With plans to bring su­r­u­fa­tinib state­side, Chi-Med vast­ly scales up man­u­fac­tur­ing with new Chi­nese plant

Hutchi­son Chi­na MediTech, or Chi-Med, is at­tempt­ing to break new ground by bring­ing its in­ter­nal­ly de­vel­oped on­col­o­gy can­di­date su­r­u­fa­tinib to US shores—which would make it just the sec­ond Chi­nese-de­vel­oped drug to do so. With that goal in mind, the firm is vast­ly scal­ing up its man­u­fac­tur­ing op­er­a­tions for a planned glob­al push.

Chi-Med is build­ing out a new large-scale man­u­fac­tur­ing fa­cil­i­ty in Zhangjiang, Shang­hai, that will to­tal 592,000 square feet of floor space and boost the com­pa­ny’s pro­duc­tion ca­pac­i­ty by more than 600% past its cur­rent op­er­a­tions in Suzhou.

The build out will come in two phas­es: first, the com­pa­ny will ex­pand its pro­duc­tion ca­pac­i­ty to churn out around 250 mil­lion tablets and 550 mil­lion cap­sules of small-mol­e­cule can­di­dates per year; then, the drug­mak­er will add ca­pac­i­ty to en­large its large-mol­e­cule pro­duc­tion.

No de­tails were pro­vid­ed on when the two phas­es would be com­plet­ed, how much the project will cost, or when op­er­a­tions are ex­pect­ed to be­gin in a news re­lease Tues­day. A Chi-Med spokesper­son could not be reached for com­ment by press time.

Chi-Med has been plan­ning since June to file an NDA for su­r­u­fa­tinib, a drug for treat­ing can­cer pa­tients with ad­vanced neu­roen­docrine tu­mors. The com­pa­ny said Tues­day it still plans to do so by the end of 2020— if ap­proved, su­r­u­fa­tinib would be­come the sec­ond can­cer drug de­vel­oped in Chi­na to be ap­proved in the U.S. af­ter BeiGene’s Brukin­sa.

Chris­t­ian Hogg

Chi-Med CEO Chris­t­ian Hogg said in a state­ment that the new fa­cil­i­ty will “sig­nif­i­cant­ly in­crease Chi-Med’s pro­duc­tion ca­pac­i­ty to bring our home-grown Chi­nese in­no­va­tions to more pa­tients in Chi­na and around the world.”

Rep­re­sen­ta­tives from As­traZeneca and Eli Lil­ly at­tend­ed a ground­break­ing cer­e­mo­ny at the site Tues­day in ad­di­tion to of­fi­cials from the Shang­hai mu­nic­i­pal gov­ern­ment, Shang­hai Free-Trade Zone, Zhangjiang Man­age­ment Com­mit­tee and Zhangjiang Group.

Chi-Med’s Suzhou site has sup­plied nu­mer­ous drug can­di­dates the space for clin­i­cal tri­als, in­clud­ing the pro­duc­tion and com­mer­cial­iza­tion of in-house-de­vel­oped Elu­nate, a col­orec­tal can­cer drug for pa­tients who have failed at least two oth­er treat­ment meth­ods. Chi-Med has nine oth­er can­cer drugs cur­rent­ly in var­i­ous clin­i­cal tri­al stages.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Abzena picks North Car­oli­na as the home for its 6th man­u­fac­tur­ing site, plans to add 325 jobs in San­ford

While Boston and San Francisco are the unquestioned leading biotech hubs in the US, drugmakers — particularly contract manufacturers — are looking elsewhere for cheaper real estate and untapped potential. Now, a San Diego-based biologics maker looking to rapidly scale up is setting down roots in North Carolina.

CDMO Abzena will add 325 jobs in Sanford, NC, as part of a $200 million biologics plant that will eventually house around 24,000 square feet of bioreactor capacity, the company said.

Geoff MacKay, Avrobio

Avro­bio is us­ing 'pod­s' to cre­ate gene ther­a­pies, and it be­lieves the ap­proach could change the game al­to­geth­er

Where other companies have gone big, Avrobio is going small. Its manufacturing operation is no different.

Instead of trying to keep up with the validation of new facilities — and spending money and precious time in the process — the company has opted for a different approach: small, automated pods that can be installed in rented clean rooms anywhere. Though production output isn’t as high as other companies, Avrobio avoids brick-and-mortar and is able to stay flexible and nimble to respond to fluctuations.