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.

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.

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.

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.

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.