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    Home > Active Ingredient News > Blood System > Yassin Pharmaceutical Bcl-2 inhibitors were again qualified by the FDA orphan drug to treat chronic lymphocytic leukemia.

    Yassin Pharmaceutical Bcl-2 inhibitors were again qualified by the FDA orphan drug to treat chronic lymphocytic leukemia.

    • Last Update: 2020-09-22
    • Source: Internet
    • Author: User
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    On September 7, ASIO Pharmaceuticals announced that the FDA had awarded it the qualification of APG-2575 orphan drug for the treatment of chronic lymphocytic leukemia (CLL), an innovative drug in the study.
    this is the second FDA-granted orphan drug qualification for APG-2575.
    July, the FDA awarded APG-2575 the first orphan drug to be qualified as Fahrenheit globulinemia (WM).
    "orphan medicine", also known as rare drugs, refers to the prevention, treatment, diagnosis of rare diseases of drugs.
    , rare diseases are those that affect fewer than 200,000 people.
    since 1983, the United States has adopted the Orphan Drugs Act to provide policy support to businesses to encourage the development of drugs for rare diseases.
    This APG-2575 FDA-granted orphan drug qualification will help the drug enjoy certain policy support in the U.S. in the areas of follow-up research and development and commercialization, including access to clinical trial fee tax relief, exemption from NDA filing fees, access to research and development grants, and in particular, approval of the U.S. market after 7 years of exclusive ownership.
    CLL is an adult leukemia characterized by a large number of cloned B lymphocytes in lymphatic tissues such as perennal blood, bone marrow, spleen and lymph nodes.
    2020, there will be about 21,040 new cases of CLL in the United States and about 4,060 deaths from the disease, according to the American Cancer Society.
    , according to the latest SEER data, there will be fewer than 200,000 CLL patients in the U.S. by 202022222.
    The development of existing Bruton tyrosine protein kinase (BTK) inhibitors and Bcl-2 inhibitors has improved the prognostication of CLL patients, but there is still a medical need for safer and more effective treatment options that can achieve deep remission in short-term treatments and are free of chemotherapy.
    APG-2575 is a new oral Bcl-2 selective small molecule inhibitor developed by Aachen Pharmaceuticals to restore the tumor cell procedural death mechanism (apoptosis) by selectively inhibiting Bcl-2 protein, thereby killing tumors and intended to be used to treat a variety of blood malignancies.
    APG-2575 is the first locally developed Bcl-2 selective inhibitor to enter the clinical phase in China.
    APG-2575 has been licensed for several Phase Ib/II clinical trials in the United States, China and Australia and is advancing the clinical development of multiple blood tumor adaptations worldwide simultaneously.
    A global phase Ib/II clinical study of relapsed/difficult-to-treat CLL/SLL (small lymphocyte lymphoma) is under way and is being recruited in the United States and Australia.
    , Chief Medical Officer, said, "CLL's treatment is a clinical requirement that is not yet fully met at the global level.
    as an important clinical development variety of the company's apoptosis product pipeline, APG-2575, after WM adaptation, quickly obtained the FDA's second orphan drug qualification, which is highly recognized and encouraged to us.
    we will accelerate the global clinical development and product launch of this drug, supported by orphan drug-related policies, and provide more treatment options for CLL patients at an early age.
    " Reference: 1. Cancer Statistics 2020, American Cancer Society 2. 2020 Cancer Incidence Data, Surveillance, Optiony, and End Results Program, National Cancer Institute On APG-2575APG-2575 is a new oral Bcl-2 selective inhibitor developed by Asaan Pharmaceuticals to selectively inhibit Bcl-2 proteins to restore the tumor cell programmed death mechanism (apoptosis), thereby killing tumors and intended to be used to treat a variety of hematostomas.
    the company has previously launched single-drug Phase I clinical trials in the United States, Australia and China.
    Since March this year, APG-2575 has been licensed for a number of Phase Ib/II clinical trials in the United States and China, and is simultaneously advancing the clinical development of multiple blood tumor adaptations, including relapsed/difficult-to-treat chronic lymphoblastic leukemia/small lymphocyte lymphoma, Fahrenheit globulinemia, recurring/difficult-to-treat acute myeloid leukemia, etc. at the global level.
    APG-2575 has two adaptive disorders have been awarded the FDA orphan drug qualification, respectively, Fahrenheit globulinemia and chronic lymphocytic leukemia.
    source: Medical Rubik's Cube!-- content display ends -- !-- to determine whether the login ends.
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