Australia's George Clinical closely tracks China's growing number of domestic Contract Research Organizations and notes that of the estimated 250-odd companies, 90% are focused on domestic work. But George Clinical, based in Sydney, also looks ahead to the day the Chinese CROs and drug companies take bigger leaps into the global business.
|George Clinical Executive Chairman Glenn Kerkhof|
"It's going to be really interesting when Chinese pharma and biotech firms start moving into global trials in a big way," said Glenn Kerkhof, who was appointed executive chairman of George Clinical in March 2015, in a telephone interview.
"We don't try to compete in the national clinical trials market in China, but watch the space closely and see that some drugs under development in China have the potential to go global."
A spate of oncology candidates in China, including an approved lymph-node cancer drug on the local market from Chipscreen Bioscience, Epidaza (chidamide), and up and coming candidates from Hutchison China MediTech and BeiGene, have caught attention.
As well, this month an Investigational New Drug application for WuXi PharmaTech ($WX) and MedImmune's novel anti-IL6 monoclonal antibody (mAb) for rheumatoid arthritis was accepted for review by the China Food and Drug Administration.
"The pace of developments in China's biotech space in oncology or other chronic disease areas capture interest not just for the market size domestically, but the potential to bring those candidates into a global sphere," said Marisa Petersen, executive director of George Clinical in a telephone interview.
"Our input is to help develop candidates that could be approved globally," Petersen said.
To be sure, CROs such as Catalent ($CTLT), Covance and Quintiles among others see the potential in China as well.
The CRO also has a sharp eye on India where diabetes and cardiovascular trends are tracked, along with China and other Asian countries, by the parent George Institute for Global Health, which conducts research on chronic disease global health trends, and is a nonprofit organization.
However, China has also attempted to change guidance on multiregional clinical trials (MRCT) causing industry concern over new administrative layers in an already stacked file of pending new drug approvals domestically.
The domestic approval scene impacts potential workflows and the ability to use insights from global trials remains a concern.
"On MRCT we are watching and waiting to see how the guidance unfolds," Petersen said. "There are some good signals with Japan, China and South Korea working on accepting data."
In clinical oncology work the stakes are high for wider acceptance of such data packages, Kerkhof said, adding that "oncology trials make up around 50% of global clinical trials activity."
- here's the George Clinical website