It’s been a big day for Jun­shi Bio­sciences as it nabs Chi­na’s first snap ap­proval for a home­grown PD-1 af­ter re­port­ed­ly clos­ing a $394 mil­lion IPO in Hong Kong.

Con­di­tion­al­ly ap­proved un­der pri­or­i­ty re­view, tori­pal­imab is in­di­cat­ed for fast-grow­ing cas­es of melanoma, ac­cord­ing to the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion.

“Clin­i­cal tri­al re­sults of this prod­uct shows that in treat­ing pa­tients with un­re­sectable or metasta­t­ic melanoma who have failed pre­vi­ous sys­temic ther­a­pies, it reach­es an ob­jec­tive re­sponse rate of 17.3%, dis­ease con­trol rate of 57.5%, and 1-year sur­vival rate of 69.3%,” the NM­PA writes in a note. “The prod­uct’s mar­ket­ing ap­proval has a pos­i­tive im­pact on the se­lec­tion of clin­i­cal drugs for can­cer pa­tients.”

With 68 check­points crowd­ing the pipeline, this is like­ly to be first of many OKs from Chi­na’s rapid­ly evolv­ing reg­u­la­to­ry agency. Da­ta provider Pharm­Cube pre­vi­ous­ly told End­points News that In­novent Bi­o­log­ics, BeiGene (Cel­gene’s part­ner) and Jiang­su Hen­grui are all be­ing tipped for a mar­ket launch in the first half of 2019.

The ap­proval, which took nine months to process and tech­ni­cal­ly goes to Jun­shi’s sub­sidiary TopAl­liance, fol­lows those of Op­di­vo and Keytru­da, the two pi­o­neers in the field that’s been dom­i­nat­ing sales glob­al­ly.

While the ma­jor­i­ty of Jun­shi’s IPO pro­ceeds will go to­ward the con­tin­ued de­vel­op­ment and com­mer­cial­iza­tion of PD-1, parts will fund its oth­er pro­grams, in­clud­ing a PC­SK9 drug and a Hu­mi­ra biosim­i­lar, ac­cord­ing to an ear­li­er fil­ing.

Pric­ing at the bot­tom of the range, Jun­shi are sell­ing their shares at $2.48 (HK$19.38) each, Reuters re­port­ed. It’s set to be­gin trad­ing on De­cem­ber 24.

CI­CC is the sole spon­sor for the float while Cred­it Su­isse acts as a joint bookrun­ner.

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Xenotransplantation is having a moment.

Last October, a team from NYU successfully transplanted a kidney from a pig into a brain-dead patient, although observers cast doubt on the importance of the experiment. Then, earlier this month, surgeons at the University of Maryland transplanted a pig heart into a dying human, who appears to still be stable.

Now, another group is planting a flag in the xenotransplantation field. Surgeons at the University of Alabama at Birmingham said Thursday they have achieved the first kidney transplant from a pig to a brain-dead patient, publishing their peer-reviewed findings online. The team, aiming to differentiate itself from the others through the genetic modifications used, is hoping there’s now enough research to soon begin clinical xenotransplantation studies.