GlaxoSmithKline's booming Shingrix, after VIP invite, wins nod to tackle China

GlaxoSmithKline’s shingles vaccine Shingrix has continuously impressed industry watchers with its explosive growth. Now, the company has added another large market to its list: China.

Shingrix has been conditionally approved in the country, China’s National Medical Product Administration (NMPA) said (Chinese) Wednesday. The green light follows China's move to invite GSK and the makers of 47 other drugs to file for approvals based on foreign data. 

In China, about 3 million adults are affected by the painful condition each year, according to the agency. That’s about three times as many as the Centers for Disease Control and Prevention’s estimate for the U.S. But for now, same as with its U.S. nod, the vaccine is only allowed in people ages 50 and above.

Shingrix has enjoyed exponential growth since its FDA green light in October 2017. In the first quarter, sales of the vaccine reached £357 million ($452 million), 43% ahead of analysts’ expectations and more than 60% more than its haul in the previous quarter. And GSK is billing the first quarter as a good measure of what’s to come throughout 2019.

But unexpectedly strong demand has already outstripped supply in the U.S. and EU. Does GSK even have the bandwidth to provide for China?

"Introduction of the vaccine into China will be phased, starting in 2020, to ensure consistent and reliable supply of the vaccine to all countries in which the vaccine has been launched. Over the next several years, GSK expects to increase supply of Shingrix globally and is investing in significant capacity expansion," GSK said in an statement Thursday.

One thing is certain: GSK is amping up its manufacturing capacity toward the goal of high-teens millions of doses over the next two or three years, CEO Emma Walmsley said on the company’s full-year 2018 earnings call in February. In April, the British drugmaker unveiled a $100 million investment to an existing site in Montana that will add additional adjuvant production capabilities that could help with supply for Shingrix, GSK's U.S. president of pharmaceuticals Jack Bailey said in a statement at the time.

But the adjuvant used in Shingrix is exactly what’s causing some safety concerns. Instead of commonly used aluminum-containing adjuvants, Shingrix uses an adjuvant formulation that contains an extract from the soapbark tree.

Adjuvants are added to vaccines to boost the immune response. However, postmarketing experience has identified an increase in incidents of hypersensitivity immune system disorders. The FDA last Friday approved GSK’s request to add the information to Shingrix’s label, which says "it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine," because these reactions are reported voluntarily.

The Chinese authority has also taken note. The NMPA is asking GSK to run postapproval studies to update the vaccine’s China-specific data—which it currently doesn’t have—and to better understand whether the novel adjuvant could lead to higher risk of immune disorders.

China has been accelerating its drug approval process, waiving China-specific trials for certain innovative medications. From its first list of "clinically urgently needed drugs" unveiled last year, it has approved 15, including Amgen’s bone cancer drug Prolia, which also nabbed (Chinese) its nod based on foreign data Wednesday. The NMPA’s Center for Drug Evaluation in March put forward its second list with 30 additional drugs, including Sanofi and Regeneron’s Dupixent, Roche’s Xofluza, Gilead’s Biktarvy and several rare disease therapies.

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