 76 years in 2020, we simply calculate that each elderly person will receive two shots. According to the current domestic PPV23 price vaccine market structure and sales estimates, the number of PPV23 vaccinations in 2020 will be approximately 12.27 million shots. This is mainly due to the outbreak of the new crown epidemic, and the new crown vaccine has not yet been launched, and the vaccination rate of 23 price has increased rapidly. Referring to the market share in 2019 and the batch issuance situation of the Central Inspection and Quarantine Bureau in 2021, it is expected that the vaccination volume will fall back in 2021 compared with 2020. We estimate that the domestic vaccination volume is about 10 million, and the penetration rate is about 2.50%. Assuming that in the next five years Penetration rates rise slowly. Based on the sales volume and sales volume in 2020, the average price of Kangtai PPV23 vaccine is approximately 186 yuan/tube. Kangtai's domestic sales from 2022 to 2025 are expected to be: 3.72/4.65/5.58/651 million yuan respectively.

3.3. The resumption of production of hepatitis B vaccine is expected to contribute to increased performance

Hepatitis B is still one of the infectious diseases with the highest incidence in my country. Viral hepatitis B (viral hepatitis type B) is an infectious disease caused by hepatitis B virus and mainly involves liver lesions. The main clinical manifestations are loss of appetite, nausea, upper abdominal discomfort, liver pain, and fatigue. . Some patients may have jaundice, fever and hepatomegaly accompanied by liver function damage. Some patients can become chronic and even develop cirrhosis, and a few can develop liver cancer. Hepatitis B virus is also a carcinogen on the WHO list of carcinogens. Hepatitis B virus can be transmitted through blood, mother-to-child and body fluids. Since 1990, the incidence rate of hepatitis B in various countries around the world has gradually shown a downward trend. Since my country incorporated hepatitis B vaccine into the immunization program in 1992, the incidence rate of hepatitis B has dropped significantly, and remarkable results have been achieved in the control of hepatitis B disease. However, from a global perspective, the incidence rate of hepatitis B in my country is The level is still significantly higher than the world average. Since 2015, the number of reported cases of hepatitis B in my country has been around 1 million, showing an overall upward trend. In 2020, as the control of the new coronavirus epidemic has provided favorable conditions for preventing the spread of hepatitis B virus, the number of cases has dropped significantly; since 2015, the number of reported deaths from hepatitis B has been at 350 -500 or so, a slight increase in deaths. The number of hepatitis B virus carriers in my country has exceeded 70 million. The control of hepatitis B disease in my country still requires long-term efforts, and the vaccination of hepatitis B vaccine is the most critical link.

Hepatitis B vaccine can be used to prevent hepatitis B. Currently, in my country, hepatitis B vaccine for newborns is a Class I vaccine, and hepatitis B vaccine for adults is a Class II vaccine. Generally, normal newborns receive the first dose of hepatitis B vaccine within 24 hours after birth, the second dose at 1 month, and the third dose at 6 months. Hepatitis B vaccine for adults is given in three doses at 0, 1 and 6 months.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

The overall batch issuance volume of hepatitis B vaccine in my country is on a downward trend, but the demand is still huge. In 2020, my country’s hepatitis B vaccine batches were issued at 64.6781 million doses. In terms of specifications, the number of batches of 10μg hepatitis B vaccine has declined significantly from 2016 to 2020, mainly affected by the decline in the number of newborns; the 20μg hepatitis B vaccine has shown a slight upward trend overall; the 60μg hepatitis B vaccine is exclusive to Kangtai, and has been more affected by the relocation and shutdown of the factory. big.

