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

On September 5, the CDE website showed that MSD's nine-valent human papillomavirus vaccine (Saccharomyces cerevisiae) new indication marketing application was accepted.

The nine-valent human papillomavirus vaccine (abbreviation: nine-valent HPV vaccine, trade name: Gardasil 9, Jia Da Xiu 9) is a nine-valent vaccine made using recombinant Saccharomyces cerevisiae CANADE3C-5 (strain 1895) to separately express virus-like particles (VLP) of recombinant human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58 L1 proteins, which are then purified and combined with an aluminum adjuvant.

In April 2018, Gardasil 9 was approved for the first time in China, indicated for the prevention of females aged 16 to 26. In August 2022, it received approval from the National Medical Products Administration (NMPA) to expand the age range, extending its use to females aged 9 to 45. In March this year, a new indication for the product was submitted for marketing approval.

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.

Among them, CTR20212488 and CTR20220441 target Chinese males aged 20 to 45 and 9 to 19, respectively, while the remaining studies were conducted in females.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account backend or send a message, and specify the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Exciting Preview

Online Live Streaming & Offline Salon