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    Home > Medical News > Latest Medical News > In the past 5 years, 10 major events in China's pharmaceutical industry

    In the past 5 years, 10 major events in China's pharmaceutical industry

    • Last Update: 2021-07-29
    • Source: Internet
    • Author: User
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    China's pharmaceutical industry has gone through a period of enthusiasm in the past five years.
    The top-down pharmaceutical policy reform is continuously accelerating the innovation, upgrading and globalization of China's pharmaceutical industry

    .
    Back to look in the past five years, which industry milestone moments memorable? The editor gave a few suggestions to list 10 major events, and welcomes everyone to leave a message to add
    .

    Three Signs of Drug Administration Reform


    Medical drug industry is one of the more obvious by the guiding influence policy
    .
    In recent years, various policy documents, industry guidelines, and drafts for comments issued by the National Medical Products Administration, the Medical Security Administration and other departments are numerous.
    The core themes are no more than three points.
    The first is to encourage innovation by improving the efficiency of review; The second is to promote the internationalization of the industry by joining ICH; the third is to realize the sustainable development of the industry in the form of "vacating the cage and changing the bird" through the payment of the medical insurance principal

    .

    1) Publication of Circular 44.
    Circular 44 issued

    in August 2015 has been recognized by the industry as an important document that has changed the pattern of China’s pharmaceutical market, and with the completion of the most comprehensive revision of the Drug Administration Law in the past 20 years, the Drug Administration The system has achieved remarkable results in five aspects: improving the quality of review and approval, solving the backlog of registration applications, improving the quality of generic drugs, encouraging research and creation of new drugs, and improving the transparency of review and approval
    .

    Especially in the past year or so, the four fast lanes of breakthrough therapeutic drugs, conditional approval, priority review and approval, and special approval have been unblocked, accelerating the review and marketing of drugs with outstanding clinical value and urgent public health needs
    .

    2) Joining ICH China formally joined ICH in June 2017.
    NMPA was elected as a member of the ICH Management Committee in June 2018 and participated in the formulation of core international rules in the field of drug registration
    .
    This not only means that China's drug supervision has begun to integrate into the international drug supervision system, but it is also the process of the entire pharmaceutical industry's comprehensive integration with the world, which directly promotes the registration and approval of local innovative drugs represented by Zebutinib in Europe, the United States and other countries .
    3) The establishment of the National Medical Insurance Bureau on May 31, 2018, the inauguration of the National Medical Insurance Bureau, which vigorously promotes the sustainable development of industry innovation from the payment level
     




    .
    These include the organization of multiple centralized purchases of drugs and consumables, the opening of the dynamic adjustment mechanism of the medical insurance drug catalog, the pilot reform of medical insurance payment methods, the establishment of a mutual assistance guarantee mechanism for the medical insurance outpatient clinics, and even the first official administrative regulations in the field of medical insurance

    .

    Two channels of capital market


    For the biotechnology industry, obtaining funds through financing and listing is an important way to support the continued development of products
    .
    The research and development of innovative drugs is inseparable from the support of capital power
    .


    4) Hong Kong Stock Exchange 18A New Deal


    The rapid growth of Chinese innovative drug companies has driven the Hong Kong Stock Exchange to make the biggest reform in the past 25 years-allowing biotech companies that have not yet achieved sales or have not yet made a profit to IPO
    .
    The new 18A policy of the Hong Kong Stock Exchange has been implemented on April 30, 2018, opening the door to unprofitable biopharmaceutical companies

    .


    For more than three years, with the help of the policy advantages of the Hong Kong stock market and the state's key support for the biopharmaceutical industry, unprofitable biopharmaceutical companies have received unprecedented attention
    .
    Since the first listing of Gery Pharmaceuticals, more than 30 innovative drug companies have landed on the Hong Kong Stock Exchange

    .


