On November 4, on the occasion of the second anniversary of the approval of the first domestic HPV vaccine, a number of breakthroughs in domestic HPV vaccine came one after another.
Xinkening (HPV Bivalent,Cecolin), the first domestic personal papillomavirus (HPV) vaccine developed by Xiamen University in conjunction with Wantai Biology, has officially passed the pre-certification (WHO Prequalification) of the World Health Organization (WHO) and is included in the procurement scope of the United Nations system, which indicates that the supervision, development and production system and product quality of Chinese vaccine products have once again been widely recognized in the world.
Industry insiders said that the domestic HPV vaccine product Xinkening through World Health Organization (WHO) pre-certification is an important event of milestone significance in the industry, which will make up for the gap in the shortage of HPV vaccine supply, indicating that more people can get safe and effective vaccines, especially women and girls in less developed areas, will stay away from the pain caused by cervical cancer.
Another good news is that so far, Wantai domestic HPV vaccine has covered CDC (Centers for Disease Control and Prevention) in 2453 districts and counties across the country, with a coverage rate of more than 85% (CDC in about 2880 districts and counties across the country). At the same time, there are 16 kinds of HPV vaccines in China, the 4-valent HPV vaccines of Chengdu Institute of Biological products and Bowei Biological, and the 9-valent HPV vaccines of Wantai Biological, Bowei Biological, Leisure Guardian and Ruike Biology are all in III phase. Among them, Xiamen University in conjunction with Wantai Biological based on structural Vaccine Technology, the world's first third-generation cervical cancer vaccine (20 price) is also under research and development, and the protection rate is expected to reach more than 99%.
The successful industrialization of the first domestic cervical cancer vaccine will benefit China's vaccine industry to a new level, realize the expansion and strength of China's independent innovative vaccine products, and promote the sustainable development of independent innovative pharmaceutical products.
Domestic vaccine "breaks the circle", China's first HPV vaccine has been certified by WHO PQ
At present, only four kinds of HPV vaccines have been successfully developed and listed in the world, including bivalent vaccine developed by British GlaxoSmithKline PLC (GlaxoSmithKline) company, tetravalent vaccine and nine-valent vaccine developed by American Merck & Co Inc (MSD) company, which were launched in 2007, 2006 and 2014 respectively.
Wantaixinkening, China's first domestic HPV vaccine, was approved for market in December 2019 and passed World Health Organization (WHO) pre-certification (WHO PQ) in October this year. Being able to pass the examination of WHO international first-class standards indicates that Wantai's vaccine development, production process level, product quality and other dimensions are in line with international standards. In the future, the road of domestic HPV vaccine in the international market will be wider and smoother.
WHO PQ certification is a prequalification provided by WHO to the United Nations Children's Fund and other United Nations vaccine procurement agencies. Certification is to ensure that vaccines used for EPI are safe and effective, so that more people can receive safe, effective and high-quality vaccines.
Since 2016, Wantai has been supported by PATH in many aspects, such as the improvement of quality system, clinical and regulatory compliance, and the construction of drug warning system. The Bill and Melinda Gates Foundation provides financial support for these efforts.
On September 6, 2019, Xiamen Wantai (Innovax) signed a cooperation agreement with global vaccine giant GlaxoSmithKline PLC (GSK), announcing that the two sides will jointly develop a new generation of human papillomavirus (HPV) vaccine based on Xiamen Wantai's innovative antigen technology and GSK's adjuvant system, indicating that China's key core technology of vaccine has been highly recognized by its international counterparts. It is also a representative event for China-EU pharmaceutical circles to promote win-win cooperation.
Xinkening vaccine was jointly developed by Xiamen Wantai and Xiamen University. Xiamen Wantai is an innovative vaccine enterprise integrating R & D, production and sales. Through cooperation with the National Infectious Disease Diagnostic Reagent and Vaccine Engineering Technology Research Center (NIDVD) of Xiamen University, a vaccine innovation research and development platform was created. At the technical level, domestic HPV vaccine has created an original Escherichia coli virion vaccine technology system, opened up a new way of genetic engineering vaccine, and has 18 international and domestic invention patents.
