Jacobio Pharma (1167.HK) announced that China's Center for Drug Evaluation (CDE) has accepted its Phase I/II Investigational New Drug (IND) application for JAB-8263, an oral BET inhibitor being developed for autoimmune diseases. According to new regulatory guidelines, the review of JAB-8263's IND application is expected to be completed within 30 working days.
The development represents a significant expansion of JAB-8263's therapeutic potential beyond oncology into autoimmune diseases, addressing a substantial unmet medical need. Dr. Yinxiang Wang, Chairman and CEO of Jacobio, emphasized the clinical significance: "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."
Clinical Development Progress
JAB-8263 has already demonstrated clinical promise in oncology applications. 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.
The drug's safety and pharmacokinetics have been evaluated in early phase trials across multiple jurisdictions. JAB-8263 was well tolerated and exhibited a favorable pharmacokinetic profile, supporting its advancement into autoimmune disease indications.
Therapeutic Innovation
JAB-8263 is an orally administered, highly potent BET inhibitor independently developed by Jacobio Pharma. The oral formulation could provide a significant advantage over current autoimmune disease treatments, which are predominantly intravenous monoclonal antibodies.
Dr. Wang noted the company's strategic approach: "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."
Company Platform and Global Reach
Jacobio Pharma operates with an induced allosteric drug discovery platform, with core projects focusing on the KRAS pathway. The company maintains R&D centers in Beijing, Shanghai (China), and Boston (USA), reflecting its global development strategy.
The company's clinical trial network spans over 180 sites in China, more than 30 sites in the USA, and over 10 sites across several European countries, positioning it to conduct comprehensive international studies for JAB-8263's autoimmune disease program.
