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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https://endpts.com/drugmakers-cut-prices-on-average-by-more-than-60-to-get-on-chinas-2022-ndrl-list-report/