FGEN FibroGen Inc

By Denise Roland and Preetika Rana 

China has for the first time approved a drug from a multinational before any other country, illustrating its efforts to speed up the arrival of cutting edge medicines, and Western companies' growing interest in the market.

The country's medicines regulator Tuesday approved AstraZeneca PLC and Fibrogen Inc.'s new anemia drug roxadustat, well ahead of any other nation.

China approved 30 foreign innovative drugs through September this year and is on track to match, or surpass, the 40 such approvals it granted in 2017 -- the most in any single year for at least a decade, according to consulting firm McKinsey & Co. In 2016, China approved three such foreign drugs. Some of those approvals have taken just weeks.

In the case of roxadustat, Beijing allowed AstraZeneca and Fibrogen to submit their clinical trial results to the regulator on a rolling basis starting last year, rather than waiting for all their key clinical trials to finish. The Chinese regulator also awarded priority review status, accelerating its assessment of the drug. Roxadustat is aimed at patients on dialysis who are suffering from anemia caused by chronic kidney disease.

The approval came just two months after the companies completed their submission. The companies haven't yet submitted the drug to the U.S. Food and Drug Administration, though plan to do so next year. It is unusual for drug companies to seek approval in China before the U.S., which is the world's biggest pharmaceuticals market.

"Things moved a lot faster in China," said John Houghton, who leads the global development of roxadustat at AstraZeneca. He said the companies didn't set out to get their first approval in China, but that the fact the drug was prioritized allowed them to make quicker progress there.

China makes up 19% of AstraZeneca's global sales, and growth has accelerated this year. Chief Executive Pascal Soriot has said he expects China to eventually overtake Europe as the company's second-largest market after the U.S.

Under its agreement with San Francisco-based Fibrogen, AstraZeneca will manage the sales of roxadustat in China and expects to launch the drug in the second half of 2019.

Drugmakers see a big opportunity in China, where the more affluent urban class can afford private insurance or pay out-of-pocket for treatments.

Another boost could come from Beijing's decision to reimburse some medicines. But despite efforts by the government to partially cover the costs of more drugs, it has so far only agreed to do so for 10 out of the 70 foreign medicines approved since the start of 2017.

Many companies have reduced prices to get their drugs onto the list, though they argue that the price discount is offset by the increased number of patients they can reach. AstraZeneca offered a discount of 71% on the price of its lung-cancer drug, Tagrisso, which was approved last year and is now on the list.

Write to Denise Roland at Denise.Roland@wsj.com and Preetika Rana at preetika.rana@wsj.com

(END) Dow Jones Newswires

December 18, 2018 11:34 ET (16:34 GMT)

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