Recently, the National Health Commission said that the mainland will promote the pilot first, encourage qualified areas to actively adopt a variety of financing models, and gradually carry out human papillomavirus vaccine, that is, HPV vaccine free vaccination.
In fact, since the second half of 2021, many provinces and cities across the country have gradually promoted the universal vaccination strategy, free or subsidized vaccination plan for women of appropriate age. In the future, the mainland will fully support the Global Strategy for Accelerating the Elimination of Cervical Cancer proposed by the World Health Organization, which clearly states that by 2030, the goal of 90% of girls in the world to complete HPV vaccination by the age of 15 will be achieved.
According to the statistics of the 21st Century Business Herald reporter, there are 4 kinds of HPV vaccines approved for marketing in the mainland, namely the bivalent vaccine of Xiamen Wantai in the mainland, the bivalent vaccine of GlaxoSmithKline in the United Kingdom, and the quadrivalent vaccine and the nine-valent vaccine of Merck in the United States, of which the nine-valent vaccine is "difficult to find".
However, Wang Mei, chief physician of the Gynecology Department of the Third Hospital of Shenzhen, told the 21st Century Business Herald that in fact, China is not only lacking in nine-valent, but also bivalent and quadrivalent vaccines. Qiao Youlin, a professor at the School of Medicine and Public Health of the Chinese Academy of Medical Sciences and Peking Union Medical College, also pointed out that the main virus types that cause cervical cancer are type 16 and 18, and bivalent vaccine can be effectively protected. "So the sooner the smaller the better, don't wait."
Xie Yang, head of the Health Economy and Real World Research In Greater China, also said that there are currently about 280 million people of 16-45 age-appropriate age in mainland China, and if calculated according to the coverage rate of 10% to 20%, the demand is 170 million to 260 million, which is a huge gap.
Pilot free vaccination in many places
According to statistics, more than 80% of women have at least one HPV infection in their lifetime, and it is now clear that more than 99% of cervical cancer is related to persistent HPV infection. The HPV virus is transmitted mainly through direct contact and sexual activity. In addition, early marriage, early childbearing, multiple sexual partners, smoking, etc. are all risk factors that trigger cervical cancer.
The National Health Commission said that the mainland will fully support the "Global Strategy for Accelerating the Elimination of Cervical Cancer" proposed by the World Health Organization, which clearly states that by 2030, 90% of girls in the world will complete HPV vaccination before the age of 15, and promote the global goal of eliminating cervical cancer through three-level prevention and treatment paths such as vaccination, screening and treatment.
However, hpv vaccination rates for girls of school age on the mainland are less than 1%. "If the vaccine problem can be solved, and screening and early treatment can be achieved, the elimination of cervical cancer in the future is very promising." Wang Mei told the 21st Century Business Herald reporter.
It is worth noting that the National Health Commission recently also said that the mainland will promote the pilot first, encourage qualified areas to actively adopt a variety of financing models, and gradually carry out human papillomavirus vaccine, that is, HPV vaccine free vaccination.
In fact, since the second half of 2021, many provinces and cities across the country have gradually promoted the universal HPV vaccination strategy, free or subsidized vaccination plan for women of the right age, such as Guangdong Province, Jiangsu Lianyungang, Inner Mongolia Ordos, Shandong Jinan, Fujian Xiamen and other provinces and cities have successively launched HPV vaccine free or subsidized vaccination plans.
It is understood that the Guangdong Provincial Finance Plan will add about 600 million yuan for free HPV vaccination in 2022-2024, and in accordance with the principle of informed and voluntary, from 2022 onwards, girls under the age of 14 who have a school registration in Guangdong Province and have newly entered the first grade of junior high school since September and have not been vaccinated with HPV vaccine will be vaccinated free of charge. After comprehensive evaluation, the vaccination was based on the domestic bivalent HPV vaccine, and a total of two injections were administered.
In December 2021, Jiangsu Province issued the "14th Five-Year Plan" Development Plan for Women and Children, especially proposing to "encourage qualified areas to promote HPV vaccination with the focus on girls aged 9-15 in school". On December 21, the free HPV vaccination of school-age girls in Lianyungang City, Jiangsu Province, was fully launched, and the pilot project was for girls in the eighth grade of Lianyun District.
In November 2021, as one of the first 15 healthy Chinese pilot cities, Jinan launched a free HPV vaccine for school-age girls, targeting girls under the age of 15 who are in the seventh grade of school, and the vaccine is the domestic bivalent HPV vaccine.
