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    Home > Medical News > Latest Medical News > Hope that China and the United States declared the listing! Yifan Pharmaceutical Class 1 new drug F-627 China Phase III clinical success.

    Hope that China and the United States declared the listing! Yifan Pharmaceutical Class 1 new drug F-627 China Phase III clinical success.

    • Last Update: 2020-08-01
    • Source: Internet
    • Author: User
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    The results of this multi-center, randomized, open and positive phase III clinical trial show that the effectiveness results of F-627 Phase III clinical trials in China have fully met the pre-set evaluation criteria of clinical trials, and the efficacy is comparable to that of the control drugs (the primary imported drug recombinant human granulocytes).
    , the overall safety of f-627 is good, compared to the control drug adverse event rate and severity, etc. are no significant difference, and F-627-related adverse reactions are mostly light moderate, indicating that F-627 has good safety and tolerance. At the same time
    , this clinical trial on immunogenic screening, validation and neutralizing antibody testing methods in accordance with the FDA's latest guidelines method sourcing and validating, the end results of this immunogenicity neutrality and antibody test are negative.
    recombinant human granulocyte seisludir (G-CSF) is a synthetic cytokine that promotes the production, release, or survival of neutrophils.
    neutrophil reduction is one of the most common dose-limiting toxicity in cancer patients during chemotherapy, so G-CSF is often given intervention to reduce infection risk, improve chemotherapy compliance, avoid chemotherapy drug reduction or treatment delay and thus reduce clinical efficacy.
    current clinical applications of G-CSF include short-acting G-CSF drugs used daily and long-acting G-CSF drugs used once per chemotherapy cycle.
    F-627 is an innovative biopharmaceutical product based on the existing dual-molecular technology platform of Shanghai Kenyon with independent intellectual property rights Di-KineTM.
    unlike the existing recombinant G-CSF, the F-627 is based on Fc fusion protein technology, the rhG-CSF dipolymer expressed by CHO cells, with long-lasting and powerful biological characteristics.
    is currently mainly used to treat granulocyte reduction caused by cancer patients during chemotherapy, to prevent patients from dying from infection or other complications, as a routine clinical treatment.
    Shanghai Jiannenglong conducted Phase III clinical trial research on F-627 in China and the United States, and was also the first major molecular innovative biological drug to enter the United States Phase II and III clinical trials. according to IMS data
    , the global market size of G-CSF in 2018 is about US$5 billion, mainly with The insatilated recombinant human granulocyte synthasi stimulator, Neulasta, developed by Amgen, which is about 80% of the market share.
    according to the data of The Inner Net, in 2018 China's G-CSF market size of about 5 billion yuan, a number of enterprises to produce short-acting G-CSF drugs and three Chinese enterprises produced polyethyl glycol modified long-acting G-CSF drugs, but so far no Chinese enterprises produced G-CSF in foreign markets approved for sale.
    F-627 conducted simultaneous preclinical and clinical phase studies in several countries around the world, including China, the United States, Europe and other countries, in which the first Phase III clinical trial in the United States (04-scenario, a placebo-controlled trial) has reached the main clinical endpoint and obtained the expected evaluation criteria; The control trial of Neulasta, originally produced by Neulasta, selected Neulasta produced by Amgen as a positive control drug, conducted head-to-head comparison tests, and the program has reached a binding agreement with the FDA to agree that Shanghai Jiannenglong will use the "special program assessment" to conduct a second Phase III clinical trial, and the trial has now entered the final phase of visit.
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