He­len Kim, Kite

With its new drug ap­pli­ca­tion for the pi­o­neer­ing CAR-T drug KTE-C19 in the fi­nal weeks from be­ing com­plet­ed and shipped to reg­u­la­tors in search of an ac­cel­er­at­ed ap­proval, Kite Phar­ma $KITE has now lined up two part­ners to man­age their prospec­tive leap in­to two key Asian mar­kets. Kite has pulled the wraps off a joint ven­ture for Chi­na while ink­ing a $250 mil­lion-plus deal to break in­to the Japan­ese mar­ket along­side Dai­ichi Sankyo.

Kite is tak­ing a $50 mil­lion up­front and $200 mil­lion in mile­stones for the Japan­ese deal, while Dai­ichi Sankyo is re­serv­ing an­oth­er $200 mil­lion in ad­di­tion­al mile­stones for each new drug can­di­date that Kite takes to the FDA over the next three years. Roy­al­ties will range from the low to mid-dou­ble dig­it range.

The biotech has com­plet­ed a deal to cre­ate a JV in Chi­na with Fo­s­un Phar­ma, which is hand­ing over $40 mil­lion up­front, $20 mil­lion for ini­tial fund­ing for clin­i­cal ac­tiv­i­ties and man­u­fac­tur­ing and a set of mile­stone pay­ments for their CAR-T in a 50/50 deal.

The deal for Japan part­ners Kite with one of the biggest play­ers in that coun­try’s phar­ma in­dus­try, and one that is com­mit­ted to build­ing up the in­fra­struc­ture to pro­duce and mar­ket these in­di­vid­u­al­ly tai­lored ther­a­pies, which ex­tract T cells from pa­tients and en­gi­neer them in­to at­tack weapons point­ed at can­cer cells.

“Dai­ichi Sankyo made a strate­gic de­ci­sion to get in­to cell ther­a­py,” says He­len Kim, Kite’s chief of busi­ness de­vel­op­ment. “The struc­ture is a more tra­di­tion­al li­cens­ing agree­ment. We will pro­vide tech­nol­o­gy trans­fer on the man­u­fac­tur­ing. It’s their de­sire to do the man­u­fac­tur­ing” in Japan.

“They’re very strong in on­col­o­gy,” she added about Fo­s­un. “They just have a huge pres­ence” in Chi­na.

Kite’s been en­gaged in a race with No­var­tis for the first ap­proval for a CAR-T ther­a­py, while one-time ri­val Juno strug­gles with a lead pro­gram which has been linked to five pa­tient deaths due to brain tox­i­c­i­ty. These first CAR-Ts have been as­so­ci­at­ed with cy­tokine re­lease syn­drome, but have al­so shown great promise in treat­ing ag­gres­sive non-Hodgkin lym­phoma, where Kite has been tar­get­ing its first ap­proval.

Kite has a Eu­ro­pean sub­sidiary that plans to wres­tle for an ap­proval on the con­ti­nent.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.