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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.