echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Antitumor Therapy > Kangfang Bio-Pipampril received FDA breakthrough therapy designation, third-line treatment for metastatic nasopharyngeal carcinoma

    Kangfang Bio-Pipampril received FDA breakthrough therapy designation, third-line treatment for metastatic nasopharyngeal carcinoma

    • Last Update: 2021-04-14
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    On March 30, Kangfang Bio-Bio announced that its anti-PD-1 monoclonal antibody drug, Paimpril (Annico), developed in cooperation with China Biopharmaceuticals, for the third-line treatment of metastatic nasopharyngeal carcinoma, was awarded by the U.
    S.
    Food and Drug Administration.
    (FDA) Granted breakthrough therapy designation.

    This is another important progress made in the United States after Paampril obtained the FDA’s fast-track approval for the third-line treatment of metastatic nasopharyngeal carcinoma and orphan drug qualifications.
    It is also Kangfang Bio’s subsequent PD-1/CTLA-4 dual antibody After that, it was the second oncology drug approved by the FDA as a breakthrough therapy.

    Obtaining this title means that Pianpril has a significant improvement in clinically significant endpoints compared to existing therapies or when there are major unmet medical needs, and will accelerate the product's future marketing process.

    Paimrizumab (AK105, PD-1 monoclonal antibody) was jointly developed and commercialized by a joint venture established by Kangfang Bio and Chia Tai Tianqing Pharmaceutical Group (CP Tianqing), a subsidiary of China Biopharmaceuticals.

    The crystalline (Fc) receptor and complement-mediated utility functions of this product are completely removed by mutations in the Fc region.
    At the same time, the antigen binding and dissociation rate is slower than that of PD-1 antibodies that have been marketed abroad.

    These characteristics enable Paampril to more effectively block the activity of the PD-1 pathway and maintain stronger T cell anti-tumor activity.
    It may become an anti-PD-1 drug with better clinical benefits.

    At the 35th Annual Meeting of the Society of Tumor Immunotherapy "SITC 2020", China Biosciences announced that Paimrizumab has undergone at least two efficacy evaluations for relapsed or refractory classic Hodgkin's lymphoma (r/ r cHL) Phase 2 clinical trial data in subjects showed that the subject’s objective response rate (ORR) reached 83.
    6% and the complete response rate (CR) reached 49.
    3% after medication, which was significantly higher than the historical control and better than the current one The PD-1 monoclonal antibody that is conditionally approved for marketing has published data.The National Medical Products Administration (NMPA) has accepted piprimumab for the treatment of relapsed or refractory classic Hodgkin's lymphoma (r/r cHL) at least after second-line system chemotherapy in May 2020.
    Application.

    The registered clinical trial of Paampril for the third-line treatment of metastatic nasopharyngeal carcinoma also reached the primary endpoint.

    The main indications for the current product layout include liver cancer, stomach cancer, lung cancer, Hodgkin's lymphoma, nasopharyngeal cancer and other diseases.

    End reference materials: [1] Kangfang Biotechnology [2] China Biopharmaceuticals (01177-HK): The latest research data of "Paampril" will be presented at SITC 2020.
    Nature: Known as "anti-cancer The “star” immunotherapy may be the “crushing talisman” for this type of cancer patients.
    AstraZeneca announced the Phase 3 clinical results of the new crown vaccine: it did not increase the risk of thrombosis, and 100% prevented severe COVID-19 from relying on morphine to treat pain.
    ! Science Sub-Journal: Gene Therapy Technology Based on CRISPR and Zinc Finger Protein to Relieve Chronic Pain Hot Article EJCN: Another Effect of Green Tea! Speed ​​up the recovery rate of gastric cancer patients after surgery.
    In adolescence, high-sugar foods and sugary beverages should be eaten and drink less, or it can significantly increase the risk of colorectal cancer in adulthood! Medical immunotherapy| Biosimilars| Vaccines| Drug resistance| Drug targets| Healthy life| Pharmaceutical company news| Drug inventory| Pharmaceutical technology| Basic research on side effects of drugs/ Translational medicine leukemia| Lung cancer| Gastric cancer| Colorectal cancer| Liver cancer| Breast Cancer | Pancreatic Cancer | Cardiovascular Diseases | Neurodegenerative Diseases | Intestinal Microbial Medical Devices / Biotechnology In Vitro Diagnosis | Medical Devices | Bio-Nano | 3D Printing | Gene Testing | Single Cell Sequencing | Gene Editing | Assisted Reproduction | Artificial Intelligence | Precision medicine policy anti-cancer drugs | 4+7 volume procurement | Consumables | Filing system | Registrant system | Healthy China | New version of the basic drug catalog | AI medical devices | Telemedicine | Same stock market with different rights/capital IPO | Financing | Cooperation | Funds | Hong Kong Stock Exchange | Science and Technology Innovation Board | Growth Enterprise Market | R & D Investment | Acquisitions | Market & Consumption
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.