Clover Biopharmaceuticals sets up a new R&D center in a buzzy Chinese hub near Shanghai

Joshua Liang, Clover Biopharmaceuticals CEO

Busi­ness in Chi­na is boom­ing, with more than a thou­sand biotech and bio­phar­ma com­pa­nies — in­clud­ing some big multi­na­tion­al play­ers — flock­ing to Zhangjiang Phar­ma Val­ley to take ad­van­tage of a grow­ing tal­ent pool in Shang­hai.

Clover Bio­phar­ma­ceu­ti­cals is the lat­est, an­nounc­ing on Wednes­day that it has be­gun con­struc­tion on a new R&D cen­ter in Zhangjiang Hi-Tech Park. The Chi­nese biotech (which al­so has a cor­po­rate of­fice in Boston) promis­es a state-of-the-art fa­cil­i­ty with new pre­clin­i­cal re­search labs, man­u­fac­tur­ing process de­vel­op­ment labs, and a GMP pi­lot man­u­fac­tur­ing plant.

In to­tal, the com­pa­ny has just un­der 270,000 square feet (about 25,000 square me­ters) to work with. Cur­rent­ly, Clover has an R&D hub about 1,200 miles away in Cheng­du.

‘Es­tab­lish­ing a new R&D Cen­ter in Shang­hai will al­low us to ex­pand our R&D ca­pa­bil­i­ties and ac­cel­er­ate our in­no­v­a­tive pipeline,’ CEO Joshua Liang said in a state­ment. ‘In the fu­ture, we plan to es­tab­lish ad­di­tion­al R&D cen­ters around the world as we ad­vance the dis­cov­ery and de­vel­op­ment of new in­no­v­a­tive prod­uct can­di­dates.’ Con­struc­tion of the new R&D fa­cil­i­ties is ex­pect­ed to be com­plet­ed next quar­ter, and the en­tire R&D cen­ter is ex­pect­ed to be done in the sec­ond half of the year. Clover said it plans on re­cruit­ing ‘hun­dreds of new hires from the area’s deep tal­ent pool.’

Clover was an ear­ly en­trant in the race for a Covid-19 vac­cine, de­vel­oped us­ing its Trimer-Tag tech plat­form. Ear­ly on, it part­nered with Glax­o­SmithK­line to test its pan­dem­ic ad­ju­vant sys­tem. Then back in Feb­ru­ary, it de­cid­ed to go with an ad­ju­vant from Dy­navax in­stead. The com­pa­ny has been award­ed just un­der $400 mil­lion from CEPI to de­vel­op its shot — and back in Sep­tem­ber, it an­nounced a 79% ef­fi­ca­cy rate against the Delta vari­ant and a 67% ef­fi­ca­cy rate against Covid-19 over­all.

On Wednes­day, Clover be­gan dos­ing pa­tients in the on­go­ing Phase II/III Spec­tra tri­al with a ho­mol­o­gous boost­er shot. Where­as es­tab­lish­ing a pres­ence in Chi­na was once a bold con­cept, a slate of Big Phar­ma com­pa­nies be­gan set­ting up shop over­seas in the last sev­er­al years — in­clud­ing Eli Lil­ly, As­traZeneca, Bay­er, Roche, J&J, Glax­o­SmithK­line, and No­var­tis — of­ten in Zhangjiang Hi-Tech Park in Shang­hai.

‘The Zhangjiang Phar­ma Val­ley is one of the top biotech hubs in Chi­na and is home to over 1,000 in­no­v­a­tive biotech­nol­o­gy and bio­phar­ma­ceu­ti­cal com­pa­nies,’ Clover said.

Their Staying Power Lies in their Patient-Centricity

Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.

Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)

It’s big days for biology.

The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.

But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.

Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.

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The FDA this week announced further changes to revamp its structure, this time with alterations to its Office of the Chief Scientist that were agreed to by HHS late last month.

The FDA’s OCS has decided to shift its technology transfer program from the Office of Regulatory Science and Innovation to the OCS Immediate Office to further enhance the effectiveness of the agency’s outside partnership programs.

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Tom Riga, Spectrum Pharmaceuticals CEO

Covid-19 has been a rough go for many drugmakers, but few more so than Spectrum Pharmaceuticals, which has seen inspection delays and unwanted CRLs haunt its chance at a first approval. Feeling the sting, Spectrum will now downsize to keep the lights on through the year.

Spectrum will cut 30% of its workforce and pivot its R&D efforts around its two furthest-along drugs as part of a restructuring effort that will pave the company’s cash runway out into next year, it announced Wednesday.

Catalent CEO John Chiminski (Catalent)

If there was one defining theme at Catalent in recent years, it was expansion, as the CDMO upped its operations all over the world, from Baltimore to Japan. It did so under longtime CEO John Chiminski, who has led the Somerset, NJ-based company for 12 years, topped by 2 years of the pandemic. This year will be the last in the C-suite for Chiminski, however, as the company announced plans for a passing of the torch this summer.

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The FDA quietly announced on Tuesday that just before New Year’s eve, the agency again paused all of its non-mission-critical inspections in the US, likely leading to an even larger backlog of inspections worldwide.

The pause, which will last at least two weeks, is meant to ensure the safety of FDA employees and the companies it regulates as the agency further adapts to the spread of Omicron.

Jeff Albers and Kate Haviland (Brad Bahner Photography/PR Newswire)

After a busy 2021 brought Blueprint Medicines its fourth FDA approval, the company is kicking off the new year with plans to shake up its C-suite.

Jeff Albers, Blueprint’s CEO for the past eight years, will be stepping down April 4 and transitioning to the executive chairman position, the biotech announced Wednesday morning. He will be replaced by COO Kate Haviland, who moves into both the chief executive and president roles. Christina Rossi also nabs a promotion from chief commercial officer to COO.

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For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.

More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.

Kicking off 2022, hundreds of pharmaceuticals, including some blockbusters, saw their list prices rise by about 5% on average. But overall, net drug prices (cost after rebates) declined for the fourth year in a row, potentially complicating already stalled drug price reform efforts.

Among the drugs seeing new increases as of Jan. 1 are Gilead’s bevy of blockbuster HIV drugs.

Biktarvy, which pulled in more than $7 billion in worldwide sales in 2020, saw a 4.8% price increase in 2021, and now, another 5.6% increase in 2022, according to a new report from the nonprofit 46brooklyn Research.
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