Chi­na is re­port­ed­ly ap­prov­ing its 6th PD-1(L)1 drug in just over a year — and Am­gen will be pleased with this one.

The OK for tislelizum­ab would be the first mar­ket­ed prod­uct to be de­vel­oped by BeiGene, the em­i­nent Bei­jing-based biotech that Am­gen re­cent­ly took a $2.7 bil­lion stake in. Chi­na’s Cen­ter for Drug Eval­u­a­tion has com­plet­ed tech­ni­cal re­view and sent the NDA to the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion with a rec­om­men­da­tion to ap­prove, Chi­nese me­dia out­let Jiemi­an re­port­ed.

BeiGene is all set to hit the ground run­ning. Hav­ing part­nered with Cel­gene to hawk Revlim­id, Abrax­ane and Vi­daza in Chi­na, the drug­mak­er has built a 700-strong com­mer­cial­iza­tion team. The Am­gen deal al­so puts them in charge of sell­ing Xge­va (deno­sum­ab), Kypro­lis (carfil­zomib) and Blin­cy­to (bli­na­tu­momab) — pro­vid­ed the last two come through af­ter Phase III de­vel­op­ment.

Fol­low­ing the ini­tial in­di­ca­tion of chron­ic Hodgkin’s lym­phoma, BeiGene has al­ready filed an sN­DA to use tislelizum­ab in urothe­lial car­ci­no­ma.

While Cel­gene once held rights to the drug out­side Chi­na, BeiGene re­gained glob­al rights af­ter its US part­ner broke off the pact in the wake of a buy­out by Bris­tol-My­ers Squibb, the mak­er of Op­di­vo.

The fast pace re­flects just how rapid­ly the check­point mar­ket has evolved in Chi­na. Jun­shi and In­novent scored the first ap­provals for their home­grown ther­a­pies, Tuoyi and Tyvyt, though ac­cord­ing to Jiemi­an it’s Mer­ck’s Keytru­da that racked up the most sales: RMB$2 bil­lion ($280 mil­lion) since last Ju­ly. The num­bers for Jun­shi’s Tuoyi and In­novent’s Tyvyt are RMB$332 mil­lion ($47 mil­lion) and RMB$308 mil­lion ($43 mil­lion), re­spec­tive­ly.

Giv­en that com­pet­i­tive — some would say com­modi­tized — land­scape, BeiGene is look­ing to make a name for it­self through zanubru­ti­nib, a BTK in­hibitor po­si­tioned to chal­lenge the dom­i­nance of Im­bru­vi­ca. The drug is un­der re­view at the FDA af­ter nab­bing break­through sta­tus.

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition.

As Merck KGaA strives to prove itself as a capable biopharma R&D player, it has begun construction on a €250 million facility dedicated to developing and manufacturing drugs for use in clinical trials.

The German drugmaker chose a location at Corsier-sur-Vevey, Switzerland, where it already has a commercial manufacturing site, in order to “bridge together research and manufacturing.”

“This investment in the Merck Biotech Development Center reflects our commitment to speed up the availability of new medicines for patients in need, and confirms the importance of Switzerland as our prime hub for the manufacturing of biotech medicines,” CEO Stefan Oschmann said at the groundbreaking ceremony, according to a statement.

AstraZeneca kicked off Monday with a flurry of good news. Apart from unveiling positive results on its stroke trial testing its clot-fighter Brilinta, and welcoming its experimental IL-23 inhibitor brazikumab back from Allergan — the British drugmaker also disclosed some upbeat gastric cancer data on its HER2-positive oncology therapy it is collaborating on with Daiichi Sankyo.

Buoyed by the performance of its oncology drugs, last March AstraZeneca chief Pascal Soriot bet big to partner with Daiichi on the cancer drug, with $1.35 billion upfront in a deal worth up to roughly $7 billion. Roughly 8 months later, as 2019 drew to a close, the FDA swiftly approved the drug — trastuzumab deruxtecan — for use in breast cancer, months ahead of the expected decision date.

San Diego-based Sorrento Therapeutics isn’t going the M&A route — at least not today.

The biotech caused quite a stir when it put out word a few weeks ago that an unidentified private equity group was bidding a billion dollars-plus for the company. The news drove a quick spike in the company’s share price as investors hooked up for the ride — that didn’t happen.

The update sparked a 5% drop in the share price $SRNE ahead of the bell. It’s now trading just above $4, without any evidence that the $7 price looked like it was firm.