Merck's 9-Valent HPV Vaccine Launches Phase III Clinical Trial in Chinese Males, Enrolling 8,100 Participants

On October 11, the Insight database revealed that MSD has publicly announced the initiation of its first Phase 3 clinical trial in China to evaluate the protective efficacy, immunogenicity, and safety of the 9-valent human papillomavirus vaccine (Gardasil 9) in Chinese males, with a planned enrollment of 8,100 participants.

Clinical Trial Details (Insight)

Source: Insight Database (http://db.dxy.cn/v5/)

Gardasil 9 is currently the only approved 9-valent HPV vaccine in China. It was approved in April 2018 for prophylactic vaccination in females aged 16 to 26 years, and in China, it is distributed by Zhifei Biological Products. The covered HPV types include: cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; as well as precancerous or atypical lesions and infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ.

Data on immunogenicity surrogate endpoints from international multicenter clinical trials indicate that the vaccine can also be administered to girls aged 9 to 15 years. Clinical studies in China targeting the 9- to 15-year-old population are currently ongoing. In the United States, the vaccine has been approved for use in females and males aged 9 to 45 years.

Data from the lot release records of the National Institutes for Food and Drug Control (NIFDC) indicate that the 9-valent HPV vaccine has experienced a significant increase in lot release volume since its market launch. In 2019, the lot release volume reached 3.3242 million doses, representing a 173.35% increase compared to 2018. In the first half of 2020, the lot release volume was 2.1598 million doses, marking an 83.13% year-on-year increase.

Epidemiological data indicate that the bivalent and quadrivalent HPV vaccines have an efficacy of approximately 70% in preventing HPV-related cervical cancer, while the nonavalent vaccine increases this to 90%, making it more highly favored. Statistics show that, at present, the nonavalent HPV vaccine has the highest market penetration rate in China, whereas the bivalent and quadrivalent HPV vaccines maintain relatively lower penetration rates. Consequently, the nonavalent HPV vaccine commands a larger market in China.

According to the Insight database, multiple companies are currently developing 9-valent HPV vaccines produced in China. The CDE clinical trial registration platform has registered 21 clinical trials for 9-valent HPV vaccines, among which four products have entered Phase III clinical trials, developed by Wantai Biological, RecBio Therapeutics, Boviobiotech, and Beijing Kangweishi Biotechnology Co., Ltd.

Phase III Clinical Trial of 9-Valent HPV Vaccine in China

Source: Insight Database (http://db.dxy.cn/v5/)