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Clinical trials, drug approvals slow in China as COVID-19 cases grow globally

The coronavirus pandemic has disrupted clinical trials and slowed regulatory approvals for therapies not combating the virus in China, company executives told S&P Global Market Intelligence.

However, the delays are temporary, and most of the affected trials are likely to make up for lost time in the next few months, the executives said.

For Hong Kong-listed cancer drugmaker Innovent Biologics Inc., early-stage trials of some new drugs under development were delayed by about a month because of the outbreak in China in January and February, CEO and President Michael Yu told Market Intelligence.

Most of the trials came back on track toward the end of March, he added.

At the peak of the outbreak in China, the central government implemented widespread measures to restrict the movement of people and contain the spread of the virus, including the complete lockdown of several cities in Hubei province, the worst-hit region.

China reported more than 82,000 cases and over 3,300 deaths from COVID-19, the respiratory illness caused by the coronavirus, according to data from Johns Hopkins University's Center for Systems Science and Engineering as of April 7.

Study disruptions

Yu said enrollment of patients for a cancer drug study in China was postponed as hospitals shifted resources to treat patients affected by the virus. Some patients already enrolled in clinical trials were also unable to keep up with their treatments or routine checkups during the outbreak, he said.

"That is one of the major issues I believe every company conducting clinical trials has faced," Yu said.

Patient enrollment for a study evaluating the Suzhou-based company's core therapy — cancer drug Tyvyt — as a treatment for lung and liver cancers, however, was already completed before the outbreak, and only patient follow-ups were hampered, he said. Tyvyt is currently approved to treat blood cancer in China.

Tianjin-based vaccine maker CanSino Biologics Inc. also said its research partner in Henan province paused most of its clinical studies during the outbreak, affecting trials of some of Cansino's developmental vaccines, including those for diphtheria, whooping cough, and tetanus, the company said in a filing with the Hong Kong Stock Exchange.

CanSino is also developing a vaccine for COVID-19.

Shanghai Fosun Pharmaceutical (Group) Co. Ltd. also faced similar challenges: "Our clinical trials were inevitably affected, both in China and globally. The impact on clinical trials in China is relatively small as the outbreak came under control quite quickly," company President and CEO Wu Yifang said.

He said the company's studies were set back by a few weeks during the height of the outbreak in the first quarter.

While he did not provide more details, he said trials are being resumed gradually. The company has a range of studies underway for indications ranging from cancer to diabetes.

The Chinese drugmaker is also developing a vaccine and a test kit for COVID-19.

There are 788 ongoing clinical trials in China; 125 of them were in Hubei province as of March 18, according to data from by McKinsey & Co. About 43% of the ongoing clinical studies in Wuhan are sponsored by the top 10 international pharmaceutical companies, the data showed.

The growing number of COVID-19 cases globally poses additional challenges.

Innovent's trials in the U.S. are also facing delays because of the worsening situation there, with more than 360,000 people infected and 10,000 deaths as of April 7. Yu said patient enrollment for clinical trials in the country has slowed and some test sites have even closed.

These delays could be prolonged in the U.S. compared to China since not enough steps were taken to tackle the pandemic, Yu said.

Fosun Pharma's Wu also said the company is monitoring the situation closely and is in close communication with its contract research organization partners.

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Slower approvals

Regulatory approvals for drugs unrelated to COVID-19 have also slowed, company executives said.

Scott Liu, CEO of Shanghai Henlius Biotech Inc., said the drug approval process was set back by about a month as regulators need to prioritize approvals for treatments related to the pandemic. The company markets HLX01, a biosimilar of Roche Holding AG's Rituxan, as a treatment for lymphoma in China. Biosimilars are lower-cost versions of biologic therapies.

China's National Medical Products Administration approved 11 innovative drugs from January to March in 2020, compared to 8 for the same period in 2019. However, the pace of growth slowed from the same period in 2019, when approvals doubled from four in the same quarter in 2018, according to data from Beijing-based research company Pharmcube.

The slowdown in non-COVID19-related approvals is partly due to some regulatory reviewers being unable to work for a while in January and February, said Chen Hao, a China healthcare policy researcher at Huazhong University of Science and Technology.

"The regulator should be able to make up for lost time. But it also depends on how the outbreak overseas plays out," he added.

Some drug applications are based on manufacturing and clinical trials carried out outside China, which require inspections and verification of data provided. These verifications have also been hampered because overseas health institutions and drug regulators are preoccupied with controlling the pandemic currently.

Meanwhile, approvals for test kits, masks and other products for combating the outbreak accelerated.

The country approved 23 coronavirus test kits through March 30, according to a statement on NMPA's website.

READ MORE: Sign up for our weekly coronavirus newsletter here, and read our latest coverage on the crisis here.