Jacobio Pharma (1167.HK), a China-based pharmaceutical company, announced on Wednesday 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 Centre for Drug Evaluation (CDE) in China and it 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

Jacobio has previously completed phase I clinical trials of JAB-8263 for solid tumour and haematological 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 company says that JAB-8263 is an orally administered, highly potent BET inhibitor that it has developed independently. Its safety and pharmacokinetics have been evaluated in early phase trials in China and the United States. According to the company, JAB-8263 was well tolerated and exhibited a favourable PK profile. Jacobio is investigating the potential of JAB-8263 in solid tumours and autoimmune diseases.