Drugmakers cut prices on average by more than 60% to get on China’s 2022 NDRL list — report

Chi­na’s Na­tion­al Re­im­burse­ment Drug List (NRDL) is a crys­tal clear ex­am­ple of the coun­try’s bar­gain­ing pow­er in the biotech and phar­ma mar­ket, as more firms have re­port­ed­ly agreed to cut their prices for 67 new med­i­cines to be in­clud­ed in its na­tion­al med­ical in­sur­ance cov­er­age start­ing in Jan­u­ary.

Be­ing on the list is lu­cra­tive. Es­sen­tial­ly, if a biotech or phar­ma com­pa­ny gets on this list, they’re cov­ered by the biggest in­sur­ance net­work in the coun­try. Giv­en Chi­na’s vast pop­u­la­tion, the Chi­nese gov­ern­ment has sig­nif­i­cant lever­age to de­cide which med­i­cines can make a prof­it. While do­mes­tic drug­mak­ers are quite will­ing to play that game, cut­ting prices sig­nif­i­cant­ly in ex­change for get­ting on the list, in­ter­na­tion­al com­pa­nies don’t do it as of­ten.

As part of a new round of ne­go­ti­a­tions, the 67 drugs, which in­clude Eli Lil­ly’s pso­ri­a­sis treat­ment Taltz and J&J’s mul­ti­ple myelo­ma drug Darza­lex, had their prices cut by more than an av­er­age of 60% to get on Chi­na’s list — 61.7% to be ex­act, ac­cord­ing to Reuters.

And at a news con­fer­ence, Chi­na’s Na­tion­al Health­care Se­cu­ri­ty Ad­min­is­tra­tion of­fi­cials said that the biggest price cut was 94%, with the prod­uct in ques­tion re­main­ing un­named.

That said, here are some of the new drugs and in­di­ca­tions on the list for next year:

Some of BeiGene’s drugs got added to the list, it an­nounced last night, this time for three drugs: the an­ti-PD1 an­ti­body tislelizum­ab in three new in­di­ca­tions; the BTK in­hibitor Bruk­isna in one new in­di­ca­tion; and the first list­ing for pami­parib, a PARP in­hibitor.

Hutchmed, a Hong Kong biotech, got to keep its metasta­t­ic CRC can­cer drug Elu­nate on the list, while adding Su­lan­da, a treat­ment for ‘non-pan­cre­at­ic neu­roen­docrine tu­mors’ (or NETs).

Do­mes­tic biotech Re­meGen, based in Yan­tai, Chi­na, got two of its drugs ap­proved to the list: Telitaci­cept, a dual-tar­get­ed TACI-Fc fu­sion pro­tein for sys­temic lu­pus ery­the­mato­sus and metasta­t­ic gas­tric can­cer ADC Disi­ta­m­ab Ve­dotin.

Shang­hai’s Jun­shi al­so an­nounced that its drug al­ready on the list — tori­pal­imab, an an­ti-PD-1 mon­o­clon­al an­ti­body — is get­ting two new in­di­ca­tions ap­proved: re­cur­rent or metasta­t­ic na­sopha­ryn­geal car­ci­no­ma af­ter fail­ure of at least two lines of pri­or sys­temic ther­a­py, and lo­cal­ly ad­vanced or metasta­t­ic urothe­lial car­ci­no­ma, af­ter fail­ure of plat­inum-con­tain­ing chemother­a­py or pro­gres­sion with­in 12 months of neoad­ju­vant or ad­ju­vant plat­inum-con­tain­ing chemother­a­py.

In­novent and Lil­ly got an ex­pan­sion of sin­til­imab, its mon­o­clon­al an­ti­body al­so known as Tyvyt for three new in­di­ca­tions:

in com­bi­na­tion with chemother­a­py for first-line treat­ment of ad­vanced or re­cur­rent non-squa­mous NSCLC with­out sen­si­tiz­ing EGFR mu­ta­tions or ALK re­arrange­ments;

in com­bi­na­tion with chemo for treat­ing ad­vanced or re­cur­rent squa­mous NSCLC;

and in com­bi­na­tion with By­vas­da (be­va­cizum­ab biosim­i­lar in­jec­tion) to treat un­re­sectable or ad­vanced he­pa­to­cel­lu­lar car­ci­no­ma (HCC).

Fi­nal­ly, As­cle­tis an­nounced that its oral di­rect an­ti-HCV ther­a­py As­cle­vir got added to the list.

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Merck’s new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO  — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

‘I think it is super worrisome,’ Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, ‘This is not going to be good.’

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Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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Novartis is plopping down $150 million in cash to pick up an experimental Parkinson’s drug and grab an option to another, a move that puts it on an increasingly popular path in the field’s search for disease-modifying therapies.

Belgium’s UCB is its partner of choice, supplying two small molecule alpha-synuclein misfolding inhibitors in a deal that can add up to nearly $1.5 billion.

Out of the pair, UCB0599 is already in Phase II trials, making Novartis confident enough to pull the trigger on co-development and commercialization, including to foot half of the R&D bill. The pharma giant will make a decision on UCB7853 once UCB wraps the ongoing Phase I program.

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Common performs onstage, December 2020 (Getty Images)

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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