Pfizer's JAK Inhibitor Tofacitinib Tablet Receives NMPA Approval for New Indication in China

Today, the official website of China's National Medical Products Administration (NMPA) announced that the new indication application for Pfizer's Tofacitinib Citrate Tablets has been approved. Public information indicates that Tofacitinib is a JAK inhibitor that has already received approval from the U.S. FDA for multiple indications. In China, Tofacitinib was first approved in 2017, and currently, clinical trials are being conducted on at least 17 diseases. The specific indication for this approval has not yet been disclosed in public information.

Screenshot source: NMPA official website

JAK (Janus kinase) is a member of the cytoplasmic tyrosine kinase family, with four subtypes: JAK1, JAK2, JAK3, and TYK2. They play crucial roles in the signal cascades of various type I and type II cytokine receptors. The signaling pathways mediated by JAK include the JAK-STAT pathway, MAPK pathway, and PI3K-AKT pathway, among others. Notably, the JAK-STAT pathway is closely associated with the occurrence of blood-related diseases such as polycythemia, thrombocytosis, leukemia, and myelofibrosis, as well as autoimmune diseases like rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, and vitiligo. Therefore, the JAK kinase family has become an important target for treating these diseases.

Tofacitinib (trade name Xeljanz) is a JAK inhibitor developed by Pfizer. It can effectively inhibit the activity of JAK1 and JAK3, blocking the signal transduction of various inflammatory cytokines. In the United States, tofacitinib was first approved in 2012 and has since received FDA approval for multiple indications, including ankylosing spondylitis (AS), rheumatoid arthritis (RA), psoriatic arthritis, ulcerative colitis, and polyarticular juvenile idiopathic arthritis.

Note: The original text has been abridged.