SOURCE / ECONOMY
China’s coronavirus test kit producers apply for FDA licenses in advance in ‘bright’ US market
Published: Jan 25, 2021 09:29 PM

A medical worker collects nucleic acid sample at a testing site in a primary school in Harbin, Northeast China's Heilongjiang Province, Jan. 22, 2021. Citizens in Harbin have been undergoing nucleic acid testing for the COVID-19 prevention and control. (Xinhua/Wang Jianwei)



Some Chinese manufacturers of coronavirus test kits said the market prospects for China-US anti-epidemic cooperation are "bright" and they "look forward to making a contribution" to the Biden administration's fight against the COVID-19 pandemic.

Virtually none of the Chinese test kit producers have entered the US market previously, partly due to trade tensions and uncertainties on both sides, industry insiders said. But months before Joe Biden took office, some domestic suppliers started applying for the FDA certification, and others saw rising order inquiries from the US, especially in January, as the market sensed the potential opportunity.

However, industry insiders also voiced concern about whether the US clients' improper use of tests kits could lead to mistrust of Chinese products - even if they have gained FDA certification - and whether the turbulent relationship between the world's two largest economies could further cast a shadow on their exports.  

Guangzhou-based coronavirus test kit maker Wondfo Biotech Co said in a statement sent to the Global Times on Monday that given the US' plan to clamp down on the deadly virus and the evolution of the situation, demand for the quick coronavirus test kits made by Chinese producers will be driven up. 

"The US fight against the coronavirus depends heavily on nucleic acid tests, but such tests involve complicated procedures and are time-consuming. The FDA encouraged local medical enterprises to launch quick testing solutions, but so far the products in the market are very limited," Wondfo said, highlighting the explosive demand for Chinese antigen and antibody detection products.

Compared with nucleic acid tests, it takes about only 15 minutes for antibody detection to yield a result, although the accuracy rate could be lower than the former. Antibody tests can also be conducted by an individual rather than being carried out by professional medical organizations, according to industry analysts. 

They noted that the quick testing measure could be applied to massive preliminary screening in the US, where the nationwide coronavirus outbreak has taken the lives of more than 400,000 people and shown no signs of abating to date. 

Wondfo said it has been in talks with a number of potential international clients and will release the information at the proper time. Currently, most demand for its products comes from western and eastern European nations.

Another Chinese leading producer of nucleic acid test kits, Maccura Biotechnology Co, said in a statement sent to the Global Times that it has the ability and "sense of responsibility" to supply the US market.

Maccura's daily output of nucleic acid test kits has reached 1 million, and it has gained Emergency Use Authorization by the FDA.

"Due to trade tensions, most Chinese nucleic acid test kit makers quit the US market last year. The US is not our strategic focus so far," Maccura said. The company said that the use of nucleic acid test kits needs to be accompanied with the right procedures, and cementing bilateral trust - on the foundation of a normalized trade relation- plays an important role in addressing related issues.

Wuhan EasyDiagnosis Biomedicine Co, another test kit producer, applied for the FDA certification several months ago and is still on the waiting list. The company could produce 3 million nucleic acid test kits and 2 million antibody detection kits a day. 

On the first day of his term, US President Joe Biden signed several executive orders aiming at getting the COVID-19 pandemic under control. He also had a call with Canadian Prime Minister Justin Trudeau, agreeing to join forces to combat the coronavirus in North America, according to media reports.

He Weiwen, a former senior trade official and an executive council member of the China Society for World Trade Organization Studies, told the Global Times that Biden cannot pin his hopes on key medical supplies from the North America, where production lags significantly behind the soaring demand. 

But he noted that for the world's two largest economies to mend crumbling relations, it is critical for both sides to solve political conflicts in the first place.


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