Regulator's support energizes test kit makers to fight COVID-19

China's private enterprises are receiving guidance and assistance from the National Medical Products Administration in an unprecedented way to reinforce the former's commitment to the research and development of COVID-19 test kits, industry insiders said.

An emergency work team from the NMPA has been tasked with extending help to private firms round the clock in order to help the latter avoid detours in their R&D efforts.

This is ample proof that the NMPA is intent on giving adequate opportunities to private businesses to play their part in society, said Shao Junbin, chairman of Liferiver, a Shanghai-based diagnostics solution provider.

Liferiver specializes in polymerase chain reaction-, or PCR-, based molecular diagnostics.

"The government has displayed an attitude of openness and inclusion toward private businesses, offering us larger space to make contributions to society's economic and social development," he said in an exclusive interview with China Daily.

Shao said that officials and professionals from the NMPA were available for consultations on the phone and online chat groups around the clock when the company was running against time to develop nucleic acid detention reagents for COVID-19 early this year.

For instance, when Liferiver was evaluating the performance of a certain indicator of the product, they could discuss their ideas based on technological guidelines with NMPA experts in advance. Feedback and advice were always forthcoming from the NMPA, which helped Liferiver to formulate a clear plan of action, Shao said.

"During the outbreak, this helped save much time in terms of paperwork, and such practice was also in line with international practice," Shao said.

As a result, the novel coronavirus detection reagent developed by Liferiver was among the first batch certified by the country as well as the World Health Organization, ensuring the supply of such test kits to the front lines of pandemic prevention and control.

Shao said Liferiver's COVID-19 test kits with strong performance in sensitivity, accuracy and stability, were among the most widely used in the country, covering all the regions.

Altogether the company has more than 36 diagnostic products for various infectious diseases, including more than 10 for different types of respiratory infections, and four star products for HPV (human papilloma virus) testing.

"One strength of our COVID-19 nucleic acid testing product is that it traces three genes of the novel coronavirus at the same time to prevent undetected infections as much as possible even when the density of the virus load is low," he said.

The test kits have been used in more than 60 countries, including over 30 in Europe, to aid local efforts to combat the pandemic. The government has also helped with coordination for cargo aircraft as many international flights were suspended during the peak of the pandemic, Shao said.

A slew of measures at the Shanghai municipality level as well as the national level have been unveiled in recent years to encourage and support the development of the private sector.

A 38-point list of measures to help strengthen technological innovations and provide market resources to private firms was released in late October.

Shao recalled that the year 2009, during the H1N1 swine flu outbreak, saw the quick development of the country's biomedicines. In that year, drug and medical product authorities began to open doors to private enterprises to contribute their intelligence and products for public health emergencies.

"A working committee was established by the country's authorities to collect potential solutions from private enterprises. Until then, such opportunities were limited to national research institutions and universities," he said.

He suggested more clinical research resources, mostly at public hospitals, can be made available to private businesses so that different market players, be it State-owned enterprises or private firms, can better contribute to the country's dual-circulation development pattern in a transparent and efficient environment.

A kit that can test the novel coronavirus and the influenza virus at the same time and produce results in 30 minutes will be submitted for approval early next month, Shao said.