GSK HPV Vaccine Cervarix Approved by NMPA Over 2-Dose for Female Aged 9 - 14

Healthcare Author: Jizhen Huang May 30, 2022 07:21 PM (GMT+8)

Established in 2000, GlaxoSmithKline has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. It also has a secondary listing on the New York Stock Exchange. GSK manufactures products for major disease areas such as asthma, cancer, infections, diabetes, and mental health. It also developed the first malaria vaccine.

Injections, vaccines

GlaxoSmithKline (GSK, Chinese: 葛兰素史克, NYSE: GSK) announced that its HPV vaccine Cervarix (bivalent human papillomavirus vaccine [HPV type16 / type18]) had been approved for a two-dose schedule for girls aged 9 - 14 by Chinese NMPA (National Medical Products Administration) recently.

As a result, Cervarix became the first imported HPV vaccine approved in China for a two-dose vaccination program for girls aged 9 - 14.

Persistent infection of high-risk human papillomavirus (HR-HPV) in the female genital tract is the main cause of cervical cancer. Epidemiological studies have shown that HPV16 and HPV18 are the most common high-risk HPV types in cervical cancer.

As primary prevention, the HPV vaccine is extremely important for the entire cervical cancer prevention and treatment. In December 2014, WHO launched "Comprehensive Control of Cervical Cancer: A Basic Practice Guide", which identifies the main opportunities and ages for cervical cancer control and prevention actions in women's lifetime.

As HPV is mainly transmitted through sexual contact, girls between 9 - 14 years old who have not had sex are the prioritized population to receive the HPV vaccine.

Cervarix is currently the only HPV vaccine that uses an innovative adjuvant system. Studies have shown that the application of the same innovative adjuvant system as Cervarix can induce a higher immune response than natural immunity and HPV vaccines adjuvanted with the same antigen and aluminum salt, thereby providing stronger and longer-lasting protection.

Previously, Cervarix was approved for marketing in China in 2016. The suitable vaccination age is 9 - 45 years old. The vaccination program was 3 doses, and the price per dose is CNY 580 (USD 81.1).

GSK’s main competitors in the HPV vaccines market include MSD (Chinese: 默沙东, NYSE: MRK), Walvax (Chinese: 云南沃森生物, SHE:300142), Hualan Bio (Chinese:华兰生物, SHE:002007), CDBio (Chinese:成大生物, SHA:688739) and Chongqing Zhifei ( Chinese: 重庆智飞生物, SHE:300122).