Jianxin Chen, ZhenGe Biotech chairman and CEO

Low-pro­file Shang­hai-based CD­MO se­cures high pro­file in­vestors for 9-dig­it Se­ries C

In a bid to ex­pand R&D and man­u­fac­tur­ing ca­pa­bil­i­ties, Shang­hai-based ZhenGe Biotech net­ted a $100 mil­lion Se­ries C Tues­day.

With of­fices in Shang­hai and the US, the transpa­cif­ic CD­MO gar­nered the sup­port of Gold­man Sachs As­set Man­age­ment, who co-led the fi­nanc­ing round with So­fi­na. Oth­er in­vestors joined in the round, in­clud­ing No­vo Hold­ings, Qim­ing Ven­ture Cap­i­tal, and sev­er­al oth­er firms.

The se­ries brings the com­pa­ny up to $225 mil­lion raised since it was found­ed in 2017. As part of the raise, ZhenGe named Kevin Xu, a man­ag­ing di­rec­tor at Gold­man Sachs As­set Man­age­ment, to its board.

ZhenGe says it has worked on close to 150 projects so far — in­clud­ing mam­malian cell cul­ture medi­um de­vel­op­ment and pro­duc­tion, cell line de­vel­op­ment projects, IND ap­pli­ca­tions and large clin­i­cal phase pro­duc­tion con­tracts. The com­pa­ny claims to have a “deep ex­per­tise” in mon­o­clon­al and bis­pe­cif­ic an­ti­bod­ies, AD­Cs, fu­sion pro­teins and vac­cines.

ZhenGe said in a state­ment the funds will be used to strength­en the biotech’s R&D ca­pa­bil­i­ties and ex­pand its GMP man­u­fac­tur­ing ca­pac­i­ty to bet­ter meet client de­mand.

Chair­man and CEO Jianx­in Chen not­ed the biotech will add mul­ti­ple 15,000L pro­duc­tion lines as part of their ex­pan­sion plans.

The biotech cur­rent­ly has fa­cil­i­ties in Shang­hai, in­clud­ing a 10,000-square-me­ter GMP pi­lot pro­duc­tion cen­ter in Shang­hai’s Free Trade Zone, and in Mary­land.

In terms of drug ca­pac­i­ty and out­put, ZhenGe al­so has a GMP medi­um pro­duc­tion line with an an­nu­al out­put of 200 tons of dry pow­der, and a com­mer­cial man­u­fac­tur­ing base with three 2,000L and three 5,000L biore­ac­tors, which are cur­rent­ly un­der con­struc­tion.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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