One of the three drugs that Chi­na’s Min­istry of Sci­ence and Tech­nol­o­gy has tapped as po­ten­tial COVID-19 treat­ments to watch has notched its first Chi­nese OK — for the flu.

While there’s no proof yet that fapilavir, or favipi­ravir, is the cure that pa­tients and physi­cians are yearn­ing for, it stands out for a unique con­stel­la­tion of qual­i­ties. It’s been com­mer­cial­ly avail­able in Japan for sev­er­al years (un­like Gilead’s ex­per­i­men­tal remde­sivir) yet it’s new to Chi­na (un­like the malar­ia drug chloro­quine phos­phate). Per­haps more im­por­tant­ly, a do­mes­tic biotech — Zhe­jiang Hisun Phar­ma — owns the rights to man­u­fac­ture and mar­ket the drug, pre­empt­ing any con­cerns about patents.

At the same time, the Min­istry of Sci­ence and Tech­nol­o­gy sug­gest­ed that chloro­quine phos­phate, a 70-year-old drug, should be in­clud­ed in the stan­dard reg­i­men af­ter show­ing promis­ing re­sults in tri­als across 10 hos­pi­tals.

Clin­i­cal guide­lines for the treat­ment of res­pi­ra­to­ry ill­ness­es re­sult­ing from the new coro­n­avirus orig­i­nat­ing from Wuhan, now named SARS-CoV-2, are evolv­ing quick­ly while de­vel­op­ment of a vac­cine to pre­vent peo­ple from get­ting in­fect­ed in the first place speeds ahead. On Tues­day Sanofi an­nounced that its Pas­teur unit will in­ves­ti­gate a pre­clin­i­cal vac­cine they made for SARS years ago, to see if it can pro­tect against COVID-19.

BAR­DA is a col­lab­o­ra­tor for the ef­fort, which will al­so see Sanofi de­ploy­ing its re­com­bi­nant DNA plat­form to pro­duce the vac­cine.

Like remde­sivir, fapilavir at­tacks RNA virus­es by in­hibit­ing RdRp (RNA-de­pen­dent RNA poly­merase). Fu­ji­film sub­sidiary Toya­ma Chem­i­cal first notched an ap­proval in Japan in 2014 and chris­tened it Avi­gan; in 2016 it li­censed Chi­na API rights to Hisun — short­ly af­ter­ward, Toya­ma al­so sup­plied the drug for an Ebo­la study that didn’t lead any­where.

Com­bat­ing the flu re­mained fapilavir’s raisons d’être, and of­fi­cial­ly it’s sanc­tioned for adults with nov­el or re­cur­ring strains of in­fluen­za when oth­er treat­ments have failed. But Hisun’s Yue Li told Pharm­Cube that the OK means physi­cians can pre­scribe the drug on a com­pas­sion­ate use ba­sis.

Along with the flu ap­proval, the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion al­so gave the green light on an IND to test fapilavir against SARS-CoV-2.

Two hos­pi­tals in Shen­zhen and Hangzhou have be­gun their own tri­als com­par­ing fapilavir against oth­er po­ten­tial treat­ments, ac­cord­ing to a Chi­nese reg­istry of clin­i­cal tri­als. Oth­er com­pounds un­der con­sid­er­a­tion in­clude Kale­tra (lopinavir/ri­ton­avir), an HIV drug owned by Ab­b­Vie; Roche’s new flu drug Xofluza; and neb­u­lized al­pha-in­ter­fer­on.

Last Fri­day Shen­zhen Third Peo­ple’s Hos­pi­tal sug­gest­ed that fapilavir had bet­ter an­tivi­ral ac­tiv­i­ty and less side ef­fects than Kale­tra, based on an 80-pa­tient study.

That puts fapilavir on the same path as remde­sivir, for which clin­i­cal tri­als were re­cent­ly kicked off. But strin­gent screen­ing re­quire­ments may be slow­ing down the high­ly an­tic­i­pat­ed study, the Wall Street Jour­nal re­port­ed. The tri­als have on­ly re­cruit­ed few­er than 200 peo­ple out of the tar­get 700 plus since Feb­ru­ary 5, who couldn’t have tak­en oth­er med­ica­tions in the pri­or 30 days and must have lab con­firmed di­ag­noses.

The Gilead drug was viewed as a top con­tender in the rush to find ef­fec­tive ther­a­pies for COVID-19, as it’s been test­ed in hu­mans as part of an Ebo­la tri­al. In fact, it ap­pears so promis­ing that the Wuhan In­sti­tute of Vi­rol­o­gy has tried to patent its use against the new coro­n­avirus while Suzhou-based Bright­Gene said it’s mass-pro­duc­ing the ac­tive phar­ma­ceu­ti­cal in­gre­di­ent and ramp­ing up pro­duc­tion of the ac­tu­al drug — with plans to li­cense it from Gilead.

For its part, the US drug­mak­er said it’s fo­cused on help­ing de­ter­mine the ef­fi­ca­cy of remde­sivir en­sur­ing man­u­fac­tur­ing ca­pac­i­ty in case of ap­proval.

Re­searchers, clin­i­cians and drug­mak­ers are pulling out all the stops to help treat and con­tain a vi­ral dis­ease that’s sick­ened more than 73,000 world­wide and tak­en 1,875 lives. De­spite the lack of proven treat­ments, 13,116 pa­tients have re­port­ed­ly re­cov­ered.

Japan, which had seen its case­load rise dra­mat­i­cal­ly due to a stream of con­firmed cas­es on the Di­a­mond Princess cruise ship now docked at the port of Yoko­hama, said it is work­ing to launch its own tri­als with HIV drugs.