For any fledg­ling biotech, re­cruit­ing the right CEO is cru­cial. But it’s an es­pe­cial­ly tough find for the new gen­er­a­tion of cross-bor­der star­tups with glob­al am­bi­tions.

Yizhe Wang

Ide­al­ly, you want some­one who is ready to blaze a speedy path from clin­i­cal de­vel­op­ment to launch and be well-equipped to man­age the prod­uct life cy­cle — which re­quires a lev­el of in­sid­er knowl­edge about how US and Eu­ro­pean com­pa­nies op­er­ate and how to nav­i­gate reg­u­la­to­ry and com­mer­cial­iza­tion land­scapes in Chi­na.

Lian­Bio had it in their found­ing CEO Bing Li. Weeks af­ter Li qui­et­ly left, the Per­cep­tive-found­ed com­pa­ny has hired his suc­ces­sor out of Eli Lil­ly.

Yizhe Wang spent the last year in In­di­anapo­lis as glob­al plat­form lead for an­ti-Covid ther­a­py at Lil­ly Re­search Lab, co­or­di­nat­ing dis­cov­ery, de­vel­op­ment and launch of bam­lanivimab. Be­fore that, he was with Lil­ly On­col­o­gy Chi­na in Shang­hai, where he first moved from Philadel­phia while work­ing for Glax­o­SmithK­line’s mar­ket­ing team.

All those years of ex­pe­ri­ence trans­lat­ed to “proven lead­er­ship guid­ing late-stage as­sets to mar­ket in Chi­na,” said ex­ec­u­tive chair­man and Per­cep­tive man­ag­ing di­rec­tor Kon­stan­tin Poukalov. The tran­si­tion was planned to fit with Lian­Bio’s next phase of growth, which in­volves sev­er­al Phase III tri­al ini­ti­a­tions over the next year and a half.

“Yizhe is some­one with trans­ac­tion­al ex­pe­ri­ence, de­vel­op­ment ex­pe­ri­ence, and im­por­tant­ly al­so com­mer­cial ex­pe­ri­ence,” said De­bra Yu, Lian­Bio’s pres­i­dent and chief busi­ness of­fi­cer. She and Li were the first em­ploy­ees. “I think he launched like sev­en drugs in Chi­na do­ing NRDL ne­go­ti­a­tions. Over this whole time he’s over­seen the com­mer­cial­iza­tion of like 20 dif­fer­ent drugs.”

Bing Li

As Lian­Bio joins a small but grow­ing cadre of well-con­nect­ed play­ers scram­bling for cut­ting-edge late-stage drugs to bring to Chi­na, peo­ple with ré­sumés like Wang’s are in hot de­mand. Just days ago, Lon­nie Moul­der tapped Hua Mu to helm his im­munol­o­gy start­up, pry­ing a key found­ing ex­ec away from Over­land — Hill­house’s own US/Chi­na play. Ever­est Med­i­cines (which was found­ed by the CBC Group) land­ed an­oth­er Lil­ly vet, Ker­ry Blan­chard, for its top job.

The ba­sic in-li­cens­ing con­cept is not new. In fact, pi­o­neers like Zai Lab and BeiGene have pop­u­lar­ized the mod­el so much that com­pe­ti­tion for as­sets has in­ten­si­fied. It is against this back­ground that the next wave has cropped up — promis­ing even more re­sources, busi­ness de­vel­op­ment prowess, ne­go­ti­at­ing pow­er, clin­i­cal plans and rel­e­vant in­fra­struc­ture, of­ten not just with­in Chi­nese bor­ders but al­so in Asia more broad­ly.

The back­ing from Per­cep­tive and the “be­spoke” plans they ham­mer out for every as­set dri­ves much of what Lian­Bio does, Yu said. As a for­mer ven­ture cap­i­tal­ist and sea­soned deal­mak­er, she’s al­so sur­prised at how many more US biotechs are now will­ing, if not ea­ger, to pur­sue the Chi­na mar­ket.

“Every­one’s do­ing it a lit­tle bit dif­fer­ent­ly,” she said, adding: “On one hand, yeah the best deals of course are com­pet­i­tive, but al­so the pool of avail­able, re­al­ly strong pro­grams, is in­creas­ing. And so as more play­ers come in, and the pool is big­ger, it’s not nec­es­sar­i­ly dri­ving up the prices.”

Aside from as­sist­ing with the al­liance man­age­ment — in­clud­ing an un­con­ven­tion­al pact with Pfiz­er — Wang will be tasked with steer­ing drugs from those an­chor­ing part­ner­ships ahead, in­clud­ing mava­camten from MyoKar­dia, in­fi­gra­tinib and BBP-398 from Bridge­Bio, sisuna­tovir from Re­Vi­ral, and TP-03 from Tar­sus.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.