John Oyler, Founder & CEO of BeiGene, at the US-China Biopharma Innovation and Investment Summit in Shanghai on October 23, 2018; Credit: Endpoints News, PharmCube

BeiGene scores first Chi­na OK with PD-1 — to be man­u­fac­tured by Boehringer In­gel­heim

On De­cem­ber 17, 2018, Jun­shi Bio­sciences notched the land­mark ap­proval for a made-in-Chi­na PD-(L)1 check­point in­hibitor by Chi­nese reg­u­la­tors. Bare­ly a year lat­er, the fourth home­grown PD-1 is mak­ing its way to a mar­ket that has since seen sev­er­al more firsts even whilst get­ting crowd­ed.

The ap­proval for BeiGene’s tislelizum­ab just be­fore 2019 end­ed is al­so mark­ing a new his­toric event: the first time a for­eign part­ner will be pro­duc­ing the mar­ket­ed drug un­der a re­formed con­tract man­u­fac­tur­ing reg­u­la­to­ry sys­tem. Boehringer In­gel­heim, a part­ner since 2013, will be sup­ply­ing the PD-1 an­ti­body for com­mer­cial use us­ing a Shang­hai fa­cil­i­ty.

“This is an im­por­tant mile­stone, not on­ly to en­sure the sup­ply of med­i­cines for pa­tients in Chi­na, but al­so for the rapid­ly emerg­ing Chi­nese bio­phar­ma­ceu­ti­cal Re­search & De­vel­op­ment land­scape,” said BeiGene CEO John Oyler in a state­ment.

In 2014 Chi­na’s drug reg­u­la­tor — since re­named the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion — be­gan pi­lot­ing a new Mar­ket­ing Au­tho­riza­tion Hold­er sys­tem un­der which drug­mak­ers with­out man­u­fac­tur­ing ca­pa­bil­i­ties can still ap­ply for mar­ket­ing ap­proval. This move opened up the op­tion of en­list­ing con­tract man­u­fac­tur­ers and sig­ni­fied a com­plete break from the pre­vi­ous sys­tem, where de­vel­op­ers must have man­u­fac­tur­ing au­tho­riza­tion to mar­ket a drug.

While BeiGene does have its own bi­o­log­ics man­u­fac­tur­ing plant in Guangzhou, it’s al­so inked a sep­a­rate deal with Catal­ent to pro­duce its first com­mer­cial drug, zanubru­ti­nib (re­cent­ly chris­tened Brukin­sa in the US).

SVB Leerink an­tic­i­pates BeiGene will launch tislelizum­ab in ear­ly 2020. The ini­tial in­di­ca­tion is third-line re­lapsed/re­frac­to­ry Hodgkin’s lym­phoma, fa­mil­iar ter­rain for any­one who’s been fol­low­ing In­novent’s Tyvyt or Jiang­su Hen­grui’s cam­re­lizum­ab. But BeiGene will have top-line Chi­nese da­ta in non-small cell lung can­cer com­ing lat­er this year, and is plot­ting sup­ple­men­tal OKs for urothe­lial can­cer, he­pa­to­cel­lu­lar car­ci­no­ma and more.

“This is BeiGene’s first in­ter­nal­ly dis­cov­ered drug ap­proved in Chi­na,” the an­a­lysts not­ed. “The ap­proval was based on re­sults from a sin­gle-arm piv­otal Phase 2 tri­al, in which tislelizum­ab demon­strat­ed a 76.9% ob­jec­tive re­sponse rate (ORR) via in­de­pen­dent re­view com­mit­tee (IRC) as­sess­ment, in­clud­ing a 61.5% com­plete re­sponse (CR) rate.”

Their mod­el es­ti­mates $85 mil­lion in 2020 Chi­na rev­enue for tislelizum­ab, part­ly from “mean­ing­ful off-la­bel sales” — as the re­cent Na­tion­al Re­im­burse­ment Drug List up­date fea­tured In­novent’s PD-1 for Hodgkin’s lym­phoma (at about $1,100 per month) but not oth­er check­points in larg­er in­di­ca­tions.

At one point Cel­gene was part­nered on this drug as part of a port­fo­lio swap which had BeiGene in charge of mar­ket­ing Abrax­ane, Revlim­id and Vi­daza in Chi­na, but cut it loose as soon as it got gob­bled up by Op­di­vo mak­er Bris­tol-My­ers Squibb. BeiGene’s de­vel­op­ment suc­cess­es bode well for Am­gen, which re­cent­ly paid $2.7 bil­lion for a rough­ly 20% stake in the biotech and en­trust­ed its R&D team with some of its own projects.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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Covid-19 roundup: Sanofi and GSK pledge 200 mil­lion vac­cine dos­es for a glob­al dis­tri­b­u­tion cam­paign

Sanofi and GSK have agreed to give 200 million doses of their vaccine candidate to the COVAX Facility, which is part of a program set up by CEPI, the WHO and Gavi to equitably distribute vaccines around the world.

The idea behind COVAX is to give all participating countries equal access to vaccines, regardless of income level. As of Oct 14, more than 180 countries had signed agreements to the COVAX Facility, including France and the UK. China joined earlier this month, pledging to make its vaccines a “global public good.” One country notably off the list is the United States.

Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Once re­ject­ed, Kala's dry eye drug now gains en­try to a field where No­var­tis is groom­ing its own block­buster

When the FDA slapped a rejection on Kala Pharma’s dry eye drug last August, the biotech’s execs promised investors that a third Phase III study — they had already started at that point — would reverse their fortune.

Today they made good on that promise, clinching an approval for Eysuvis, an ocular corticosteroid being positioned as a first-line, short term treatment of dry eye disease.

Boasting a technology invented by Bob Langer out of MIT, Eysuvis is a corticosteroid, loteprednol etabonate, delivered by mucus-penetrating particles. It promises to enhance penetration into target tissue on the ocular surface, achieving an effect quicker than systemic corticosteroids and stronger than over-the-counter eye drops.

Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

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UP­DAT­ED: The dis­rup­tors at EQRx have their eyes on the PD-(L)1 mar­ket — tee­ing up $150M cash to grab 2 back­bone ther­a­pies from Chi­na

EQRx is paying top dollar to bring a pair of PD-(L)1 drugs into its portfolio of fast-follow therapies, offering $150 million upfront in what could shape up to be a $1.3 billion alliance with China’s CStone.

As early as 2017 Celgene had bet on a made-in-China PD-1 via its pact with BeiGene, quickly followed by Arcus as the second checkpoint wave was looming; more recently Eli Lilly imported longtime partner Innovent’s PD-1 in a $1 billion deal. All are diving into a space now dominated by Merck’s Keytruda franchise, where six other players are trying to catch up by carving out their own niches — and more are on their way to tap into the various I/O pairings anchored by a PD-(L)1. But none so far has quite shared EQRx’s explicit mission to disrupt the multibillion-dollar market by offering a lower cost option.