MSD's Gardasil Becomes First and Only HPV Vaccine Approved for Males in China
MSD
Pharmaceutical R&D and Manufacturer
Shanghai, China, January 8, 2025——MSD (MSD is the corporate name of Merck & Co., Inc. in Rahway, New Jersey, U.S.) announced Gardasil®[1][Quadrivalent Human Papillomavirus Vaccine (Saccharomyces cerevisiae)] has received marketing approval from the National Medical Products Administration for multiple new indications, applicable for males aged 9-26. The approval of the new indications marks Gardasil®Becomes the first and currently only HPV vaccine approved for use in males in China.
Gardasil®The new indication approved this time is applicable for males aged 9-26 to prevent anal cancer caused by HPV16 and HPV18, genital warts (condyloma acuminata) caused by HPV6 and HPV11, as well as the following precancerous or atypical lesions caused by HPV6, HPV11, HPV16, and HPV18: Grade 1, Grade 2, and Grade 3 Anal Intraepithelial Neoplasia (AIN).
"We are very pleased to witness the Gardasil®Six years later, several new indications have been approved in China, which is undoubtedly a milestone breakthrough. This also marks Gardasil®"Has become the first and currently the only HPV vaccine approved for use in males in China, marking a new step forward in advancing public health in China!"Anna Van Acker, Senior Vice President of MSD Global and President of MSD China, said"Since the approval of MSD's HPV vaccine in China, it has protected the health of 51 million Chinese women. We have every reason to believe that the approval of the new indication will continue to protect more eligible men. MSD will also honor its commitment to being rooted in China and benefiting China, continuing to work closely with all sectors of society to enhance public awareness of diseases caused by HPV. We deeply understand the urgency of promoting the cause of joint prevention of HPV for both men and women, and will strengthen cooperation with the government to significantly improve the accessibility and affordability of HPV vaccines, contributing to the implementation and advancement of the Healthy China 2030 strategy."
"The approval and market launch of the new indication for the HPV vaccine marks another milestone in the country's response to the Healthy China 2030 initiative. HPV vaccination is an effective method for preventing HPV-related diseases and serves as a primary prevention measure against HPV infection-related conditions."[2]HPV vaccines can prevent not only cervical cancer, but also anal cancer and genital warts caused by HPV infection.[3]。” Distinguished Professor and Researcher Youlin Qiao, School of Public Health and Preventive Medicine, Peking Union Medical College"It is believed that, compared to women, HPV infections in men receive little attention. However, in fact, the prevalence of genital HPV infection in men is higher than that in women globally."[3]Recently, the International Papillomavirus Society (IPVS), in further response to the WHO's "Global Strategy to Accelerate the Elimination of Cervical Cancer," which aims to achieve the interim "90-70-90" targets by 2030, has actively called on all countries to adopt vaccination programs that include both boys and girls as soon as possible. This involves promoting the HPV vaccine equally to eligible boys and girls to expand vaccine coverage and maximize population-level immunity.[4]。”
Persistent infection with high-risk types of HPV may not only lead to cervical cancer but also anal cancer, vaginal cancer, vulvar cancer, penile cancer, oropharyngeal cancer, and precancerous lesions, among other diseases.[5]Anal cancer originates in the skin cells near the anal verge or in the transitional zone cells between the anus and rectum (anal canal). According to World Health Organization data projections, new cases and deaths from anal cancer will increase annually worldwide from 2022 to 2025.[6][7]Relevant data shows that 88% of anal cancers are attributed to persistent HPV infection.[8]Genital warts (condyloma acuminata) refer to another common disease caused by HPV.[9], prone to recurrence, and approximately 90% of genital warts are associated with low-risk HPV types 6 and 11 infections.[10]。
"HPV infection is one of the significant public health issues globally."[11]Vaccination is the best method to prevent cervical cancer and other HPV-related cancers.[12]HPV infection can mostly be cleared by the immune system, so most HPV infections are transient and asymptomatic. However, persistent infection with certain types of HPV can lead to precancerous lesions.[5]。”Professor Wang Qianqiu, Director of the Clinical Prevention and Treatment Department at the STD Control Center of the Chinese Center for Disease Control and Prevention, and Dermatology Hospital (Institute) of the Chinese Academy of Medical SciencesHe added, "HPV spreads through multiple routes of direct or indirect contact, and trauma or skin damage is also an important factor in HPV infection."[13]。”
"The approval and market launch of the new indication for the HPV vaccine is exciting news for all sectors of society. It will also provide more innovative options for the prevention of HPV infection-related diseases, including cancer, for a wide range of eligible women and men."Dr. Li Zhengqing, Global Senior Vice President of MSD and President of MSD China Research and Development CenterEmphasized: "As the world's first company to launch the nine-valent and quadrivalent HPV vaccines, MSD has, over the years, continuously explored the potential of HPV vaccines in preventing HPV-related diseases across different populations based on rigorous clinical research and a large amount of real-world data. MSD is currently conducting several clinical studies on new indications for HPV vaccines in China, hoping to apply research results from China to benefit more people in need and improve the health of the Chinese public."
