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    Home > Medical News > Medical Research Articles > Another new indication of nerve growth factor in Shandong unnamed mice is approved

    Another new indication of nerve growth factor in Shandong unnamed mice is approved

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    Drug clinical trial approval document (SZ: 002581): Notice on obtaining drug clinical trial approval document

    Shandong Weiming biomedical Co., Ltd., a wholly-owned subsidiary of Shandong Weiming biomedical Co., Ltd

    (hereinafter referred to as "the company") received the drug clinical trial approval document issued by the State Food and Drug Administration on August 10, 2016, The relevant information is hereby announced as follows: 1

    Main contents of clinical trial approval document: drug name: mouse nerve growth factor for injection acceptance No.: cxsl15000054 min approval No.: 2016l06472 dosage form: injection application items: domestic drug registration specification: 18 μ g (≥ 9000au) / branch classification: biological products for treatment Applicant: Weiming biomedical Co., Ltd

    approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, the product meets the relevant requirements of drug registration, and is approved to carry out clinical trials with diabetic foot as the proposed indication

    2

    In other related situations, the company's product "mouse nerve growth factor for injection" (trade name "enjingfu") is a new national class a drug with completely independent intellectual property rights, which is mainly used for the repair and treatment of nerve injury

    "Enjingfu" added the application of "diabetic foot" indication, and obtained the notice of acceptance of drug registration application on May 27, 2015

    Diabetic foot refers to the disease state of ulcer and gangrene in diabetic foot due to the decrease of lower limb protection function caused by neuropathy, the insufficiency of arterial perfusion caused by macrovascular and microvascular diseases, which is one of the most serious chronic complications of diabetes and the highest treatment cost, and the serious can lead to amputation

    The two main causes of diabetic foot formation are peripheral neuropathy and tissue ischemia

    Nerve growth factor can protect the survival of neurons, promote the repair of myelin sheath, promote the directional regeneration of axons and form functional connections, so as to repair the damaged nervous system; at the same time, nerve growth factor can promote the angiogenesis of ischemic necrosis tissue, so as to promote the wound healing of diabetic foot, and may improve the local ischemia of tissue

    At present, there is no nerve growth factor related products for diabetic foot marketing at home and abroad

    According to the requirements of laws and regulations related to drug registration in China, after obtaining the approval documents of clinical trials, the drugs need to carry out clinical trials and be reviewed and approved by the State Food and drug administration before production and marketing

    According to the data v3.2 of Xianda, there are 4 domestic listed mouse nerve growth factors: shutaishen, Wuhan Haite, Lizhu and Weiming

    The sales of sample hospitals are better than shutaishen, but the sales of Weiming and Weiming are not much worse

    Now, Weiming has obtained a clinical approval document of new indications with larger market, once it is listed, the sales will be higher

    As for the declaration situation, except for the listed ones, there are no other manufacturers to declare, and it may be difficult to carve up the existing market

    Drug clinical trial approval document (SZ: 002581): Notice on obtaining drug clinical trial approval document

    Shandong Weiming biomedical Co., Ltd., a wholly-owned subsidiary of Shandong Weiming biomedical Co., Ltd

    (hereinafter referred to as "the company") received the drug clinical trial approval document issued by the State Food and Drug Administration on August 10, 2016, The relevant information is hereby announced as follows: 1

    Main contents of clinical trial approval document: drug name: mouse nerve growth factor for injection acceptance No.: cxsl15000054 min approval No.: 2016l06472 dosage form: injection application items: domestic drug registration specification: 18 μ g (≥ 9000au) / branch classification: biological products for treatment Applicant: Weiming biomedical Co., Ltd

    approval conclusion: according to the drug administration law of the people's Republic of China and relevant regulations, after examination, the product meets the relevant requirements of drug registration, and is approved to carry out clinical trials with diabetic foot as the proposed indication

    2

    In other related situations, the company's product "mouse nerve growth factor for injection" (trade name "enjingfu") is a new national class a drug with completely independent intellectual property rights, which is mainly used for the repair and treatment of nerve injury

    "Enjingfu" added the application of "diabetic foot" indication, and obtained the notice of acceptance of drug registration application on May 27, 2015

    Diabetic foot refers to the disease state of ulcer and gangrene in diabetic foot due to the decrease of lower limb protection function caused by neuropathy, the insufficiency of arterial perfusion caused by macrovascular and microvascular diseases, which is one of the most serious chronic complications of diabetes and the highest treatment cost, and the serious can lead to amputation

    The two main causes of diabetic foot formation are peripheral neuropathy and tissue ischemia

    Nerve growth factor can protect the survival of neurons, promote the repair of myelin sheath, promote the directed regeneration of axons and the formation of functional connections, so as to repair the damaged nervous system; at the same time, nerve growth factor can promote the angiogenesis of ischemic and necrotic tissue, so as to promote the wound healing of diabetic foot, and may improve the local ischemia of tissue

    At present, there is no nerve growth factor related products for diabetic foot marketing at home and abroad

    According to the requirements of laws and regulations related to drug registration in China, after obtaining the approval documents of clinical trials, the drugs need to carry out clinical trials and be reviewed and approved by the State Food and drug administration before production and marketing

    At present, there are 4 domestic listed mouse nerve growth factors for injection: Shutai Shen, Wuhan Haite, Lizhu and Weiming

    Shutai Shen has a good sales volume in the sample hospital, but the sales volume of Weiming and Weiming are not much worse

    Now, Weiming has obtained a clinical batch of new indications with a large market

    Once it is listed, the sales volume will be higher

    As for the declaration situation, except for the listed ones, there are no other manufacturers to declare, and it may be difficult to carve up the existing market.
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