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.

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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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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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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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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No­var­tis chips in $10M for IPO-bound part­ner Pli­ant; Tenax shares soar on heart drug da­ta

Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.