In 2021, Ordos City, Inner Mongolia launched a free vaccination of bivalent cervical cancer vaccine for women aged 13 to 18 years old. According to official data, as of the end of June, the city of Ordos had received 15,000 doses, with a target population vaccination rate of 31%.
In addition, Chengdu will follow the principle of "informed consent, independent choice, and voluntary vaccination" to universally vaccinate female students aged 13 to 14 in Chengdu. Parents (guardians) of students can choose between domestic/imported bivalent and imported quadrivalent HPV vaccines independently, and the vaccination subsidy of 600 yuan / person will be given by financial funds, and the difference in vaccine fees and vaccination service fees (20 yuan / dose) after subsidies shall be borne by the parents (guardians) of the recipients.
It is worth noting that at a press conference held by the Shanghai Women's Federation recently, it was revealed that the Shanghai Women's Federation will submit a proposal at the upcoming "two sessions" of the city this year: free HPV vaccination for girls aged 9-15 in the city. Starting from this year, it is expected that by 2030, the full HPV vaccination rate of female adolescents aged 12-18 in Shanghai will reach more than 90%, achieving the World Health Organization's global HPV vaccination target.
The vaccine market demand is huge
According to the statistics of the 21st Century Business Herald reporter, there are 4 hpvage vaccines approved for marketing in the mainland, namely the bivalent vaccine of Xiamen Wantai in the mainland, the bivalent vaccine of GlaxoSmithKline in the United Kingdom, and the quadrivalent vaccine and the nine-valent vaccine of Merck in the United States. Among them, the bivalent HPV vaccine can prevent high-risk types 16 and 18 viruses; the quadrivalent HPV vaccine adds the prevention of type 6 and type 11 viruses on the basis of bivalent; and the nine-valent HPV can prevent 9 subtypes of HPV viruses.
In terms of vaccination age, bivalent applies to women aged 9 to 45 years, quadrivalent applies to women aged 20 to 45, and nine-valent applies to women aged 16 to 26. However, because the nine-valent vaccine covers more subtypes of the virus, many young women prefer the nine-valent vaccine.
At present, there is a large gap in hpvage vaccines in mainland China. Taking the nine-valent as an example, the National Bureau of Statistics earlier data showed that the age-appropriate population (16-26 years old) of the nine-valent HPV vaccine is about 120 million. According to the data released by Zhifei Bio (the exclusive agent of Merck's nine-valent HPV vaccine in China), the annual batch issuance volume of the domestic Merck nine-valent HPV vaccine in 2019 was 3.324 million, and only 5.066 million in 2020.
According to data from the Central People's Procuratorate, the number of HPV vaccines issued in mainland China was 1.46 million in 2017, 7.13 million in 2018, and 10.8754 million in 2019. In the whole year of 2020, a total of 15.43 million HPV vaccines were approved, of which about 7.22 million and 500,000 were issued in the fourth and ninth price batches, respectively, with a year-on-year increase of 36% and 52% respectively.
Xie Yang introduced that at present, there are about 280 million people of the right age between 16 and 45 years old in the mainland, and if calculated according to the coverage rate of 10% to 20%, the demand is 170 million to 260 million. As a result, the current gap is enormous.
Frost & Sullivan pointed out that the size of China's HPV vaccine market will increase to 13.1 billion yuan in 2020, and is expected to reach 69 billion yuan by 2030, with a compound annual growth rate of 18.0% from 2020 to 2030, of which HPV nine-valent vaccine will have the largest market share in the HPV vaccine market in 2030.
It is worth noting that at present, many provinces and cities in the mainland have piloted the promotion of free or subsidized HPV vaccines for women of appropriate age, which will benefit domestic bivalent vaccines. The price advantage of Wantai Biological Bivalent Vaccine Xinkenin is obvious, and the total cost of vaccinated 9 to 14-year-olds is 658 yuan, and the total cost of vaccinated 15-45-year-olds is 987 yuan; in contrast, the total cost of GlaxoSmithKline bivalent vaccination is 1740 yuan, and the total cost of VACcination of Merck Quadrivalent and 9-valent Vaccines is 2394 and 3894 yuan.
In addition, many experts on the mainland pointed out that HPV vaccination should be minimized as soon as possible. Among them, the nine-valent vaccine is suitable for the age group of 16 to 26 years old, while the bivalent vaccine is suitable for the age group of 9 to 45 years old, which can cover more young people.
Domestic enterprises R & D racing
As the only domestic HPV vaccine on the market, "Xinkoning" was jointly developed by Wantai Canghai and Xiamen University, with a unit price of 329 yuan, compared with GSK's divalent HPV vaccine of nearly 600 yuan.
