echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Biochemistry News > Biotechnology News > Tiantian Biology - License-in- independent research and development innovation model is beginning to show results.

    Tiantian Biology - License-in- independent research and development innovation model is beginning to show results.

    • Last Update: 2020-09-30
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Recently, Tiantian Bio announced two heavyweight deals in succession.
    is an approximately $1.74 billion global development and commercial cooperation agreement with AbbVie on the CD47 single-resistant lemzoparlimab (TJC4), which will bring innovation to China The transfer of drug interests has reached a new level, and another agreement is for Capital Group, led by Gao Gao Capital, to invest about $418m in Tiantian Bio through a private placement, the largest private placement in the history of China's biotechnology sector.
    1. Tiantian Biologo Photo Source: Tiandi Biolog: Two large-scale heavy-weight transactions on The Sky Bio's official website have focused the eyes of the industry on Tiandi Bio, an innovative biopharmaceutical company.
    , why can Tiantian creatures be favored by both foreign big pharmaceutical companies and capital? Such as EGFR) short-lived activation, activated KRAS can activate downstream paths, common PI3K-AKT-mTOR signaling paths that control cell production, and RAS-RAF-MEK-ERK signal paths that control cell proliferation, which belong to one of many signaling paths, which also lays a biological foundation for many target associations.
    1, License-in model accelerated pipeline layout In fact, for all the relatively senior innovative biopharmaceutical companies, its greatest wealth is research and development pipeline, its research and development pipeline products innovation, effectiveness, diversity and market expectations of the size of the company's value.
    , in terms of ways to enrich the pipeline, in addition to independent research and development, it is generally through License-in or direct acquisition of related companies to obtain equity in other products.
    However, whether it is License-in or a direct acquisition of a related company, a higher level of research and development is required in addition to strong capital, which is reflected first in the need for sufficient capacity to identify products that are worthy of License-in, and secondly, in terms of sufficient clinical development capabilities to advance the clinical progress of the product.
    Generally speaking, most of the pharmaceutical giants who internationally expand their research and development pipelines through License-in or direct acquisitions of related companies have the financial resources and the strength to expand their product lines in this way.
    at home, with the exception of a few sporadic transactions, traditional pharmaceutical manufacturers such as Hengrui Pharmaceuticals, Zhengda Tianqing, Shi Pharmaceutical Group and so on rarely through License-in or direct acquisition of related companies to expand research and development pipeline.
    Unlike traditional pharmaceutical manufacturers have a wealth of product pipeline reserves, many of the less senior innovative biopharmaceutical enterprises independently developed products are still in the early clinical stage, in order to quickly launch marketable products, some innovative biopharmaceutical companies have chosen to explore foreign potential products, and then License-in to obtain its domestic rights and interests to promote its domestic listing, Tiantian Bio is the leader in such enterprises.
    , according to the Tiantian Biological website, Tiantian Bio already has 6 License-in products, namely TJ202 (CD38 single resistance), TJ101 (long-lasting growth factor), TJ301 (IL-6 monoantigen), Enoblituzumab (B7-H3 monoantigen), TJ107 (long-acting rhIL-7), TJ210 (C5a antibody).
    Figure 2. Tiantian Biological Research and Development Pipeline (I) Source: Tianbi Biological Website TJ202 (CD38 Monoantial) Originally developed by MorphoSys, Tiantian Bio has the right to develop the drug in Greater China, according to Tiantian Biologicals Website Based on clinical studies conducted in Australia and Germany for relapsed or refractive multiple myeloma phase I/IIa, TJ202 has a higher difference than existing CD38 monoantigens, with shorter infusion times and a smaller rate of adverse reactions to infusion.
    , Tiantian Bio has conducted a three-line monotherapy study for multiple myeloma (Phase II) and a second-line therapy study (Phase III) on TJ202.
