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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.