Shingrix is a non-live and recombinant subunit adjuvanted vaccine, which will be administered intramuscularly in two doses.
Shingles is caused by the reactivation of the varicella zoster virus (VZV), which is the same virus responsible for chickenpox.
According to the company, the approval is in response to last year’s inclusion of Shingrix on a list of 48 ‘clinically needed new medicines’ in China designated for expedited review.
The company is also planning to increase supply of Shingrix across the globe over the next several years and is investing in significant capacity expansion.
Shingrix’s approval is said to follow a comprehensive phase III clinical trial program assessing its efficacy, safety and immunogenicity in over 38,000 people.
The pooled analysis of ZOE-50 and ZOE-70 pivotal efficacy studies showed Shingrix efficacy against shingles greater than 90% across all age groups studied, in addition to sustained efficacy over a follow-up period of four years.
The vaccine aggregates an antigen glycoprotein E and an adjuvant system AS01B, which will generate a better immune response that can help overcome the decline in immunity that occurs as people age.
GSK said that the vaccine will be introduced in China in phases starting in 2020 for consistent and reliable supply to the customers.
At present, GSK has license for Shingrix in the EU, the US, Canada, Japan and Australia.
GSK Vaccines chief medical officer and senior vice president Dr Thomas Breuer said: “Today’s approval of Shingrix in China is recognition of the significant scientific advance this vaccine represents.
“In the pivotal studies the vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a disease that affects one in three people across the Asia-Pacific region.
“We welcome the Chinese government’s progress to enable faster entry of new products into China and we look forward to working with the relevant agencies to bring the benefits of this vaccine to local communities.”