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    Home > Medical News > Latest Medical News > Applications for new drug re-entry drug Ripretinib were accepted by the State Drug Administration.

    Applications for new drug re-entry drug Ripretinib were accepted by the State Drug Administration.

    • Last Update: 2020-07-28
    • Source: Internet
    • Author: User
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    Guide: China's State Drug Administration has also accepted a new drug listing after the U.Sapproved reptinib for the treatment of patients with advanced gastrointestinal interstitial tumors () treated with a variety of kinase inhibitors, including imartinibReding Pharmaceuticals and announced that the State Drug Administration of China () has accepted applications for the listing of new drugs from Ruptinib for the treatment of advanced gastrointestinal intercomma () adult patients who have been treated with various types of kinase inhibitors, including imatinibRuptini has recently been approved for listing in the US, Canada and AustraliaDrYing Du, founder, chairman and chief executive officer of Reding Pharmaceuticals, said: "There is still a significant unmet demand for patients in China, especially those who have become resistant to past treatment sourcingBased on recent U.Sapprovals and excellent clinical data from research, we believe that Ruptinib is expected to change the treatment of patients in the countryWe will actively cooperate with the review and approval department to benefit patients in the country as early as possible"The recent approval of Riptini in the United States and the earlier-than-expected acceptance of new drug applications in China underscore its potential for the future," the President and CEO saidEvery year, there is a huge unmet clinical need in more than one newly diagnosed patient in ChinaWe look forward to continuing to work with Reding Pharmaceuticals to bring Riptinib to patients awaiting new treatments at an early date"An international multicenter clinical study of phase randomized, double-blind, placebo-controlled studies designed to assess the safety, tolerance and effectiveness of rupitinib and placebo comparison in patients with advanced patients who have previously been treated with treatments including imatinib, shonetinib, and rigofenibPatients were randomly assigned to the daily mgritus or placebo group in proportion to the ratioThe main endpoint is the progression-free survival () determined by an independent radiology review based on the criteria for evaluating the efficacy of solid tumorsAccording to previously reported studies, the median progression survival period was months while the placebo group was only a month and the risk of disease progression or death was significantly reduced (risk ratio)The secondary endpoints identified by an independent radiology review through the use of improved criteria include objective mitigation rates () and total lifetime () The objective remission rate of rupitinib was () Riptinib's median total survival was months while the placebo group was months and the risk of death was reduced (risk ratio) The most common adverse reactions are hair loss, weakness, nausea, abdominal pain, constipation, muscle pain, diarrhea, loss of appetite, sactoma syndrome and vomiting The administration patients who gave the drug had an adverse reaction that caused the permanent discontinuation of the drug due to adverse reactions caused by the dose interruption of the dose of the patient due to adverse reactions caused by the dose reduction
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