Chi­na reg­u­la­tors of­fer VIP treat­ment for 48 over­seas drugs they're ready to hus­tle up with ac­cel­er­at­ed re­views

Chi­na wants nov­el drugs al­ready ap­proved over­seas to be avail­able in the coun­try faster. And in case some drug­mak­ers didn’t get the memo, it’s now come up with a di­rect ap­peal.

Eight months af­ter the Chi­nese drug ad­min­is­tra­tion rolled out its new pri­or­i­ty re­view path­way, its Cen­ter for Drug Eval­u­a­tion has un­veiled a list of 48 drugs (which you can see be­low) ap­proved in the US, EU or Japan that are ur­gent­ly need­ed in the clin­i­cal set­ting. As long as the com­pa­nies can pro­vide ev­i­dence that the drug works equal­ly well across races, they can im­me­di­ate­ly ap­ply for mar­ket­ing ap­proval with the da­ta they have and will be el­i­gi­ble for pri­or­i­ty re­view.

In a re­cent re­port, the CDE con­clud­ed that they took an av­er­age of 59 work­ing days to process an NDA once it’s ac­cept­ed for pri­or­i­ty re­view. That’s light­ning fast by EMA or FDA stan­dards — even for their break­through drug pro­grams.

Can­cer drugs make up a quar­ter of the group, with Roche/Chugai’s ALK in­hibitor alec­tinib hy­drochlo­ride (Ale­cen­sa) and Mer­ck’s PD-1 star pem­brolizum­ab (Keytru­da) top­ping the list. Am­gen’s deno­sum­ab, which was first OK’d in Eu­rope as Pro­lia in 2010, is the old­est drug in this sub­set; where­as enasi­denib me­sy­late (Id­hi­fa), a new AML ther­a­py de­vel­oped by Cel­gene and Agios, got its green­light on­ly a year ago.

When putting the list to­geth­er, reg­u­la­tors wrote, they gave spe­cial con­sid­er­a­tion to new treat­ments for rare con­di­tions, as well as drugs that tar­get se­ri­ous, life threat­en­ing dis­eases with no ef­fec­tive ther­a­pies cur­rent­ly avail­able.

Oth­er “want­ed” drugs in­clude Spark’s $ONCE gene ther­a­py Lux­tur­na, Bio­gen’s $BI­IB SMA drug Spin­raza, and Alex­ion’s $ALXN Soliris — all con­sid­ered ground­break­ing at the time of their first ap­proval. No­tably, Soliris, which treats the rare dis­or­der parox­ys­mal noc­tur­nal he­mo­glo­bin­uria, has been ap­proved in the US for more than 10 years.

The list marks an­oth­er move by an agency that’s pushed out re­form af­ter re­form in the past few years, in­clud­ing a de­ci­sion to ac­cept over­seas clin­i­cal da­ta in NDAs — sav­ing for­eign drug­mak­ers the headache of con­duct­ing tri­als in Chi­na.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.