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    Home > Medical News > Medical Research Articles > Innovent and Ascent Pharmaceuticals jointly announced that China's first third-generation BCR-ABL inhibitor, Nerlik, has been approved for the treatment of chronic myeloid leukemia

    Innovent and Ascent Pharmaceuticals jointly announced that China's first third-generation BCR-ABL inhibitor, Nerlik, has been approved for the treatment of chronic myeloid leukemia

    • Last Update: 2022-01-02
    • Source: Internet
    • Author: User
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    Resistant gram ® is Yasheng pharmaceutical development potential best-in (Best-in-class) of new drugs, won the national "Key New Drug Creation" special support


    Resistant gram ® approved mainly based on two pivotal registration Phase II clinical study data, respectively HQP1351CC201 research, HQP1351CC202 research


    CML is a malignant tumor related to white blood cells


    Resistant gram ® Chinese clinical trial principal investigator, director of Peking University Institute of Hematology, Department of Hematology, director of People's Hospital of Peking University Professor Huang Xiaojun said: "The efficacy and safety data from clinical studies continue to show us the past, resistant gram ® has great potential for the treatment of drug-resistant chronic myeloid leukemia, and it is very hopeful to become the'Best-in-Class' drug in this field


    Resistant gram ® Chinese clinical trial principal investigator, Department of Hematology, People's Hospital of Peking University Professor Ren Jiangqian deputy expressed: "CML-CP and CML-AP patients with T315I mutation Once there, all of a generation or second-generation TKI these patients are invalid


    Cinda bio-Founder, Chairman and CEO Yu De Dr Super , said: "We are delighted resistant gram ® successfully approved in China for the deep biological Cinda layout Adds a new generation of anti-tumor products in the field of hematological tumors of


    Ascend medicine chairman, CEO Dr.


    About chronic myeloid leukemia

    Chronic Myeloid Leukemia (CML) is a malignant tumor formed by the clonal proliferation of bone marrow hematopoietic stem cells.


    With the launch of TKI drugs targeting BCR-ABL, the treatment of CML has been innovated, but acquired drug resistance has always been the main challenge for CML treatment


    About resistant gram ®

    Resistant gram ® is a pharmaceutical Ascend original class of drugs, the third-generation oral BCR-ABL inhibitor, is the first approved Chinese market targeting third generation BCR-ABL resistant CML therapy of BCR-ABL And a variety of BCR-ABL mutants, including the T315I mutation, have outstanding effects, and have received special support from the national "Major New Drug Creation " project


    October 2020, resistant gram ® is NMPA Drug Evaluation Center (CDE) into priority review, TKI for the treatment of adult patients with drug-resistant and T315I mutation in chronic phase CML or acceleration of the; March 2021 , This species was included in the breakthrough treatment species by CDE


    In July 2021, Ascent Pharmaceuticals (6855.


    * Note -resistant gram ® registered trademark of Ascend medicine 

    Regarding two key registration phase II clinical studies

    1) Chronic Myeloid Leukemia-Study of HQP1351CC201 in Patients in Chronic Phase

    • HQP1351CC201、、II ,BCR-ABL1 TKIT315I CML-CP


      • HQP1351CC202、、II ,BCR-ABL1TKITKIT315ICML-AP


        “,”,,


        Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model
        .
        A product chain including 26 new drug varieties has been established, covering multiple disease fields such as tumors, metabolic diseases, and autoimmunity.
        Among them, 7 varieties have been selected for the national "Major New Drug Innovation" special project
        .
        The company has 6 products (sintilimab injection, trade name: Daboshu ® , English trademark: TYVYT ® , bevacizumab biosimilar drug, trade name : Dyotong ® , English trademark: BYVASDA ® ; Adalimumab biosimilar drug, trade name: Su Lixin ® , English trademark: SULINNO ® ; Rituximab biosimilar drug, trade name: Dabohua ® , English trademark: HALPRYZA ® ; pemigatinib oral inhibitor , Trade name: dalbertan ® , English trademark: PEMAZYRE ® ; oribatinib tablets, trade name: Nerlik ® ) was approved for marketing, Sintilizumab 's application in the United States was accepted by the FDA, 5 The variety has entered phase III or critical clinical research, and another 15 products have entered clinical research
        .

