Beijing, Shanghai, and Boston, May 14, 2026 — Jacobio Pharma (1167.HK) announced today that its proprietary BET inhibitor JAB-8263 has been approved by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate a Phase IIa clinical trial for rheumatoid arthritis (RA). The approval marks an important milestone as JAB-8263 expands from oncology into autoimmune diseases, further validating Jacobio’s capabilities in mechanism-driven innovation.
JAB-8263 has already demonstrated encouraging clinical efficacy and safety in oncological disease, with about 100 cancer patients have anticipated in clinical studies of JAB-8263 across China and the United States. At the 66th American Society of Hematology (ASH) Annual Meeting in 2024, Jacobio presented preliminary results from the Phase I clinical trial of JAB-8263 in myelofibrosis (MF). The data showed that JAB-8263 was well tolerated and demonstrated encouraging efficacy signals.
JAB-8263 is a highly potent BET inhibitor independently discovered and developed by Jacobio, with global intellectual property rights. Unlike currently approved therapies for autoimmune diseases, BET proteins play important roles in autoimmune diseases through epigenetic regulation. Emerging evidence suggests that BET inhibitors may have therapeutic benefit in autoimmune diseases such as rheumatoid arthritis, with the potential to improve long-term treatment experience for patients through an oral small-molecule approach targeting epigenetic mechanisms.
The Phase IIa clinical trial will primarily evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of JAB-8263 in patients with rheumatoid arthritis.
About Jacobio
Jacobio Pharmaceuticals Co., Ltd., headquartered in Beijing, focuses on the R & D of innovative medicines, It dedicates to provide breakthrough innovations to treat major diseases and bring more solutions to promote human health. The vision of Jacobio is to become a global leader in pharmaceutical industry. Jacobio has established an R & D center in Boston, USA, to strengthen and coordinate the global development of new drugs.