Analysis of the current situation and development trend of China's vaccine industry under the epidemic situation
Last Update: 2020-06-19
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In recent years, China has successively launched heavyweight vaccine products, such as 2014 DTaP Hib quadruple vaccine, AC Hib triple vaccine, EV71 vaccine, 4 / 9 Price HPV vaccine and 4 price influenza vaccine, which are heavyweight products in relevant fieldsAt the end of 2019, CFDA approved Watson biological's 13 valent pneumonia combined vaccine and Xiamen Wantai's 2-valent HPV vaccine respectively, announcing that both sides will break the monopoly of related vaccine varieties of foreign pharmaceutical giants in China< br / > in 2020, the vaccine industry has a series of heavy-duty products waiting for approvalThe production of Bifidobacterium vaccine (tuberculosis vaccine), Changchun hi tech nasal spray influenza vaccine and Kangtai biological 13 valent pneumonia combined vaccine has been declared, and it is expected to be approved in successive yearsIn addition, Watson biological 2-valent HPV vaccine completed phase III clinical, waiting for data Unblinding; Kangtai biological human diploid cell rabies vaccine has obtained clinical summary, waiting for application for production, EV71 vaccine is in phase III clinical, and is expected to be approved for market after 2021< br / > affected by the new outbreak, it will strongly promote the sustainable development of the vaccine industry2020 will be the harvest year of the vaccine, and the multi linked multi price is the future development direction of the vaccine< br / > the total amount of national vaccine batch signing is stable as a whole < br / > in 2019, the total amount of domestic vaccine batch signing and issuing is about 550 million doses, an increase of about 2.0% compared with 2018In the first half of 2018, affected by the industry events, the total amount of batch signing and issuing is about 220 million doses, and the recovery is obvious in the second half of the yearThe total amount of batch signing and issuing is about 330 million doses left and right, indicating that after the adjustment of vaccine industry events and vaccine approval regulatory system, the vaccine production department began to recoverThe total amount of vaccine endorsement in China has been stable at about 550 million doses for five consecutive years (2015-2019)In 2018, affected by industry events, it was the lowest point of batch issuance in the past five years< br / > Figure 1 total amount and growth rate of vaccine batch over the years (unit: 100 million doses) < br / > source: China National Academy of inspection, YueKai securities < br / > current situation and trend of major vaccine industries < br / > (I) influenza vaccine: the number of influenza vaccine batch of all varieties has bottomed out, and the total number of influenza vaccine batch has nearly doubled year on year < br / > after the last influenza season (2018-2019) influenza vaccine shortage in China, In the 2019-2020 flu season, the issuance of all types of influenza vaccines (including trivalent influenza vaccine and quadrivalent influenza vaccine) hit the bottom and rebounded, with the annual issuance of about 30.78 million doses, up 90.9% year on year< br / > among them, 21.07 million doses of trivalent influenza vaccine (including children's type) were issued in batches throughout the year, up 91.5% year on year, 28% of which were children's type (0.25 ml / dose), and the rest were adult type (0.5 ml / dose), accounting for 72%; about 9.71 million doses of tetravalent influenza vaccine were issued in batches throughout the year, up 89.6% year on yearLast year, four price influenza vaccine manufacturers added Jiangsu jindick to be approved for production, accounting for about 31.5% of the total approved influenza vaccine, basically the same as last year< br / > in the past decade, the median of the total number of influenza vaccine batches issued is about 35 millionThe annual number of influenza vaccine batches issued in 2016-2018 fell below 30 million due to industry events, which, combined with the aggravation of influenza epidemic, leads to the situation that the supply of influenza vaccine in China is in short supply According to the median volume of batch issuance in ten years, the penetration rate of influenza vaccination in China is less than 3%, which is a huge gap compared with that in developed countries in Europe and the United States, and there is a large room for growth in the future < br / > in terms of competition pattern, Hualan biology continued to take the lead with a market share of 42% Influenza vaccine (including three and four price influenza vaccine) has been produced and approved by six enterprises in total, including Hualan biology, Sanofi Pasteur, Changchun Institute, Beijing Science and technology, Guoguang biology and Jiangsu jindick, which was newly approved with four price influenza vaccine last year According to the full scope statistics of all types of influenza vaccines, Hualan biology continues to lead in the field of influenza vaccines