On December 31, 2019, the State Drug Administration announced that it approved the listing registration application of bivalent human papillomavirus vaccine (E. coli) (trade name: cecolin) of Xiamen Wantai Canghai Biotechnology Co., Ltd. (hereinafter referred to as Wantai).
It is understood that the vaccine is the first cervical cancer vaccine independently developed by China jointly developed by Wantai company and Xiamen University and transformed by Wantai. It will become the third cervical cancer vaccine in the world and the first approved cervical cancer vaccine in China, which means that China's cervical cancer vaccine will end the history of relying on import.
The reporter noted that the instructions of Wantai HPV vaccine show that vaccinators aged 9 to 14 only need to vaccinate Wantai HPV vaccine twice to complete the whole vaccination course. This is the first time that the two needle method of cervical cancer vaccine has been approved in China.
At present, the imported HPV vaccine has not been approved by the two needle method in China. " There is no Chinese data in the description of imported vaccine that two doses of vaccine can be given to the 9-14-year-old group. " Wei Lihui, director of Obstetrics and Gynecology of the people's Hospital of Peking University, vice chairman of the society of Obstetrics and Gynecology of the Chinese Medical Association and honorary director of the Department of Obstetrics and Gynecology of Peking University, told the Securities Daily that Wantai HPV vaccine was found after seven months of follow-up of 975 bridging clinical trial volunteers, The effect of two injections in half a year for those aged 9 to 14 is the same as that of three injections at an older age.
The earlier the vaccination, the better the preventive effect
Cervical cancer vaccine, also known as HPV vaccine, is a vaccine to prevent cervical cancer. Cervical cancer is mainly caused by infection with human papillomavirus (HPV). The vaccine effectively prevents the related cervical precancerous lesions and cervical cancer by preventing the infection of HPV subtypes covered by the vaccine. The study found that 99.7% of cervical cancer is caused by infection with HPV, and HPV can also cause other relatively rare cancers, such as laryngeal cancer, lung cancer and anal cancer.
It is understood that there are more than 100 known types of HPV viruses, of which at least 14 genotypes (called 'high-risk type') are considered to cause cervical cancer. Bivalent HPV vaccine has a protective effect on two high-risk types (HPV-16 and HPV-18), which cause 84.5% of cervical cancer in Chinese population.
Before Wantai HPV vaccine was officially approved, only GlaxoSmithKline's bivalent vaccine and Merck's tetravalent and jiuvalent vaccines were listed in the world.
According to insiders, for the Chinese people, the protection rate of two prices is 84.5% and that of nine prices is 90%. In fact, there is not much difference. The World Health Organization also clearly pointed out in 2017: "the existing evidence shows that from the perspective of public health, there is no difference in immunogenicity, efficacy and effect of bivalent, tetravalent and jiuvalent vaccines in preventing HPV related cervical cancer of types 16 and 18. All three vaccines can prevent most related cancers."
It is worth mentioning that the applicable age of bivalent HPV vaccine on the domestic market is 9 to 45 years old; The applicable population of nine valent HPV vaccine is women aged 16-26 years; The age of application of tetravalent HPV vaccine is 20 to 45 years old.
In the opinion of experts, the earlier the vaccination, the better the preventive effect. The results of HPV epidemiological studies in China show that the HPV infection rate in the age group from 15 to 19 years old has been as high as 30.55%. Therefore, HPV vaccination is best before women's first substantive contact. " The existing HPV vaccines at home and abroad have no therapeutic effect on people who have been infected with HPV. Therefore, blindly pursuing the nine valent vaccine will miss the opportunity of vaccine prevention because they are infected during the waiting period. " Some experts said.
Protection rate attracts attention
In 2012, under the leadership of Professor Qiao Youlin, director of Epidemiology Research Office of Cancer Hospital of Chinese Academy of Medical Sciences, Wantai started the multi center phase III clinical trial of HPV vaccine.
In an interview with Securities Daily, Qiao Youlin said that the domestic vaccine has good safety and immunogenicity in women aged 9 to 45. Among women aged 18 to 45, the domestic vaccine has the same effectiveness as Merck and GlaxoSmithKline vaccine in preventing HPV16 / 18 related precancerous changes and persistent infection. China has thus become the third country in the world to successfully develop and produce HPV vaccine after the United States and Britain.
According to the clinical trial analysis report, the vaccine is effective in preventing HPV16 / 18 related precancerous lesions, The protection rate (95% confidence interval) reached 100% (55.6-100), which was higher than or equal to other tetravalent and bivalent HPV vaccines; in terms of the efficacy of preventing HPV16 / 18 6-month persistent infection, the protection rate (95% confidence interval) reached 97.8% (87.1-99.9), which was higher than or equal to foreign bivalent and tetravalent vaccines. The adverse reaction of Wantai bivalent cervical cancer vaccine was mild.
There is a market gap of more than 1 billion
According to media reports, since the first HPV vaccine was launched in 2006, the cumulative sales of HPV vaccine has been about 350 million. At present, the annual demand is increasing day by day, and the global demand is about 100 million pieces a year. However, the world's annual supply capacity is only 30 million doses, about one third of the total demand. There are also repeated situations in China where it is difficult to obtain an injection and Yaohao injection.
At present, about 356 million people in China need HPV vaccine. However, according to the statistics of China Institute for food and drug control, in 2017, China issued 1.46 million HPV vaccines; 7 million in 2018; There are 8.7 million tubes from January to November 2019. According to the calculation that one person needs three needles to complete the whole process, there is still a huge market gap of more than 1 billion tubes to be met.
On the other hand, the price of imported HPV vaccine is generally high. For example, the whole process cost of nine valent vaccine is about 4000 yuan, while that of imported two valent vaccine is about 2000 yuan. The high price excludes a large part of Chinese women who need vaccination, and those who want vaccination can't afford it.
Qiao Youlin said: 'the director general of the World Health Organization put forward the strategic goal of global elimination of cervical cancer at the 2018 World Health Assembly. By 2030, 90% of girls aged 9-14 in the world need to be vaccinated against HPV. " Wantai HPV vaccine has the same efficacy and good safety as imported vaccines, but it has advantages in price and output, which will greatly improve the popularity of cervical cancer vaccination. It also makes the WHO global plan to eliminate cervical cancer possible.
According to Wantai, the price of its HPV vaccine is set at 329 yuan / injection, 658 yuan for the whole process from 9 to 14 years old and 987 yuan for older people, half of the price of imported bivalent vaccine.