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.”

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.