In the whole year, a total of 12.93 million doses of three and four price influenza vaccines were approved, accounting for 42% of the total number of influenza vaccines approved in the country; among them, 4.572 million doses of three price influenza vaccines were approved, accounting for 21.7% of the total number of influenza vaccines; 8.36 million doses of four price influenza vaccines were approved, accounting for 86.1% of the total number of influenza vaccines; the market competition of four price influenza vaccines is loose, Hualan biological production resources incline to tetravalent influenza vaccine < br / > (2) pneumonia vaccine: a large number of batches have been signed, and it will be a golden period for development in the future < br / > 1 In recent years, there are three kinds of pneumonia vaccine products listed in China: 23 price pneumonia polysaccharide vaccine and 13 price pneumonia combined vaccine In addition, Pfizer 7 price pneumonia combined vaccine product has expired its domestic registration certificate and exited the market in 2014 < br / > at present, there are two kinds of pneumonia vaccines issued and listed in batches in China, of which 23 valent polysaccharide vaccine is suitable for children and adults over 2 years old, but not for children and adults over 2 years old, It is impossible to vaccinate the children under 2 years old; the imported Pfizer 13 valent pneumonia combined vaccine is approved to be suitable for children aged 6-15 months in China, and the vaccination procedure is three times of basic immunization for children aged 2, 4 and 6 months, and one time of enhanced immunization for children aged about 12-15 months The age of adaptation is relatively narrow, and children who miss the vaccination age cannot be vaccinated At the end of last year, the domestic version of Watson biological 13 valent pneumonia conjugate vaccine was newly approved for marketing The age range of adaptation is from 6 weeks to 5 years (before the 6th Birthday) for infants and children, with a wide age range < br / > there are many innovative pneumonia vaccines in the research process in the world, among which, Pfizer 20 valent pneumonia vaccine (20vpnc), which was recognized as FDA breakthrough therapy in September 2018, is currently in phase III clinical trials; MSD 15 valent pneumonia vaccine (v114), which was recognized as FDA breakthrough therapy in January 2019, is the first in the clinical progress of foreign pneumonia vaccine products, The primary end point was reached in May The top clinical progress of pneumonia vaccine in domestic research includes: the phase III clinical trial of 13 valent pneumonia vaccine of minhai Biology (Kangtai biology subsidiary) has been completed and is in the stage of application for listing; the phase III clinical trial of 13 valent pneumonia vaccine of Lanzhou Institute is in the stage < br / > 2 Competition pattern: Pfizer's 13 price product batch has been increasing year by year Domestic enterprises account for the main share of 23 price products < br / > 2019 Only Pfizer has issued 13 price pneumonia combined vaccine in domestic market Since Pfizer's 13 price pneumonia vaccine products went on the market in 2016, it has been approved in large quantities year by year, but still in short supply < br / > in 2019, a total of 9.47 million doses of 23 valent pneumonia vaccine were issued, with a year-on-year increase of 34.3% In recent years, with more vaccine enterprises' 23 price pneumonia products being approved and listed one after another, the number of approved and issued is increasing In 2016, there were 3.69 million doses, 5.257 million doses in 2017 and 7.047 million doses in 2018 There are four enterprises in China that produce and issue 23 price pneumonia vaccine, one of which is imported from moshadong (approved to be listed in China in 1996 and represented by Zhifei Biology), three of which are domestic, namely Chengdu Institute (approved in 2006), Watson Biology (approved in 2017) and minhai Biology (subsidiary of Kangtai biology, approved in 2019) A total of 8.02 million doses of domestic 23 valent pneumonia vaccine have been issued, accounting for 84.7% of the total amount issued Domestic 23 valent pneumonia vaccine products occupy the main market share in China < br / > in 2019, Watson biological 23 valent pneumonia vaccine products were approved and issued 3.578 million doses, a year-on-year increase of 121.5%, and the market share of approved and signed products rose to the first, 37.7%; Chengdu approved and issued 3.55 million doses, ranking the second in the market, with the market share of approved and signed products of 37.5%; mosadong approved and signed 1.449 million doses, a market share of 15.3%; in 2019, the newly approved and listed marine biological products of 893000 doses, a market share of 9.4% < br / > Fig 2 the amount of 23 price pneumonia vaccine issued in batches from 2017 to 2019 (unit: 10000 doses) < br / > source: China National Procuratorate, YueKai securities < br / > (3) epidemic meningitis vaccine: all kinds of products are in full bloom < br / > 1 Overview of epidemic