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.

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.