        Cinda Bio has established an internationally advanced high-end biopharmaceutical development and industrialization talent team, including many returned experts, and has cooperated with international partners such as Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center, and Hanmi of South Korea.
        Reach strategic cooperation
        .
        Cinda Bio hopes to work with everyone to improve the development level of China's biopharmaceutical industry to meet the people's access to medicines and the people's pursuit of life and health
        .
        For details, please visit the company's website: or the company's LinkedIn account .

        About Yasheng Pharmaceutical

        Yasheng Pharmaceutical is a biomedical company based in China and facing the world.
        It is committed to the development of innovative drugs in the treatment of tumors, hepatitis B and aging-related diseases
        .
        October 28, 2019, Asia-sheng medicine in the Hong Kong Stock Exchange Main Board listing, stock code: 6855.
        HK
        .

        Ascent Pharmaceuticals has a self-constructed protein-protein interaction targeted drug design platform, and is at the forefront of new drug development in the apoptosis pathway in the world
        .
        The company has established 8 new class 1 small molecule drug product pipelines that have entered the clinical development stage, including inhibitors that inhibit key proteins in the apoptosis pathway such as Bcl-2, IAP, or MDM2-p53; a new generation of drugs that appear in cancer treatment Inhibitors of kinase mutants, etc.
        , are the only innovative company in the world that has clinically developed varieties in the field of key proteins in the apoptosis pathway
        .
        The company is currently conducting more than 40 phase I/II clinical trials in China, the United States, Australia and Europe
        .
        The company has undertaken a number of major national scientific and technological projects, including 5 special projects for "Major New Drug Development", including 1 "Enterprise Innovative Drug Incubation Base" and 4 "Innovative Drug Research and Development", and another special project for "Prevention and Control of Major Infectious Diseases".

        .
        Aoribatinib (trade name: Nalike®), the core product used for the treatment of drug-resistant chronic myeloid leukemia, has been included in the priority review and review by the Center for New Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.
        A breakthrough therapeutic product, which has been approved in China, is the company's first listed product
        .
        This variety has also been approved by the U.
        S.
        FDA for fast-track review, orphan drug qualification, and EU orphan drug qualification
        .
        Up to now, the company has a total of 4 new drugs under development that have obtained 12 FDA and 1 EU orphan drug qualification certifications
        .
        The company has undertaken a number of major national scientific and technological projects, including 5 special projects for "Major New Drug Development", including 1 "Enterprise Innovative Drug Incubation Base" and 4 "Innovative Drug Research and Development", and another special project for "Prevention and Control of Major Infectious Diseases".

        .

        Relying on strong R&D capabilities, Yasheng Pharmaceuticals has deployed intellectual property rights globally, and cooperated with leading biotechnology companies such as UNITY, MD Anderson, Mayo Medical Center, Dana-Farber Cancer Institute, Merck, AstraZeneca, Pfizer, etc.
        And pharmaceutical companies and academic institutions have reached global partnerships
        .
        The company has established an international talent team with rich experience in original innovative drug research and development and clinical development.
        At the same time, the company is building a late-stage commercial production and marketing team with high standards
        .
        Yasheng Pharmaceutical will continue to improve its research and development capabilities, accelerate the progress of the clinical development of the company's product pipeline, and truly implement the mission of "solving the unmet clinical needs of patients in China and even the world" to benefit more patients
        .

        Cinda Biosciences forward-looking statement

        The information published in this press release may contain certain forward-looking statements
        .
        These statements are inherently risky and uncertain
        .
        When using "expect," "believe," "forecast," "expect," "intend," and other similar expressions, all matters related to the company are intended to indicate that they are forward-looking statements
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        The company has no obligation to continuously update these forward-looking statements
        .

        These forward-looking statements are based on the current views, assumptions, expectations, estimates, forecasts and understandings of the company’s management regarding future affairs at the time the statement was made
        .
        These statements are not guarantees for future development, and will be affected by risks, uncertainties and other factors.
        Some of them are beyond the control of the company and are difficult to predict
        .
        Therefore, due to future changes and developments in our business, competitive environment, political, economic, legal and social conditions, actual results may differ significantly from the information contained in the forward-looking statements
        .

        The company, the directors of the company, and employee agents shall not undertake (a) any obligation to correct or update any forward-looking statements contained in this website; and (b) if any forward-looking statements cannot be realized or become incorrect.
        Responsibility
        .

        Ascent Pharmaceuticals forward-looking statement

        The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
        .
        Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear
        .
        Please read this article carefully and understand that our actual future results or performance may differ materially from expectations
        .
        All statements in this article are made on the date of publication of this article and may change due to future developments
        .

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