George Chen (D3 Bio)

Here's a $200M Chi­na start­up idea — if you can read be­yond the big words

What does it take to gath­er $200 mil­lion from top VC play­ers in Chi­na these days?

Not much that can be shared pub­licly, D3 Bio sug­gests as it launch­es with the hefty Se­ries A this morn­ing. But the in­gre­di­ents feed­ing in­to the Shang­hai-based as­pir­ing glob­al biotech may be in­dica­tive of things that would turn heads at places like Boyu Cap­i­tal, Ma­trix Part­ners Chi­na, Se­quoia Cap­i­tal Chi­na, Temasek, and WuXi AppTec’s Cor­po­rate Ven­ture Fund.

First, you need a con­nect­ed, sea­soned leader who’s been im­mersed in the ranks of glob­al bio­phar­ma.

D3 Bio co-founder and CEO George Chen put in the years at the NIH, Eli Lil­ly, Glax­o­SmithK­line, and J&J af­ter get­ting an MBA from Penn’s Whar­ton, lend­ing a hand to more than 70 INDs and 30-plus NDAs. He was chief med­ical of­fi­cer at BeiGene for two years be­fore leav­ing to head up As­traZeneca’s on­col­o­gy R&D in Chi­na.

Then it’s all about hit­ting the right themes: “Pre­ci­sion med­i­cine” has a next-gen­er­a­tion ring to it; a fo­cus on im­munol­o­gy and on­col­o­gy puts you in the same league as the big guys; talk of build­ing “back­bone” drugs that can spawn a pipeline and new com­bi­na­tions is al­so key.

Top it all with a busi­ness mod­el that lever­ages Chi­na’s grow­ing tal­ent pool, re­sources and re­search out­put, and you have a win­ning idea.

“As far as we know, D3’s ap­proach is unique,” Chen wrote in an email to End­points News, “we start with in­sights from clin­i­cal de­vel­op­ment and an as­sess­ment of mar­ket needs and, take those in­sights to the lab to guide the clin­i­cal de­vel­op­ment path.”

So rather than start­ing out with new sci­en­tif­ic dis­cov­er­ies or plat­form tech­nolo­gies, D3 — which stands for de­vel­op­ment, dis­cov­ery, then de­vel­op­ment again — would “sur­vey the clin­i­cal land­scape” to find de­fi­cien­cies in stan­dard-of-care treat­ments. The next step is iden­ti­fy­ing dis­ease tar­gets and de­liv­ery meth­ods that may plug that gap, and they go from there.

“D3 Bio an­tic­i­pates that hav­ing a clear un­der­stand­ing dur­ing pre­clin­i­cal de­vel­op­ment both of rel­e­vant can­cer bio­mark­ers and the ther­a­peu­tic im­prove­ment or re­place­ment goals will make drug dis­cov­ery and de­vel­op­ment as ef­fi­cient and fo­cused as pos­si­ble,” reads a press re­lease.

As with BeiGene, the har­bin­ger for a new breed of biotechs root­ed in Chi­na but run­ning on glob­al bio­phar­ma rules, D3 Bio prides it­self on lever­ag­ing what Chen calls an “ad­vanced” R&D sys­tem.

It will in­volve a mix of in­ter­nal dis­cov­ery and in-li­cens­ing deals for ear­ly-stage as­sets, Chen added — some­what dis­tinct from bring­ing in late-stage pro­grams for a quick flip to the mar­ket, an ap­proach that’s gained re­newed mo­men­tum. The Se­ries A should sus­tain the com­pa­ny for a few years as it cre­ates and push­es for­ward the pipeline.

So what kinds of drugs, dis­eases and pace should we ex­pect from D3 Bio?

“Stay tuned – D3 will be shar­ing specifics about its pipeline at the ap­pro­pri­ate time,” Chen wrote.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Or­biMed, bio­phar­ma's biggest in­vestor, clos­es $3.5B in three new pri­vate funds

One of the world’s leading biopharma investors has pulled in its next rounds of cash, with the funds planned to go to dozens of companies around the world.

OrbiMed raised $3.5 billion across three private investment funds, it announced Monday, as it continues building on its long track record in healthcare and biopharma. All in all, the firm expects to invest in at least 60 companies across the US, Asia and Europe.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.