PIPELINE

We have a broad portfolio of programs

in clinical and research stages

Cevidoplenib

  1. 01.
    About the Drug Candidate

    Cevidoplenib is an oral, low-molecular-weight, synthetic new drug candidate that treats rheumatoid arthritis and other autoimmune diseases by selectively inhibiting SYK (Spleen Tyrosine Kinase).
    By using Cevidoplenib, superior efficacy and safety that are differentiated from conventional non-selective kinase inhibitors can be achieved thanks to its strong inhibitory effect on SYK-mediated intracellular signaling and SYK-dependent cellular activities.

    SYK is a non-receptor tyrosine phosphorylating enzyme that is responsible for signaling during the activation of various immune cells; it is one of important kinases that mediate intracellular signaling during the immune receptor (B-cell receptor, FcεRI, and FcγRIII)-mediated signaling process in various immune cells, including mast cells, dendritic cells, neutrophils, macrophages, NK cells, and B cells. Considering its mechanism of action, SYK is likely to be associated with a wide variety of autoimmune diseases, such as rheumatoid arthritis, asthma, allergic rhinitis, lymphoma, leukemia, epithelial carcinoma, functional gastrointestinal disorders, immune thrombocytopenia, Biscotti-Aldrich syndrome, systemic lupus erythematosus, multiple sclerosis, irritable shock, and osteoporosis.

  2. 02.
    Current Progress

    Cevidoplenib has completed phase 2 clinical trial for ITP.
    Depending on future progress, we believe there is potential to expand target indications to multiple other autoimmune diseases

  3. 03.
    About the Disease
    • Immune Thrombocytopenia, ITP

      Immune thrombocytopenia (ITP) is a hemorrhagic disease caused by autoimmunity, where thrombocytopenia and easy or excessive bruising and bleeding are observed as platelets are destroyed by an immune mechanism.
      Major symptoms commonly observed include mild bleeding from the gums or mucous membranes in the oral cavity, nasal bleeding, excessive menstruation, and hematuria. Intraretinal bleeding causes vision impairment, and intracranial bleeding is the most dangerous complication, which, although in rare cases, can cause neurological symptoms, leading to disability.

      There are two types of immune thrombocytopenia: acute ITP, which recovers after a short period of time, and chronic ITP, which shows a long-term progress, with acute ITP accounting for about 90% of the cases. Most incidences of chronic ITP occur in adults, but 80% of cases of ITP in children are of the acute type. The acute form usually disappears within 3 to 6 months without treatment. If hypothrombocytopenia persists for 6 to 12 months or longer, it is classified as chronic ITP.

      The incidence rate varies from country to country.
      In the United States, the incidence of ITP is about 66 per million people per year in adults and about 50 per million in children.

      Treatment methods include steroids, immunoglobulin therapy and splenectomy, TPO receptor agonists (Nplate or Promacta), anti-tumor drugs, and immunosuppressants.