Kangtai Hepatitis B workshop resumed production and ushered in rapid growth. my country's hepatitis B vaccine can be divided into three types: CHO cell, Hansenula yeast, and Saccharomyces cerevisiae. The CHO cell type hepatitis B vaccine is mainly produced by Huayao Jintan (North China Pharmaceutical), and the Hansenula yeast type is mainly produced by Dalian Hanxin (Aimee Hanxin). Letter), Saccharomyces cerevisiae type hepatitis B vaccine is mainly produced by Kangtai Biologics and GlaxoSmithKline. Saccharomyces cerevisiae type hepatitis B vaccine accounted for the largest proportion of hepatitis B vaccines before 2018. Later, due to the relocation and suspension of production of the Kangtai hepatitis B vaccine workshop, it has been gradually replaced by CHO cell type and Hansenula yeast type hepatitis B vaccines in recent years. According to the results reported in the public literature, there is no significant difference in the effectiveness, stability and adverse reaction rate of the three current vaccines. At the end of 2020, the company's hepatitis B workshop resumed production, with production capacity returning to 25 million units from July to December (the original workshop's annual production capacity was 30 million units). The market share increased from 3% in 2020 to 40.46% in Q1 of 2021.

Kangtai is the earliest hepatitis B vaccine manufacturer in China with a profound corporate background.The company has the most comprehensive hepatitis B vaccine product line in China, including three specifications: 10μg, 20μg, and 60μg. Among them, the company’s independently developed “60μg recombinant hepatitis B vaccine (Saccharomyces cerevisiae)” for special populations who do not respond to hepatitis B vaccine is an internationally recognized product. The first of its kind, it fills the gap in the country. The production base was relocated in 2018, and the inventory was in a state of depletion from 2019 to 2020. The batch release volume of hepatitis B vaccine dropped significantly. Production resumed in 2021, with a total batch release of 25.7478 million vaccines. We believe that the company can quickly resume the establishment of sales channels for hepatitis B vaccines with its strong sales network, and the newly built workshops can fully meet production capacity needs. The company's hepatitis B vaccine sales are expected to further grow in 2022. The price of

’s exclusive product 60μg has increased significantly and is expected to continue to contribute to performance growth. The 60μg hepatitis B vaccine independently developed by Kangtai Biotech for adult non-responders received registration approval from the State Food and Drug Administration for the first time on March 26, 2010, and obtained registration approval from the Guangdong Provincial Food and Drug Administration on March 9, 2015. The drug re-registration approval document issued has achieved full coverage of the adult hepatitis B vaccine population. The company is currently the only company in China that produces 60μg hepatitis B vaccine.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

The small size hepatitis B vaccine belongs to the immunization program vaccine. The vaccination rate is close to 100%, and the room for incremental growth is weak. According to public bidding price statistics, the winning bid price of the 60 μg hepatitis B vaccine has increased from the original 220/tube to the current 320/tube, a price increase of nearly 50%. Assuming that there will be 9-10 million newborns in China every year in the next five years, the company will successfully resume hepatitis B vaccine production in 2021. With years of market position and quality control experience, the sales of products of various specifications can gradually return to previous levels. We make the following predictions:

1) It is estimated that the sales volume of 60ug hepatitis B vaccine in 2022-24 will be 1.2 million, 1.4 million, and 1.6 million respectively, and the revenue contribution in 2022-24 will be 3.8/4.5/540 million yuan.

2) After the production of small-dose hepatitis B vaccine resumes, it will return to previous levels, and sales are expected to maintain steady growth. The estimated revenue of hepatitis B vaccine in 2022-24 is 627/705/814 million yuan.

. Promote the strategic depth of R&D layout to ensure mid- and long-term performance growth

4.1. Oral pentavalent live attenuated rotavirus vaccine

Rotavirus has a high incidence rate in children and has huge market potential. Rotavirus is the main cause of severe diarrhea in children under 5 years old in the world. The Global Burden of Disease Report shows that the incidence of rotavirus diarrhea is 35% to 52%, and among the deaths of children under 5 years old in developing countries , 5% are caused by rotavirus diarrhea. Rotavirus vaccine has great market potential as the main preventive method. Merck's pentavalent rotavirus vaccine had global sales of US$791 million in 2019, ranking among the top ten in global vaccine sales. At present, domestic rotavirus vaccine products include Merck & Co.’s pentavalent products and Lanzhou Institute of Technology’s unit-price products. Based on the public winning bid prices and batch release estimates of each province, the domestic rotavirus vaccine output value is as high as 2.5 billion yuan.

