Af­ter a makeover and hir­ing spree, Chi­na's drug agency is romp­ing and stomp­ing on new re­views and ap­provals

When it comes to the re­forms at Chi­na’s drug agency, now un­der­go­ing a name change, pol­i­cy changes and even their out­comes are rel­a­tive­ly easy to spot, but num­bers are hard­er to come by. In a year­ly re­port re­leased last week, though, the agency of­fered some rare sta­tis­tics to track its progress over the past few years and il­lu­mi­nate R&D pri­or­i­ties in the coun­try.

The re­port high­lights some big trends that have ma­jor im­pli­ca­tions for all com­pa­nies look­ing to land a mar­ket­ing OK and roll out new drugs in the boom­ing Asian mar­ket. Af­ter beef­ing up the num­ber of reg­u­la­tors on staff, Chi­na’s FDA slashed re­view times to a frac­tion of what they had been. There’s been a con­tin­ued de­cline in the over­all num­ber of back­logged ap­pli­ca­tion, thanks to in­creased speed at the agency. In drug INDs alone, the Cen­ter for Drug Eval­u­a­tion han­dled 542 ap­pli­ca­tions and ap­proved 481 of them — among those, 399 cas­es (shared by 170 drugs) were for nov­el drugs.

On­col­o­gy and di­ges­tive drugs dom­i­nat­ed the group of nov­el drug INDs ap­proved last year. In bi­o­log­ics, on­col­o­gy al­so takes up the biggest chunk of INDs, with hema­tol­ogy emerg­ing as the run­ner-up.

Each IND took an av­er­age of 120 work­ing days to eval­u­ate, 1.09 times the pe­ri­od re­quired by law — a dras­tic im­prove­ment from, say, 2012, when records show that al­most half of the ap­pli­ca­tions would take longer than 400 days to process.

Ag­gres­sive hir­ing of new staff was like­ly a key fac­tor to speed­ing up the reg­u­la­to­ry op­er­a­tion. With new units spe­cial­iz­ing in clin­i­cal test­ing and da­ta man­age­ment, the CF­DA made 223 new hires, in­clud­ing two “chief sci­en­tists.”

The CDE al­so ramped up the pri­or­i­ty re­view sys­tem, which was launched in 2016. By their count, first rounds for INDs, NDAs and AN­DAs took an av­er­age of 39, 59 and 81 work­ing days once they were ac­cept­ed for pri­or­i­ty re­view.

By the end of 2017, 423 ap­pli­ca­tions of all sorts were in­clud­ed for pri­or­i­ty re­view, with 45% of that be­ing new drugs with clear clin­i­cal ben­e­fit (oth­er com­mon rea­sons in­clud­ed si­mul­ta­ne­ous ap­pli­ca­tion in the US/EU and first copy­cat). Rare dis­ease drugs took up 5% of the cas­es.

The CDE’s 110 pri­or­i­ty re­view ap­provals trans­lat­ed to 57 drugs, and 50 of those were ap­proved in 2017. Over­seas phar­mas won big: Re­gen­eron’s Eylea, Ab­b­Vie’ Hu­mi­ra, In­cyte’s Jakafi and Cel­gene’s Vi­daza (to be mar­ket­ed by part­ner BeiGene) were among those ap­proved through the pri­or­i­ty re­view track.

Giv­en the gov­ern­ment re­vamp an­nounced weeks ago, this would be the last re­port is­sued by a stand­alone CF­DA. But chang­ing its name to Chi­na Drug Ad­min­is­tra­tion and go­ing un­der the purview of an um­brel­la mar­ket su­per­vi­sion agency like­ly won’t stop the reg­u­la­tors from build­ing an even more ag­gres­sive sys­tem.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.