Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the National Medical Products Administration (NMPA) of China has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males aged 9-26. This milestone approval marks GARDASIL as the first HPV vaccine authorized for use in males in China, aiming to help prevent certain HPV-related cancers and diseases.

GARDASIL is now approved in China for the prevention of anal cancers caused by HPV Types 16 and 18, genital warts (condyloma acuminata) caused by HPV Types 6 and 11, and grade 1, grade 2, and grade 3 anal intraepithelial neoplasia (AIN) caused by HPV Types 6, 11, 16, and 18.

“The approval of GARDASIL for males in China is a significant step forward in advancing public health,” said Joseph Romanelli, president of Human Health International at Merck. “Since its initial approval, our HPV vaccines have helped protect over 50 million females in China from HPV-related cancers and diseases. We are now proud to extend this protection to males, helping reduce the burden of HPV-related cancers and diseases among this population.”

Indications for GARDASIL®

• In females aged 9 through 45 years, GARDASIL is indicated to prevent cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, along with precancerous or dysplastic lesions and genital warts caused by HPV Types 6, 11, 16, and 18.
• In males aged 9 through 26 years, GARDASIL is indicated to prevent anal cancer and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18, as well as genital warts caused by HPV Types 6 and 11.