GSK Submits New Indication Application in China for Shingrix, Which Generated Approximately $4.3 Billion in Global Revenue in 2023

On February 3, the CDE website showed that GSK's recombinant shingles vaccine Shingrix had submitted a new indication for marketing authorization in China.

Shingrix is the second shingles vaccine approved by the FDA after Zostavax. The vaccine was first approved by the FDA in October 2017 for the prevention of shingles in adults aged 50 years and older; in July 2021, a new indication was approved by the FDA for the prevention of shingles in individuals aged 18 years and older who are at increased risk due to known disease or treatment-induced immunodeficiency or immunosuppression. In May 2019, Shingrix received conditional approval from the NMPA in China for the prevention of shingles in adults aged 50 years and older. Results from the ZOSTER-049 extension study showed that Shingrix provides at least 10 years of protection against shingles in adults aged 50 years and older, with an efficacy rate exceeding 90% across different age groups of 50 years and above.

According to GSK's recently disclosed 2023 performance, Shingrix performed very brightly, achieving nearly £3.446 billion (approximately $4.3 billion, +17%) in revenue for the full year, making it the top-selling product for GSK. GSK stated that this product is expected to achieve peak annual sales of over £4 billion.

On October 9, 2023, Zhifei Biological Products and GSK signed an exclusive distribution agreement for Shingrix. GSK will exclusively supply the recombinant zoster vaccine to Zhifei Biological Products, with the agreed minimum annual procurement amount for the contract products totaling 20.64 billion yuan.

Copyright © 2024 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 reproduce it, please leave a message or send a notification to the WeChat Official Account backend, and include 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.