A publicly traded Chinese drug developer, BrightGene Bio-Medical Technology Co., said today it has successfully manufactured the active pharmaceutical ingredients (APIs) of remdesivir (GS-5734), the Gilead Science antiviral candidate being tested in China human clinical trials as a treatment for the 2019-nCoV novel coronavirus.
“[BrightGene] actively responded to the national call to fight the new coronavirus (2019-nCoV) epidemic, and recently successfully developed and synthesized the technology and preparations for the drug synthesis of [remdesivir] technology,” the company stated today.
“The company successfully imitated the development and production of [remdesivir] APIs by virtue of its technical accumulation in the development of high-end APIs and special injections,” BrightGene added in its statement, issued through the Shanghai Stock Exchange. “The company has produced [remdesivir] bulk drugs, and the batch production of Remdesivir preparations is in progress.”
BrightGene acknowledged that its marketing of remdesivir “still needs to be authorized” by Gilead, adding, “There are many uncertainties in this process, such as drug approval.” BrightGene did not discuss in its statement what if any efforts the company has undertaken to pursue authorization from Gilead for the imitation product: “If the product can be approved for marketing, it will be supplied to relevant patients mainly through donations during the epidemic.”
“Therefore, considering production costs, pricing, sales volume and other considerations, this product is not expected to have a significant impact on the company’s operating performance in 2020,” BrightGene’s statement continued.
Shares of BrightGene closed 20% higher today on the news, rising to RMB 52.12 ($7.48) a share. The company has a market cap of RMB 21.369 billion (about $3.1 billion), according to Bloomberg.
BrightGene’s acknowledgement was the company’s second statement in recent weeks related to coronavirus. On January 28, BrightGene and its Founder and Executive Chairman Jiandong “J. D.” Yuan each donated RMB 1 million ($143,426) to the Wuhan Red Cross toward “urgently needed medical material procurement and personnel material protection.”
“The epidemic is a common enemy,” BrightGene stated, adding that the company “has always been with the people of the whole country, especially the people in Wuhan, where the epidemic situation is most severe, to overcome the difficulties.”
The theme of a national struggle against a common foe has been emphasized in recent public statements by Chinese President Xi Jinping, who has characterized China’s initial response as marked by “shortcomings and deficiencies.”
“China has the confidence and capability to secure full victory in the battle against the novel coronavirus pneumonia outbreak while also completing its socioeconomic tasks,” Xi was paraphrased by Xinhua as stating on Tuesday, a day after he was photographed as having his temperature taken while inspecting novel coronavirus pneumonia prevention and control work at the Anhuali community center in Beijing’s Chaoyang district.
44,653 Confirmed cases in China
According to updated coronavirus figures reported today by China’s National Health Commission, 97 deaths and 2,015 new cases of infections were confirmed on Tuesday. To date, 44,653 people have been confirmed as infected with 2019-nCoV, and 1,113 people have died—more than triple the 349 who died in the SARS outbreak of 2002–03—with 4,740 patients cured and discharged from hospitals.
Gilead is partnering with Chinese health authorities on human clinical trials of remdesivir that have already begun in Wuhan, the center of the novel coronavirus outbreak. China’s state-owned Xinhua news agency has reported that the trials have officially launched following approval by China’s National Medical Products Administration of applications by the China-Japan Friendship Hospital and the Chinese Academy of Medical Sciences to conduct the clinical studies.
Friendship Hospital plans to study a total of 761 patients in two trials—one trial to assess 308 with mild or moderate infection, the other 453 severely infected patients—at Jinyintan Hospital in Wuhan.
“Obviously we’re waiting for data, both in vitro and then in people to ensure that the drug actually works,” Gilead chairman and CEO Daniel O’Day said February 4, addressing analysts on his company’s conference call following release of fourth-quarter and full-year 2019 results, according to a transcript published by Seeking Alpha. “We are investing pretty heavily to make sure that we’re prepared as best as we can.”
“In terms of manufacturing, our team has really been working night and day,” O’Day added, “It’s been very impressive to watch this team over the past couple of weeks really ramp up to the extent that we can. If our capacity is going up every day, we’re looking at all the options we have expecting to be prepared for what may come.”
Also today, the World Health Organization (WHO) said it is renaming the 2019-nCoV virus as COVID-19, with director general Tedros Adhanom Ghebreyesus stating that the new name “did not refer to a geographical location, an animal, an individual or group of people, and which is also pronounceable and related to the disease”.
“Having a name matters to prevent the use of other names that can be inaccurate or stigmatizing. It also gives us a standard format to use for any future coronavirus outbreaks,” Tedros added.