Sen. Tom Cotton (R-AR) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Black­list Chi­nese ge­net­ic se­quenc­ing com­pa­nies, law­mak­ers ar­gue — cit­ing po­ten­tial for 'bioweapons,' na­tion­al se­cu­ri­ty risk

As Chi­nese biotech com­pa­nies spread their wings glob­al­ly, a pair of law­mak­ers — and known Chi­na hawks on the Hill — are call­ing for a promi­nent ge­net­ic se­quenc­ing play­er to be black­list­ed.

Sen. Tom Cot­ton (R-AR) and Rep. Mike Gal­lagher (R-WI) sin­gled out Bei­jing Ge­nomics In­sti­tute, which has re­brand­ed it­self as BGI Ge­nomics, as a com­pa­ny that should be added to mul­ti­ple sanc­tion lists along with oth­er, un­named Chi­nese biotech com­pa­nies.

Al­low­ing BGI to ac­cess US DNA da­ta, they warned, is a mat­ter of na­tion­al se­cu­ri­ty be­cause its re­search with the mil­i­tary “could have an ap­pli­ca­tion in fu­ture bioweapons.”

In a let­ter ad­dressed to Trea­sury Sec­re­tary Janet Yellen, Com­merce Sec­re­tary Gi­na Rai­mon­do, and De­fense Sec­re­tary Lloyd Austin, they asked for BGI to be put on the De­part­ment of the Trea­sury’s Non-SDN Chi­nese Mil­i­tary In­dus­tri­al Com­plex Com­pa­nies List, the De­part­ment of Com­merce’s En­ti­ty List, and the De­part­ment of De­fense’s list of Chi­nese mil­i­tary com­pa­nies.

Found­ed in 1999 by Chi­nese sci­en­tists who had par­tic­i­pat­ed in the Hu­man Genome Pro­ject, BGI of­fers next-gen­er­a­tion se­quenc­ing ser­vices rang­ing from re­search to every­day use. Dur­ing the Covid-19 pan­dem­ic, its di­ag­nos­tics have been de­ployed in mul­ti­ple coun­tries — al­though its at­tempt to build test­ing labs in the US was shot down by in­tel­li­gence of­fi­cials.

Still, BGI and at least 14 oth­er Chi­nese health­care com­pa­nies per­form ge­net­ic se­quenc­ing for US health­care pa­tients in oth­er ar­eas.

What makes its tac­tics to ac­quire Amer­i­can ge­nom­ic da­ta ag­gres­sive, ac­cord­ing to Cot­ton and Gal­lagher, is sus­pect­ed da­ta shar­ing with the Chi­nese gov­ern­ment and BGI’s “his­to­ry of col­lab­o­ra­tion” with the Peo­ple’s Lib­er­a­tion Army and serv­ing mil­i­tary in­ter­ests.

They point­ed out that the for­mer head of PLA Na­tion­al De­fense Uni­ver­si­ty “iden­ti­fied bi­ol­o­gy as one of sev­en ‘new do­mains of war­fare’ in­clud­ing the pos­si­bil­i­ty of ‘spe­cif­ic eth­nic ge­net­ic at­tacks,’ in a 2017 pub­li­ca­tion.”

A re­view of 40 pub­licly-avail­able re­search pa­pers demon­strates BGI’s work on PLA pri­or­i­ties, such as im­proved high-al­ti­tude sol­dier per­for­mance, neu­ro­science, and pathogens. BGI’s world­wide pre­na­tal test was it­self de­vel­oped in col­lab­o­ra­tion with the PLA. BGI has al­so part­nered with the PLA’s Na­tion­al Uni­ver­si­ty of De­fense Tech­nol­o­gy (NUDT) to ad­vance bioin­for­mat­ics re­search and lever­age su­per­com­put­ers for bi­o­log­i­cal re­search. Joint BGI-PLA re­search could have an ap­pli­ca­tion in fu­ture bioweapons — which is es­pe­cial­ly con­cern­ing be­cause BGI’s na­tion­al gene bank is pre­sum­ably made avail­able for mil­i­tary re­search.

The two al­so high­light­ed Chi­na’s fi­nan­cial sup­port for the com­pa­ny, in­clud­ing $1.5 bil­lion in state sub­si­dies that al­lowed it to “un­der­cut the DNA se­quenc­ing mar­ket,” and a con­tract giv­ing BGI the re­spon­si­bil­i­ty of run­ning Chi­na’s na­tion­al gene data­base.

“The Unit­ed States must not turn a blind eye to the threat posed by Chi­nese biotech­nol­o­gy com­pa­nies op­er­at­ing at the CCP’s be­hest,” they wrote. “Black­list­ing BGI and its fel­low biotech com­pa­nies will help the Unit­ed States counter the Chi­nese Com­mu­nist Par­ty’s ef­forts to cap­ture Amer­i­cans’ most pri­vate in­for­ma­tion—their DNA.”

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

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FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

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ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.