Merck’s HPV Vaccine Gets Green Light From China Regulator

According to a statement released by Merck, its human papillomavirus vaccination (HPV) has been authorized for male use in China. This news provides the American pharmaceutical company with much-needed relief in a critical region where demand has been decreasing among females.

The vaccination, Gardasil, has already been given the go-ahead for use in females; nevertheless, the distributor of the vaccine in China has cut supply owing to the low demand for the vaccine. Merck has said that the sluggish sales in China would likely persist in 2025.

According to the firm, this is the first HPV vaccination for males to be authorized by China’s National Medical Products Administration. It is intended for use by children and men between the ages of 9 and 26 years, with the goal of preventing specific cancers and disorders associated with HPV.

In women, HPV is a prevalent cause of cervical cancer, while for males, it is associated with an increased risk of genital warts and numerous other forms of cancer.

Gardasil has been among Merck’s main growth drivers outside of the U.S., following in the footsteps of the blockbuster cancer medicine Keytruda.

Its sales have taken a blow in recent months, with revenue from the vaccine declining 11% to just over $2.3 billion in the quarter ending September 30. A significant portion of its overseas growth came from China when it was authorized for women in 2017.

According to Merck, the demand for its products was also affected by Beijing’s anti-corruption drive, which resulted in significant interruptions to corporate operations and led to global pharmaceutical companies losing their connection with hospitals.

Overall, the firm’s sales dropped to under $996 million from $1.67 billion, a drop of over 40% in just a year.

This news comes just a few days after it was announced that Merck bought a new vaccine plant from WuXi Biologics for over $520 million. Since the firm was WuXi Biologics’ only client at the Dundalk location, with a 20-year contract to manufacture vaccines valued at $150 million per year, the acquisition of the factory was an obvious choice.

Ireland’s Foreign Direct Investment Agency (IDA) and Merck’s MSD Ireland division announced the transaction on Monday. The firms anticipate finalizing the acquisition in the first part of this year. The plant, already employing 200 individuals, will accommodate a further 150 workers by year-end, as reported by the IDA.