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    Home > Medical News > Medicines Company News > Johnson & Johnson CD38 monoclonal antibody new indication approved in China, sales of 4.19 billion U.S. dollars in 2020

    Johnson & Johnson CD38 monoclonal antibody new indication approved in China, sales of 4.19 billion U.S. dollars in 2020

    • Last Update: 2021-05-10
    • Source: Internet
    • Author: User
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    Recently, the official website of the State Food and Drug Administration showed that Xi’an Janssen’s application for new indications for Darzalex injection (Darzalex) in China (acceptance number: JXSS2000019/20) has been approved by the NMPA.
    The indications are: combined with lenalidomide and dexamethasone or combined with bortezomib and dexamethasone to treat adult patients with multiple myeloma who have received at least first-line treatment in the past.
    This product is approved in China The second indication.

    Xi'an Janssen submitted a listing application for this indication to NMPA in April 2020, and was included in the priority review by CDE in October 2020.

    Multiple myeloma (MM) is an incurable hematological malignancy.
    Its incidence in my country has exceeded that of acute leukemia, ranking second in hematological malignancies.
    Although many progresses have been made in the treatment of multiple myeloma in recent years, most patients still face the problem of relapse or drug resistance.
    Relapsed and refractory multiple myeloma bother clinicians and threaten the lives of patients.

    CD38 is highly expressed in multiple myeloma cells.
    Daratumumab has a unique dual mechanism.
    On the one hand, it can directly bind to CD38 and induce the death of myeloma cells through multiple mechanisms to achieve rapid remission; on the other hand, it can activate immune cells CD8+ toxic T cells and toxic T cells by regulating the immune microenvironment.
    CD4+ helper T cells continue to promote the death of myeloma cells.

    Daratumumab is the first fully human monoclonal antibody targeting CD38 approved globally and domestically.
    This drug is a blockbuster product of Janssen, which was approved by the FDA in November 2015 and July 2019.
    It has been approved for marketing conditionally in China.
    It is used as a single agent to treat adult patients with relapsed and refractory multiple myeloma.
    The patient has previously received treatments including proteasome inhibitors and immunomodulators and the disease progressed during the last treatment.
    The financial report shows that the global sales of daratumumab in 2020 will reach 4.
    19 billion U.
    S.
    dollars (+39.
    8%).

    Medicine Rubik's Cube NextPharma

    Medicine Rubik's Cube NextPharma

    In addition, Xi'an Janssen submitted a listing application for Darzalex Faspro in China on November 6 last year.
    Clinical data shows that compared with intravenous injections, subcutaneous injections have a similar overall response rate and pharmacokinetic characteristics, and only need about 3-5 minutes, while intravenous injections require several hours.
    In addition, the incidence of systemic drug-related reactions (ARRS) for subcutaneous injections was reduced by nearly 1/3 compared with intravenous injections (13% vs 34%).

    In addition, the clinical application of Fuhong Henlius daratumumab biosimilar drug was granted the default approval of CDE on January 12 this year.

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