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.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

London Stock Exchange-listed PureTech Health announced Wednesday that it’s looking to extend to Nasdaq. But due to its “strong cash position,” the biotech says it isn’t issuing any new shares in the potential secondary listing.

The company’s shares closed at £256.50 Tuesday on the London Stock Exchange. Its candidate LYT-100 is currently in Phase I development for various indications, including lymphatic flow disorders and fibrotic and inflammatory disorders. PureTech is expecting a Phase Ib readout in lymphatic flow disorders later this year, and is also planning to launch a Phase II study for the drug to treat respiratory conditions experienced after Covid-19.