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    Home > Medical News > Latest Medical News > The first domestic epothilone class 1 new drug Utidelon injection is about to be approved

    The first domestic epothilone class 1 new drug Utidelon injection is about to be approved

    • Last Update: 2021-03-27
    • Source: Internet
    • Author: User
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    On March 10, Chengdu Huahao Zhongtian Pharmaceutical Co.


    Utidelone (UTD1) is a genetically engineered epothilone analog, which induces cell apoptosis by promoting the polymerization of tubulin.


    There have been many clinical trials of epothilone analogues, including BMS semi-synthetic epothilone B derivatives (BMS-247550, BMS-310705) and chemically synthesized dehydroepothilone D analogues (KOS-1584), Novartis’s natural product Epothilone B (EPO906) and Bayer’s chemical total synthesis ZK-EPO, etc.


    According to Insight, there are currently 7 clinical trials registered for UTD1, of which CTR20150582 is an evaluation of the open and multiple clinical trials of epothilone (UTD1) injection combined with capecitabine in the treatment of patients with metastatic or locally advanced breast cancer.


    Among them, CTR20150579 is a phase III clinical study aimed at evaluating UTD1 injection combined with capecitabine in the treatment of patients with advanced metastatic breast cancer.


    The phase III study took 21 days as a treatment cycle.


    The results of the study show that compared with capecitabine alone, Utidrolone + capecitabine can significantly prolong the PFS of patients with advanced breast cancer, and at the same time significantly improve the overall survival and objective remission rate of patients.


    In addition, the Phase II clinical trial of Utidrolone for advanced non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) is currently underway.


    Uti Delong is the only Chinese breast cancer innovative drug that has been selected as the most influential international clinical oncology annual meeting ASCO twice (2016 and 2018).


    In addition, Chengdu Huahao Zhongtian Pharmaceutical Co.


    Uti Delong is the first in the world to use natural epothilone-producing bacteria or heterologous host bacteria as the starting bacteria to obtain through unique combinatorial biosynthesis technology and myxobacteria genetic engineering breeding technology, has applied for or obtained a number of related International and domestic invention patents.


    At present, Ixabepilone has not been approved in China, and it has been included in the "List of Recommendations for the First Batch of Encouraging Generic Drug Catalogues" announced in June 2019.


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