A Penn­syl­va­nia CD­MO spe­cial­iz­ing in cell and gene ther­a­py man­u­fac­tur­ing is re­ceiv­ing a big in­flux of cash from a South Ko­re­an drug­mak­er — and it has plans for a ma­jor hir­ing spree.

SK, the hold­ing com­pa­ny of SK bio­science, will in­vest $350 mil­lion of eq­ui­ty fi­nanc­ing in­to the Cen­ter for Break­through Med­i­cines, with plans to add an ad­di­tion­al 2,000 em­ploy­ees as part of a re­dux at the CD­MO’s King of Prus­sia, PA fa­cil­i­ty.

CBM will use the funds to add au­toma­tion to its man­u­fac­tur­ing op­er­a­tions from pre-clin­i­cal all the way through com­mer­cial scale. That in­cludes process de­vel­op­ment, vi­ral vec­tor man­u­fac­tur­ing, cell pro­cess­ing, plas­mid DNA and cell bank­ing, it said. The com­pa­ny will bring 700,000 ad­di­tion­al square feet of ca­pac­i­ty on­line and hire staff mem­bers for its site out­side Philadel­phia. The space will be run by The Dis­cov­ery Labs.

Bri­an O’Neill

The deal has been in the works since last Jan­u­ary. It comes eight months af­ter SK’s takeover of the French gene and cell ther­a­py com­pa­ny Yposke­si.

CBM was es­tab­lished in 2019. It an­nounced over the sum­mer that it would in­vest $132 mil­lion in pro­duc­tion ca­pac­i­ty in mR­NA and vi­ral vec­tor op­er­a­tions in a project set to be op­er­a­tional by 2024. That ex­pan­sion will add more than 1 mil­lion square feet of pro­duc­tion space in An­dong, South Ko­rea, and was the first site in the coun­try to get the OK for Covid-19 vac­cine man­u­fac­tur­ing on the con­ti­nent.

“We chose to part­ner with SK based on our shared deep de­sire to cure can­cer and erad­i­cate ge­net­ic dis­ease,” CBM chair­man Bri­an O’Neill said in a state­ment. “Thou­sands of peo­ple are dy­ing every day, and we have the abil­i­ty to cure pa­tients by man­u­fac­tur­ing these new tech­nolo­gies.

Dong Hoon Lee

The move is a step in the right di­rec­tion for SK Pharmte­co to be­come a top-tier CD­MO by 2025, Dong Hoon Lee, the EVP of SK, said in a state­ment.

In Au­gust, South Ko­re­an Pres­i­dent Moon Jae-in said that he hopes the coun­try can be­come one of the five largest man­u­fac­tur­ing bases in the world by 2025. Moon added biotech man­u­fac­tur­ing to the list of na­tion­al strate­gic tech­nolo­gies along with semi­con­duc­tors and bat­ter­ies and of­fers tax breaks for those com­pa­nies to help pay for ma­te­ri­als, parts and equip­ment.

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.