Big Pharma Wins Drug Approval in China Ahead of West for First Time -- Update
December 18 2018 - 11:49AM
Dow Jones News
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)
Copyright (c) 2018 Dow Jones & Company, Inc.
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