Chi­na green­lights sec­ond home­grown PD-1 in 10 days as In­novent cel­e­brates its first drug OK with Eli Lil­ly

You can count on the crowd­ed pool of made-in-Chi­na check­point in­hibitors to rip­ple fast.

Chi­nese reg­u­la­tors have hand­ed an ap­proval to In­novent and its part­ners at Eli Lil­ly for sin­til­imab, just 10 days af­ter Jun­shi scored the his­toric OK for its own home­grown PD-1.

Michael Yu

Sin­til­imab is the fourth check­point to be ap­proved in Chi­na and, so far, the on­ly one joint­ly de­vel­oped by a multi­na­tion­al drug­mak­er and a lo­cal biotech (the oth­er two are Mer­ck’s Keytru­da and Bris­tol-My­ers Squibb’s Op­di­vo). Its man­u­fac­tur­ing op­er­a­tions — a crit­i­cal field in the mar­ket­ing bat­tles to come — is the largest in the coun­try (at three 1000L lines cur­rent­ly) and has passed muster with Lil­ly, CEO Michael Yu told Pharm­Cube in an in­ter­view.

The ap­proval is based on a study of 96 pa­tients with re­lapsed/re­frac­to­ry clas­si­cal Hodgkin’s lym­phoma, which hit a ob­jec­tive re­sponse rate of 79.2% and a dis­ease con­trol rate of 97.9%. In­novent filed the NDA in April and the new­ly dubbed Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion — or NM­PA, suc­ces­sor to CF­DA — is­sued a pri­or­i­ty re­view des­ig­na­tion to speed things up.

To be mar­ket­ed as Tyvyt (In­novent’s first com­mer­cial prod­uct), sin­til­imab is al­so be­ing test­ed in first- and sec­ond-line set­tings, with 20-plus clin­i­cal tri­als un­der­way.

In No­vem­ber, the com­pa­nies cit­ed a Phase Ib suc­cess for non-small cell lung can­cer that’s help­ing jus­ti­fy a Phase III pro­gram. Oth­er po­ten­tial in­di­ca­tions in­clude gas­tric can­cer, liv­er can­cer and esophageal can­cer.

In­novent was among the lead­ing PD-1 de­vel­op­ers tipped for mar­ket launch­es in the first half of 2019 along­side BeiGene and Jiang­su Hen­grui. But it was Jun­shi Bio­sciences — now pub­licly list­ed in Hong Kong — that won the race for the first made-in-Chi­na PD-1 OK for a melanoma drug. A re­cent count by Pharm­Cube put the num­ber of PD-1/L1 agents in de­vel­op­ment in Chi­na at 68, part of a big wave of new check­points now in the clin­ic around the world.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.