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Coronavirus outbreak begins to disrupt booming China drug trials

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Coronavirus outbreak begins to disrupt booming China drug trials

The fast-spreading coronavirus is starting to disrupt the testing of experimental medicines in China, posing a threat to plans by global drugmakers that have invested billions of dollars to harness the potential of the Asian economic powerhouse.

The U.S. clinical trial database lists nearly 500 studies with a site in the city of Wuhan, which has endured the brunt of an outbreak that has killed more than 1,100 people and infected more than 44,000 in China. About 20% of global trials are now conducted in China, up from about 10% just five years ago, according to GlobalData Plc.

China has imposed a virtual lockdown on Wuhan and severely restricted travel in its wider province of Hubei and some other cities.

While it is too early in the outbreak first detected in December to fully assess its impact on clinical trials, if it goes on much longer the pharmaceutical industry’s China strategy is likely to be disrupted.

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Virus-curbing efforts by the government have made it difficult for trial patients to reach hospitals running studies, according to interviews with two contract research organizations that conduct trials for drugmakers, local drug companies, and doctors.

Others fear to become infected if they return to a healthcare facility for a trial.

“Hospitals aren’t focused on clinical trials right now,” said Ian Woo, president, and chief financial officer of Everest Medicines, which is developing drugs for the Chinese market. “They have plenty of other things to be focused on.”

The outbreak has delayed the launch of new studies, and research organizations like dMed Biopharmaceutical Co said they have been unable to send staff to monitor trial sites.

Affected ongoing studies include trials testing a Novartis medicine for a rare blood disorder, a cancer drug from BeiGene Ltd and a treatment for a type of spinal arthritis from Chinese drugmaker Tasly Pharmaceutical Group, according to doctors involved.

Beijing-based BeiGene, which has more than 20 trials ongoing in Wuhan, said it was working to minimize potential delays and disruptions, but that it was “too early to speculate on any specific impact on our clinical trial and commercial progress in China.”

Other drugmakers with trials in China, including Roche, Zai Lab Ltd and Hutchison China MediTech Ltd (Chi-Med), also said it was too soon to speculate on the outbreak’s consequences. But the impact is being felt.

Shenghao Tu, who is working on the Tasly clinical trial in Wuhan, said the study in his hospital has been suspended.

“This is a problem that (we) never encountered before,” Tu said.

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The issue is not limited to Wuhan.

Two doctors testing the BeiGene cancer drug tislelizumab in Beijing and Guangzhou city said efforts to contain the virus have hampered patient enrollment and capacity.

Both their hospitals now require that each room hold only one patient to prevent cross-infection, reducing the number they can accommodate.

vanguard

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