<td id="ezax4"><mark id="ezax4"><label id="ezax4"></label></mark></td>
    <delect id="ezax4"></delect>
    <label id="ezax4"></label>
    <delect id="ezax4"></delect>
    <wbr id="ezax4"><ins id="ezax4"><table id="ezax4"></table></ins></wbr>
    <listing id="ezax4"><source id="ezax4"></source></listing>
    <wbr id="ezax4"><object id="ezax4"><progress id="ezax4"></progress></object></wbr>
    <wbr id="ezax4"></wbr>
    <listing id="ezax4"><video id="ezax4"><input id="ezax4"></input></video></listing>
    <wbr id="ezax4"><ins id="ezax4"></ins></wbr>
    Understanding the development process and trend of cell gene therapy
    Click:137  Update time:2022-11-25  【Close
    CGT (Cellular and Gene Therapy) refers to the process of transferring the determined genetic material to specific target cells of patients, modifying the expression of individual genes or repairing abnormal genes through gene addition, gene modification, gene silencing, etc., to achieve the goal of curing diseases.


    Advantages of cell gene therapy

    01 | Highly targeted
    The treatment of tumor is highly targeted and has significant effect. It basically does not damage normal tissues when killing cancer cells.


    02 | Unique mechanism

    It is non cytotoxic, effective, non-toxic and well tolerated.


    03 丨 Few side effects and adverse reactions

    Compared with traditional surgery, radiotherapy and chemotherapy, there are basically no side effects and adverse reactions, and patients will not suffer during treatment.


    Development History


    Global drug pipeline under research


    According to ASCGT data, of the 3633 CGT clinical trials in the world, 2024 are gene therapy pipelines, including gene editing of CAR-T therapy, accounting for 55%; 803 items are cell therapy pipelines that do not involve gene editing, accounting for 22%.


    Pipeline of drugs under research in China

    There are more than 700 clinical research pipelines of CGT drugs in China. In addition to 5 listed drugs, there are 2 applications for listing, 259 Phase I clinical projects, 233 Phase II clinical projects, 20 Phase III clinical projects, 26 approved clinical projects, and 52 clinical applications.

    Forecast of global and domestic CGT market size

    Data source: Frost Sullivan Consulting (China)'s domestic market in 2016-2020 has a compound annual growth rate of 12.2%, and the market size in 2020 will be 23.8 million yuan. Although the Chinese market started late, it is expected that under the influence of multiple factors such as policy promotion, medical technology progress, and the increase in the number of patients, the track is expected to surge to 17.885 billion yuan in 2025, which has great potential.



    CGT regulatory policies of various countries

     America

    The United States is a pioneer in the field of gene cell therapy, with a complete and more conservative and prudent regulatory system. In 2017, FDA approved the first gene therapy product, five years later than the EU. As early as 1984, the United States proposed to regulate the CGT industry, with NIH and FDA conducting double supervision. Since Jesse's death accident occurred in 1999, the United States has strengthened industry supervision, and FDA and NIH have successively issued a number of CGT industry supervision decrees. In 2018, in order to promote the development of the industry, FDA restarted the release of three new guidelines for the development of specific diseases (hemophilia, retinopathy, rare diseases), and updated three existing guidelines to solve production problems related to gene cell therapy.


    European union
    The European Medicines Agency (EMA) manages CGT according to human drugs in the EU. The gene therapy, cell therapy products and tissue engineering products are defined as Advanced Therapy Medicinal Products (ATMP). The gene cell Therapy is applied for according to the drug application, reviewed by the ATMP committee under EMA, and the review comments are submitted to the CHMP (Committee for Medicinal Produces for Human Use) for final decision, which is finally approved by EMA. So far, the EU has issued a number of guiding principles related to safety supervision.

    China
    China has carried out basic research and clinical trials in the field of CGT relatively early, regulatory policies and regulations are relatively backward, and the content is relatively simple. The specific issues involved in multiple links of related research and development were not explained and stipulated in detail, the laws and regulations were not strong, and the approval was relatively loose. In 2018, under the influence of "the world's first gene editing baby event", China began to strengthen legislation in biosafety, gene technology, biomedicine and other fields. In 2019, the Biosafety Law and the Regulations of the People's Republic of China on the Administration of Human Resources Genetics were promulgated. In 2020, gene editing and cloning of human embryos into human or animal bodies were included in the criminal law, "If the circumstances are serious, he shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention and shall also be fined; if the circumstances are especially serious, he shall be sentenced to fixed-term imprisonment of not less than three years but not more than seven years and shall also be fined." The Civil Code, which came into force in 2021, also clearly states that "Those engaged in medical and scientific research activities related to human genes, human embryos, etc. shall abide by laws, administrative regulations and the relevant provisions of the State, and shall not endanger human health, violate ethics, or harm public interests." From the regulatory level, it has become stricter and more standardized.
    Last:Abapatide in the field of osteoporosis treatment: an improved development path from subcutaneous injection to transdermal drug delivery
    Next:Subcutaneous implantation of naltrexone: a new therapy for opiate use disorder

    LINDMIK PHARMA

    Lindmik Pharmaceutical(Suzhou)Co.,Ltd is a high-tech pharmaceutical enterprise focusing on the research and development, production and sales of innovative pharmaceutical preparations.Equipped with a number of its own innovative R&D platform of dosage forms, including the transdermal drug delivery system, and at the same time, actively introducing the world’s leading nano-based drug delivery, microspheres drug delivery and other cutting-edge pharmaceutical technologies by means of “license in”, the company is a new rapidly developing company pharmaceutical companies that catches people’s eyes.

    SIGN UP

    LINDMIK MAP

    OUR CONTACT

    • 12th Floor, Building 5, Tianyun Plaza, 111 Wusongjiang Avenue, Guoxiang Street, Wuzhong District, Suzhou City

    • 0512-66020899

    • 0512-66022699

    • 215124

    © COPYRIGHT Lindmik Pharmaceutical(Suzhou)Co.,Ltd. All Rights Reserved 
    久久av这里有精品_大伊香蕉精品一区二区_成人无码免费视频97_日韩欧美精品有码在线
    <td id="ezax4"><mark id="ezax4"><label id="ezax4"></label></mark></td>
      <delect id="ezax4"></delect>
      <label id="ezax4"></label>
      <delect id="ezax4"></delect>
      <wbr id="ezax4"><ins id="ezax4"><table id="ezax4"></table></ins></wbr>
      <listing id="ezax4"><source id="ezax4"></source></listing>
      <wbr id="ezax4"><object id="ezax4"><progress id="ezax4"></progress></object></wbr>
      <wbr id="ezax4"></wbr>
      <listing id="ezax4"><video id="ezax4"><input id="ezax4"></input></video></listing>
      <wbr id="ezax4"><ins id="ezax4"></ins></wbr>