Hav­ing qui­et­ly launched its own mR­NA vac­cine ef­forts against the nov­el coro­n­avirus to match the high­er pro­file cam­paigns of Mod­er­na and Cure­Vac, Ger­many’s BioN­Tech has of­fered a glimpse on its progress as it un­veils an al­liance with a promi­nent Chi­nese play­er.

Ugur Sahin

Fo­s­un Phar­ma will team up with BioN­Tech to con­duct tri­als of its Covid-19 vac­cine, BNT162, in Chi­na. To get on board, Fo­s­un bought $50 mil­lion worth of BioN­Tech eq­ui­ty $BN­TX and promised up to $85 mil­lion more in pay­ments.

In a sep­a­rate state­ment, BioN­Tech said it plans to ini­ti­ate clin­i­cal test­ing in late April, rolling out a glob­al de­vel­op­ment pro­gram in Eu­rope (start­ing in Ger­many), the US and Chi­na.

Shares surged 39.02% to $43 in pre-mar­ket trad­ing, buck­ing the down­ward trend in a tur­bu­lent mar­ket (the Nas­daq Biotech In­dex is al­so trad­ing up).

While Fo­s­un has rights to com­mer­cial­ize the re­sult­ing vac­cine in Chi­na, BioN­Tech is still ex­plor­ing what to do in the rest of the world. It’s in “ad­vanced dis­cus­sions” with Pfiz­er around that — echo­ing com­ments made by its phar­ma part­ner ear­li­er this month.

The deal marks the first pub­lic an­nounce­ments BioN­Tech has made on Pro­ject Light­speed, its de­vel­op­ment pro­gram in re­sponse to the vi­ral in­fec­tion that’s fast en­gulf­ing the world, since qui­et­ly dis­clos­ing the project ini­ti­a­tion in a Feb­ru­ary SEC fil­ing. As of Mon­day morn­ing, world­wide cas­es are edg­ing to­ward 170,000, with mul­ti­ple Eu­ro­pean coun­tries and parts of the US now on lock­down.

Like fel­low Ger­man biotech Cure­Vac — whom the US gov­ern­ment has re­port­ed­ly tried to lure in­to mov­ing state­side — BioN­Tech’s vac­cine ap­proach in­volves us­ing mR­NA to trick the body in­to pro­duc­ing a ver­sion of the SARS-CoV-2, which would then in­cite an im­mune re­sponse. Its man­u­fac­tur­ing part­ner Poly­mun will be in charge of pro­duc­ing a glob­al sup­ply out of fa­cil­i­ties in Eu­rope.

“In ad­di­tion, we are work­ing on a nov­el ther­a­peu­tics ap­proach for those pa­tients who have al­ready been in­fect­ed – we plan to dis­close more on that ef­fort in the com­ing weeks,” Ugur Sahin, founder and CEO, said in a state­ment.

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

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.