Based on this platform technology, Xiamen Wantai previously developed Hecolin, the only hepatitis E vaccine approved for commercialization in the world, completely reversing the international academic perception that prokaryotic systems cannot be used in the development of virus vaccines. At the same time, the key technologies have applied for 12 invention patents in 14 major countries. Yikoning, the world's first hepatitis E vaccine, was launched in China in October 2012.
The clinical protection rate of domestic HPV vaccine is 100%. Experts call for early vaccination.
On May 18, 2020, Keke, a 10-year-old girl in Wuhan, was vaccinated with domestic HPV vaccine Xinkening R in Hubei Maternal and Child Health Hospital, becoming the first batch of domestic HPV vaccine vaccinators. Coco's mother, Ms. Peng, a 44-year-old obstetrician, was also vaccinated.
Before deciding to vaccinate herself and her children with home-made HPV vaccines, Ms. Peng carefully studied the differences among bivalent, tetravalent and nine-valent HPV vaccines. It is understood that at present, each dose of domestic bivalent vaccine is priced at 329 yuan, while the cost of one dose of imported bivalent vaccine is from 580 yuan. However, from the comparison of the protection rate and other aspects, the domestic vaccine is not inferior to the foreign vaccine.
According to the analysis report of clinical trials, the protection rates of GlaxoSmithKline PLC bivalent vaccine, Merck & Co Inc tetravalent vaccine and domestic Xinkening bivalent vaccine in preventing precancerous lesions associated with HPV16/ 18 were 87.3%, 32.3100 and 55.7100 respectively.
In the prevention of 6-month persistent infection of HPV16/ 18, the protection rates of xinkening bivalent vaccine, GlaxoSmithKline PLC bivalent vaccine and Merck & Co Inc tetravalent vaccine were 97.7% (86.2-99.9), 96.8% (88.0-99.6) and 75.9% (43.5-91.1), respectively.
Before the domestic HPV vaccine was put on the market, there were only two imported bivalent, tetravalent and nine-valent HPV vaccines produced by Merck & Co Inc of the United States and GlaxoSmithKline PLC of the United Kingdom. There is a huge gap between the HPV vaccine and the actual demand of women of the right age because of the long-term insufficient supply and high pricing.
Before Xinkening was approved, among the three imported HPV vaccines listed in China, bivalent HPV vaccines were suitable for women aged 9-45 years old, while tetravalent and nine-valent HPV vaccines were suitable for women aged 20-45 and 16-26 years old, respectively. However, at present, there is a large gap in the vaccine, and many women of the right age say that "it is difficult to get an injection."
Many people pursue "high-priced" vaccines. In fact, for HPV vaccines, early vaccination is more noteworthy than the price. Professionals believe that HPV vaccination is beneficial as soon as possible. A study in the Lancet medical journal shows that young women who receive an earlier bivalent cervical cancer vaccine can reduce their risk of cervical cancer by up to 87% compared with those who are not vaccinated between the ages of 20 and 30. Some experts in China have also called on everyone to be vaccinated as soon as possible, especially girls between the ages of 9 and 14, rather than waiting for high-priced vaccines.
Two years ago, in December 2019, the application for registration of bivalent human papillomavirus vaccine "Xinkening" jointly developed by Xiamen Wantai and Xiamen University was formally approved by the State Drug Administration, becoming the first domestic cervical cancer vaccine approved. And in May 2020 in China officially listed for sale.
With Xinkening approved to go on the market, the domestic market monopolized by imported HPV vaccines ushered in vaccine products from local companies. Now, it has passed the World Health Organization (WHO) pre-certification, which can be purchased by the United Nations system, and is expected to alleviate the global shortage of HPV vaccine supply.
Domestic bivalent HPV vaccine was jointly developed by Xiamen Wantai and Xiamen University for 18 years. As an innovative vaccine product, Xinkening has its own intellectual property rights. Studies have shown that there are more than 200 known HPV viruses in the world, of which at least 14 are high-risk types, which are thought to cause about 99.7% of cervical cancer. 84.5% of cervical cancer in the Chinese population is caused by two high-risk types, HPV16 and HPV18. This is also the reason why the first domestic HPV vaccine was developed specifically for HPV16 and HPV18.
