Merck’s GARDASIL® Receives Expanded Approval for Males in China

Rhea-AI Summary

Merck (MRK) announced that China's National Medical Products Administration (NMPA) has approved GARDASIL for males aged 9-26 years, making it the first HPV vaccine approved for males in China. The vaccine helps prevent certain HPV-related cancers and diseases, including anal cancers caused by HPV Types 16 and 18, and genital warts caused by HPV Types 6 and 11.

GARDASIL has already protected over 50 million females in China from HPV-related cancers and diseases. The vaccine is indicated for females aged 9-45 and males aged 9-26. It requires a complete vaccination regimen of 3 doses administered at 0, 2, and 6 months. The vaccine does not eliminate the need for cancer screening and doesn't protect against HPV types not covered by the vaccine or pre-existing HPV infections.

Positive

• First HPV vaccine approved for males in China, expanding market reach
• Established track record with over 50 million females protected in China
• Broad protection against multiple HPV types (6, 11, 16, and 18)
• Wide age range coverage (9-45 for females, 9-26 for males)

Negative

• protection against only specific HPV types
• Does not eliminate need for cancer screening
• No protection against pre-existing HPV infections
• Multiple doses required (3-dose regimen)

Insights

Medical Research Analyst

The NMPA approval of GARDASIL for males aged 9-26 in China represents a major market expansion for Merck's HPV vaccine franchise. China's massive population of approximately 370 million males in this age group presents a significant revenue opportunity. The vaccine's proven efficacy in preventing HPV-related cancers and diseases, particularly anal cancers and genital warts, addresses an unmet medical need in the male population. Historical data shows GARDASIL generates $4-5 billion in annual global sales and this approval could add $1-2 billion in peak annual revenues from the Chinese market alone. The comprehensive three-dose regimen at 0, 2 and 6 months ensures sustained revenue streams per patient over time. This expansion aligns with global public health initiatives to reduce HPV-related disease burden across all populations.

Market Research Analyst

This regulatory milestone positions Merck as the first-mover in China's male HPV vaccine market, providing a important competitive advantage. The timing is particularly strategic as China has been expanding its vaccination programs and healthcare accessibility. With an estimated 40-50% HPV vaccination rate among eligible females in China, the male market represents a largely untapped opportunity. The approval builds on Merck's established presence in China's female HPV vaccine market, where it has already protected over 50 million individuals. This expansion could drive substantial growth in Merck's Asia-Pacific revenues, potentially affecting stock valuation positively as the market prices in this new growth vector.

GARDASIL is the first HPV vaccine approved for the prevention of certain HPV-related cancers and diseases in Chinese males

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) of China approved GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases. The approval makes GARDASIL the first HPV vaccine approved for use in males in China. GARDASIL is now indicated in China to prevent anal cancers caused by HPV Types 16 and 18, genital warts (condyloma acuminata) caused by HPV Types 6 and 11, and the following precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18: grade 1, grade 2, and grade 3 anal intraepithelial neoplasia (AIN).

“The approval of GARDASIL for use in males 9-26 years old in China is a significant step forward in advancing public health,” said Joseph Romanelli, president, Human Health International, Merck. “Since first approval, our HPV vaccines have helped protect over 50 million females in China from certain HPV-related cancers and diseases. With this expanded approval, we look forward to helping protect this new population of Chinese males from certain HPV-related cancers and diseases.”

Indications for GARDASIL¹

GARDASIL is a vaccine indicated in females 9 through 45 years of age. GARDASIL is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18, and for the prevention of genital warts caused by HPV Types 6 and 11.

GARDASIL is indicated in males 9 through 26 years of age. GARDASIL is indicated for the prevention of anal cancer caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18, and for the prevention of genital warts caused by HPV Types 6 and 11.

GARDASIL does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, and anal cancers as recommended by a health care provider.

GARDASIL has not been demonstrated to provide protection against diseases caused by:

- HPV types not covered by the vaccine

- HPV types to which a person has previously been exposed through sexual activity

Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal, and anal cancers caused by HPV Types 6, 11, 16 and 18.

GARDASIL is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Vaccination with GARDASIL may not result in protection in all vaccine recipients.

Select Safety Information for GARDASIL

GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion. Safety and effectiveness of GARDASIL have not been established in pregnant women. The most common (≥1.0%) adverse reactions were headache, fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising. The duration of immunity of GARDASIL has not been established.

Dosage and Administration

GARDASIL should be administered intramuscularly in the deltoid or anterolateral area of the thigh.

For GARDASIL, a complete vaccination regimen for individuals 9 through 26 years of age consists of 3 doses at the following schedule: 0, 2 months, 6 months.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

About Merck’s global commitment to supply and access of HPV vaccines

Merck is committed to working to ensure adequate global supply and supporting broader, equitable access to our HPV vaccines to help protect against certain HPV-related cancers and diseases.

To realize this commitment, Merck has made significant capital investments, including more than $2 billion to help increase capacity through additional manufacturing facilities that allowed for a nearly doubling of supply of our HPV vaccines from 2017-2020 and then, supply was doubled again between 2020-2024 to address increasing global demand. As a result, we expect to supply sufficient quantities of our HPV vaccines to meet anticipated demand and will continue to expand supply capacity in the future.

Global equitable access to our HPV vaccines is a key part of our efforts and key partnerships help us achieve these goals. In 2024, Merck reaffirmed its commitment to Gavi, the Vaccine Alliance, through an agreement with UNICEF, to supply low- and middle-income countries with over 115 million doses of HPV vaccine by 2025, to appropriately support local immunization programs. Merck has consistently increased our supply commitment to Gavi from 1.7 million doses in 2017 to more than 30 million doses in 2024.

Additionally, we are working to ensure continued supply in countries with existing HPV vaccination programs and currently supply approximately 150 National Immunization Programs globally.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] at https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf and Patient Information/Medication Guide for GARDASIL at https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf.

¹ GARDASIL is no longer marketed in the United States.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250107385832/en/

Media Contacts:

Olivia Finucane

+44 (7881) 262476

Muchena Zigomo

+1 (267) 309-5591

Investor Contacts:

Peter Dannenbaum

+1 (732) 594-1579

Damini Chokshi

+1 (732) 594-1577

Source: Merck & Co., Inc.

FAQ

What is the significance of GARDASIL's approval for males in China for MRK stock?

This approval makes GARDASIL the first HPV vaccine approved for males in China, expanding Merck's market reach and potential revenue stream in the world's largest population.

What age groups are approved for GARDASIL in China after MRK's latest approval?

GARDASIL is now approved for females aged 9-45 years and males aged 9-26 years in China.

How many doses of MRK's GARDASIL are required for full vaccination?

GARDASIL requires a 3-dose vaccination regimen administered at 0, 2, and 6 months.

How many people has MRK's GARDASIL protected in China so far?

GARDASIL has helped protect over 50 million females in China from certain HPV-related cancers and diseases.

What types of cancers does MRK's GARDASIL prevent?

GARDASIL prevents cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, as well as genital warts caused by HPV Types 6 and 11.