meningitis vaccine industry < br / > epidemic meningitis vaccine is one of the major categories of vaccine issued in batches in China, with a large number of vaccine varieties and manufacturers At present, there are mainly group A Meningococcal polysaccharide vaccine, group AC meningococcal polysaccharide vaccine, group AC combined with meningococcal meningitis vaccine, group acyw135 polysaccharide vaccine and various types of polyclonal meningitis vaccine, among which group A Meningococcal polysaccharide vaccine and group AC meningococcal polysaccharide vaccine are class I vaccines, the rest are class II vaccines, and the age of each vaccine is partially overlapped In addition, there are a variety of innovative meningitis vaccines under development, such as the acyw135 group of meningitis polysaccharide combined vaccine (MCV4) kangxinuo entering the listing application process, Watson biology and Zhifei biology are in clinical trials, in addition, Luoyi biology is also developing the AC Hib triple vaccine, Zhifei biology has applied for the acyw135 group Hib triple vaccine, but CFDA does not approve the registration temporarily < br / > 2 The pattern of batch issuance and market competition of various kinds of meningococcal vaccine < br / > in recent years, the overall batch issuance of meningococcal vaccine is on the rise, from 49.49 million doses in 2015 to 73.25 million doses in 2018 The main vaccines are group A and group C meningococcal polysaccharide vaccines, accounting for about 78% of the total batch, while the other two kinds of meningococcal vaccines (AC Hib triple vaccine, group AC meningococcal conjugate vaccine, group acyw135 meningococcal polysaccharide vaccine) account for about 22% < br / > in 2019, a total of 63.5 million doses of various types of meningococcal vaccines (including AC Hib triple vaccine) were issued in batches, of which group A and group C meningococcal polysaccharide vaccines were issued in batches in the whole year, accounting for about 69.1% of the total number of meningococcal vaccines Group a and group C meningococcal polysaccharide conjugate vaccines were the second largest meningococcal vaccine Last year, 7.91 million doses were issued in batches, accounting for 12.4%, In addition, group A Meningococcal polysaccharide vaccine and AC Hib triple vaccine were all about 4 million doses, and group acyw135 meningococcal polysaccharide vaccine had 3.38 million batches with the least amount (4) rabies vaccine for human use: the second generation is the main generation, and the largest in the world 1 Overview of rabies vaccine for human use industry China is one of the countries with high incidence of rabies, ranking the second in the world (only next to India); according to the data disclosed by the National Health Commission, from 2017 to 2018, China had 516 cases of rabies and 422 cases of rabies, 502 and 410 cases of deaths, with a mortality rate of 97% Rabies vaccination is the only effective way to prevent and control rabies < br / > according to the matrix of cell culture, there are four kinds of rabies vaccines listed in China, which are human rabies vaccine (chicken embryo cell), human rabies vaccine (hamster kidney cell), human rabies vaccine (Vero cell) and human rabies vaccine (human diploid cell) The safety and immune effect of the four kinds of vaccines are better, which are mainly different in production cost and vaccination cost per person, The antibody response of human diploid cell vaccine is faster and better than other three vaccines < br / > 2 The distribution pattern and market competition of rabies vaccine batches < br / > in recent years, the total number of domestic rabies vaccine batches is maintained at 60-80 million, i.e 12-16 million (4-5 stitches / person) per year, and about 55.66 million of all kinds of rabies vaccines are issued in 2019 in China Among them, 49.89 million doses of Vero cell rabies vaccine (water needle and freeze-dried) were approved and issued, with a market share of 89.6%; 3.45 million doses of hamster kidney cell rabies vaccine were approved and issued, with a market share of 6.2%; only Chengdu Kanghua of China was approved and issued for production of human diploid cell rabies vaccine, with a market share of 4.2%; two foreign enterprises imported the chicken embryo cell rabies vaccine, There is no import batch issued in 2019 < br / > at present, there are more than 10 enterprises (including two imports) producing rabies vaccine in China, and Chengda biology is the only one, accounting for 67.6% of the total number of rabies vaccine batches in 2019 Vero cell rabies vaccine has the largest number of manufacturers In 2019, six enterprises including adult biology issued the production batch; hamster kidney cell rabies vaccine was produced by Henan Yuanda and Zhongke biology; currently, human diploid cell rabies vaccine is only produced exclusively by Chengdu Kanghua, Subsequently, there are clinical trials of minhai biology, Zhejiang Pukang and Chengda biology under Kangtai < br / > (V) cervical cancer vaccine (HPV vaccine): batch
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