Sev­en PD-(L)1 play­ers could be vy­ing for a place on Chi­na's drug re­im­burse­ment list. How far will they go?

New up­dates to the process of as­sem­bling Chi­na’s lat­est Na­tion­al Drug Re­im­burse­ment List could mean that sev­en ad­di­tion­al PD-(L)1 drugs will be cov­ered by gov­ern­ment-spon­sored in­sur­ance schemes — but like­ly not with­out sig­nif­i­cant dis­counts.

De­vel­op­ers of ther­a­pies ap­proved by the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion be­fore Au­gust 17 will be el­i­gi­ble to ap­ply for in­clu­sion on the list. The dead­line al­so ap­plies to any drug that scored new in­di­ca­tions.

A spot on the NDRL is a sought-af­ter prize for bio­phar­ma com­pa­nies try­ing to tap in­to the Chi­nese mar­ket. But giv­en the in­tense ne­go­ti­a­tion, it re­mains a bal­anc­ing act and an­a­lysts have pre­dict­ed some multi­na­tion­al play­ers may de­cide it’s not worth the cost.

Un­der new rules, Covid-19 ther­a­pies cur­rent­ly rec­om­mend­ed by Chi­na’s Na­tion­al Health Com­mis­sion may al­so be re­im­bursed, as may BeiGene’s BTK in­hibitor Brukin­sa.

But the bright­est spot­light re­mains on the PD-(L)1 mar­ket, where it’s long been spec­u­lat­ed that the del­uge of new en­trants would crowd out any space for any one brand to charge pre­mi­um prices. And as Eli Lil­ly’s re­cent $1 bil­lion deal with In­novent un­der­scored, US com­modi­ti­za­tion may not be far be­hind.

The ques­tion now in Chi­na is how much low­er they might go.

Tyvyt, which Lil­ly grabbed US rights to, is cur­rent­ly the on­ly check­point drug on the NDRL. It’s ap­proved for third-line clas­si­cal Hodgkin’s lym­phoma and sells for RMB2843 ($403) per 100mg, about 64% less than the orig­i­nal price of RMB7838/100mg ($1117.96) pri­or to in­clu­sion.

Roche’s Tecen­triq, which nabbed the green­light in Feb­ru­ary and would there­fore not have been el­i­gi­ble un­der a pre­vi­ous plan, can now join Mer­ck (Keytru­da), Bris­tol My­ers Squibb (Op­di­vo), As­traZeneca (Imfinzi), Shang­hai Jun­shi (Tuoyi), Jiang­su Hen­grui (cam­re­lizum­ab) and BeiGene (tislelizum­ab) in po­ten­tial­ly plac­ing a bid. Hen­grui may seek re­im­burse­ment for non-small cell lung can­cer, he­pa­to­cel­lu­lar car­ci­no­ma and esophageal squa­mous cell car­ci­no­ma, hav­ing added these in­di­ca­tions to the la­bel af­ter an ini­tial OK in clas­si­cal Hodgkin lym­phoma.

Look­ing be­yond PD-1, BeiGene could al­so be seek­ing NRDL in­clu­sion for Brukin­sa, ac­cord­ing to Gold­man Sachs an­a­lyst Ziyi Chen. In a note quot­ed by Bio­Cen­tu­ry, she not­ed that the BTK in­hibitor was ap­proved by the NM­PA in June, six months af­ter the FDA did, mak­ing it a ben­e­fi­cia­ry of the up­dat­ed guid­ance. Se­cur­ing re­im­burse­ment could give it more foot­ing against ri­vals at Ab­b­Vie and J&J, whose Im­bru­vi­ca is up for price re-ne­go­ti­a­tion.

Mean­while, with Covid-19 treat­ments, Roche’s Actem­ra, the malar­ia drug chloro­quine phos­phate, rib­avirin and al­pha-in­ter­fer­on are the bet­ter-known drugs fea­tured on the most up-to-date ver­sion of the na­tion­al pro­to­col. Nonethe­less, the com­mer­cial prospects are like­ly min­i­mal giv­en the low case­loads in Chi­na.

Per the guid­ance is­sued by the Na­tion­al Health­care Se­cu­ri­ty Ad­min­is­tra­tion this Mon­day, com­pa­nies have un­til the end of Au­gust to ap­ply for in­clu­sion. Ex­pert re­view will take place in Sep­tem­ber and Oc­to­ber; ne­go­ti­a­tion and price-set­ting will then fol­low. The lat­est ver­sion of the NDRL will be made pub­lic by the end of De­cem­ber.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.