Jacobio Pharma (1167.HK) announced that it has submitted the Phase I/II Investigational New Drug (IND) application for its BET inhibitor JAB-8263 for the treatment of autoimmune diseases to the Center for Drug Evaluation (CDE) in China and has been accepted. According to new regulatory guidelines, the review of JAB-8263’s IND application is expected to be completed within 30 working days
Dr. Yinxiang Wang, Chairman and CEO of Jacobio, said: “Autoimmune diseases affect 5%-9% of the global population. Currently, the majority of therapies are monoclonal antibodies administered intravenously, with only a few oral drugs approved. Through our internal translation research and discovery efforts, we intend to expand the therapeutic value of our BET inhibitor from oncology to autoimmune diseases, ultimately benefiting a broader patient population.”
Previously, Jacobio has completed phase I clinical trials of JAB-8263 for solid tumor and hematological malignancies in both China and the United States. Data presented at the 2024 American Society of Hematology (ASH) Annual Meeting showed that JAB-8263 demonstrated good tolerability.
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