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    Home > Active Ingredient News > Drugs Articles > Add code preparation CD47 single anti-Xinda biological domestic once again submitted a new application for clinical trials.

    Add code preparation CD47 single anti-Xinda biological domestic once again submitted a new application for clinical trials.

    • Last Update: 2020-09-25
    • Source: Internet
    • Author: User
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    On September 12, CDE's official website showed that Xinda Bio filed a clinical trial application for IBI188 in China, which has been accepted by CDE, which is the fourth clinical trial application for IBI188 in China.
    data source: CDE recombinant all-human source anti-CD47 monoclonal antibody IBI188 Cyntaf biodeveloped recombinant all-human source anti-CD47 monoclonal antibody IBI188 is an IgG4 monoclonal antibody that binds to CD47 antigen specificity on the surface of tumor cells, blocking CD4 The 7-SIRP alpha signaling path, which inhibits the "don't eat me" signal transmitted by CD47, causes macrophages to recognize the "eat me" signal transmitted by tumor cells, thereby devouring tumor cells and exerting the body's anti-tumor effects, and is intended to treat a variety of blood and solid tumors, including non-Hodgkin's lymphoma and ovarian cancer.
    it is worth mentioning that, in addition to IBI188 monoantibodies, Xinda Bio's in-study product pipeline also has a new type of dual-specific antibody that can target both CD47 and PD-L1.
    this dual-anti-drug product was approved in China in January 2020 for clinical use in the treatment of adaptive diseases such as solid tumors and blood tumors.
    september 2018, Xinda BioCD47 monoanti-resistant research product IBI188 was approved for clinical trials issued by the State Drug Administration of China.
    of the same year, IBI188 received FDA-issued approval for clinical trials of drugs intended for the treatment of advanced malignancies and lymphomas.
    Up to now, Xinda Bio has launched 3 clinical trials in China around IBI188 monoantitones, and the adaptations include high-risk bone marrow hyperplising abnormal syndrome, acute myeloid leukemia, and advanced malignant tumors in the initial diagnosis, and IBI188 has entered the stage of simultaneous clinical trials between China and the United States.
    source: Drug clinical trial registration and information publicity platform Domestic approved clinical similar products as one of the hot targets in the field of anti-tumor immunotherapy, CD47 has been known by the industry as PD-1/PD-L1 antibodies, the next "star" in the field of tumor immunity, has become a hot topic of research at home and abroad.
    , no CD47 antibodies have been approved for market worldwide.
    , according to incomplete statistics, more than 20 companies are currently involved in the development of CD47 target antibodies worldwide, including Forty Seven, which is developing CD47 antibodies.
    in early March, Gilead Sciences bought Forty Seven for $4.9 billion, sparking renewed industry concern about CD47 antibody immunotherapy.
    of the pharmaceutical companies preparing CD47 antibodies in China, 7 CD47 antibodies from five pharmaceutical companies have been approved for clinical trials, including 4 monoantigen products and 3 CD47 dual specific antibodies.
    data source: public data collation From the current clinical trial situation, Xinda Bio in the cd47 single-resistance product IBI188 development progress is fast.
    note that, in addition to Xinda Bio's IBI188, Tiantian Bio's CD47 monoantigen in-study product TJC4 has been launched in the United States in June 2019 in Phase I clinical studies.
    .
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