Chi­na is re­port­ed­ly ap­prov­ing its 6th PD-1(L)1 drug in just over a year — and Am­gen will be pleased with this one.

The OK for tislelizum­ab would be the first mar­ket­ed prod­uct to be de­vel­oped by BeiGene, the em­i­nent Bei­jing-based biotech that Am­gen re­cent­ly took a $2.7 bil­lion stake in. Chi­na’s Cen­ter for Drug Eval­u­a­tion has com­plet­ed tech­ni­cal re­view and sent the NDA to the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion with a rec­om­men­da­tion to ap­prove, Chi­nese me­dia out­let Jiemi­an re­port­ed.

BeiGene is all set to hit the ground run­ning. Hav­ing part­nered with Cel­gene to hawk Revlim­id, Abrax­ane and Vi­daza in Chi­na, the drug­mak­er has built a 700-strong com­mer­cial­iza­tion team. The Am­gen deal al­so puts them in charge of sell­ing Xge­va (deno­sum­ab), Kypro­lis (carfil­zomib) and Blin­cy­to (bli­na­tu­momab) — pro­vid­ed the last two come through af­ter Phase III de­vel­op­ment.

Fol­low­ing the ini­tial in­di­ca­tion of chron­ic Hodgkin’s lym­phoma, BeiGene has al­ready filed an sN­DA to use tislelizum­ab in urothe­lial car­ci­no­ma.

While Cel­gene once held rights to the drug out­side Chi­na, BeiGene re­gained glob­al rights af­ter its US part­ner broke off the pact in the wake of a buy­out by Bris­tol-My­ers Squibb, the mak­er of Op­di­vo.

The fast pace re­flects just how rapid­ly the check­point mar­ket has evolved in Chi­na. Jun­shi and In­novent scored the first ap­provals for their home­grown ther­a­pies, Tuoyi and Tyvyt, though ac­cord­ing to Jiemi­an it’s Mer­ck’s Keytru­da that racked up the most sales: RMB$2 bil­lion ($280 mil­lion) since last Ju­ly. The num­bers for Jun­shi’s Tuoyi and In­novent’s Tyvyt are RMB$332 mil­lion ($47 mil­lion) and RMB$308 mil­lion ($43 mil­lion), re­spec­tive­ly.

Giv­en that com­pet­i­tive — some would say com­modi­tized — land­scape, BeiGene is look­ing to make a name for it­self through zanubru­ti­nib, a BTK in­hibitor po­si­tioned to chal­lenge the dom­i­nance of Im­bru­vi­ca. The drug is un­der re­view at the FDA af­ter nab­bing break­through sta­tus.

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.