    According to its official website, Tiantian Bio plans to submit NDA applications for TJ202 single-drug therapy and NDA applications for combination therapy in China in 2021, and Tiantian Bio also submitted an IND application for TJ202 treatment of systemic lupus erythematosus in April last year.
    TJ101 (Long-Acting Growth Factor) was originally developed by Genexine, which has the right to develop the drug in Greater China.
    , unlike other existing daily administrations of recombinant human growth hormone (rhGH), TJ101 enables weekly administration to improve patient access to the drug and drug dependence.
    According to the Website of Heavenly Biology, clinical trials conducted by Genexine in the early stages have shown that TJ101 has similar efficacy compared to Genotropin, a short-acting rhGH that requires daily injections, and that TJ101 has better safety (no serious adverse events associated with drug therapy).
    NMPA has now accepted TJ101's Phase III clinical trial for the treatment of child growth hormone deficiency, which is expected to start in the fourth quarter of this year.
    TJ301 (IL-6 monoantitor) was originally developed by Pfizer Pharmaceuticals as a selective, highly differentiated IL-6 inhibitor and is considered a broad-spectrum autoimmune disease drug.
    According to the Website of Tiantian Biology, the drug has shown good tolerance in previous clinical studies in Germany, no dose-related AE, and the expected efficacy has been observed in patients with ulcerative colitis (UC) and Crohn's disease.
    , Tiantian Has conducted Phase II clinical studies of TJ301 in several locations, including Taiwan, Korea and Chinese mainland.
    Figure 3. Full ecological source of Tiantian biological products: Enoblituzumab (B7-H3 monoantigen) was originally developed by MacroGenics, which has the right to develop the drug in Greater China.
    B7-H3 is a trans-membrane protein that belongs to the B7 family and functions in tumor growth and immune response.
    B7-H3 is often overexposed in various types of cancers, including lung, head and neck, esophageal, prostate, endometrial and breast cancer, and is associated with disease progression and poor prognosis in many tumor types.
    has plans to submit Phase II or registered clinical trials for Enoblituzumab treatment recurrence or transfer of SCCHN.
    TJ107 (long-lasting rhIL-7) was also developed by Genexine and is the world's first and only long-acting restructuring person, IL-7.
    According to the Tiantian Biological Website, TJ107 can treat lymphocyte reduction in tumor patients caused by a variety of tumor treatments, on the other hand, from the study of tumor animal models found that TJ107 may increase the activity and proliferation of T lymphocytes to achieve synergy with PD-1 antibodies.
    plans to submit an application for TJ107 Phase II clinical trials to the NMPA this year.
    TJ210 (C5aR Antibody) was originally developed by MorphoSys and is a highly affinity antibody for the complement factor C5a subject 1 (C5aR1), which can be used in tumors as well as autoimmune system diseases.
    has been awarded development rights for the drug in Greater China and is currently in the IND application phase in the United States.
    2, independent research and development solid pipeline cornerstone In the License-in mode to accelerate pipeline layout to obtain rapid market products at the same time, Tianyi Bio will also devote a lot of energy to their own research and development strength to strengthen its research and development pipeline, forming a stable output and diversified product pipeline pattern.
    basis, Tiantian Bio independently developed TJM2 (GM-CSF antibody), TJC4 (CD47 antibody), TJD5 (CD73 antibody), TJX7 (CXCL13 antibody), PD-L1-based dual-specific antibody and "Fortified" dual-specific antibody.
    Figure 4. Tiantian Biological Research and Development Pipeline (II) Source: Tiantian Biological Website TJM2 (GM-CSF Antibody) is a self-developed medium antibody for human granulocyte-macrophage cluster stimulation factor (GM-CSF).
    GM-CSF is an important cytokine that polarizes macrophages into an inflammatory M1 ideotype and induces other inflammatory cytokines, such as tumor necrotizing factors (TNF), leucin-1 (IL-1), IL-6, IL-12 and IL-23, and GM-CSF plays a vital role in the pathogenesis and disease progression of a variety of autoimmune diseases.
