John Rim, Samsung Biologics CEO

Amidst large in­vest­ment from par­ent com­pa­ny, Sam­sung Bi­o­log­ics seeks to ramp up biotech fund­ing

Dur­ing End­points News’ time in San Diego for #BIO22, it was hard to miss all the Sam­sung Bi­o­log­ics signs plas­tered along­side the high­way to the air­port, adorn­ing near­ly every lamp post. How­ev­er, ad­ver­tis­ing is not the on­ly place where Sam­sung is look­ing to spend.

Last month, it was re­port­ed that South Ko­rea’s Sam­sung Group raised spend­ing by more than 30% to KRW 450 tril­lion, or around $360 bil­lion, to in­vest in sev­er­al lines of busi­ness in­clud­ing elec­tron­ics and biotech, among oth­ers. Sam­sung Bi­o­log­ics CEO John Rim spoke to End­points at #BIO22 to dis­cuss how this in­vest­ment will af­fect the biotech arms of one of South Ko­rea’s largest con­glom­er­ates.

Rim said that a sig­nif­i­cant por­tion of that mon­ey will be in­vest­ed in­to biotech, but a hard fig­ure was not giv­en to End­points. Rim did in­di­cate that the com­pa­ny is build­ing out a plat­form that will be com­plet­ed around Oc­to­ber, with it com­ing ful­ly on­line next year on the back of the in­vest­ment.

Al­so, the com­pa­ny is in the process of pur­chas­ing ad­di­tion­al land, dubbed Bio Cam­pus Two, which will be ad­ja­cent to their cur­rent 60-acre cam­pus in Song­do, South Ko­rea. Rim said their cur­rent cam­pus is now ful­ly oc­cu­pied and is now in need of ex­pan­sion. This new cam­pus will be planned to be ful­ly staffed with­in the next 10 years and be 30% larg­er, Rim said. Ac­cord­ing to a reg­u­la­to­ry fil­ing, the com­pa­ny will spend around KRW 426 Bil­lion, or $347 mil­lion, to ac­quire the land for the new 80-acre cam­pus.

While Sam­sung Bi­o­log­ics is al­so build­ing out an­oth­er plant in Song­do, la­beled as a ‘su­per plant’ with a $2 bil­lion price tag, Rim said that the in­vest­ment will al­so build out two more man­u­fac­tur­ing plants to bring their to­tal to six.

Rim did not share any specifics on the size or cost of the pro­posed plants, but said the idea is to have sim­i­lar-sized fa­cil­i­ties to what they have now. Rim said they are fac­ing a very ro­bust client de­mand, and the com­pa­ny will look for the right time for an of­fi­cial an­nounce­ment on their de­vel­op­ment. The com­pa­ny will al­so look to in­vest in ad­di­tion­al fa­cil­i­ties re­lat­ed to CDO, gene ther­a­py and mR­NA pro­duc­tion.

Rim said that the com­pa­ny will not on­ly be look­ing at large-scale pro­duc­tion but open in­no­va­tion and mul­ti-modal prod­ucts as well.

“The Sam­sung Group has said biotech­nol­o­gy will be the sec­ond arm of growth be­yond Sam­sung Elec­tron­ics. So, there’s a huge amount of fo­cus and at­ten­tion around that area. And Ko­rea is fo­cused on biotech­nol­o­gy be­cause they see that as an on­go­ing growth in­dus­try,” Rim said.

As to why the Sam­sung Group sees this as a greater in­vest­ment op­por­tu­ni­ty, Rim pre­sent­ed sev­er­al fac­tors, such as im­prov­ing tech­nol­o­gy, an ag­ing pop­u­la­tion and a con­tin­ued in­crease in GDP over time.

How­ev­er, this in­vest­ment comes at a time when oth­er South Ko­re­an con­glom­er­ates are al­so throw­ing their weight around in biotech man­u­fac­tur­ing. In May, the Lotte Group ac­quired a drug man­u­fac­tur­ing fa­cil­i­ty from Bris­tol My­ers Squibb in Syra­cuse, NY.

Rim said bud­ding com­pe­ti­tion from oth­er con­glom­er­ates is a good thing as it speaks to the rapid­ly grow­ing in­ter­est in biotech in Ko­rea. As for fu­ture ac­qui­si­tions in the US, Rim said that while noth­ing is con­firmed, the com­pa­ny will be keep­ing its eye out for fu­ture tar­gets to ac­quire.

This in­jec­tion is ul­ti­mate­ly set­ting Sam­sung Bi­o­log­ics on a ma­jor build­ing spree, with deep in­vest­ments in­to man­u­fac­tur­ing and oth­er biotech op­er­a­tions.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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