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

Feb 03, 2024 08:31 CST Updated 08:31

GSK

Pharmaceutical R&D Manufacturer

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. This vaccine was first approved by the FDA in October 2017 for the prevention of shingles in adults aged 50 and older; in July 2021, a new indication was approved by the FDA for the prevention of shingles in individuals aged 18 and above who are at increased risk due to known diseases or treatments causing immunodeficiency or immunosuppression.

In May 2019, Shingrix was conditionally approved by the NMPA for market launch in China to prevent shingles in adults aged 50 and above. Results from the ZOSTER-049 extended study showed that Shingrix can provide at least 10 years of shingles protection for adults aged 50 and above, with an efficacy rate exceeding 90% across different age groups within this population.

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, ZF Bio signed an exclusive distribution agreement with GSK for Shingrix. GSK will exclusively supply ZF Bio with the recombinant zoster vaccine. The estimated minimum annual procurement amount for the agreed products is RMB 20.64 billion in total.。

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