FiercePharma reports that China's National Medical Products Administration has conditionally approved GlaxoSmithKline's (GSK +1.1%) shingles vaccine Shingrix, allowing it to file for approval there based on data generated in other countries.
The product has been a winner for the company since the FDA nod in October 2017. Last quarter, it generated £357 million ($452 million) in sales, 43% above expectations and up more than 60% sequentially.
To meet demand, GSK is pouring $100M into its Montana facility to boost capacity to high-teens millions of doses over the next couple of years.
The adjuvant used in the vaccine, an extract from the soapbark tree native to Chile, has been associated with cases of hypersensitive immune system disorders. It plans to add the information to its U.S. label. The Chinese regulator wants the company to conduct postapproval studies to update the product's China-specific data and to better understand the adjuvant's potential link to the disorders.
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