The pentavalent rotavirus vaccine is more effective and is expected to become a mainstream choice. There are only two rotavirus vaccines on the market in China, including Merck's pentavalent rotavirus vaccine and Lansheng's monovalent rotavirus vaccine. Merck's pentavalent rotavirus vaccine was launched in China in 2018, with nearly 4 million batches issued by 2020. doses, the number of batches issued accounted for 37%, and the growth rate far exceeded that of Lansheng's unit price rotavirus vaccine in the same period. In 2021, 6.49 million doses of pentavalent rotavirus vaccine were issued in batches, a significant increase of 62%. The pentavalent rotavirus vaccine has longer protection time and better vaccination compliance. We believe that the pentavalent rotavirus vaccine with longer protection time may gradually replace the monovalent rotavirus vaccine and become the mainstream prevention method.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

Many companies are developing pentavalent rotavirus vaccines, and competition is becoming increasingly fierce. In August 2021, Kangtai Biological's clinical trial application for pentavalent rotavirus vaccine was accepted. As for the 5-valent vaccine, currently only the imported vaccine from Merck is on the market. Among the relevant pipelines under development, Lanzhou Institute's 3-valent vaccine, Wuhan Institute's 6-valent vaccine and GSK's live attenuated human rotavirus vaccine are in the lead.Kangtai's related products cover the main virus serotypes G1, G2, G3, G4 and G9 that cause diarrhea in China. In the future, the 5-valent vaccine will be launched on the market and can achieve rapid volume with the benefit of the price and the company's strong marketing capabilities.

4.2. Join hands with Jiachen Xihai to lay out the mRNA vaccine business

mRNA technology is the most disruptive technology in the vaccine field in recent years, and it has shined in the research and development of new crown vaccines. Due to the COVID-19 epidemic, BioTech and Moderna, two companies deeply involved in mRNA vaccine technology, have experienced explosive growth, and their COVID-19 vaccine products are selling well around the world. The advantages of mRNA vaccines are rapid development and long-lasting efficacy, but the disadvantage is that the research and development technology requires high requirements. At present, many companies around the world have deployed various types of mRNA vaccine research and development, with the main targets being the new coronavirus, tumors and influenza. Domestically, some companies have also begun to deploy, including Watson Biotech, Aimi Vaccine, Fosun Pharma, CSPC Pharmaceutical Group, Sri Lanka Microbiology and CanSino.

joins hands with Jiachen Xihai to lay out the mRNA platform. Minhai Biotechnology, a subsidiary of Kangtai, and Jiachen Xihai jointly carried out research on the application of mRNA (self-replicating and non-self-replicating) platform technology in the direction of human infectious disease vaccines, with the "mRNA Rabies Vaccine Project" as the first formal cooperation project between the two parties. Minhai Biotech will establish an mRNA vaccine technology platform step by step, including an mRNA expression platform, an mRNA stock solution preparation process platform, and an mRNA human infectious disease vaccine preparation process platform. At the same time, it will establish the quality of the mRNA human infectious disease vaccine products (including stock solution and finished product). Control related detection methods. Jiachen Xihai will transfer the production process and detection methods of the mRNA platform technology to Minhai Biotech step by step, and will be responsible for the antigen selection of the mRNA human infectious disease vaccine, the design optimization of the mRNA, the optimization and finalization of the delivery vector and preparation, and the pilot samples for small trials. preparation and other preclinical studies. At present, Jiachen Xihai and Minhai Biotech have built a complete mRNA vaccine preparation process platform, which is suitable for the production of self-replicating mRNA vaccines and non-replicating mRNA vaccines. Relying on Minhai Biotech’s mature vaccine production platform, its mRNA vaccine is expected to be fully localized. Production materials will all use domestic raw and auxiliary materials to further reduce the production cost of the vaccine.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

