The London-listed company - which is known as Chi-Med and is
collaborating with Eli Lilly on the drug - said on Wednesday that
the National Medical Products Administration of China had approved
Elunate or fruquintinib in colorectal cancer.
The medicine is the first China-discovered and developed mainstream
cancer drug to win unconditional approval following a randomized
clinical trial. Shares in Chi-Med rose more than 4 percent on the
The green light shows the country's progress in speeding up drug
approvals and underlines China's emerging role in biotech, as
Beijing tries to move the pharmaceutical sector up the value chain
from its traditional position making cheap generic drugs.
Chi-Med Chief Executive Christian Hogg believes biotech will follow
the same playbook as other high-tech areas like solar panels and
bullet trains, where China is already a global force.
"China's time is coming ... the biotech infrastructure that has been
built in China is very strong and the pool of scientific talent is
very deep," he told Reuters.
"Fruquintinib represents the first one across the finish line, but
we have other drug candidates in clinical trials and there are many
other companies in China with drug innovations in development."
Elunate will only be rolled out in the United States and Europe
following its Chinese approval - a marked reversal from the
historical pattern, which has seen patients in China getting new
drugs years after their arrival in Western markets.
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China is now the world's second-biggest drug market, behind the
United States, and is gaining in importance for global
pharmaceuticals companies' growth plans. In the case of Elunate, Eli
Lilly's sales force will market the product in China.
AstraZeneca and partner FibroGen also hope to score a China-first
drug approval before the end of 2018 with their new anemia treatment
roxadustat, which could win approval in China before it does so in
the United States or Europe.
Enthusiasm for Chinese biotechnology stocks has led to a wave of new
companies listing on Nasdaq and, more recently, in Hong Kong, amid
investor excitement over the size of the Chinese market and recent
moves to accelerate drug approvals.
But the market has been volatile and shares in the first company to
take advantage of Hong Kong rules allowing listings from pre-profit
biotechs dropped sharply in their first month of trading.
"There will be periods of overenthusiasm and under-enthusiasm, but
the fundamental drivers are there and will remain," Hogg said.
(Reporting by Ben Hirschler; Editing by Dale Hudson)
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