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    Home > Medical News > Medicines Company News > Aasheng Pharmaceuticals Announces Interim Results for 2020: The first application for new drug listing has been submitted to continue to advance global strategic cooperation.

    Aasheng Pharmaceuticals Announces Interim Results for 2020: The first application for new drug listing has been submitted to continue to advance global strategic cooperation.

    • Last Update: 2020-08-30
    • Source: Internet
    • Author: User
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    Guide: During the reporting period, the company made great progress in clinical development, external cooperation, patent layout and so on.
    August 18, Asain Pharma announced its interim results for the year ended June 30, 2020.
    the reporting period, the company has made great progress in clinical development, external cooperation, patent layout, etc., especially in June this year submitted the company's first new drug listing application (NDA), ushered in a major milestone.
    innovation investment continued to increase the code, the product pipeline further expanded the company in the first half of 2020 research and development expenditure of RMB 240 million, innovation investment continued to increase the code.
    As of June 30, 2020, ASAT has built a rich product line of eight clinically active small molecule candidates, with more than 40 Phase I or II clinical trials underway in China, the United States and Central Australia.
    develops product pipelines that focus primarily on inhibitors of key proteins in apoptosis pathways, restart apoptosis procedures for tumor cells by inhibiting Bcl-2/Bcl-xL, IAP, MDM2-p53, and a new generation of inhibitors targeting kinase mutants in cancer treatment.
    in addition to the eight current candidate drugs that have entered the clinical development phase, the company's product pipeline has been further expanded to include the preclinical candidate drug MCL-1 inhibitor AS00491, APG-3526, EED inhibitor APG-5918, and the fourth-generation BCR-ABL inhibitor AS1266, which is still in the exploratory phase.
    has made significant progress in research products during the reporting period of the first new drug market application, and the global clinical development has been fully advanced, and the company's first NDA has been submitted.
    as the core product of Aasheng Pharmaceuticals, the third generation BCR-ABL/KIT inhibitor HQP1351 has reached a number of significant milestones during the reporting period.
    In June 2020, based on the results of two key registered clinical studies, the Company submitted to the National Drug Administration (NMPA) New Drug Review Center (CDE) a new drug market application (NDA) for the treatment of patients with chronic myeloid leukemia (CML) with T315I mutations.
    is the first new drug to go on sale since the company's inception and is expected to become the first third-generation BCR-ABL inhibitor to be listed in China.
    third critical study of first- and second-generation TKI drug resistance/intolerance is under way and actively recruiting patients.
    reporting period, HQP1351 also received a series of FDA-granted orphan drug qualifications and review of fast-track qualifications, international development is advancing simultaneously.
    APG-2575, the main product of Yasheng Pharmaceutical Apoptosis Pipeline, is a new type of oral Bcl-2 selective inhibitor, which is the first domestic Bcl-2 selective inhibitor to enter the clinical stage.
    since March this year, APG-2575 has obtained clinical licenses for a number of Ib/II studies in the United States and China, comprehensively advancing the clinical development of multiple blood tumor adaptations.
    In the United States, APG-2575 has received two consecutive FDA clinical licenses to conduct global Phase Ib/II clinical studies as a single-drug or combined treatment for relapse/difficult-to-treat chronic lymphoblastic leukemia/small lymphocyte lymphoma (CLL/SLL), Fahrenheit globulinemia (WM).
    , the global Phase Ib/II study on the treatment of relapses/difficult-to-treat CCLSLs has rapidly completed the first patient drug delivery in the United States.
    In China, APG-2575 has been clinically approved by CDE to conduct phase Ib/II clinical studies of single-drug or combined treatment of relapse/difficult acute myeloid leukemia (AML), as well as single-drug or combined treatment of recurrence/difficult-to-treat CLL/SLL.
    of particular concern was the fact that in July this year, APG-2575 went to the next city and was approved by the FDA for the treatment of WM orphan drugs.
    in addition to this, other products in research, including the original dual-target Bcl-2/Bcl-xL inhibitor APG-1252, MDM2-p53 inhibitor APG-115 and IAP inhibitor APG-1387, have made significant progress, and a number of data have been selected for this year's ASCO (American Society of Clinical Oncology) Annual Meeting and the AACR (American Association for Cancer Research) Annual Meeting to further show international impact.
    has reached a number of international strategic cooperations and actively explored joint treatments in addition to building a strong in-house research and development team, ASIO has maintained global partnerships with leading multinational pharmaceutical companies, biotechnology pharmaceutical companies and academic institutions.
    reporting period, the company has reached a number of global cooperation and actively explores a number of disease areas of joint treatment.
    In June this year, the company reached a global clinical partnership with Acerta Pharmaceuticals, AstraZenefa's Center of Excellence for Blood Research and Development, to explore a combination of Bcl-2 selective inhibitor APG-2575 and BTK inhibitor CALQUENCE® to assess the clinical effectiveness of the combination drug in patients with recurrent treatment of CLL/SLL.
    July, the company announced a global clinical research collaboration with MSD to explore the treatment of advanced solid tumors with the MDM2-p53 inhibitor APG-115 in collaboration with KEYTRUDA®
    addition, the company and the National Hematological System Disease Clinical Research Center reached a strategic cooperation in July, will be jointly established the National Blood System Disease Clinical Medical Research Center Yasheng Research Institute, plus the field of blood tumor research and clinical development.
    's expanding global network of collaborations provides companies with global recognition and brand awareness, as well as better access to major and candidate drugs to better advance product development.
    strengthen the global IP layout and consolidate the industry leadership as a China-based, global-oriented original innovative drug research and development enterprises, ip layout is essential to the company's business development.
    with its strong research and development capabilities, AAEM continues to have a strategic intellectual property layout at the global level and exclusive licensing of authorized patents or patent applications for candidate products worldwide.
    as of June 30, 2020, the company has 96 granted patents and more than 300 patent applications worldwide, of which 80 patents have been granted overseas. Dr. Yang Dajun, Chairman and CEO of
    AsiaSheng Pharmaceuticals, said, "In the first half of 2020, under the special circumstances of the global outbreak of new crowns, we have overcome difficulties and achieved many breakthroughs, especially by submitting the company's first application for the listing of new drugs since its inception, re-establishing the company's development milestones, and taking important steps from research and development enterprises to product-listed enterprises; The apoptosis line series, including APG-2575, has made great progress, the relevant data are frequently displayed in authoritative academic conferences, the company's international academic influence continues to increase, our international cooperation has accelerated, in the first half of the year with AstraZene, Mercerton and the National Blood System Disease Clinical Center and other multinational pharmaceutical companies and academic institutions to establish global cooperation to promote product development.
    Looking to the future, we will continuously improve our research and development capabilities, strengthen our global intellectual property layout and consolidate our industry leadership, and we will accelerate the progress of global clinical development of existing product pipelines, further promote the application process for HQP1351 new drugs, and realize the market as soon as possible, and truly fulfill our mission of 'solving the unsolved clinical needs of patients in China and around the world' for the benefit of more patients.
    , we also continue to pay attention to the healthy development of finance and protect the interests of shareholders and investors.
    "
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