It may not be sur­pris­ing that Shang­hai Jun­shi Bio­sciences has pushed back some clin­i­cal tri­als to pri­or­i­tize its Eli Lil­ly-part­nered Covid-19 an­ti­body. But what ex­act­ly was suck­ing up their time is al­most cer­tain to raise some eye­brows: The com­pa­ny spent months find­ing enough mon­keys on which to test the ex­per­i­men­tal drug.

Jun­shi’s plight high­lights a se­ri­ous, if oft-un­der­looked, chal­lenge that’s be­set the whole bio­med­ical re­search en­ter­prise. Test­ing a mol­e­cule on non-hu­man pri­mates is of­ten a cru­cial fi­nal step be­fore it can be moved in­to the clin­ic, but a con­flu­ence of fac­tors have re­sult­ed in a short­age in both the US and Eu­rope just as drug­mak­ers were scram­bling to put their ex­per­i­men­tal pro­grams through tri­als at record speed.

Jun­shi COO Feng Hui told in­vestors on a call on Fri­day that the short­age was acute be­tween Feb­ru­ary and June, when the biotech was com­pet­ing with oth­er com­pa­nies and in­sti­tutes.

But the is­sue re­mains un­re­solved. Just days ago, the Eu­ro­pean An­i­mal Re­search As­so­ci­a­tion brought at­ten­tion to a “grow­ing short­age of pur­pose-bred macaque mon­key” used in Covid-19 and oth­er vi­tal re­search.

One of the main bot­tle­necks is how Chi­na, a main source of mon­keys for med­ical re­search, has banned the ex­port from breed­ing fa­cil­i­ties since the be­gin­ning of 2020 cit­ing con­cerns about the spread of the coro­n­avirus.

“The on­go­ing em­bar­go is now be­gin­ning to have se­ri­ous con­se­quences for re­search in Eu­rope and the rest of the world,” the group wrote in a state­ment. Kirk Leech, the ex­ec­u­tive di­rec­tor, added: “Mon­keys play a crit­i­cal role in the de­vel­op­ment of vac­cines, such as those for Covid-19, and ur­gent in­ter­na­tion­al co-op­er­a­tion is need­ed to lift the ban.”

In a let­ter urg­ing the WHO to in­ter­vene, EARA ar­gued that “while the sus­pen­sion was pru­dent at the time it has be­come clear that an­i­mals ex­port­ed from Chi­na pos­sess a very low risk of trans­mit­ting any com­mu­ni­ca­ble dis­ease.” Re­search mon­keys, they added, are al­so sub­ject to strict rules in han­dling and trans­porta­tion, in­clud­ing quar­an­tine and per­son­al pro­tec­tive equip­ment re­quire­ments.

Still, those fac­ing the chal­lenge are not op­ti­mistic that the prob­lem will be solved soon. As the At­lantic re­port­ed in Au­gust, Bio­qual — which has done pri­mate re­search for Mod­er­na’s vac­cine and sev­er­al oth­er Covid-19 play­ers — said while it was ini­tial­ly able to reuse some an­i­mals from non-dis­ease stud­ies, the sup­ply had been used up.

New macaques al­so cost $10,000, dou­ble the orig­i­nal price.

“This may just be the be­gin­ning,” R. Kei­th Reeves, a vi­rol­o­gist at Har­vard work­ing on HIV, told the At­lantic. “And I think that we’re all prepar­ing for there to be sig­nif­i­cant de­lays.”

For its part, Jun­shi has pro­ceed­ed in­to hu­man tri­als of its an­ti­body. Re­sults from a re­cent study test­ing it in com­bi­na­tion with bam­lanivimab, the an­ti­body de­vel­oped by Eli Lil­ly and Ab­Cellera, im­pressed an­a­lysts and paved the way for an emer­gency use au­tho­riza­tion re­quest. The FDA has grant­ed an EUA for bam­lanivimab.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

So­cial: AP Im­ages

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.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.