China's Homegrown HPV Vaccine Challenges Merck's Gardasil Dominance

China's pharmaceutical landscape is witnessing a significant shift as the country's first domestically produced nine-valent HPV vaccine enters the market at a substantial discount compared to its international competitor. This development marks a potential turning point in the global HPV vaccine market and poses a direct challenge to Merck's Gardasil franchise.

Wantai's Cecolin 9 Debuts at Competitive Price Point

Wantai BioPharm's subsidiary, Xiamen Innovax Biotech, has introduced Cecolin 9, China's first domestically developed nine-valent HPV vaccine, at a price of 499 yuan ($70) per dose. This pricing strategy positions the vaccine at approximately 60% less than Merck's Gardasil 9, which is currently priced at around 1,300 yuan per dose in China.

The approval of Cecolin 9 in June for girls and women aged 9 to 45 years old marks a significant milestone in China's pharmaceutical industry. The vaccine's dosing regimen includes a two-dose course for those aged 9 to 17 and a three-dose regimen for adults, closely mirroring Gardasil 9's administration schedule.

Merck's Gardasil Faces Mounting Pressure

The introduction of a lower-priced domestic competitor comes at a challenging time for Merck's Gardasil franchise. Once a top growth driver for the company, Gardasil has experienced a dramatic downturn in China, with sales plummeting by approximately $1.1 billion in the first quarter of 2025. This decline contributed to a 41% decrease in global Gardasil sales, which fell to $1.3 billion during the same period.

Merck CEO Rob Davis has attributed the slowdown to multiple factors, including the Chinese government's anti-corruption efforts in the healthcare sector and a general decline in discretionary consumer spending. The fact that HPV vaccines are not included in China's national immunization program, requiring out-of-pocket payments, further complicates the market dynamics.

Comparative Efficacy and Market Potential

In a head-to-head study conducted in China with women aged 18 to 26 years, Cecolin 9 demonstrated noninferior immune responses and similar adverse reaction rates compared to Gardasil 9. While slight differences were observed for each HPV type, the overall performance of the domestic vaccine appears competitive.

Despite the current challenges, the Chinese HPV vaccine market still holds significant potential. Wantai reports that only 27% of eligible Chinese women have received at least one dose of an HPV vaccine, compared to a 67% penetration rate in Western countries. This disparity suggests substantial room for growth in the Chinese market.

As the competition intensifies, both Merck and Wantai are pursuing strategies to strengthen their positions. Merck has reportedly offered promotional pricing in some areas and increased its marketing efforts. Meanwhile, Wantai is seeking World Health Organization prequalification for Cecolin 9 to facilitate its introduction outside of China and is conducting phase 3 trials to expand its use to men.