    TJM2 is a GM-CSF-medium antibody that binds high affinity and blocks its signaling and downstream path.
    Has submitted TJM2's Phase IB study for RA patients to the NMPA in August 2019 and plans to use it in cytokine release syndrome (CRS) caused by CAR-T therapy; Tiantian Bio conducted a multi-center, randomized, double-blind, placebo-controlled clinical trial in the United States to treat patients with severe new coronavirus pneumonia with cytokine release syndrome, which has now advanced to Part II to assess its efficacy, safety and cytokine levels.
    TJC4 (CD47 antibody) was also developed by Heavenly Creatures.
    CD47 is a glycosylated cross-membrane protein present in many different cell types, including tumor cell surfaces, in the tumor micro-environment, the tumor cell CD47 and macrophage SIRP alpha binding will initiate inhibitory signaling path, so that macrophages no longer devour tumor cells, and CD47 monoantitor can block this process, promote the occurrence of phagocytosis.
    According to the Tiantian Biological Website, TJC4 is different from other CD47 monoantials in that its inhibition of red blood cells is relatively mild, while retaining the ability to bind with tumor cells at the same time can minimize the injection of CD47 monoants caused by anemia and other adverse blood events.
    , TJC4 has conducted Phase I clinical studies in the United States, has obtained IND approval from NMPA in China, and plans to conduct Phase I clinical studies of blood system tumors.
    TJD5 (CD73 antibody) is also a monoantigen developed in-house by Tiantian.
    CD73 is a key link in the CD39-CD73-A2aR path through which ATP is hydrolysed by CD39 into ADP and AMP, amp and then CD73 in the tumor micro-environment Adenosine is an immunosuppressive metabolite that inhibits the immune cell's immune response by binding to the G protein-coupled adenosine lipolyme A2a (A2aR) expressed on immune cells.
    and TJD5 blocks amp's process of producing adenosine, weakening the immune suppression of immune cells in the body.
    , TJD5 has conducted Phase I clinical studies in the United States in association with Atezolizumab for solid tumors, and clinical trials are planned in the country.
    TJX7 (CXCL13 Antibody) is a humanized, humanized and meso-nalized antibody that is developed by Tiantian Bio to target CXCL13 coercion factors and can be used to treat diseases of its own immune system.
    the drug is currently in the CMC and preclinical development phases.
    Figure 5. Development source of dual-specific antibodies: The development of dual-specific antibodies based on PD-L1 is also an important part of Tiantian bio-autonomous research and development pipeline, in PD-1/PD-L1 monoantibodies have been initially shown today, the development of PD-1/PD-L1-based dual-specific antibodies has also become a hot project.
    this area of development, Tianbi has developed a range of dual-specific antibodies based on its own PD-L1 monoantigen skeleton in combination with 4-1BB antibodies, IL-7, B7-H3 antibodies, and CD47 antibodies.
    "Fortified" dual-specific antibody, or "enhanced" dual-specific antibody, currently owns two such products, TJ-C4GM and TJ-CLDN4B.
    , TJ-C4GM is an "enhanced version" of its CD47 monoantial and GM-CSF, while TJ-CLDN4B targets tumor-related antigens and 4-1BB, both of which are currently in the CMC and preclinical development phases.
    3. Conclusion From the two heavy news recently announced by Tianji Bio, both foreign-funded large pharmaceutical companies and capital markets have great confidence in Tiandi Bio's current development model, which shows that the outside world has recognized Tianyi Bio's accelerated pipeline layout through the License-in model, combined with the development model of independent research and development of solid pipeline cornerstones.
    For other domestic pharmaceutical enterprises, this development model is also very reference significance, after all, "one person short, everyone's chief", in the cultivation of their own strength, may as well look at the outside world's new things, perhaps there will be unexpected gains.
    References . . . . . . . . . . . . . . . . . . . . . . . . . . . .
    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.