MSD's 9-Valent HPV Vaccine (Recombinant) Receives NMPA Approval for Male Indication in China
MSD
Pharmaceutical R&D and Manufacturer
Shanghai, China, April 14, 2025——MSD (MSD is the corporate name of Merck & Co., Inc. in Rahway, New Jersey, U.S.) announced Gardasil®9[1][9-valent Human Papillomavirus Vaccine (Saccharomyces cerevisiae)] (hereinafter referred to as "9-valent HPV vaccine") has received marketing approval from the National Medical Products Administration for multiple new indications, applicable to males aged 16-26. This approval enables MSD's Gardasil.®9 Becomes the First and Currently Only Approved Nine-Valent HPV Vaccine in China for Both Eligible Males and Females, Marking a New Phase of "Joint Male-Female Prevention of HPV-Related Cancers and Diseases" in China.
Gardasil®Covers 9 types of HPV: 6, 11, 16, 18, 31, 33, 45, 52, and 58.[1]The male indication approved this time can prevent anal cancer caused by HPV16 and 18, genital warts (condyloma acuminata) caused by HPV6 and 11, and the following precancerous or atypical lesions caused by HPV6, 11, 16, and 18: Grade 1, 2, and 3 anal intraepithelial neoplasia (AIN).
"We are very pleased to welcome the approval of the indication for males for the nine-valent HPV vaccine; since the nine-valent HPV vaccine was approved for its first indication in China in 2018, we have been committed to providing more health protection measures for the Chinese public, and have successively welcomed the expanded age range of 9-45 years, the two-dose vaccination schedule for ages 9-14, and now the approval of the indication for males. This undoubtedly reflects the government's continuous efforts and unwavering commitment in accelerating the elimination of cervical cancer, expanding vaccine accessibility, and providing diverse health options for the Chinese public."Anna Van Acker, Senior Vice President of MSD Global and President of MSD China"HPV vaccine is currently the world's only vaccine that effectively prevents cancer. By the end of 2024, Gardasil..."®The cumulative number of doses administered has exceeded 300 million; in China, Gardasil®"9 has also provided protection for over 33 million eligible women. However, HPV infection does not discriminate by gender. We deeply understand the urgency of promoting the cause of joint prevention for both men and women. We hope that through the approval of new indications, we can protect the majority of women while benefiting more men, bringing welfare to families, communities, and the entire society, and strive to jointly build a future without HPV-related diseases."
HPV infection is one of the important public health issues threatening human health.[2]HPV infection is relatively common.[3]The World Health Organization states that approximately 80% of men and women will be infected with at least one type of HPV in their lifetime.[4]HPV has relatively strong resistance to the external environment.[5]; Sexual behavior is the main route of HPV infection, but not the only one. HPV infection can also occur through mother-to-child transmission and direct contact, such as skin and mucous membrane contact.[5]。
Most HPV infections are usually asymptomatic.[4], and most can be naturally cleared through the human immune mechanism, but a few infected individuals may also progress to persistent infection, and eventually develop precancerous lesions and invasive cancer.[5]The World Health Organization disclosed that, as of 2019, approximately 690,000 new cancer cases worldwide were directly related to HPV infection.[6] [7]At the same time, relevant studies have shown that from 2007 to 2015, the number of HPV-related cancer cases and the incidence rate in China increased year by year.[8]。
Relevant studies show that HPV6/11/16 are common infection types among Chinese males.[9]Persistent infection with certain types of HPV can lead to various cancers, including anal cancer.[3]、[5]According to the World Health Organization's data forecast, the number of new cases and deaths from anal cancer worldwide will increase year by year from 2022 to 2050.[10]Relevant data show that 88% of anal cancers are attributed to persistent HPV infection.[11]Low-risk HPV can cause genital warts, also known as condyloma acuminata, which are prone to recurrence, and about 90% are associated with low-risk HPV types 6 and 11 infections. [12]。
"HPV vaccination is one of the effective methods for preventing HPV-related diseases and cancers, and is one of the primary prevention measures for controlling HPV infection-related diseases."[13]"Preventing HPV infection can not only reduce the burden of cancer but also alleviate the pressure on public health and medical systems."Distinguished Professor and Researcher Youlin Qiao from the School of Population Medicine and Public Health at Peking Union Medical CollegeIt is believed that "HPV infection does not differentiate by gender, and the natural clearance rate in males after infection is lower than in females."[14],Males may also develop diseases such as anal cancer and genital warts due to persistent HPV infection.[15]Co-administration of HPV vaccines to both males and females not only helps achieve herd immunity but also prevents HPV-related diseases in males.[16], and can further respond to the call of the WHO's "Global Strategy to Accelerate the Elimination of Cervical Cancer" to accelerate the achievement of the phased "90-70-90" targets, and help ultimately achieve the global goal of eliminating HPV-related cancers and diseases.[17]。”
"The approval and market launch of the nine-valent HPV vaccine for males, based on scientific data from MSD's clinical trials and long-term follow-up studies, marks another significant milestone in MSD's response to Healthy China 2030. The approval of this new indication not only provides a diverse range of options for the prevention of HPV-related diseases among eligible male populations but also represents a solid step forward in accelerating the elimination of HPV-related cancers and diseases in China."Dr. Zhengqing Li, Senior Vice President of MSD Global and President of MSD China Research and Development CenterEmphasized: "As the first company in the world to launch the nine-valent HPV vaccine, MSD will continue to invest in research and development, constantly exploring the potential of HPV vaccines in preventing related diseases among different populations. To date, Gardasil®Gardasil 9 is currently the only nine-valent HPV vaccine with clinical research data in male populations and has undergone ten years of real-world vaccination testing overseas. MSD is currently conducting multiple clinical studies on HPV vaccines in China, hoping to obtain more research results in China to benefit more people in need."
