China approves Gardasil for male HPV prevention

Published 2025-01-08, 06:54 a/m
MRK
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RAHWAY, N.J. - Merck (NS:PROR) & Co., Inc. (NYSE: MRK), a global healthcare company, announced that the National Medical (TASE:PMCN) Products Administration (NMPA) of China has approved the use of GARDASIL® for males aged 9 to 26. This marks the vaccine as the first in China to prevent certain human papillomavirus (HPV)-related cancers and diseases in males.

The vaccine is now authorized to prevent anal cancers caused by HPV Types 16 and 18, genital warts due to HPV Types 6 and 11, and various precancerous or dysplastic lesions associated with HPV Types 6, 11, 16, and 18. This expansion of GARDASIL's indication in China is a significant advancement in public health efforts to combat HPV-related diseases.

Joseph Romanelli, president of Human Health International at Merck, expressed the company's commitment to enhancing public health by stating, "With this expanded approval, we look forward to helping protect this new population of Chinese males from certain HPV-related cancers and diseases." InvestingPro data shows Merck's strong market position, with revenue growing at 6.51% and maintaining a GREAT financial health score. Subscribers can access 10+ additional ProTips and comprehensive analysis through the Pro Research Report.

Previously, GARDASIL was indicated for females aged 9 through 45 years for the prevention of cervical, vulvar, vaginal, and anal cancers, as well as precancerous lesions and genital warts caused by specific HPV types. The vaccine's indications for males also include the prevention of anal cancer and precancerous lesions.

Despite the vaccine's preventive capabilities, it does not substitute the need for regular cancer screenings as recommended by healthcare providers. It is also not designed to protect against all types of HPV or those previously encountered through sexual activity.

GARDASIL's safety profile includes a contraindication for individuals with severe allergic reactions to yeast or after a previous dose of the vaccine. Common adverse reactions reported include headache, fever, nausea, dizziness, and reactions at the injection site. The vaccine should be administered as a three-dose series over six months.

Merck has made considerable investments to ensure the global supply of GARDASIL, including a commitment to supply over 115 million doses to low- and middle-income countries by 2025 through an agreement with UNICEF and Gavi, the Vaccine Alliance. With its robust financial position and expected net income growth this year, as highlighted by InvestingPro analysts, Merck appears well-positioned to fulfill these commitments while maintaining its strong market presence in the pharmaceutical sector.

The information in this article is based on a press release statement from Merck & Co., Inc.

In other recent news, Merck & Co., Inc. announced positive results from two pivotal Phase 3 trials for its investigational HIV-1 treatment regimen, doravirine/islatravir (DOR/ISL), meeting primary efficacy endpoints. Concurrently, the company secured an exclusive global licensing agreement with LaNova Medicines Ltd. for LM-299, a novel cancer therapy. These developments come amidst Merck's recent in-licensing of a preclinical oral small molecule, GLP-1RA HS-10535, from Hansoh Pharma, marking its entry into the obesity treatment market.

Analyst firms have been closely monitoring Merck's activities. BMO (TSX:BMO) Capital Markets downgraded its rating on Merck's stock from Outperform to Market Perform, citing concerns over the performance of its Gardasil franchise in China and potential challenges for its cancer drug Keytruda. Meanwhile, Bernstein maintained its Market Perform rating on Merck's stock, despite the company's recent strategic moves.

TD (TSX:TD) Cowen raised concerns about the global pharmaceutical industry's future, highlighting the impact of U.S. tariffs and geopolitical tensions, while noting that large-cap pharmaceutical companies like Merck are well-positioned to mitigate these risks. These are recent developments in the pharmaceutical industry and Merck's operations.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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