On July 2, 2025 Jacobio Pharma (1167.HK) reported 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 (Press release, Jacobio Pharmaceuticals, JUL 2, 2025, View Source [SID1234654225]). According to new regulatory guidelines, the review of JAB-8263’s IND application is expected to be completed within 30 working days

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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) (Free ASH Whitepaper) Annual Meeting showed that JAB-8263 demonstrated good tolerability.

About JAB-8263

JAB-8263 is an orally administered, highly potent BET inhibitor independently developed by Jacobio Pharma. Its safety and pharmacokinetics have been evaluated in early phase trials in China and the United States. JAB-8263 was well tolerated and exhibited a favorable PK profile. Jacobio is investigating the potential of JAB-8263 in solid tumors and autoimmune diseases.