Ahead of FDA de­ci­sion on BTK drug, Am­gen-part­nered BeiGene is one step clos­er to Chi­na OK for PD-1

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.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

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.

Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

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.

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Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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