According to the annual report, the operating income of Wantai Bio in 2020 was 2.354 billion yuan, an increase of 98.88% over 2019, and the net profit attributable to the shareholders of the listed company was 677 million yuan, an increase of 224.13% over the year-on-year increase of 2019.
Wantai Bio said that the increase in operating income is mainly due to the new revenue of the bivalent cervical cancer vaccine, as well as the sales of new coronavirus reagents and the new GSK technical cooperation revenue. Among them, "Xinkening" has achieved sales revenue of about 693 million yuan since it was officially put into the market, which has become one of the main reasons for the substantial growth of Wantai Bio's performance in 2020.
In addition, on October 17, 2021, Xiamen Wantai, a wholly-owned subsidiary of Wantai Biologics, received an official letter from the World Health Organization (WHO) confirming that its divalent human papillomavirus vaccine Xinkoning passed the WHO pre-certification (WHO PQ certification), which means that overseas markets are expected to be opened in the future.
It is understood that the actual procurement of wantai biological bivalent HPV vaccine in 2020 is about 2.07 million. In the future, with the pilot of HPV free vaccination in many places, the market potential of domestic divalent HPV vaccine will be further expanded. In terms of production capacity, Wantai Bio once told investors that the annual production capacity of the bivalent HPV vaccine is 10 million copies, and it is expected to expand to 30 million copies in the future.
However, from a global perspective, it is a major trend for high-priced vaccines to replace low-priced vaccines. It is reported that after the listing of the nine-valent HPV vaccine in 2018, the proportion of the quartileal vaccine batch issuance that originally accounted for the majority of the market decreased year by year, accounting for 44.02% in 2020; and the market share of the nine-valent vaccine increased all the way, from 17.06% in the first year of listing to 56.36%, accounting for half of the HPV vaccine.
Wantai Bio also said in its annual report that the company's nine-valent cervical cancer vaccine is undergoing phase III clinical trials, and is one of the first companies in China to enter phase III clinical trials of nine-valent cervical cancer vaccines. According to the annual report, the company's research and development expenses for the nine-valent HPV vaccine in 2020 reached 78.67 million yuan, an increase of 263.92% year-on-year. According to industry experience, if Wantai Bio's nine-valent vaccine can be successfully approved for listing, it will not be until 2024 at the earliest.
The market is also optimistic about Wantai Biology. It is reported that in April 2020, Wantai Bio landed on A shares, and the stock price rose by 44% on the first day of listing, corresponding to a total market value of 5.463 billion yuan. As of January 18, 2022, the total market value of Wantai Biotech was nearly 140 billion yuan.
In addition, Merck is also actively expanding its indications. At the fourth CIIE, Merck China President Anna Tian told the 21st Century Business Herald that as of September 2021, the HPV vaccine has benefited nearly 14 million Chinese women of appropriate age, and we will continue to invest heavily in research and development innovation in the future to expand the indications for HPV vaccines and benefit more age groups in need. In addition, Merck recently launched a Phase 3 clinical trial for the first time in China to evaluate the protective efficacy, immunogenicity and safety of the nine-valent human papillomavirus vaccine (JiadaXiu 9) in Chinese men, and plans to enroll 8100 people.
Currently, Zhifei Bio is the exclusive agent of Merck quadrivalent and nine-valent HPV vaccines. According to the annual report, in 2020, the batch issuance of 9-valent HPV vaccines by Zhifei Biological Agent reached 5.07 million bottles, and the batch issuance of quadrivalent HPV vaccines reached 7.22 million bottles; the revenue from agent products reached 13.955 billion yuan, accounting for 91.86% of the revenue structure, an increase of 51.88% year-on-year.
At present, the huge stock of HPV vaccine market in mainland China is triggering a new round of research and development competition for pharmaceutical companies.
According to the China Commercial Industry Research Institute, in the field of 9-valent vaccines, bowei biology, connaught guard and Wantai biology have entered the third phase of clinical stage. In the field of 4-valent vaccines, there are three products that are clinically carried out. At present, the fastest progress is the products of Beijing and Chengdu Institute of Biological Products, which have entered the third phase. In the field of 2-valent vaccines, in addition to Wantai Biologics, Shanghai Zerun's layout of HPV vaccines has progressed the fastest, and it has reached the approval stage and is about to enter the commercialization stage. At the same time, in order to cope with competition, some domestic companies have focused on higher-priced HPV vaccine products. The 11-valent HPV vaccine developed by China Biology Institute has entered the clinical phase 2 stage, and the 16-valent HPV vaccine under research by Zhejiang Pukang has been in the clinical phase 1 stage.