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.

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.