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    Home > Medical News > Medical World News > In 2020, it will sell for $4.19 billion, and D'Aleto Yudnant will submit a new listing application in China

    In 2020, it will sell for $4.19 billion, and D'Aleto Yudnant will submit a new listing application in China

    • Last Update: 2021-03-11
    • Source: Internet
    • Author: User
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    At the beginning of the new year, Johnson and Johnson's Xi'an Yangsendaretoyu single anti-domestic 3.1 registration applications were accepted by CDE.
    , according to Johnson and Johnson, D'Aleto's global sales reached $4.19 billion in 2020, up 39.8% year-on-year.
    Darzalex is an humanized, anti-CD38 IgG1 monoclonal antibody acquired by Johnson and Johnson from Genmab for $1.1 billion, expressed in C with tumor cells D38 binding induces tumor apoptosis through a variety of immune-related mechanisms, such as cytotoxic action (CDC), antibody-dependent cell-mediated cytoxic action (ADCC), and antibody-dependent cell phagocytosis (ADCP), as well as Fc gamma subjects.
    In November 2015, Daleitoyu Monoanti was approved by the FDA to join forces with amines and dexamisong, or boronitazome and dexamisson, for multiple myeloma (MM) patients who had received at least one treatment, becoming the world's first approved CD38 targeted single resistance.
    May 2016, the drug was approved in the European Union for the treatment of relapse or recurring (R/R) MM.
    , Darzalex has been approved for mm's multi-line, second-line and first-line therapies in many countries and regions around the world, becoming mm's clinical mainstream therapy.
    addition, Johnson and Johnson has introduced Darzalex's sub-administering program (which divides Darzalex's first intravenous infusion from a single one-time infusion into two consecutive days of intravenous infusion, effectively reducing the duration of the first infusion) and subdern injection forms (The dosage form uses Halozyme's ENHANZE drug delivery technology, which contains recombinant human hyalurase PH20 (rHuPH20), reducing the treatment time from a few hours to 3-5 minutes, with the product named Darzalex Faspro.)
    In addition to treating MM, the Daleitoyu monocytose injection form was approved by the FDA in January to treat newly diagnosed light chain (AL) amyloid adult patients with a combined boronitazome, cyclophosphamide, and dexamide (i.e., D-VCd) for the newly diagnosed light chain (AL) amyloid adult patients, becoming the first and only drug to treat AL amyloid degeneration.
    , Darzalex's global sales have been rising year by year, reaching $4.19 billion in 2020.
    It's worth noting that Darzalex will become Johnson and Johnson's second-highest-selling heavyweight product in 2020 (first place is Stelara, or Usnu single resistance).
    Domestically, The Dretoyu monoantigen injection was approved by NMPA in July 2019 for single-drug treatment of adult patients with relapsed and refractic multiple myeloma, including patients who had previously received a protease inhibitor and an immunomodulant and who had progressed during the last treatment, a product called meth.
    In addition, according to the CDE website, the Daleitoyu single anti-injection also submitted in the country a joint amine and dexamisong or boronitazome and dexamisson, the treatment of adult patients with multiple myeloma who have received at least first-line treatment in the past, the relevant acceptance number is JXSS2000019/20.
    , the Daleitoyu single anti-skin injection form has also been reported in the country, the declared adaptive disorder is the primary light chain amyloid change.
    this time, Daleitoyu single anti-injection in the country to submit 3.1 category registration applications, the specific contents of the declaration has yet to be officially announced.
    according to the insight database, the latest winning bid of Daleitoyu single resistance in many parts of the country was 19710.00 yuan/branch (400mg/20ml), 5460.00 yuan/branch (100mg/5ml).
    according to the drug instructions, each one count, the year 52 weeks need 44, the overall annual treatment costs are expensive, far beyond the national burden level.
    Photo Source: Lilac Garden is worthy of national expectations, China's Fuhong Hanyu has begun to lay out the Daleitoyu single anti-bioharmaceous similarity market, its Dharetoyu monobial-like drug HLX15 (recombinant anti-CD38 all-human monoclonal antibody injection) has been approved clinically, adaptive mm.
    It is known that HLX15 is an all-human anti-CD38 IgG1 monoclonal antibody developed by Fuhong Hanxuan, with reference to the "Biosychic Drug Research and Evaluation Technical Guidelines (Trial)" issued by NMPA and issued by EMA Guideline on Similar Biological Medicinal Products has used the principles of progressive progressive, matching and similarity evaluation to conduct head-to-head pharmacological analysis and in vitro pharmacology studies on HLX15 and the original study of Daleitoyu monoantigen.
    results show that HLX15 is highly similar to the original Dretoyu single resistance.
    addition, it is worth mentioning that in foreign countries, Daretoyu monolithic has been approved for similar competition.
    In March 2020, Sanofi's CD38 antibody Sarclisa (isatuximab-irfc) was approved by the FDA for use in R/RMM adult patients who had previously received at least two treatments, including nalamine and protease inhibitors.
    , the Phase III clinical study of Sarclisa's combined Coffezome and Desemisson Standard Care Program for the treatment of R/RMM also yielded positive results.
    Jefferies, a Wall Street investment bank, expect Sarclisa's annual sales peak to exceed $1bn.
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