The preclinical research on the COVID-19 Delta variant mRNA vaccine and the verification of the mRNA vaccine platform have been completed, and the development of the Omicron mRNA vaccine is progressing smoothly. JCXH-104 is a sequence-optimized non-replicating mRNA vaccine targeting the S antigen of the new coronavirus mutant strain. At present, the preclinical research of the new coronavirus delta strain mRNA vaccine (JCXH-104) has been completed, and the rolling application for IND is in progress. This product breaks the limitations of similar vaccines being stored at 2℃-8℃ for 24 hours and at room temperature for 2 hours. It is expected to achieve long-term storage at 2℃-8℃ and can be stored at room temperature for several weeks. It can be flexibly adapted to China Different regions have different anti-epidemic needs to maximize the accessibility of mRNA vaccines. In addition, the immune effect verification and evaluation work of the vaccine and multivalent vaccine against Omicron has also been completed. The prepared Omicron variant mRNA vaccine can induce high titers of neutralizing antibodies in mice.

. COVID-19 Vaccine

Domestic COVID-19 vaccine companies are accelerating their research and development, have rich technical routes, and are expected to compete in the international market. There are currently 7 new coronavirus vaccines on the market in China, which are mainly divided into two categories: inactivated vaccines and recombinant vaccines. Companies with inactivated vaccines approved for marketing include Wuhan Institute, Beijing Sinovac, Beijing Institute, Kangtai Biology and the Institute of Biology of the Academy of Medical Sciences; companies with recombinant vaccines approved for marketing include Zhifei Biotech and CanSino. In addition, companies that have entered the clinical stage include Watson Biotech, Wantai Biotech, Ai Di Wei Xin, Si Microbiology, etc.

Epidemic control cannot be relaxed, and vaccination work continues to advance. In view of the fact that the Omicron strain currently prevalent in the world is highly transmissible and the vast majority of infected people have mild symptoms, some overseas countries have already relaxed their control over the new coronavirus epidemic, which may have a negative impact on domestic epidemic prevention and control efforts. More pressure. At present, local cases of COVID-19 continue to appear in many cities in China, and the anti-epidemic situation remains very severe.According to data released by the Joint Prevention and Control Mechanism of the State Council, as of May 5, a total of 3.35 billion doses of new coronavirus vaccines have been reported across the country, 1.25 billion people have completed the full course of vaccination, 760 million people have completed enhanced immunization, and 500 million people are still in the country. Strengthen the needle space above the needle. The WHO has repeatedly emphasized that existing coronavirus vaccines focus on reducing severe illness and death and protecting health systems. Therefore, although Pfizer's specific COVID-19 drug has been approved in China, the promotion of booster shots is still the focus of epidemic prevention work. Since the press conference of the Joint Prevention and Control Mechanism of the State Council announced on February 19 that the sequential booster immunization was approved, many places across the country have started the sequential booster immunization of the new coronavirus vaccine, with full vaccination of Sinopharm Beijing Company, Wuhan Company, and Beijing Science and Technology Target groups over 18 years of age who are 6 months old and older, including Xing Company’s inactivated vaccine, and Tianjin CanSino’s adenovirus vector vaccine, can choose Zhifei Longkoma’s recombinant protein vaccine or CanSino’s adenovirus vector vaccine for sequential booster immunization , as of May 5, more than 30 million people have been vaccinated sequentially. In addition, Kangtai’s inactivated COVID-19 vaccine has also been approved for a homologous booster shot.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

