By Fineline Cube 
US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced marketing approval from China’s National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) 9-valent vaccine Gardasil 9 in males aged 16 to 26. This approval expands the vaccine’s availability to a new demographic, further addressing the prevention of HPV-related diseases in China.
Gardasil 9: Expanded Indication
Gardasil 9 was first approved in China in April 2018 for females aged 16-26 to prevent cervical cancer, vulvar cancer, vaginal cancer, anal cancer, genital warts, and other HPV-related conditions. In 2022, the approved age range for females was expanded to 9-45 years. The latest approval extends protection to males aged 16-26, aligning with global standards and enhancing public health efforts to reduce HPV-related diseases.
Market Expansion and Impact
This approval follows MSD’s earlier success in January 2024, when the company received marketing approval in China for its quadrivalent HPV vaccine Gardasil in males aged 9-26, marking the first HPV vaccine for men in the country. The expanded indications for Gardasil 9 further solidify MSD’s leadership in the HPV vaccine market and contribute to broader prevention strategies against HPV-related cancers and conditions.-Fineline Info & Tech