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    Home > Medical News > Latest Medical News > From January to March 2022, CDE will undertake to accept 18 new Chinese medicine registration applications

    From January to March 2022, CDE will undertake to accept 18 new Chinese medicine registration applications

    • Last Update: 2022-04-15
    • Source: Internet
    • Author: User
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    [Pharmaceutical Network Industry News] In recent years, with the accelerated innovation and development of the pharmaceutical industry and favorable policies supporting the development of new traditional Chinese medicines, more and more traditional Chinese medicine companies have strengthened the research and development of new medicines.
    results
    .

    According to the catalogue of varieties accepted by CDE, from January to March 2022, CDE has undertaken and accepted a total of 18 applications for registration of new Chinese medicines
    .

    From the perspective of application types, there are 6 new drugs in category 1.
    1 of traditional Chinese medicine, namely Taizishenyue Capsules, Pomegranate Flower Suppositories, Chaijin Jieyu Anshen Tablets, Zaobai Anshen Granules, Qingda Granules, and Xiaoerxiangru Granules.
    Yuan Pharmaceutical and other pharmaceutical companies
    .

    Not long ago, Yili Pharmaceutical submitted a clinical application for a new drug category 1.
    1 of the traditional Chinese medicine of Xiaoerxiangru Granules
    .

    According to public information, Xiaoer Xiangyu Ganmao Granules have obvious antibacterial, antiviral, anti-inflammatory and antipyretic effects, which can enhance the body's immunity and disease resistance.
    It is a new traditional Chinese medicine for the treatment of four-season colds
    .

    The pediatric cold medicine market that Yili Pharmaceutical has attacked is huge.
    The market size will exceed 3 billion yuan in 2020, and the market potential is huge
    .

    It is worth mentioning that at the end of 2021, the company also obtained Huzhen Qingfeng Capsule, a class 1 new drug for gout.
    The results of clinical trials show that it can be used for the treatment of mild to moderate acute gouty arthritis, which belongs to the syndrome of damp-heat accumulation in traditional Chinese medicine
    .

       Judging from the 18 companies that have applied for the registration of new Chinese medicines, Kangyuan Pharmaceuticals has gone steadily on the road of research and development of innovative Chinese medicines
    .

    From January to March 2022, the company has received a total of 5 new Chinese medicine registration applications, including 2.
    3 new Chinese medicines Cistanche Total Glycosides Capsules, Dazhu Hongjingtian Capsules, Jinzhen Oral Liquid, 1.
    1 new Chinese medicines Zaobo Anshen Granules, And Lingguizhugan Granules, a class 3.
    1 new traditional Chinese medicine
    .

    Among them, the indications of 11 kinds of traditional Chinese medicine Xinzaobai Anshen Granules are: nourishing blood and calming the soul, clearing away heat and eliminating vexation
    .

    It is used for insomnia due to deficiency of liver blood and internal disturbance of deficiency heat, symptoms of deficiency, irritability, insomnia, or difficulty falling asleep, or restless sleep at night, or even sleeplessness at night; often accompanied by: heat in hands, feet, night sweats, dry mouth and less fluid Forgetfulness, tinnitus, palpitations, restless embolism, red tongue with little coating, rapid pulse
    .

    For chronic insomnia, see the above syndromes
    .

       In addition, Weihai Life, Good Doctor Panxi Pharmaceutical, Suzhou Yusen and other pharmaceutical companies have also accepted 2 new Chinese medicine registration applications
    .

       The past 2021 has been a record year for the approval of new Chinese medicines in the past five years.
    A total of 11 new Chinese medicines have been approved for marketing, indicating that the reform of the Chinese medicine review and approval system has achieved initial results
    .

    On January 10, 2022, it was announced that the 1.
    2 class innovative drug icariin soft capsule had recently been approved by the State Food and Drug Administration for marketing.
    This is also the first innovative traditional Chinese medicine drug approved for marketing in China this year
    .

       The policy continues to encourage and support the research and development of new Chinese medicines, and a series of regulations and related technical guidance in line with the characteristics of traditional Chinese medicines, such as the newly revised "Administrative Measures for Drug Registration", "Requirements for Registration Classification and Application Materials of Traditional Chinese Medicines", and "The Fourteenth Five-Year Plan for the Development of Traditional Chinese Medicines" The principles have been issued and implemented one after another, fully respecting the development rules of traditional Chinese medicine, encouraging the inheritance and innovation of traditional Chinese medicine, and greatly stimulated and released the vitality and potential of traditional Chinese medicine innovation
    .

    In particular, the "14th Five-Year Plan" for the development of traditional Chinese medicine proposes to build a high-level traditional Chinese medicine inheritance protection and technological innovation system, and to reform and improve the management of traditional Chinese medicine registration, which will boost the entire research and development of new traditional Chinese medicines
    .

    According to industry forecasts, in the next few years, more than 12 new Chinese medicines will be approved for listing each year
    .

     Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
    .

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