Chinese drugmakers are gearing up to carry out clinical trials for potential COVID-19 therapies in overseas markets as they struggle to find an adequately sized patient population in the country.
Tianjin-based CanSino Biologics Inc., Shanghai Junshi Biosciences Co. Ltd. and Beijing-based Sinovac Biotech Ltd. are among Chinese companies testing drug and vaccine candidates for COVID-19.
While there has been a recent spike in COVID-19 cases in China, the total patient population is still not enough for large-scale advanced drug studies, according to one industry expert.
China reported around 84,000 COVID-19 cases and about 3,000 related deaths until March. Since then, the outbreak has subsided apart from sporadic spikes in Beijing and the provinces of Xinjiang and Liaoning.
Currently, China has around 781 people infected with the coronavirus, according to the National Health Commission.
"That’s far from enough for [late-stage] trials," said Chen Hao, a China healthcare policy researcher at Wuhan-based Huazhong University of Science and Technology.
A phase 3 trial for a vaccine, which aims to evaluate the effectiveness of a product in large populations, needs to enroll at least 1,000 patients if the aim is to seek emergency approval. Otherwise, more than 10,000 volunteers will be needed for the study, Chen said.
Phase 1 or phase 2 trials, in contrast, mainly focus on assessing safety and preliminary efficacy in small groups.
The age, gender and prior health conditions of patients also have to be considered during the screening process, Chen added.
"Not many of the existing patients in China meet the requirements," he said.
Only 212 of the 1,208 clinical trials being carried out globally for COVID-19 therapies and vaccines are in China as of July 31. In contrast, U.S. has 321 ongoing trials, according to research firm Global Data.
With the pandemic spreading unabated, governments across the globe are desperately seeking an effective treatment or vaccine. The U.S., among the worst-hit nations, has recorded over 4.5 million cases and more than 150,000 deaths as of July 31, according to Johns Hopkins University's Center for Systems Science and Engineering.
All these virus hot spots present opportunities to hold COVID-19 drug and vaccine trials, said Jeremy Lim, a professor at the Saw Swee Hock School of Public Health at the National University of Singapore.
However, given escalating political tensions between the U.S. and China, it might be hard for Chinese companies to hold clinical studies without partnering with American companies, he added.
"I doubt Americans will choose to participate in such a [Chinese] study compared to those carried out by companies such as Pfizer Inc. and Moderna Inc.," he added.
One of the few notable partnerships in this space is between Shanghai-based Junshi and Eli Lilly and Co., which agreed to carry out overseas trials for Junshi's experimental COVID-19 therapy, JS016.
The Indianapolis-based drugmaker, which is overseeing trials on JS016 in the U.S, has completed a phase 1 study and is now preparing to initiate a phase 2 study, Junshi's assistant general manager, Yu Wenbing, told S&P Global Market Intelligence.
Hong Kong-listed Cansino, one of the leading contenders among Chinese companies developing a COVID-19 vaccine, has also said it will conduct late-stage trials overseas due to a lack of eligible patients in China.
The company's experimental COVID-19 vaccine was found to be safe and induced significant immune responses in a phase 2 study in China, according to results published July 20 in medical journal The Lancet.
Meanwhile, China National Biotec Group Co. Ltd. plans to initiate a phase 3 trial for its vaccine in the United Arab Emirates with Abu Dhabi-based technology company Group 42 Holding Ltd., while Chinese vaccine manufacturer Sinovac Biotech has joined hands with Brazilian entity Instituto Butantan to undertake a phase 3 trial for the former's COVID-19 vaccine candidate in Brazil.
Suzhou-based Alphamab Oncology has also tied up with Institut Pasteur of Shanghai, a research institution under the state-run Chinese Academy of Sciences, to develop a COVID-19 therapy. CEO Xu Ting said Alphamab plans to start animal tests by October and clinical trials by the end of this year.
"We will likely use Institut Pasteur of Shanghai's network and resources in places such as Brazil, India or Africa for clinical studies," Xu said in an interview with Market Intelligence.
Some investors noted that continuing trials for COVID-19 drugs and vaccines overseas can also help China better prepare for any future large virus outbreak.
"The outbreak was quite disruptive. It closed the Chinese economy for about two months, and you don't want that to happen again," said Brad Loncar, Kansas-based biotech investor and CEO of Loncar Investments.
Alphamab’s Xu and Shanghai Junshi’s Yu both said their companies will use trial results to seek approval for their treatments in China. Alphamab may even consider initiating trials in China if there are enough patients in the near future, Xu said.
"The virus will definitely come back [to China], but given the contact tracing system in the country, it’s unlikely the outbreak will be huge," he said, adding that any potential COVID-19 drug or vaccine could also be granted fast-track approval in China.