The Car­lyle Group is in­vest­ing $260 mil­lion to grab a mi­nor­i­ty stake in Shen­zhen Salu­bris Phar­ma­ceu­ti­cal, a sto­ried gener­ic mak­er that’s in­creas­ing­ly in­vest­ing in new drug R&D.

The cash is good for a 5% stake in Shen­zhen-list­ed Salu­bris, giv­ing the pri­vate eq­ui­ty play­er ac­cess to a port­fo­lio of treat­ments and de­vices in the car­dio­vas­cu­lar, on­col­o­gy and an­ti-in­fec­tive ar­eas. As the Chi­nese gov­ern­ment’s re­im­burse­ment re­forms spur con­sol­i­da­tion in the gener­ic drug mar­ket, some play­ers are poised to gain mar­ket share, Car­lyle not­ed in a state­ment.

While Salu­bris’ rev­enues have his­tor­i­cal­ly been dri­ven by sales of main­stays like the blood thin­ners clopi­do­grel and bi­valirudin, the com­pa­ny’s been up­ping its bet on ear­ly-stage drug de­vel­op­ment.

That means in-li­cens­ing enar­o­du­s­tat, a hy­pox­ia-in­ducible fac­tor pro­lyl hy­drox­y­lase (HIF-PH) in­hibitor, from Japan’s JT; tak­ing the lead on back­ing Virac­ta, a biotech work­ing on vi­ral-as­so­ci­at­ed can­cers; as well as push­ing through in­ter­nal­ly dis­cov­ered can­di­dates, in­clud­ing an an­giotensin re­cep­tor-NEP in­hibitor and a re­com­bi­nant fu­sion pro­tein for heart fail­ure.

Lever­ag­ing Car­lyle’s ex­per­tise, net­work and re­sources, Salu­bris says it is look­ing to ex­pand both do­mes­ti­cal­ly and glob­al­ly — with plans to do more tri­als over­seas. M&A is al­so on the ta­ble.

For Car­lyle, it’s a chance to tap in­to “one of the strongest fran­chis­es” in the car­dio- and cere­brovas­cu­lar (CCV) seg­ment in Chi­na, said Ling Yang, a man­ag­ing di­rec­tor of the Car­lyle Asia Buy­out ad­vi­so­ry team. Salu­bris is now the sec­ond largest do­mes­tic com­pa­ny in the space, ac­cord­ing to Car­lyle.

The firm boasts of long-stand­ing op­er­a­tions in Chi­na built over 20 years, in­vest­ing more than $9.5 bil­lion worth of eq­ui­ty as it en­tered the sec­ond half of 2020.

More promi­nent in its Chi­na deal streak are the in­vest­ments in the pep­tide API man­u­fac­tur­er Am­bio and the clin­i­cal lab­o­ra­to­ry Adi­con, among oth­er moves in medtech and health­care.

Glob­al­ly, Car­lyle — which has re­cruit­ed re­tired Pfiz­er chief Ian Read to be a deal scout — has been known for its role as a ma­jor in­vestor in con­tract re­search or de­vel­op­ment/man­u­fac­tur­ing or­ga­ni­za­tions, in­clud­ing PPD and AM­RI. Most re­cent­ly it struck a deal with In­dia’s Pi­ra­mal Phar­ma to pur­chase around 20% of its shares for $490 mil­lion.

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.