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.

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.