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China Eases Path for Foreign Drugmakers’ Hepatitis C Treatments
Four global drug companies to be granted priority-review status
April 22, 2016 6:14 a.m. ET
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SHANGHAI-- China will grant four global drug companies priority-review status to launch groundbreaking new hepatitis C treatments in China, a rare move to open the lucrative market to foreign players.
China’s Food and Drug Administration expedites domestic drug applications to encourage innovation. But its lengthy drug-approval process for foreign companies means none of the direct-acting antiviral agents that have been shown to cure more than 90% of hepatitis C patients within a few months have been approved in China, which has among the highest rates of the disease in the world with an estimated 10 million people infected.
Chinese patients tired of old-generation therapies such as interferon injections have increasingly traveled overseas to access the new therapies.
Hepatitis C treatments from Gilead Sciences Inc., AbbVie Inc., Bristol-Myers Squibb Co and Janssen Pharmaceuticals Inc.’s Chinese joint venture Xian Janssen are now expected to enter the world’s second-largest pharmaceuticals market in a shorter time, according to an announcement from the Center for Drug Evaluation this week. Two domestic companies and a Taiwanese company also will get priority review-status for hepatitis C drugs.
Industry experts say priority-review status doesn’t guarantee approval but welcomed the move.
“It shows that the CFDA is serious about prioritizing important new innovative medicines that address real unmet medical need or improve substantially on what’s currently available, whether they originate in domestic or [global] pharma companies,” said Laura Nelson Carney, senior research analyst at Bernstein Research.
In a rare response to a request to comment on its strategy, the CFDA said it welcomes innovative drugs to enter China, “the earlier, the better.” But it stressed that speed shouldn’t trump quality and that the review process would follow strict standards.
Spokespeople for Gilead Sciences, AbbVie, Xian Janssen and Bristol-Myers Squibb all welcomed the decision and said they were looking forward to bringing new hepatitis C treatments to people in China.
It is unclear how much sooner the foreign drugs will reach the Chinese patients. The drug regulator says it will start the review process within 10 days for drugs that have been prioritized. On average, standard applications to start trials take about 17 months while applications to market drugs take a further 20 months, according to the analysis by IMS Health.
Since a policy was enacted in February to prioritize innovative treatments for a number of diseases, including viral hepatitis, AIDS and tuberculosis, several domestic companies have secured priority status. The latest batch of companies was the first including foreign ones.
The treatments must show significant advantage over drugs already on the market.
The policy also encourages foreign companies to manufacture drugs in China, saying companies will qualify for priority treatment if they submit applications for approvals in China simultaneously with U.S. and European Union approvals and use the same production standards as in those markets.
Global drugmakers have long complained that the delay of drug approvals in China has squeezed their profits. The sales of off-patent branded drugs are still the main source of revenue for global companies in China, partly because they are of better quality than domestic generic drugs and partly because the long approval process means companies only have a short window to profit from patented brand drugs before patents expire.
The Chinese drug regulator has pledged to lift the quality of domestic generics as part of an effort to bring down drug prices and bring them more in line with branded drugs from foreign companies.
Some global drugmakers have shifted focus away from mature drugs in China toward innovative ones. In February, British pharmaceutical giant AstraZeneca PLC sold the regional commercial rights of two best-selling heart drugs, Plendil and Imdur, to China Medical System Holdings Ltd. for $310 million and $190 million respectively. The company also disclosed that it is developing three innovative products in China via local manufacturing.
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