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.

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.