Biosecurity laws to be fast-tracked within China

Richard Tadd Industry News

Top leadership in Beijing has faced difficult decisions over the previous weeks. Though new cases of COVID-19 continue to see a downward trend, much of this can be attributed to the fast and firm response of the officials, with the shutting down of crowded public spaces and city centres being just some examples of the measures taken.

Senior figures in both cabinet and ministry organisations, such as the NHC and NMPA, have agreed to begin a fast-track process within mainland China, with medical device registration and new trials being two of the primary aims. This comes after an address by President Xi Jinping earlier in the month, in which he outlined the importance of such a move not only to preserve public health and accelerate the discovery of a treatment for COVID-19, but to safeguard national security.

In the same address, he called for large-scale reforms to be made with regard to the Chinese emergency health response program, noting that it had been a “major test for the national governance system and governance capacity” and that it had fallen short of its intended goals in this particular instance. Despite this assertion, Tedros Adhanom Ghebreyesus, director general of the World Health Organisation, had earlier praised the Chinese response. Tedros noted that Xi had shown the levels of “political commitment” and “political leadership” that should be expected of all countries facing a potential health crisis.

Elsewhere, Chinese healthcare companies have been kept extremely busy with the ever-increasing desire to find treatments for the outbreak. According to StatNews, on 19 February 2020, there were, in China, 121 clinical trials regarding the COVID-19 virus either underway or shortly to be initiated, out of a total 124 active trials. Just a week prior to that, this tally was at 70 total trials.

Jake Mathon, an analyst at UK-based Informa Pharma Intelligence, stated: “As of this moment, you’re looking at 40,000-plus patients being targeted. It’s an amazingly fast response and the sheer number of patients involved is pretty staggering.” Many of these trials are making use of academic medical centres and government bodies, in addition to top Chinese CRO firms.

The coronavirus has far from an exclusive hold on Chinese biopharmaceuticals, however. With support from the Li Ka Shing Foundation – a foundation that aims to fund social, educational and healthcare initiatives – UK-based Owlstone Medical in Cambridge has opted to run its preliminary medical trials in China, in collaboration with Shanghai’s Renji Hospital.

In a statement, Billy Boyle, co-founder and CEO of Owlstone Medical, noted: “Expansion into China through the establishment of an in-country Breath Biopsy lab and formation of high value partnerships is an important part of Owlstone Medical’s strategy.” The breathalyser developed by the firm is part of a wider worldwide trend to move towards more efficient diagnostic equipment that will increase survival rates through early detection. Lung cancer is among the primary disease targets for the trial.

It is reassuring to note that despite the outbreak, industry leaders worldwide are still choosing to recognise the benefits of China clinical trials.