    5) The establishment of the Science and Technology Innovation Board


    The research and development of new drugs is not only a technology-intensive task, but also a task that requires continuous capital
    .
    Since the official launch of the Shanghai Stock Exchange's Science and Technology Innovation Board on July 22, 2019, the Science and Technology Innovation Board has achieved a series of achievements in serving the development of science and technology enterprises and advancing the improvement of the capital market system

    .


    On the basis of the 18A of the Hong Kong Stock Exchange, the Sci-tech Innovation Board has once again broadened the financing channels for innovative pharmaceutical companies, especially under the leadership of Microchip Technology.
    Nearly 10 unprofitable innovative pharmaceutical companies have passed the "standard 5" in the A-share market.
    When they are listed, they use the capital market to achieve faster development, and to bring more new and good drugs to the market earlier to benefit human health

    .

    Five types of new therapies rush to market


    Innovative drug research and development is based on a temporary mission to meet the demand of the bed
    .
    With the reform of drug review and approval policies and the assistance of the capital market, the development of innovative drugs is entering a period of rapid development.
    The number of innovative drugs that have been applied for listing and clinical applications are increasing year by year.
    Start-ups are emerging in an endless stream.
    The types of drugs are more advanced than those in the era of chemical drugs.
    Significant expansion

    .
    To PD-1 / L1, represented by tumor immunotherapy, rituximab, adalimumab monoclonal antibody , bevacizumab monoclonal antibody and a series of bio-similar drugs, as well as the new crown vaccine, ADC and cell therapy is approved, it is It demonstrates the results of reforms in the past five years .
    6) Tumor immunotherapy On December 17, 2018, the NMPA approved the marketing application of teriprizumab injection, which opened the prelude to the domestic PD-1 drug competition .
    With the launch of 4 domestically-made PD-1 drugs and their subsequent inclusion in medical insurance, the cost of immunotherapy has been reduced from hundreds of thousands of yuan to only about 10,000 yuan for individuals, greatly improving the availability of drugs for the common people .
    7) bio-similar drugs February 25, 2019, NMPA approval of rituximab injection re-listing application macro Hanlin, which is China's first positive type approved similar domestic bio-medicine, bio-similar drugs clear our country The registration approval path .
    So far, 16 domestic biosimilar drugs have been approved, breaking the market monopoly of original research drugs, and will also greatly reduce the burden on patients and improve the availability of drugs.
    This is one of the encouragement points of China's drug regulatory policy
    .
    8) New Crown Vaccine On December 31, 2020, Sinopharm China Bio-New Crown Inactivated Vaccine obtained NMPA conditional approval for marketing













    .
    Up to now, China has now conditionally marketed 5 new coronavirus vaccines, including 3 inactivated vaccines, 1 adenovirus vector vaccine, and 1 recombinant protein vaccine (CHO cell)

    .
    The approval of the new crown vaccine for the market will gradually build a universal immune barrier, inject confidence in the global fight against the epidemic, and provide strong support for the vaccine to become a global public product

    .
    9) ADC drug On June 9, 2021, as the first ADC marketed drug self-developed by a Chinese pharmaceutical company , Vidicituzumab was the first to be approved by the NMPA for HER2 overexpression locally advanced or locally advanced or overexpression that has received at least two systemic chemotherapy.
    Treatment of metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction)
    .
    This breaks the situation that there is no original domestic new drug in the ADC drug field, fills the gap in the global treatment of HER2 overexpression gastric cancer patients, and is a milestone in the development history of China's independent innovative biological drugs .
    10) CAR-T Cell Therapy On June 22, 2021, NMPA approved Fosun Kate's application for the market application of Akirensai injection targeting CD19 autologous chimeric antigen receptor CAR-T cell therapy in China, which is the first in China Cellular drugs approved for marketing .
    The approval of Achilles is the first year of China's cell therapy.
    WuXi Biotech's similar product Regiron has been submitted on June 29 last year and is expected to be approved within this year .
    Standing at a new starting point, let us draw forward strength from the development of the industry, compose a new journey for the pharmaceutical industry in the new era, and look forward to the next five years of the industry!









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