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According to the ICO Information Center on HPV and Cancer's 2019 work report, there are about 570,000 new cases of cervical cancer and 311,000 deaths worldwide each year, the third highest cancer among women in the world and the second highest among women aged 15-44.
years, the incidence and mortality rate of cervical cancer in China has been on the rise, with nearly 110,000 new cases and nearly 50,000 deaths in 2018.
of studies have shown that cervical cancer is caused by a persistent infection of the human papillomavirus (HPV), and HPV can be detected in almost all cases of cervical cancer.
clinical outcomes of persistent HPV infection include cervical and precanceral lesions, other genital tumors and precanceroid injuries, genital warts and respiratory multiple papilloma disease, which create a significant socio-economic burden.
HPV vaccine is considered to be the most effective way to prevent HPV infection, and it is of great significance to prevent HPV infection effectively through preventive vaccination.
announced that the company developed recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-price vaccine (E. coli) for new cervical cancer Vaccine, the vaccine for the first time in the world successfully applied the E. coli expression system to the nine-price cervical cancer vaccine, established a new HPV vaccine antigen expression, purification process, can be competitive cost advantage to produce a good immunogenicity and can induce high titration neutral antibody vaccine.
the vaccine was approved for Phase I, II, and III clinical trials of this product on November 6, 2017 by the State Food and Drug Administration.
This product was launched in 2019 with the aim of initially evaluating the safety and immunogenicity of vaccines in humans, and clinical trial results support the continuation of Phase III clinical studies in larger populations in accordance with the registration process to further evaluate the safety and technology of this product.
as of July 31, 2020, the company's research and development of recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-price vaccine (E. coli) has been invested in research and development costs of about 77.75 million yuan (unaudited).
as of July 31, 2020, there are no approved nine-price cervical cancer vaccine manufacturers listed in China.
, only Merca East has nine prices of cervical cancer vaccine approved for production and sale.
in China its nine-price vaccine through Chongqing Zhifei Biological Products Co., Ltd. agent sales.
According to data issued by the China Food and Drug Inspection Research Institute, the number of nine-price cervical cancer vaccines issued in 2019 was 3.3242 million, an increase of 173.35 percent over 2018, and 2.1598 million in the first half of 2020, an increase of 83.13 percent over the same period last year.
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