Coherus CEO Denny Lanfear (L) and Junshi CEO Li Ning

Two months af­ter CRL, FDA ac­cepts Co­herus, Jun­shi's re­sub­mis­sion for PD-1 stud­ied in Chi­na

Chi­na-on­ly clin­i­cal da­ta has not fared well be­fore the FDA this year. But in one case, the reg­u­la­to­ry agency might be will­ing to budge a lit­tle.

Co­herus Bio­Sciences, the US part­ner for Jun­shi Bio­sciences, an­nounced Wednes­day morn­ing that the FDA has ac­cept­ed a BLA re­sub­mis­sion for its PD-1 drug two months af­ter a CRL. The com­pa­nies are seek­ing a nod for tori­pal­imab plus chemother­a­py in first-line ad­vanced re­cur­rent or metasta­t­ic na­sopha­ryn­geal car­ci­no­ma (NPC), plus tori­pal­imab alone for sec­ond-line and lat­er re­cur­rent or metasta­t­ic NPC af­ter plat­inum-con­tain­ing chemother­a­py.

Set for a fi­nal ac­tion date of Dec. 23, the FDA said last month that the time­line for the re­view would be six months, say­ing that on-site in­spec­tions would be re­quired. If the FDA gives Co­herus the green light, the biotech plans to launch tori­pal­imab in the US in Q1 of 2023.

The drug was ap­proved in 2018 in Chi­na, where it is mar­ket­ed as Tuoyi.

A biosim­i­lars play­er, Co­herus spent $150 mil­lion last year to li­cense the PD-1 can­di­date from Jun­shi, join­ing three oth­er ma­jor US com­pa­nies at the time (Eli Lil­ly, EQRx and No­var­tis) that promised to un­der­cut the high-priced mar­ket for PD-1 in­hibitors by bring­ing in Chi­nese drugs and sell­ing them well be­low the price of Mer­ck’s Keytru­da or Bris­tol My­ers Squibb’s Op­di­vo. Lil­ly dished out $200 mil­lion to In­novent, EQRx doled out $150 mil­lion to Cstone, and No­var­tis paid BeiGene $650 mil­lion, with the lat­ter duo ex­pect­ing a de­ci­sion next week on tislelizum­ab.

How­ev­er, the FDA re­buked Eli Lil­ly back in Feb­ru­ary for try­ing to get its PD-1 can­di­date sin­til­imab ap­proved based on Chi­nese da­ta alone, which ini­tial­ly sug­gest­ed that Co­herus and oth­er com­peti­tors might not be able reach mar­ket.

In the af­ter­math of the sin­til­imab re­jec­tion, Chi­nese biotech Hutchmed got thrown a CRL for its small in­hibitor can­di­date over sim­i­lar con­cerns of da­ta most­ly from Chi­na. Jun­shi al­so said at the time that it re­ceived a CRL from US reg­u­la­tors, which it claimed had noth­ing to do with da­ta. Rather, Jun­shi said it was “a qual­i­ty process change.”

In­ter­est­ing­ly, with Co­herus and Jun­shi’s two Phase II stud­ies from which the orig­i­nal BLA was based, both were main­ly done in Chi­na, with the sec­ond study in­clud­ing some sites in Sin­ga­pore and Tai­wan.

“We be­lieve tori­pal­imab ad­dress­es an im­por­tant un­met need for pa­tients with NPC for whom there are cur­rent­ly no ap­proved im­munother­a­pies in the Unit­ed States, and the FDA has stat­ed that this in­di­ca­tion war­rants reg­u­la­to­ry flex­i­bil­i­ty with re­spect to the suf­fi­cien­cy of sin­gle coun­try clin­i­cal da­ta,” Co­herus CEO Den­ny Lan­fear had said at the time.

Lan­fear said to­day in a state­ment that “the tori­pal­imab re­sub­mis­sion is one of sev­er­al key de­vel­op­ment and com­mer­cial­iza­tion mile­stones we are sharply fo­cus­ing on over the next twelve months, and we are pleased with the Com­pa­ny’s ex­e­cu­tion and progress on all of them.”

Fol­low­ing po­ten­tial ap­proval, Co­herus added Wednes­day in a re­lease that its next steps in­clude look­ing at the drug in broad­er in­di­ca­tions or in com­bo with oth­er can­cer drugs or im­munother­a­pies, keep­ing co-de­vel­op­ment agree­ments on the ta­ble. Jun­shi and Co­herus al­ready teased broad­er in­di­ca­tions last De­cem­ber, show­cas­ing pos­i­tive re­sults from an in­ter­im analy­sis of the drug plus chemo in more than 400 pa­tients with ad­vanced squa­mous and non-squa­mous NSCLC. That analy­sis said the drug com­bi­na­tion demon­strat­ed sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in over­all sur­vival.

Co­herus’ stock price went up slight­ly af­ter the mar­kets opened, with $CHRS up 2.5%.

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.

FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

FDA's vac­cine ad­comm to re­view first fe­cal trans­plant to treat C. dif­fi­cile in­fec­tions

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.