GSK prevention of cervical cancer innovative vaccine approved for listing in the mainland

GSK prevention of cervical cancer innovative vaccine approved for listing in the mainland

July 21, 2016 Source: Xinhuanet

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GlaxoSmithKline (GSK) announced today that the human papillomavirus (HPV) vaccine [types 16 and 18] (trade name: Xirui Shi) was approved by the State Food and Drug Administration of China and became the first in mainland China. An approved HPV vaccine to prevent cervical cancer. It is understood that Shirley is registered in the Mainland for the vaccination of women aged 9-25, using three doses of immunization procedures, and is expected to be officially listed at the beginning of next year.

According to the data, cervical cancer is the second most common cancer among women aged 15-44 in China. There are about 130,000 new cases in China each year, accounting for 28% of the total number of new cases of cervical cancer in the world. On a global scale, a new case is detected on average every minute, and one woman dies of cervical cancer every two minutes.

It is reported that a six-year clinical trial of Xirui in China has enrolled more than 6,000 subjects with vaccination and control. The results show that the vaccine has high protective efficacy against a certain carcinogenic HPV-related cervical disease and has a satisfactory benefit-to-risk ratio. This result is consistent with data from global clinical studies. The introduction of HPV vaccination while carrying out a cervical cancer screening program will significantly reduce the incidence of cervical cancer and precancerous lesions, thereby reducing the burden of disease.

GSK Senior Vice President Ji Haiwei said: “Improving the accessibility of innovative medicines and vaccines is a clear strategy of GSK China. We believe that through cooperation with relevant government departments, it will enhance the Chinese people's access to innovative vaccines like Xirui. To achieve this goal, we will explore innovative pricing methods to support the inclusion of Cirrus into the National Program Immunization Program."

According to GSK, in addition to improving the accessibility of vaccines, ensuring the quality of vaccines has always been an important part of the company's work. GSK China stated that it fully supports the newly revised regulations on vaccine circulation and vaccination management issued by the Chinese government and implements the commitment of “based on China, joining hands with China, and serving China”.

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