In a high­ly un­usu­al step, a Chi­nese com­pa­ny said it has be­gun mass pro­duc­ing an ex­per­i­men­tal Gilead drug that US doc­tors used to treat pa­tients in­fect­ed with the nov­el coro­n­avirus.

Bright­Gene Bio-Med­ical Tech­nol­o­gy Co said in a fil­ing to the Shang­hai stock ex­change that it de­vel­oped tech­nol­o­gy to man­u­fac­ture remde­sivir and be­gan mass pro­duc­ing the ac­tive phar­ma­ceu­ti­cal in­gre­di­ent for the event the drug is ap­proved by Chi­nese au­thor­i­ties while the out­break is on­go­ing. They said they are in the process of mak­ing the full drug.

Al­though oth­er com­pa­nies have start­ed pro­duc­ing com­pounds for po­ten­tial clin­i­cal tri­als, Bright­Gene stands out both for its scale and be­cause the com­pa­ny does not have the rights to the ex­per­i­men­tal drug, remde­sivir, and says it will li­cense it from Gilead. Gilead has sup­plied suf­fi­cient dos­es of the drug for Chi­nese re­searchers to be­gin clin­i­cal tri­als on sev­er­al hun­dred pa­tients, but the com­pa­ny has shown lit­tle in­di­ca­tion of how they would pro­ceed if the drug is ap­proved.

The Wuhan In­sti­tute of Vi­rol­o­gy has al­so filed for a patent to use remde­sivir against the nov­el coro­n­avirus, re­cent­ly dubbed COVID-19 by the World Health Or­ga­ni­za­tion. Gilead CEO Daniel O’Day said in re­sponse that the com­pa­ny “will not get in­to a patent dis­pute.”

Chi­na could al­so in­voke a “com­pul­so­ry li­cense,” a le­gal ma­neu­ver that al­lows coun­tries to over­ride patents in emer­gen­cies, but it has not done so.

Gilead could not be im­me­di­ate­ly reached for com­ment. Bloomberg was the first to re­port the news.

Gilead orig­i­nal­ly de­vel­oped remde­sivir as an an­tivi­ral to treat Ebo­la and a sim­i­lar in­fec­tion known as Mar­burg Virus, but in clin­i­cal tri­als af­ter the last Ebo­la out­break in West Africa, it proved less ef­fec­tive than Re­gen­eron’s REGN-EB3 an­ti­body and an­oth­er an­ti­body de­vel­oped by the US gov­ern­ment. Those tri­als, how­ev­er, es­tab­lished the drug as large­ly safe.

Doc­tors in Wash­ing­ton state turned to the drug as they strug­gled to treat the first US case of the out­break in Jan­u­ary. The pa­tient re­cov­ered, al­though doc­tors cau­tioned that the drug would have to be test­ed in clin­i­cal tri­als to show ef­fi­ca­cy.

So­cial im­age: Coro­n­avirus via CDC

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.