▎WuXi AppTec Content Team Report
On August 30, Merck & Co. (MSD) announced that the new indication of its nine-valent human papillomavirus vaccine (hereinafter referred to as “nine-valent HPV vaccine”) has been approved by the National Medical Products Administration of China The approval of the NMPA indicates that the applicable population of MSD’s nine-valent HPV vaccine has also been expanded to women aged 9-45 years. Previously, the product was approved in China for women aged 16 to 26.
The nine-valent HPV vaccine with a three-dose schedule is suitable for protection against HPV 16, 18, 31, 33, 45, 52 and 58, according to a Merck press release cervical cancer caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58; cervical intraepithelial neoplasia (CIN1/ 2/3) and adenocarcinoma in situ of the cervix (AIS); and persistent infection by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58< /strong>.
Image source: NMPA official website
Cervical cancer is one of the most common gynecological malignancies. Data from the American Cancer Research Center shows that almost all cervical cancers are caused by HPV, and HPV also causes more than 90% of anal cancers, 60% to 75% of oral cancers, vaginal cancers, penile cancers, and vulvar cancers. There are more than 200 HPV types that have been identified so far, which can be divided into low-risk and high-risk types according to whether they are carcinogenic or not. Among them, high-risk types include HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68, etc..
The 2021 ICO/IARC (Human Papillomavirus and Cancer Information Center/International Agency for Research on Cancer) report on HPV and related diseases in China shows that women aged 15-44 in China in 2020 In China, cervical cancer ranks third in both incidence and mortality among female cancers. In China, about 98% of cervical cancers are caused by high-risk HPV types. Although HPV 16 and 18 are high-risk HPV types that are widely prevalent worldwide, there are differences in China. An epidemiological study of HPV infections in 1.7 million women in China showed that women in China were the most The susceptible high-risk HPV types are HPV 16, 52, and 58.
Nine-valent HPV vaccine developed by Merck & Co. Virus-like particles composed of capsid proteins are highly purified and mixed. The vaccine was conditionally approved by the NMPA in April 2018 and is suitable for women aged 16 to 26 years for the prevention of cervical, vulvar, vaginal, anal and genital cancers caused by HPV Warts, persistent infections, precancerous or atypical lesions.
Professor Qiao Youlin from the School of Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College pointed out that HPV vaccination in adolescent girls is likely to stimulate a better immune response, and women who have not had sex The HPV vaccine will provide the best protection. As women age, women’s ability to clear new and previous HPV infections decreases, making them more susceptible to persistent HPV infection and cervical cancer risk. Studies have shown that for women who have had sex, the HPV vaccine also has a good protective effect.
“In order to reduce the threat of cervical cancer to women’s health, my country has attached great importance to the comprehensive prevention and treatment of cervical cancer in women in recent years. We have seen that the quadrivalent HPV vaccine has been approved for use in China in 2020. Domestic women aged 9-45 years old have provided more help to increase the vaccination rate of key populations in my country and promote the primary prevention of cervical cancer.” Professor Qiao Youlin said, “Today, the approval of the nine-valent HPV vaccine for age expansion is even more important. We are very excited that it will bring more choices to protect the health of women of different ages in my country to prevent HPV infection and reduce the risk of related diseases, and further promote my country to accelerate the pace of eliminating cervical cancer.”
Currently, Merck is also conducting a number of clinical studies on new HPV vaccine indications in China. According to the China Drug Clinical Trial Registration and Information Publicity Platform, the company is conducting a number of Phase 3 clinical trials, including: evaluating the nine-valent HPV vaccine in China
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Phase 3 clinical trial of protective efficacy, immunogenicity, and safety in
; evaluation of a two-dose immunization schedule of nine-valent HPV vaccine in Chinese men aged 9 to 14 years, and a Phase 3 open-label immunogenicity and safety study evaluating the vaccine’s three-dose immunization schedule in aged Chinese men.