Chi­na can­cer spe­cial­ist Zai Lab has made its name in-li­cens­ing West­ern drugs and us­ing its deep knowl­edge of the East Asian mar­ket to churn out re­sults. The biotech has now signed two more li­cens­ing deals for a trio of drugs, in­clud­ing a very sud­den jump in­to the neu­ro­science space.

First, Zai Lab inked a deal Tues­day with Karuna Ther­a­peu­tics for rights in main­land Chi­na, Hong Kong, Macau and Tai­wan to KarXT, an in­ves­ti­ga­tion­al M1/M4-pre­fer­ring mus­carinic ag­o­nist be­ing test­ed to treat a va­ri­ety of psy­chi­atric con­di­tions.

Zai Lab will shell out $35 mil­lion up­front in this one with the po­ten­tial for an ad­di­tion­al $80 mil­lion in de­vel­op­ment and reg­u­la­to­ry mile­stones and $72 mil­lion in sales mile­stones on top of roy­al­ties.

Karuna is eval­u­at­ing KarXT in a slate of late-stage tri­als to treat schiz­o­phre­nia and psy­chosis in Alzheimer’s pa­tients with two Phase III stud­ies for the schiz­o­phre­nia pro­gram ex­pect­ed to read­out in 2022. Mean­while, the com­pa­ny is set to be­gin an ad­di­tion­al Phase III tri­al look­ing at KarXT as an ad­junct ther­a­py for pre­vi­ous­ly treat­ed adults by the end of the year.

Mean­while, an up­com­ing Phase III study for KarXT in psy­chosis in Alzheimer’s is set to kick off by mid-2022.

The deal is sig­nif­i­cant in that it rep­re­sents Zai Lab’s first for­ay in­to neu­ro­science, an­oth­er branch­ing out for the can­cer spe­cial­ist. In a state­ment, CEO Saman­tha Du had this to say about why her team de­cid­ed to make the leap:

Our col­lab­o­ra­tion with Karuna is a sig­nif­i­cant mile­stone for Zai Lab, mark­ing the ex­pan­sion and di­ver­si­fi­ca­tion of our de­vel­op­ment and com­mer­cial port­fo­lio in­to neu­ro­science, our fourth ther­a­peu­tic area. KarXT is well po­si­tioned to serve as the an­chor as­set in our new neu­ro­science fran­chise. Zai Lab’s mis­sion is to de­liv­er in­no­v­a­tive med­i­cines to ad­dress un­met med­ical needs of pa­tients, and we look for­ward to work­ing with Karuna to bring KarXT to pa­tients in need in Greater Chi­na as soon as pos­si­ble.

In a sec­ond pact signed Tues­day, Zai Lab will pay $25 mil­lion up­front and a po­ten­tial ad­di­tion­al $590 mil­lion in down­stream mile­stones for rights to Blue­print Med­i­cines’ in­ves­ti­ga­tion­al EGFR TKI in­hibitors BLU-945 and BLU-701 in Chi­na, Hong Kong, Macau and Tai­wan, the com­pa­nies said Tues­day.

Both drugs are be­ing de­vel­oped specif­i­cal­ly to tar­get drug re­sis­tant mu­ta­tions in EGFR-pos­i­tive lung can­cer pa­tients who do not re­spond to oth­er EGFR in­hibitors. BLU-945 specif­i­cal­ly tar­gets the T790M and C797S and mu­ta­tions while BLU-701 tar­gets C797S with pre­clin­i­cal mod­els show­ing a high de­gree of CNS pen­e­tra­tion, po­ten­tial­ly mak­ing it a good op­tion for pa­tients with brain metas­tases.

Zai Lab sees these drugs as po­ten­tial first-in-class op­tions in Chi­na for EGFR-pos­i­tive NSCLC pa­tients whose dis­ease pro­gress­es with oth­er EGFR in­hibitors, and Blue­print is us­ing the deal as part of a glob­al clin­i­cal ef­fort to see both drugs reach ap­proval in Chi­na and else­where.

If ei­ther drug does get ap­proved in Chi­na, Blue­print will be due tiered roy­al­ties in the “low teens to mid-teens.”

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.

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

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.