About MSD
At MSD (the corporate name of Merck & Co., Inc. in Kenilworth, NJ, USA), we unite in pursuit of a shared mission: harnessing the power of leading-edge science to save and improve lives around the world. For over 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We are committed to being a top research-intensive biopharmaceutical company—today, we stand at the forefront of innovation, delivering transformative solutions to advance the prevention and treatment of diseases in humans and animals. We have built a diverse and inclusive global workforce, conducting our business responsibly every day to ensure a safe, sustainable, and healthy future for all people and communities. For more information, visit www.msd.com and follow us on X (formerly Twitter), LinkedIn, and YouTube.
About MSD China
China is a crucial part of MSD's global growth strategy. MSD’s China headquarters is located in Shanghai, with a research and development center in Beijing and manufacturing facilities in Hangzhou, Ningbo, and Tianjin, integrating R&D, manufacturing, and commercial operations. We are fully committed to providing high-quality innovative medicines, vaccines, and services to the people of China, benefiting Chinese society. For more information, please visit MSD China's official website or follow MSD China's official social media account on WeChat.
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[1]Previously, Gardasil®9 was approved in China for the prevention of vaccination in females aged 9 to 45. This product is suitable for preventing the following diseases caused by the HPV types contained in this product:
And the following precancerous or atypical lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
As well as persistent infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
[2]Zhu Kongxin, et al. Real-world Study on the Effectiveness of HPV Vaccines. Chinese Journal of Microbiology and Immunology, 2023, 43(3) 230-238.
[3] HPV and Cancer – NCI
[4] WHO-Questions and Answers about HPV
[5]Expert Consensus on Immunoprophylaxis of Human Papillomavirus-Related Diseases Such as Cervical Cancer. Chinese Journal of Preventive Medicine. 2019;53(8):761-803
[6] Global burden of cancer attributable to infections: the critical role of implementation science，The Lancet Global Health, Volume 8, Issue 2, February 2020, Pages e153-e154
[7] WHO – Human papillomavirus and cancer
[8] Duan R, et al. Cancer Epidemiol Biomarkers Prev. 2022 ;31(5):1130-1136.
[9] Liu Y, et al. J Infect Public Health. 2023,16(7):989-995.
[10] IACR Cancer Tomorrow, 2024
[11]Yuan Meiwen, et al. Chinese Journal of Epidemiology. 2022, 43(5): 702-708.
[12]Chinese Society of Dermatology and Venereology, Chinese Medical Association. Chinese Journal of Dermatology and Venereology. 2021;35(4):359-374.
[13]Chinese Society of Gynecologic Oncology, Chinese Association of Maternal and Child Health Studies, Colposcopy and Cervical Pathology Branch, Ma Ding, et al. Clinical Application of Human Papillomavirus Vaccine: Chinese Expert Consensus [J]. Peking Union Medical College Journal, 2021, 12(2): 189-201.
[14] Malagón T et al. Epidemiology. 2021;32(3)368–377.
[15] Irene Man, Damien Georges, Rengaswamy Sankaranarayanan, Partha Basu, Iacopo Baussano. Building resilient cervical cancer prevention through gender-neutral HPV vaccination. eLife. 2023;12. doi:10.7554/eLife.85735
[16] Williamson AL. Viruses. 2023 Jun 26;15(7) 1440.
[17]Global Health Sector Strategy on HIV, Viral Hepatitis and Sexually Transmitted Infections 2022-2030