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    Home > Medical News > Medical Research Articles > Notice of China Resources Shuanghe Pharmaceutical Co., Ltd. on the approval and approval opinions of wholly owned subsidiary China Resources SECCO for clinical trials

    Notice of China Resources Shuanghe Pharmaceutical Co., Ltd. on the approval and approval opinions of wholly owned subsidiary China Resources SECCO for clinical trials

    • Last Update: 2020-04-03
    • Source: Internet
    • Author: User
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    The board of directors and all directors of the company guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and shall be jointly and severally liable for the authenticity, accuracy and completeness of the contents

      Recently, the wholly-owned subsidiary of China Resources Shuanghe Pharmaceutical Co., Ltd

    (hereinafter referred to as "the company") China Resources SECCO Pharmaceutical Co., Ltd

    (hereinafter referred to as "China Resources SECCO") received the approval document for clinical trial of drug and the notice of approval opinion for tadalafil API approved and issued by the State Food and Drug Administration (hereinafter referred to as "the State Food and Drug Administration") " Now the relevant information is announced as follows: 1

    Main contents of the drug approval document (2) other indications of drug research: the drug is applicable to the type 2 diabetes mellitus (non insulin dependent) patients with diet control, weight loss and exercise unable to effectively control hyperglycemia

    Repaglinide can be used in combination with metformin, and the synergistic effect of both can control blood glucose more effectively than when they are used alone

    Repaglinide is a new type of short acting oral glucose regulator

    Clinical research shows that repaglinide can improve the clinical symptoms of diabetes, correct various metabolic disorders caused by hyperglycemia, effectively delay the progress of the course of disease, and effectively prevent and treat various complications caused by diabetes

    Application date: September 11, 2012 as of the date of this announcement, the cumulative R & D cost of the drug registration application is about 790000 yuan

    (3) market situation of similar drugs (4) sales data, production and use of similar drugs (1) production and sales data

    Regolide tablets were approved for marketing in the United States on December 22, 1997, with the trade name of NovoNorm? / prandin? / prandinet?, and the original manufacturer is Novo Nordisk Inc, the company's 2014 annual report published on its website, shows that the annual global sales of NovoNorm? Products are DKK 1.728 billion

    On the domestic side, according to the data of "2014 key city public hospital chemicals - diabetes drugs - repaglinide", the annual sales volume of repaglinide in key city public hospitals in 2014 was about RMB 200 million

    2

    Usage According to the data of "2015 key city public hospital chemicals - diabetes drugs - regraine" collected by minenet, the top five cities in the city share pattern are: Shanghai 21.97%, Beijing 18.73%, Tianjin 17.36%, Guangzhou 8.55%, Chongqing 6.69%; the enterprise share pattern is: Novo Nordisk 88.26%, Jiangsu Haosen 11.35%, Kangrui 0.24%, Beijing Wansheng Pharmaceutical Co., Ltd

    is 0.13%, Beijing Beilu Pharmaceutical Co., Ltd

    is 0.02%

    (V) research and development progress: according to the requirements of laws and regulations related to drug registration in China, human bioequivalence (be) test shall be carried out after the drug is approved by the drug evaluation center of the State Food and drug administration before it can be produced and marketed

    After receiving the official approval of the drug, Cr Secco has started the clinical research of the drug

    After completing the clinical research, it will submit the corresponding data to the drug review center of the State Food and Drug Administration for review

    If the review is passed, the registration approval and approval number can be obtained

    (6) the risk indicates that the same type of drug on the market has the characteristics of high safety and less adverse reactions

    However, according to relevant research and development experience, research and development may be terminated due to effectiveness and other issues in human bioequivalence (be) experimental research

    Due to the particularity of drug research and development, the period from clinical trial approval to production is long and there are many links, so the drug is vulnerable to unpredictable factors

    Please pay attention to the investment risk

    II

    The main contents of the notice on approval opinions of tadalafil APIs are detailed in the announcement on obtaining approval documents for clinical trials of drugs by wholly owned subsidiary China Resources SECCO (interim announcement 2015-066) issued by the company on December 17, 2015

      Due to the characteristics of high-tech, high-risk and high added value of pharmaceutical products, the initial research and development of new drugs, as well as the long cycle and many links from the application for approval of research and clinical trials to production, the specific sales situation of the drugs after production may be affected by market environment changes and other factors, with great uncertainty

    Please make careful decisions and pay attention to prevent investment Capital risk

    It is hereby announced

    Board of directors of China Resources Shuanghe Pharmaceutical Co., Ltd

    January 7, 2016
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