About MSD
At MSD (the corporate name of Merck & Co., Inc. in New Jersey, U.S.), we are united in our 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-tier research-intensive biopharmaceutical company — today, we stand at the forefront of innovation, delivering cutting-edge solutions to advance the prevention and treatment of diseases in humans and animals. We have built a diverse and inclusive global workforce, operating responsibly every day to ensure a safe, sustainable, and healthy future for all people and communities. For more information, please visitwww.msd.com`, and follow us on X (formerly Twitter), LinkedIn, and YouTube platforms.`
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 plants in Hangzhou, Ningbo, and Tianjin, integrating R&D, manufacturing, and commercial operations. We are fully committed to providing the people of China with high-quality innovative medicines, vaccines, and services for the benefit of 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]Gardasil® has previously been approved in China for the indication of preventing diseases caused by high-risk HPV types 16 and 18 in females aged 9 to 45:
Clinical trials in Chinese women have not yet confirmed the protective effect of this product against low-risk HPV types 6 and 11 related diseases.
[2]Chinese Society of Gynecologic Oncology, Chinese Association of Cervical Pathology and Colposcopy, Martin, et al. Clinical Application of Human Papillomavirus Vaccine
Chinese Expert Consensus [J]. Peking Union Medical Journal, 2021, 12(2): 189-201.
[3]Teng Qiuli, Niu Maoyuan, Liu Yuying, et al. The Harm of HPV Infection to Men and the Protection of HPV Vaccination for Men [J]. Chinese Journal of Immunology, 2022(004)038
[4] Garland SM, Bhatla N, Woo YL, et al. IPVS STATEMENT on HPV vaccination: No longer supply constraints: Towards achieving WHO vaccine targets. Vaccine. 2024;42(26). doi:10.1016/j.vaccine.2024.126400
[5]Expert Consensus on Immunoprevention of Human Papillomavirus-Related Diseases Such as Cervical Cancer. Chinese Journal of Preventive Medicine. 2019;53(8):761-803
[6]MSD Manual for the General Public - Anal Cancer
[7] IACR Cancer Tomorrow, 2024
[8]Yuan Meiwen, et al. Chinese Journal of Epidemiology. 2022, 43(5): 702-708.
[9] Pennycook KB, McCready TA. Condyloma Acuminata. [Updated 2023 Jun 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547667/
[10]Chinese Society of Dermatology and Venereology, Chinese Journal of Dermatology and Venereology. 2021;35(4)359-374
[11]Zhu Kongxin, et al. Real-world Study on the Effectiveness of HPV Vaccines. Chinese Journal of Microbiology and Immunology, 2023, 43(3) 230-238.
[12] WHO Human papillomavirus and cancer
[13]Chinese Medical Association, et al. Guidelines for the Diagnosis and Treatment of Viral Warts at the Primary Level (2022) [J]. Chinese Journal of General Practitioners, 2022, 21(10): 904-913