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    Home > Medical News > Latest Medical News > Reding Riptini China listing application was accepted for treatment of gastrointestinal interstitial tumor.

    Reding Riptini China listing application was accepted for treatment of gastrointestinal interstitial tumor.

    • Last Update: 2020-08-09
    • Source: Internet
    • Author: User
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    On July 20, Reding Pharmaceuticals and Deciphera Pharmaceuticals jointly announced that the State Drug Administration of China (NMPA) had accepted applications for the listing of new drugs for the treatment of adult patients with advanced gastrointestinal interstitonoma (GIST) who have been treated with three or more kinase inhibitors, including imatini.
    Ruptini has recently been approved for listing in the US, Canada and Australia.
    GIST is a gastrointestinal sarcoma driven by a genetic mutation that originates from a particular nerve cell in the gastrointestinal wall. The most common mutation in
    patients was the KIT protein kinase mutation, which accounted for about 80% of cases.
    about 6% of newly diagnosed patients carry the PDGFR alpha mutation.
    Ripretinib is a tyrosine kinase switch control inhibitor that regulates kinase switches and activation rings using a unique dual mechanism to widely inhibit KIT and PDGFR alpha kinases.
    Ripretinib inhibits the initiation and secondary KIT mutations involved in GIST on the exosomes 9, 11, 13, 14, 17 and 18, as well as the primary exoon 17 D816V mutations involved in SM.
    Ripretinib also inhibits the major PDGFR alpha mutations in the exosomes 12, 14 and 18 associated with the GIST subset, including the exon 18 D842V mutation.
    Ruptinib (product name QINLOCK ™) has been approved by the U.S. FDA for the treatment of advanced GIST adults who have been treated with three or more kinase inhibitors, including imatinib.
    Ruptinib's listing application is based on a phase 3 randomized, double-blind, placebo-controlled international multicenter clinical study, INVICTUS, designed to assess the safety, tolerance and effectiveness of riptinib in 129 patients with advanced GIST patients who have previously been treated with imartinib, shonetinib and rigofenib. the main endpoint of
    is the progression-free survival (PFS) determined by an independent radiology review based on the solid tumor efficacy evaluation criterion (RECIST).
    According to previous reports, the median progression-free survival period in the study was 6.3 months, compared with 1.0 months in the placebo group, and the risk of disease progression or death was significantly reduced by 85% (risk ratio of 0.15, p-lt;0.0001).
    independent radiology review sedatiby seiscored through the use of improved RECIST standards identified secondary endpoints including Objective Mitigation Rate (ORR) and Total Lifetime (OS).
    the objective mitigation rate of rupitinib was 9.4%, while the placebo group was 0% (p-0.0504).
    the median total survival of ruptinib was 15.1 months, compared with 6.6 months in the placebo group, and the risk of death was reduced by 64% (the risk ratio was 0.36). "There is still significant unmet demand for GIST patients in China, especially those who have become resistant to past treatment sourcing, " said Dr. Du Ying, founder, chairman and chief executive officer of re-ding Pharmaceuticals,
    .
    based on recent FDA approvals and excellent clinical data from INVICTUS studies, we believe that Ruptinib will hopefully change the treatment of GIST patients in China.
    we will actively cooperate with the review and approval department to benefit GIST patients in the country as soon as possible. Steve Hoerter, President and CEO of
    " Deciphera, said: "The recent approval of Riptini in the United States and the earlier than expected new drug market applications in China highlight its potential for the future.
    there are more than 30,000 newly diagnosed GIST patients in China each year, and there is a huge unmet clinical need.
    we look forward to continuing to work with Reding Pharmaceuticals to bring Riptinib to patients awaiting new treatments at an early date.
    " Deciphera Pharmaceuticals is developing Riptinib to treat KIT and/or PDGFR-driven cancers, including gastrointestinal mesomas (GIST), systemic hypertrophy (SM) and other cancers.
    Reding Pharma has an exclusive licensing agreement with Deciphera and has the right to develop and commercialize Riptini in Greater China (Chinese mainland, Hong Kong, Macau and Taiwan).
    References: The application for the listing of the new drug Ripretinib, the anti-tumor drug, was accepted by the State Drug Administration. Retrieved 2020-07-20, from.
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