Xi'an Yangsen Yiyi (Ibtini capsule) New indications approved by the State Drug Administration
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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today, Theof Johnson andCorporation (http://Xi'an Yangsen Pharmaceutical Co., Ltd., asubsidiary of china'sPharmaceutical(http:// announced that its new indications of Eyre (ibitini capsules) have been approved by the StatePharmaceutical(http://Regulatory Authoritybillion can be used in the treatment of patients with Fahrenheit hyperglobulinemia (WM) who have received at least one treatment in the past, or are not suitable for first-line treatment of patients receiving chemotherapy;studiestwo single-armtrials
(http://and a randomized controlled trial, confirmed the safety and efficacy of emoludle in treating patients with Fahrenheit cytoglobulin, an open, multi-center, one-arm trial was entered into a group of 63 patients with Fahrenheit cyloproteinemia who had previously been treated with Fahrenheit, and given ibutinib 420mg a daily oral monodotherapy The researchers and the Independent Review Commission (IRC) used the standards of the International Working Group on Fahrenheit Cyloproteinemia to assess efficacy results show that the total remission rate of patients reached 90.5%, the main remission rate reached 73% The patient's 2-year progression-free survival rate was 69.1% and the total survival rate was 95.2% another single-drug treatment group included 31 patients with Fahrenheit cyloglobulin helobaemia who had previously been treated with the treatment of the ritoxinocosis monosytry regimen after failure Median follow-up 18.1 months, the total remission rate of the single-drug treatment group was 90%, the main remission rate was 71%, the median no progression survival was not reached
in addition, in the evaluation of ibutinib or placebo combined attribution, randomized, double-blind, placebo-controlled, phase III study (1 127) 150 patients with Fahrenheit cyloglobulinemia (45 percent of first-treatment patients; 55 percent of treated patients) randomly received ibutinib capsules (420 mg per day) or placebo in combination with rituxima The median follow-up time was 26.5 months, with a significant lysine-free survival (PFS) in patients in the ibutini-combined ritoxinor group (not reaching vs 20.3 months), with a 30-month progression survival rate of 82% in the ibitini and rituxitrim group, compared to 28% in the placebo and ritoxil monosota ibutini-combined rituxima group had an 80 percent lower risk of disease progression or death than in the placebo-combined ritoxinor group The data was published in an oral report at the American College of Oncology's annual meeting (ASCO) in 2018 and published in the New England Journal of Medicine
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