You can count on the crowd­ed pool of made-in-Chi­na check­point in­hibitors to rip­ple fast.

Chi­nese reg­u­la­tors have hand­ed an ap­proval to In­novent and its part­ners at Eli Lil­ly for sin­til­imab, just 10 days af­ter Jun­shi scored the his­toric OK for its own home­grown PD-1.

Michael Yu

Sin­til­imab is the fourth check­point to be ap­proved in Chi­na and, so far, the on­ly one joint­ly de­vel­oped by a multi­na­tion­al drug­mak­er and a lo­cal biotech (the oth­er two are Mer­ck’s Keytru­da and Bris­tol-My­ers Squibb’s Op­di­vo). Its man­u­fac­tur­ing op­er­a­tions — a crit­i­cal field in the mar­ket­ing bat­tles to come — is the largest in the coun­try (at three 1000L lines cur­rent­ly) and has passed muster with Lil­ly, CEO Michael Yu told Pharm­Cube in an in­ter­view.

The ap­proval is based on a study of 96 pa­tients with re­lapsed/re­frac­to­ry clas­si­cal Hodgkin’s lym­phoma, which hit a ob­jec­tive re­sponse rate of 79.2% and a dis­ease con­trol rate of 97.9%. In­novent filed the NDA in April and the new­ly dubbed Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion — or NM­PA, suc­ces­sor to CF­DA — is­sued a pri­or­i­ty re­view des­ig­na­tion to speed things up.

To be mar­ket­ed as Tyvyt (In­novent’s first com­mer­cial prod­uct), sin­til­imab is al­so be­ing test­ed in first- and sec­ond-line set­tings, with 20-plus clin­i­cal tri­als un­der­way.

In No­vem­ber, the com­pa­nies cit­ed a Phase Ib suc­cess for non-small cell lung can­cer that’s help­ing jus­ti­fy a Phase III pro­gram. Oth­er po­ten­tial in­di­ca­tions in­clude gas­tric can­cer, liv­er can­cer and esophageal can­cer.

In­novent was among the lead­ing PD-1 de­vel­op­ers tipped for mar­ket launch­es in the first half of 2019 along­side BeiGene and Jiang­su Hen­grui. But it was Jun­shi Bio­sciences — now pub­licly list­ed in Hong Kong — that won the race for the first made-in-Chi­na PD-1 OK for a melanoma drug. A re­cent count by Pharm­Cube put the num­ber of PD-1/L1 agents in de­vel­op­ment in Chi­na at 68, part of a big wave of new check­points now in the clin­ic around the world.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.