Dynamic Matters On July 18th, GlaxoSmithKline (GSK) officially announced that its Cervarix (Chinese name: Shirley) human papilloma (HPV) virus vaccine (types 16 and 18) was obtained by the State Food and Drug Administration (CFDA). The listing permit has become the first HPV vaccine approved for the prevention of cervical cancer in China. Main points HPV vaccine has important clinical value and market value HPV vaccine can effectively prevent cervical cancer in women. Cervical cancer is the second most common malignant tumor in China. According to the annual report on cancer registration in China, there are about 150,000 new cases of cervical cancer in China each year, and about 80,000 people die from the disease. The main cause of cervical cancer is the infection of high-risk subtype HPV viruses such as 16, 18. According to statistics, more than 70% of cervical cancer patients are HPV16 and HPV18 positive. The use of HPV vaccine can effectively prevent the infection of high-risk HPV virus, thereby reducing The incidence of cervical cancer. The preventive HPV vaccines that are currently used worldwide are mainly Gardasil from Merck (MSD) and Cervarix from GSK. Gardasil is a four-valent vaccine for HPV 6, 11, 16 and 18. Cervarix is ​​a bivalent vaccine for HPV 16 and 18, with annual sales of more than $2 billion worldwide. It is reported that Cervarix is ​​registered in China for the vaccination of 9 to 25-year-old women. The population of China's age-appropriate population is about 117 million. The price of Cervarix and Gardasil in Hong Kong is about 3,000 Hong Kong dollars. According to the conservative calculation of 10% penetration rate, HPV vaccine is domestic. There are about 35 billion markets. The approval of domestic HPV vaccine approval may start in 2006. The two HPV vaccines of MSD and GSK have been listed in more than 100 countries and regions in the United States, Europe, Australia and other countries. In 2007, they were listed in Hong Kong, China, but the mainland has not been obtained. Approved for listing. In fact, MSD and GSK's two HPV vaccines began clinical trials in China in 2005 and 2006 respectively. The reason for the delay in listing may be the review indicators for the prevention of HPV vaccine. The CFDA review uses “cancer or emergenceâ€. The data of grade 2 or higher neoplasia in the cervical epithelium is used as the endpoint, which makes the clinical trial process 10 to 20 years. Recently, WHO has released a new experimental technical specification for HPV vaccine, which clearly recommends that national regulatory agencies can use “sustained viral infection†as an endpoint for evaluating vaccine effectiveness in clinical evaluation of HPV vaccines before they are marketed. The launch of the GSK Cervarix vaccine does not exclude the CFDA's adoption of the new WHO's current specification, which uses continuous infection data as an endpoint. It is expected that the MSD Gardasil vaccine currently in the clinical data verification phase may also be approved in the near future, and this may also lead to a much earlier schedule for the domestic HPV vaccine.
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