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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,500+ biopharma pros reading Endpoints daily — and it's free.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,500+ biopharma pros reading Endpoints daily — and it's free.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty


I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,500+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.