CBI member, GlaxoSmithKline has announced that it has obtained ‘conditional approval’ from China’s National Medical Product Administration to launch its shingles vaccine, Shingrix.
In China, about 3 million adults are affected by shingles each year. Responding to significant public need, the Chinese Government included shingles in a list of “clinically urgently needed new drugs”, released by China’s State Drug Administration to foreign pharmaceuticals companies last August. This list was released to encourage foreign drug developers to apply foreign data and evidence to fulfil China’s drug needs and expedite approval. Consequently, GSK’s Shringix vaccine has been approved for use in China on the same conditions as by the US Federal Drug Administration (FDA) –- the vaccine is only allowed in people ages 50 and above.
Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines 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. It can result in lasting pain and other complications which can severely impact the quality of people’s lives. [GSK] 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.”
Shingrix is currently licensed for use in the EU, US, Canada, Japan and Australia, and has performed incredibly well across all markets. In the first quarter of 2019, following US FDA approval, sales of the vaccine reached £357 million – 45% ahead of analysts’ expectations and more than 60% more than the previous quarter.
To read the official press release, please follow the link.
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