Sanofi gets se­ri­ous in Chi­na with plans to hire 300 for $76M R&D site in Cheng­du

Sev­er­al big phar­mas have re­cent­ly shut­tered their re­search op­er­a­tions in Chi­na, but Sanofi is ap­par­ent­ly buck­ling down in the re­gion with a new glob­al R&D hub. The com­pa­ny is hir­ing 300 peo­ple in Cheng­du, Chi­na to run a tech-fo­cused op­er­a­tion that’s meant to speed up analy­sis of its clin­i­cal tri­als.

Sanofi is in­vest­ing €66 mil­lion ($76.6 mil­lion) in the hub and will have it ful­ly staffed by 2020. The R&D cen­ter is sup­posed to sup­port Sanofi’s drug de­vel­op­ment by man­ag­ing glob­al mul­ti-cen­ter clin­i­cal tri­al da­ta and files. The com­pa­ny says it will “take ad­van­tage of lo­cal tal­ents” to strength­en Sanofi’s dig­i­tal ca­pa­bil­i­ties, speed­ing up tri­als re­sults.

Zhang Ji

“Through this new hub, we will take full ad­van­tage of our glob­al ex­pe­ri­ence and R&D ca­pa­bil­i­ties to­geth­er with lo­cal sci­en­tif­ic re­search strengths to fur­ther im­prove in­no­va­tion,” said Zhang Ji, SVP and glob­al head of Sanofi R&D Op­er­a­tions, in a state­mentOur goal is to link Chi­na’s in­no­v­a­tive achieve­ments with the glob­al ecosys­tem and de­vel­op in­no­v­a­tive drugs in Chi­na that could ben­e­fit pa­tients around the world.”

The new hub builds on Sanofi’s ex­ist­ing pres­ence in Chi­na, which in­cludes the Sanofi Chi­na head­quar­ters in Shang­hai along with 11 re­gion­al of­fices. With the Chi­na R&D Cen­ter and the Asia-Pa­cif­ic R&D Cen­ter in Shang­hai — com­bined with Sanofi Chi­na’s oth­er of­fices — the com­pa­ny em­ploys 9,500 in the re­gion.

Sanofi’s Chi­na pres­ence. SANOFI

But some big phar­mas have gone the op­po­site di­rec­tion in Chi­na, with­draw­ing from their op­er­a­tions rather than build­ing on them. GSK, for ex­am­ple, an­nounced last year it would close down its neu­ro­science R&D site in Chi­na — a $100 mil­lion project once boast­ed to em­ploy 1,000 peo­ple in Shang­hai. And in the same year, No­var­tis an­nounced it was shut­ter­ing two units in Chi­na.

Sanofi’s new unit in Chi­na is said to be lever­ag­ing gene ther­a­py, mon­o­clon­al an­ti­bod­ies, mul­ti-spe­cif­ic an­ti­bod­ies, and polypep­tide tech­nol­o­gy to tack­le di­a­betes, car­dio­vas­cu­lar dis­ease, vac­cines, on­col­o­gy, im­munol­o­gy and in­flam­ma­tion, rare dis­eases, mul­ti­ple scle­ro­sis, and neu­rol­o­gy.

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

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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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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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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