There is still market space for the COVID-19 vaccine in the post-COVID-19 era. We believe that the epidemic may change from a global epidemic to a local epidemic in the future, and regular booster vaccinations (one dose per year) will still be needed in the future. On the demand side, according to the three-shot vaccination procedure and a vaccination rate of 70%, excluding China, the United States, Europe, India and other countries, there is still a market demand of about 4 billion doses of the new crown vaccine. On the supply side, judging from the production capacity announced by each company, Sinopharm has an annual production capacity of 7 billion, Sinovac Biologics has an annual production capacity of 2 billion, CanSino has an annual production capacity of 700 million, Zhifei Biologics has an annual production capacity of 500 million, and Kangtai Biologics has an annual production capacity of 400 million. , the annual production capacity of the Medical College is 500 million to 1 billion, and the total annual production capacity exceeds 11 billion doses, which can fully guarantee the demand of domestic and foreign markets. In addition, the development of vaccines against Omicron is still accelerating, and the first batch of products is expected to be launched in the fall of 2022, when the fourth dose of vaccination is expected to be released. In 2021, China's COVID-19 vaccines were donated to more than 80 countries and exported to more than 50 countries. Domestic COVID-19 vaccine companies are expected to further open up the international market in the future and shift from domestic sales to exports. In 2021, China exported 2 billion doses of COVID-19 vaccines, and is expected to export 1 billion doses in 2022. It is estimated that domestic companies will still have room for 30 billion yuan (30 yuan/dose) in revenue from COVID-19 vaccine export business in 2022. Looking at the domestic market in the short term, the domestic booster shot market will still be 500 million in 2022.

Kangtai Biological's inactivated vaccine homologous booster shot has been approved, and the export of adenovirus vector vaccines has been steadily advancing. Kangtai Biological's inactivated COVID-19 vaccine has been approved for homologous booster vaccination, and the adenovirus vector vaccine in collaboration with AstraZeneca has received emergency use authorization in Indonesia. According to the company's 2021 annual report, it is estimated that Kangtai's new crown vaccine will sell approximately 50 million doses at home and abroad in 2021. The inactivated vaccine started selling earlier, with an estimated average price of 50 yuan/tube, and the adenovirus vector vaccine will be sold later, with an estimated average price of 33 yuan/tube. It is expected that Kangtai's new crown vaccine will still have sales of 300-400 million yuan in 22-23.

6. Profit forecast and investment analysis

6.1. Kangtai Biotechnology’s profit forecast

Considering the company’s operating conditions, we make the following assumptions:

1) PCV13: Kangtai Biotechnology adopts a conservative pricing strategy, pricing 458 yuan/branch. Sales volume in 2022-24 will be 375/480/5.5 million units respectively.

2) PPV23: Affected by the new crown epidemic, sales volume in 2022-24 is 200/250/3 million.

3) DTP combined vaccine: The sales volume of quadruple vaccine in 2021-23 is 350/425/5 million respectively. The vial-packaged quadruple vaccines will be sold out in 2021, and after 2021 they will all be pre-filled.

In addition, Kangtai Biotech's first dual-carrier 13-valent pneumococcal polysaccharide conjugate vaccine obtained a drug registration certificate in September 2021, obtained a batch release certificate for the first time in October 2021, and will be marketed in China in November - DayDayNews

4) Hepatitis B vaccine: After the resumption of production, production capacity was released and sales gradually returned to the level of previous years. Sales of the exclusive product 60μg hepatitis B vaccine continued to grow. Overall hepatitis B sales in 2021-23 are 627/705/814 million.

5) Freeze-dried human rabies vaccine (human diploid cells): It is expected to be priced at 300 yuan. After approval for marketing, sales volume in 2023 will be 2.5 million.

Profit Forecast:

Without considering the new crown vaccine, we estimate that the company’s operating income in 2022-24 will be 4.102/57.96/7.029 billion yuan. At the same time, we conservatively estimate that the new crown vaccine will contribute 395/325 million yuan in revenue in 22-23. It is expected that the company as a whole Net profit is 1.558/20.02/2.552 billion yuan.

6.2. Investment analysis

The company has a rich product system: the 13-valent pneumonia conjugate vaccine will be launched in the first year, and the human diploid vaccine and chickenpox vaccine are expected to be launched in recent years to contribute to performance growth and have great performance flexibility; the quadruple vaccine + 23 price Pneumonia + hepatitis B, as the company's basic products, continue to contribute incrementally; the company has strong reserves of products under development, and multiple products are being accelerated; in the post-COVID-19 era, Kangtai's dual-technological route COVID-19 vaccine still has market space for booster shots at home and abroad.

(This article is for reference only and does not represent any investment advice on our part. If you need to use relevant information, please refer to the original text of the report.)

Selected report source: [Future Think Tank]. Future Think Tank - Official website

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