UPDATED 5 MARCH 2020: BrightGene has since been censured by the Shanghai Stock Exchange (SSE) for making misleading claims and disclosing inaccurate information over its alleged manufacture of remdesivir.
In a statement, the SSE said that BrightGene has not gained approval from China’s drug regulator to manufacture the drug, and neither has it gained a licence from the patent owner Gilead to manufacture the drug on a large scale.
BrightGene has only been able to make small quantities of the drug, rather than the enough for commercial sale, which it had originally claimed.
ORIGINAL ARTICLE 13 FEBRUARY 2020: Chinese pharma BrightGene has reported that it has successfully copied remdesivir, an experimental therapy which has shown promise against the novel coronavirus.
However, Gilead which holds all patents around the development and production of the drug – including for its development as a treatment for coronavirus.
The novel coronavirus – recently named COVID-19 by the World Health Organization – has claimed 1,350 lives so far, with the majority of cases occurring in China, the epicentre of the outbreak.
The country has reported almost 60,000 cases of the infection, which has spread to a number of countries – including the UK, which has reported a total of nine confirmed cases.
In an attempt to stop the spread of the disease, researchers as well as Chinese health authorities have been testing a number of experimental therapies against COVID-19.
The one with the most potential – so far – has been antiviral drug remdesivir, which Gilead had already been developing as a treatment for Ebola disease and Marbug virus infections.
Although BrightGene has said it has successfully developed and manufactured copies of the drug, it has also maintained that it will not launch the drug until it has received licensing from Gilead, conducted clinical trials and obtained approval.
A study of remdesivir in COVID-19 has already begun enrolling patients in China, with a Gilead spokesman confirming that two clinical trials will be conducted in Wuhan, the city where the first cases of the novel coronavirus were observed.
A Chinese state-owned news agency – Xinhua – has reported that trials have already officially launched, following the approval by China’s National Medical Products Administration of applications by the China-Japan Friendship Hospital, as well as the Chinese Academy of Medical Sciences, to conduct the trials.
The Friendship Hospital will study 761 patients with COVID-19 in two trials – one to assess those with mild-to-moderate cases of the virus and another to assess severely affected patients in Wuhan.
The news reflects a larger issue of patent exclusivity in China, and in particular, around remdesivir. Researchers at the Wuhan Institute of Virology have already filed an application in China to patent remdesivir, although Gilead has indicated that it already holds a patent for the drug in China.
Following its announcement, BrightGene saw its share climb 20%, increasing to RMB 52.12 ($7.48) per share.