FBI crack­down on Chi­na’s R&D es­pi­onage in­ten­si­fies with new ar­rests and one fugi­tive in San Fran­cis­co

In­ten­si­fy­ing the crack­down on undis­closed Chi­nese ties with­in US re­search in­sti­tu­tions, the Jus­tice De­part­ment has charged four sci­en­tists — three of them study­ing bi­ol­o­gy or med­i­cine — with visa fraud for al­leged­ly ly­ing about their work for Chi­na’s mil­i­tary.

The FBI has ar­rest­ed three and is point­ing fin­gers at the Chi­nese con­sulate in San Fran­cis­co for har­bor­ing the fourth, putting at­ten­tion and pres­sure on Chi­na’s diplo­mat­ic mis­sions just one day af­ter the US or­dered the clo­sure of its Hous­ton out­post.

In a state­ment, the fugi­tive re­searcher is iden­ti­fied as Juan Tang. She en­tered the US in De­cem­ber 2019 af­ter ap­ply­ing for a visa to the Uni­ver­si­ty of Cal­i­for­nia, San Diego.

“Juan Tang was a vis­it­ing re­searcher in the De­part­ment of Ra­di­a­tion On­col­o­gy, fund­ed by the Chi­nese Schol­ar­ship Coun­cil, a study-based ex­change pro­gram af­fil­i­at­ed with the Chi­na’s Min­istry of Ed­u­ca­tion and Xi­jing Hos­pi­tal in Chi­na,” the uni­ver­si­ty told lo­cal me­dia. “Her work was sole­ly based in the re­search lab­o­ra­to­ry and she left the Uni­ver­si­ty at the end of June.”

Per court doc­u­ments, Tang claimed on her visa ap­pli­ca­tion that she’s nev­er served in the mil­i­tary. But an FBI in­ves­ti­ga­tion turned up ev­i­dence of her be­ing a uni­formed of­fi­cer of the Peo­ple’s Lib­er­a­tion, in­clud­ing a pho­to of her in the uni­form and ref­er­ences to her em­ploy­ment at the Air Force Mil­i­tary Med­ical Uni­ver­si­ty. When con­front­ed by agents, she once again de­nied hav­ing been a mem­ber of the mil­i­tary — and sought refuge at the Chi­nese con­sulate be­fore the feds could ar­rest her on June 26.

While the fo­cus on mil­i­tary as­so­ci­a­tion is un­usu­al, the FBI’s cam­paign to stem for­eign in­flu­ence in US bio­med­ical re­search goes back years. Up­on their warn­ing, the NIH has alert­ed grantee in­sti­tu­tions to pos­si­ble undis­closed fund­ing from and work for for­eign in­sti­tu­tions, — par­tic­u­lar­ly Chi­nese ones. The probes have fo­cused main­ly on the Thou­sand Tal­ents pro­gram, an inia­tive orig­i­nal­ly set up to woo Chi­nese na­tives back to Chi­na but had al­so been ex­tend­ed to Amer­i­can sci­en­tists such as Alan List and Charles Lieber.

As with these new ac­cu­sa­tions, the is­sue of­ten lies with fail­ure to dis­close and vi­o­la­tions of rules rather than ac­tu­al, proven theft of in­tel­lec­tu­al prop­er­ty.

The same threads in Tang’s case echoes with those against the three oth­er sci­en­tists, who were al­so named.

Xin Wang, who did re­search at UCSF, wrote about his for­mer em­ploy­ment as a pro­fes­sor of med­i­cine in the army but al­leged­ly hid his cur­rent po­si­tion as a tech­ni­cian in a lab. He lat­er re­vealed that his su­per­vi­sor back in Chi­na had asked him for in­for­ma­tion on the lay­out of his UCSF lab and the work he did there, some of which were fund­ed by NIH grants.

Chen Song, 38, was ac­cused of us­ing a Bei­jing hos­pi­tal as a “false front” to cov­er up her re­al em­ploy­er, the PLA. The neu­rol­o­gist con­duct­ed re­search on brain dis­ease at Stan­ford Uni­ver­si­ty.

Kaikai Zhao was a grad­u­ate stu­dent study­ing ma­chine learn­ing and ar­ti­fi­cial in­tel­li­gence at In­di­ana Uni­ver­si­ty who omit­ted his ser­vice and at­ten­dance at a cou­ple of mil­i­tary-af­fil­i­at­ed schools.

“These mem­bers of Chi­na’s Peo­ple Lib­er­a­tion Army ap­plied for re­search visas while hid­ing their true af­fil­i­a­tion with the PLA,” John De­mers, As­sis­tant At­tor­ney Gen­er­al for Na­tion­al Se­cu­ri­ty, said in a state­ment. “This is an­oth­er part of the Chi­nese Com­mu­nist Par­ty’s plan to take ad­van­tage of our open so­ci­ety and ex­ploit aca­d­e­m­ic in­sti­tu­tions.”

John Brown, the ex­ec­u­tive as­sis­tant di­rec­tor of the FBI’s Na­tion­al Se­cu­ri­ty Branch, re­it­er­at­ed the al­most cliché line that the US wel­comes stu­dents, aca­d­e­mics and re­searchers — but they won’t al­low the Chi­nese gov­ern­ment to in­fil­trate and ex­ploit this benev­o­lence.

“In in­ter­views with mem­bers of the Chi­nese Peo­ple’s Lib­er­a­tion Army in over 25 cities across the U.S., the FBI un­cov­ered a con­cert­ed ef­fort to hide their true af­fil­i­a­tion to take ad­van­tage of the Unit­ed States and the Amer­i­can peo­ple,” he said.

But amid re­ports that the Trump ad­min­is­tra­tion is con­sid­er­ing can­cel­ing the visas of thou­sands of Chi­nese grad­u­ate stu­dents and re­searchers who have di­rect ties to uni­ver­si­ties af­fil­i­at­ed with the Peo­ple’s Lib­er­a­tion Army — and fol­low­ing a failed at­tempt to kick out stu­dents whose schools are go­ing vir­tu­al — how wel­comed in­di­vid­ual sci­en­tists feel is a whole oth­er ques­tion.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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