Merck's 9-valent HPV Vaccine Gardasil 9 Receives CDE Acceptance for New Indication in China

On March 3, the CDE website showed that the new indication application for MSD's nine-valent human papillomavirus vaccine (Saccharomyces cerevisiae) has been accepted.

The 9-valent human papillomavirus vaccine (abbreviation: 9-valent HPV vaccine, trade name: Gardasil 9) adopts a three-dose immunization schedule, which is suitable for preventing cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical intraepithelial neoplasia (CIN grades 1/2/3) and adenocarcinoma in situ of the cervix caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; as well as persistent infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

In August 2022, the Chinese National Medical Products Administration approved the expanded age indication for Gardasil 9, extending its use from females aged 19-26 to those aged 9-45.

The PharmaCube database shows that Gardasil 9 has conducted 7 clinical trials in China, including 5 Phase III studies and 2 post-marketing surveillance studies.

Specifically, regarding the Phase III studies, the three studies with registration numbers CTR20190574, CTR20190587, and CTR20221250 are focused on women, while the two studies CTR20212488 and CTR20220441 are centered on men.

According to MSD's financial report, the Gardasil/Gardasil 9 vaccine portfolio contributed $6.897 billion in product revenue, a year-on-year increase of 22%. This growth was mainly driven by demand outside the United States, particularly in China. In January 2023, ZF BioPharmaceutical Co., Ltd. renewed a vaccine procurement agreement with MSD worth 100 billion yuan, primarily covering approximately 98 billion yuan worth of HPV vaccines. In the future, sales of Gardasil/Gardasil 9 are expected to break records again.

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