HPV vaccine marketed
At present, there are three types of HPV vaccines that have been marketed globally. They are the bivalent vaccines for HPV16 and 18 produced by GlaxoSmithKline in the United Kingdom, and the four-valent vaccines for HPV6, 11, 16, and 18 produced by Merck in the United States. Nine-valent vaccine against HPV6, 11, 16, 18, 31, 33, 45, 52, 58 types.
Bivalent four-valent nine-valent vaccine
What's the difference?
Different valence vaccines have different coverage for cervical cancer vaccines. Among them, bivalent vaccines prevent HPV16 and 18 high-risk types, which can prevent about 70-80% of cervical cancers; tetravalent vaccines are in bivalent vaccines. In addition, two low-risk types of HPV that can cause genital warts were added, while the nine-valent vaccine added another five high-risk types of HPV, which could prevent about 90% of cervical cancer and about 90% of genital warts.
Taiwan Straits Network January 1 According to Xiamen Daily, the cervical cancer vaccine developed by Xiamen University researchers for 18 years has been approved for marketing. This is also the first domestically produced cervical cancer vaccine in China.
The State Drug Administration released news yesterday that the State Drug Administration approved the listing of Xiamen Wantai Canghai Biotechnology Co., Ltd.'s bivalent human papilloma virus vaccine (E. coli) [brand name: Xinconing (Cecolin)] Application, this is the first domestic papillomavirus vaccine approved for women aged 9-45.
However, it is unclear how much domestic cervical cancer vaccines will be priced.
The vaccine was jointly developed by Xiamen University's National Infectious Disease Diagnostic Reagent and Vaccine Engineering Technology Research Center and Xiamen Wantai Canghai Biotechnology Co., Ltd., which is a subsidiary of Yangshengtang Co., Ltd., that is, after the completion of the laboratory at Xiamen University, Xiamen Wantai is responsible for technology conversion into products.
9 to 14 year olds need only two shots
One shot less than similar vaccines abroad
The human papilloma virus (HPV) vaccine, commonly known as the cervical cancer vaccine, can be used to prevent cervical cancer in women, male and female genital cancer, and genital warts.
This time the Xiamen-approved bivalent human papilloma virus vaccine (E. coli) was approved as the first HPV vaccine to be produced in China. It is targeted at HPV16 and 18 types, that is, a bivalent vaccine, and was completed with the continuous support of the national major new drug creation project. R & D and industrial transformation. The State Food and Drug Administration has incorporated it into priority review categories in accordance with relevant regulations such as the "Announcement on Optimizing the Issues Related to the Review and Approval of Drug Registration", and hastened the approval of its application for listing registration.
The team of Xiamen University National Infectious Disease Diagnostic Reagent and Vaccine Engineering Technology Research Center, led by Professor Xia Ningshao, started the development of cervical cancer vaccine in 2002, that is, the first domestically produced cervical cancer vaccine took 18 years.
According to reports, compared with foreign cervical cancer bivalent vaccines, Xiamen-derived cervical cancer vaccines only require two shots for people aged 9 to 14, and foreign-made cervical cancer bivalent vaccines require three shots.
Researchers said that after being approved for listing registration, they can be put into production immediately. However, the products produced must be tested before they can be put on the market.
It is currently estimated that the first domestic cervical cancer vaccine will be available in the first half of this year.
Nine-valent cervical cancer vaccine developed by the team
Approved for Phase II clinical trial
Xia Ningshao's team also revealed that the second-generation cervical cancer vaccine developed by the team has been clinically approved in 2017 and is currently undergoing a phase II clinical trial, which the industry calls a "nine-valent cervical cancer vaccine." The second generation is relative to the first generation of bivalent and tetravalent vaccines.
This is also the world's second second-generation cervical cancer vaccine. The world's first second-generation cervical cancer vaccine was developed by Merck Company in the United States and has been approved for marketing in 2015.
Clinical trials generally take four to five years, which means that domestically produced second-generation cervical cancer vaccines are expected to be available as early as 2023.
Cervical cancer is the second leading killer of cancer in women worldwide. According to statistics, there are 130,000 new cases of cervical cancer in China every year, and about 20,000 to 30,000 women die of cervical cancer each year. Almost all cervical cancers are caused by human papillomavirus (HPV) infection. In addition to cervical cancer, HPV infection is also associated with a variety of external genital cancers or skin diseases. (Reporter 佘 峥)