Bye CF­DA: Chi­na's drug reg­u­la­tor to take new shape in ma­jor gov­ern­ment re­struc­tur­ing

A sweep­ing gov­ern­ment re­or­ga­ni­za­tion has re­wo­ven the Chi­na Food and Drug Ad­min­is­tra­tion in­to the fab­ric of an over­ar­ch­ing mar­ket su­per­vi­sion ad­min­is­tra­tion, giv­ing birth to a drug reg­u­la­tor un­der its purview.

The changes mean that af­ter five years of di­rect­ly re­port­ing to the State Coun­cil, the CF­DA will no longer be a stand­alone agency. The new­ly cre­at­ed mar­ket su­per­vi­sion ad­min­is­tra­tion will have a broad man­date cov­er­ing an­ti-mo­nop­oly laws, price con­trol, con­sumer goods qual­i­ty and safe­ty, etc — and that in­cludes every­thing food-re­lat­ed. It will, how­ev­er, leave the mat­ters of drug ap­proval to a sub-ad­min­is­tra­tion ded­i­cat­ed to drug reg­u­la­tion.

Of note is the fact that the new drug reg­u­la­tor’s au­thor­i­ty on­ly ex­tends to the provin­cial lev­el, del­e­gat­ing post-ap­proval mar­ket­ing and sales mon­i­tor­ing to coun­ty and city mar­ket su­per­vi­sion de­part­ments.

Those de­part­ments al­ready ex­ist in a num­ber of lo­cal gov­ern­ments, which con­sol­i­dat­ed com­merce, qual­i­ty con­trol and food/drug de­part­ments in­to one big struc­ture in­stead of fol­low­ing the ex­am­ple of the State Coun­cil in 2013, which cre­at­ed the stand­alone food and drug ad­min­is­tra­tion.

Hu Yinglian

That helps avoid con­fu­sion about over­lap­ping au­thor­i­ties, while al­low­ing the pro­fes­sion­al work of drug eval­u­a­tion in pro­fes­sion­al hands, Chi­nese Acad­e­my of Gov­er­nance pro­fes­sor Hu Yinglian told lo­cal mag­a­zine Cai­jing.

The reshuf­fle plan, which is wide­ly ex­pect­ed to be for­mal­ly en­dorsed by the Na­tion­al Peo­ple’s Con­gress lat­er this week, is the lat­est in a se­ries of back and forth changes over the past two decades.

Start­ing out as a stand­alone drug ad­min­is­tra­tion in 1998, the agency added food to its name in 2003, went un­der the au­thor­i­ty of the Na­tion­al Health Com­mis­sion in 2008, on­ly to be­come its own en­ti­ty again in 2013 — un­til now.

Ex­act­ly what the new struc­ture would look like re­mains un­clear, but we do know one thing for sure: Pres­i­dent Xi Jin­ping would like­ly stay in pow­er for the rest of his life to over­see these changes, thanks to a con­sti­tu­tion­al amend­ment passed weeks ago.

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.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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.

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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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

David Meline (file photo)

Mod­er­na’s new CFO took a cut in salary to jump to the mR­NA rev­o­lu­tion­ary. But then there’s the rest of the com­pen­sa­tion pack­age

David Meline took a little off the top of his salary when he jumped from the CFO post at giant Amgen to become the numbers czar at the upstart vaccines revolutionary Moderna. But the SEC filing that goes with a major hire also illustrates how it puts him in line for a fortune — provided the biotech player makes good as a promising game changer.

To be sure, there’s nothing wrong with the base salary: $600,000. Or the up-to 50% annual cash bonus — an industry standard — that comes with it. True, the 62-year-old earned $999,000 at Amgen in 2019, but it’s the stock options that really count in the current market bliss for all things biopharma. And there Meline did well.

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