Human papillomavirus recombinant vaccine nonavalent (Xiamen Innovax Biotech)

China has approved its first domestically developed 9-valent human papillomavirus (HPV) vaccine on Thursday, creating new competitive pressure for Merck & Co.'s Gardasil/Gardasil 9 in a market where the US drugmaker has already paused shipments and withdrawn long-term sales projections.The newly approved vaccine, called Cecolin 9, was developed through a collaboration between Xiang An Biomedicine Laboratory, Xiamen University and Wantai BioPharm, and makes China only the second country after the US capable of independently producing high-valency HPV vaccines.The approval comes as Merck grapples with collapsing demand for Gardasil in China, where the company temporarily suspended shipments in February and rescinded its annual sales target of $11 billion for the jab by 2030. Still, CEO Robert Davis said at the time that China continued to represent "a significant long-term opportunity" for the franchise, attributing the shipping pause to excess inventory.Gardasil generated $8.6 billion globally in 2024, down 3% from the prior year, with first-quarter sales this year plummeting 41% to $1.3 billion. Merck has said the pause in Gardasil deliveries to China would last until at least mid-year.According to Chinese officials, Cecolin 9 has been tested in five clinical trials conducted across China since 2019, involving more than 11,000 healthy volunteers aged nine to 45, and demonstrated over 98% protection against persistent HPV infections and 100% protection against cervical infectionsThe vaccine covers the same high-risk HPV strains as Gardasil 9, including types 16 and 18, plus five other types (31, 33, 45, 52 and 58). For girls aged 9 to 17, two doses provided immune responses comparable to three doses in older women ages 18 through 26, Chinese officials said.The competitive threat extends to pricing as well, where Chinese HPV vaccines typically cost a tenth that of Gardasil at about CNY 300 ($42). "The perceptions of domestic products have been improving," said Justin Wang, partner at L.E.K. Consulting in Shanghai said in a recent Bloomberg report. "The huge price difference will result in a significant share going to domestic products."