Domestic HPV vaccine is in the leading position in the world in preventing precancerous lesions and persistent infection of HPV16 and HPV18. It is reported that the phase III clinical trial data of Xinkening, China's first HPV vaccine, are based on samples of more than 7000 people in five provinces in China. Not only the sample size is large, but also the data are more localized. The protection rate against precancerous lesions associated with HPV16/ 18 has reached 100%, which is a remarkable achievement in the vaccine community in China.
China is taking action to eliminate cervical cancer
"Cervical cancer means death for many women, but it's not supposed to be. Fortunately, the human papillomavirus vaccine can significantly reduce the number of cases and put the world on track to eradicate this deadly disease. " Trevor Mondale, president of the global health program at the Bill and Melinda Gates Foundation.
HPV (human papillomavirus) is mainly transmitted through sexual behavior, and persistent infection of high-risk HPV can cause cervical cancer. Cervical cancer is the third highest incidence of cancer among women aged 15-44, with more than 85% of cases occurring in developing countries. It is estimated that in 2020, there were 110000 new cases of cervical cancer and nearly 60, 000 deaths in China. The age of onset is getting younger, and the economic and psychological burden on women can not be ignored.
Cervical cancer, in particular, occurs in women in less developed areas. Data show that 85% of the world's cases occur in low-and middle-income countries, with sub-Saharan Africa and Asia having the highest incidence. According to the World Health Organization's Global Strategy for the accelerated Eradication of Cervical Cancer, the 194 member countries that have pledged to join the strategy, including China, will vaccinate 90 per cent of girls by 2030 against HPV by the age of 15.
On November 17, 2020, WHO launched a global strategy to accelerate the elimination of cervical cancer, highlighting three key measures to eliminate cervical cancer, including cervical cancer vaccination. Cervical cancer is the only cancer that can be prevented by vaccination. Vaccination and regular screening are necessary measures to prevent cervical cancer.
China has taken active action to eliminate cervical cancer. Up to now, domestic HPV vaccines have covered CDC (Centers for Disease Control and Prevention) in 2453 districts and counties across the country, with a coverage rate of more than 85% (CDC in about 2880 districts and counties). At present, free HPV vaccination has been implemented in cities such as Ordos in Inner Mongolia, Xiamen in Fujian and Jinan in Shandong Province. Guangdong Province recently announced that it will give free vaccination to girls under the age of 14 from next year. However, industry insiders also expressed concern that the vaccination situation of HPV vaccine in China is still not optimistic. It is understood that since the HPV vaccine was put on the market in China, a total of 34.8907 million have been issued, corresponding to 11.63 million vaccinations. the vaccination rate is only 3.2 per cent (380 million people aged 9-45 years old), of which the vaccination rate of 9-14 years old is less than 1 per cent. In 2018, the vaccination rate of the age-appropriate population in the United States, Australia, the United Kingdom and other developed countries has reached 60%, 80%.
Experts call for strengthening the education and popularization of HPV vaccine and promoting the attention of school-age students and parents through the linkage of hospitals, communities and schools. In the next few years, with the launch of more domestic HPV vaccines and the gradual inclusion of them in free vaccination programs in conditional areas, the process of prevention and treatment of cervical cancer in China is expected to accelerate.
On April 10 this year, Wantai and the China Women's Foundation donated 5000 doses of domestic HPV vaccine to the Jiangxi Women's and Children's Foundation to help the local grass-roots cervical cancer prevention and treatment work. In June 2020, at the Global Vaccine Summit of the Global Alliance for Vaccines and Immunization (GAVI) for the next five years, Wantai pledged to fully support the HPV vaccine promotion program, which benefits 84 million 9-year-old and 13-year-old women around the world, after passing the WHO pre-certification, to help accelerate the elimination of cervical cancer and contribute to China.
Wang Hao / Wen