Star drugs like BM­S' Op­di­vo, As­traZeneca's Lyn­parza will get speedy OKs in Chi­na this year, new re­port pre­dicts

Now that Chi­na has re­vamped its drug re­view process to speed things up for de­vel­op­ers, a new re­port pre­dicts that Bris­tol-My­ers Squibb $BMY, As­traZeneca $AZN and Am­gen $AMGN are among the lead­ing multi­na­tion­al phar­ma gi­ants that will win ap­proval for some block­buster hope­fuls. Oth­ers stand to ben­e­fit from mar­ket­ing drugs de­vel­oped by Chi­nese part­ners.

The re­port, pro­duced by Bei­jing-based da­ta provider Pharm­Cube, high­lights 16 prod­ucts Chi­nese reg­u­la­tors are ex­pect­ed to green light in 2018. Over half of them in­volve an over­seas play­er in bio­phar­ma.

The re­port came out just ahead of the CF­DA’s up­dat­ed set of guide­lines for a pri­or­i­ty re­view path­way, con­tin­u­ing an em­pha­sis on speed­ing re­views and new drug ap­provals spot­light­ed through­out last year. Com­pa­nies can now seek pri­or­i­ty re­view of drug can­di­dates that meet one of a list of cri­te­ria, or prove ef­fec­tive in treat­ing sev­er­al ma­jor dis­eases. And a host of key out­fits are rush­ing in to see how they can be­gin to cap­i­tal­ize on the boom­ing Chi­nese health care mar­ket.

On track to be Chi­na’s first PD-1/PD-L1 check­point treat­ment, BMS’ Op­di­vo (nivolum­ab) is high up on the list. The ap­pli­ca­tion was ac­cept­ed in No­vem­ber and grant­ed pri­or­i­ty re­view in De­cem­ber. The hopes for a speedy ap­proval is high giv­en its clin­i­cal ben­e­fits and the at­ten­tion it has gar­nered (not to men­tion that the bi­o­log­ic queue is rel­a­tive­ly short). Con­sid­er­ing As­traZeneca’s lung can­cer drug Tagris­so was OK’d with­in three weeks of get­ting ac­cel­er­at­ed re­view, a Q1 ap­proval does not seem far-fetched.

As­traZeneca is cheer­ing on its own Lyn­parza for ovar­i­an can­cer, which was the first im­port­ed drug to in­clude in­ter­na­tion­al mul­ti­cen­ter da­ta in its ap­pli­ca­tion. Pharm­Cube is look­ing at a Q3 ap­proval for this one, giv­en that it does get fast-tracked.

In the fourth quar­ter there’s Am­gen’s Repatha (evolocum­ab) and No­var­tis’ Zyka­dia (cer­i­tinib) — which low­ers cho­les­terol and treats lung can­cer, re­spec­tive­ly. And if things go smooth­ly, Eli Lil­ly will pock­et a good chunk of rev­enue from mar­ket­ing fruquin­tinib, a prod­uct de­vel­oped by Chi­na’s Hutchi­son MediPhar­ma, which lays claim to be­ing the first true home grown drug to aim at a mar­ket­ing launch. It treats col­orec­tal can­cer, the sec­ond-most preva­lent can­cer in Chi­na.

Here’s the full list:

  1. Fron­tier Biotech: al­bu­ver­tide
  2. Bris­tol My­ers-Squibb: nivolum­ab
  3. Jiang­su Hen­grui Med­i­cine: 19K
  4. CT­TQ: an­lo­tinib hy­drochlo­ride
  5. Jiang­su Hen­grui Med­i­cine: py­ro­tinib
  6. Hutchin­son MediPharm/Eli Lil­ly: fruquin­tinib
  7. As­traZeneca: Lyn­parza  (ola­parib)
  8. Ei­sai: Lenvi­ma (lenva­tinib)
  9. Fi­bro­Gen/AZ: rox­adu­s­tat
  10. Han­soh: PEX168
  11. No­var­tis: Zyka­dia (cer­i­tinib)
  12. Am­gen: Repatha (evolocum­ab)
  13. As­cle­tis: danopre­vir
  14. Gilead: Har­voni (ledi­pasvir/so­fos­bu­vir)
  15. Eli Lil­ly: Trulic­i­ty (du­laglu­tide)
  16. Gilead: Vem­lidy (teno­fovir alafe­namide)


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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Fangliang Zhang, AP Images

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,200+ biopharma pros reading Endpoints daily — and it's free.

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.