(Yicai Global) June 1 -- Bioeasy Biotechnology has followed other Chinese biotech companies in asking for the medical device registration certificate for its Covid-19 antigen test kits to be cancelled amid low prices for such products.

Bioeasy made the request voluntarily, a notice on the National Medical Products Administration website showed yesterday. So far this year, Covid-19 antigen test kit makers have applied to cancel the registration certificates of eight such products.

Bioeasy is adjusting its lineup based on market needs and the decision to not renew the registration certificate will not impact the firm's daily operations and development, an insider at the Shenzhen-based company told Yicai Global.

Test kits were in short supply in China when cases surged after the country eased Covid-19 controls at the end of last year, pushing prices to over CNY5 (70 US cents) per kit. Since then, various products have been made available on local e-commerce platforms for less than CNY2 each, with some priced at less than CNY1.

Last year, the NMPA approved more than 40 kits for sale based on the need to control and prevent the spread of Covid-19, according a source in the vitro diagnostics sector. Approval conditions were relatively loose back then, with many products getting the green light without carrying out clinical trials, the person added.

The duration of a kit's registration certificate is not endless, and if holders want to renew it, they must provide related clinical trial results, such as verifying its sensitivity to new strains. But this can cost hundreds of thousands of Chinese yuan (equivalent to tens of thousands of US dollars) a month.

“The price of kits is too low now, so spending money to keep the registration certificate has become not worthy for companies,” the person in vitro diagnostics said. As profits from the kits are very thin, makers are mostly clearing their stocks without considering the expense, pricing products at less than CNY1 each, he noted.

Editors: Liao Shumin, Martin Kadiev