In a bid to in­crease its mar­ket share in Chi­na, Am­gen has agreed to a part­ner­ship with a Shang­hai biotech — a col­lab­o­ra­tion and out-li­cens­ing agree­ment for two of its drugs.

Am­gen and Fo­s­un Phar­ma an­nounced a deal Mon­day in a bid to in­crease Am­gen’s pres­ence in the coun­try. The stat­ed goal so far is to com­mer­cial­ize Am­gen’s block­buster pso­ri­a­sis drug Ote­zla along­side Parsabiv, a drug for sec­ondary hy­per­parathy­roidism in adults with chron­ic kid­ney dis­ease and on a spe­cif­ic type of dial­y­sis.

This is Am­gen’s most re­cent step in the coun­try in a bid that goes back years. In 2019, Am­gen spent $2.7 bil­lion to grab a 20.5% stake in Bei­jing-head­quar­tered BeiGene, ex­press­ing an ini­tial de­sire to tap in­to the world’s most pop­u­lous coun­try and one of the biggest mar­kets on the world stage.

Fo­s­un and Am­gen said that their col­lab­o­ra­tion will fo­cus on bring­ing the two med­i­cines to Chi­nese pa­tients more quick­ly and uti­lize Fo­s­un’s al­ready-es­tab­lished com­mer­cial ca­pa­bil­i­ties in the coun­try. But on the ap­proval front, Am­gen is on­ly halfway there.

While Ote­zla has al­ready been ap­proved by Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion as of last Au­gust, Parsabiv is still await­ing mar­ket­ing au­tho­riza­tion in the coun­try. Parsabiv has al­ready got­ten the thumbs up from both the EMA and FDA in 2016 and 2017, re­spec­tive­ly.

Am­gen did not re­spond to a re­quest for com­ment be­fore pub­li­ca­tion.

Fo­s­un chair­man Wu Yi­fang said in a state­ment, “We are very pleased to en­ter in­to this part­ner­ship with Am­gen to bring two in­no­v­a­tive med­i­cines, Ote­zla and Parsabiv, to Chi­nese pa­tients.”

Am­gen Chi­na’s gen­er­al man­ag­er Irene Hsu added that out-li­cens­ing the two med­i­cines “can give full play to both com­pa­nies’ ad­van­tages” to en­sure pa­tient ac­cess and al­low Am­gen to fo­cus on car­dio­vas­cu­lar dis­ease and bone health in the coun­try.

Ac­cord­ing to the two com­pa­nies, Chi­na has 6.5 mil­lion pa­tients with pso­ri­a­sis and about 735,000 pa­tients on dial­y­sis.

Fi­nan­cial de­tails and oth­er specifics about out-li­cens­ing and the du­ra­tion of the deal were not dis­closed.

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.