Medical Guanlan Medical Guanlan September 5, 2024 08:35 Shanghai

Reported by WuXi AppTec Content Team

Today (September 5th), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) just announced that Hengrui Pharmaceutical's application for the new indication of imatinib sulfate tablets has been accepted, but the specific indication has not been disclosed yet. Ivarmacitinib tablet is an orally administered highly selective JAK1 inhibitor, which has previously submitted three marketing applications in China for the treatment of ankylosing spondylitis, atopic dermatitis, and rheumatoid arthritis.

According to publicly available information from Hengrui Pharmaceutical, imatinib (SHR0302) is a independently developed JAK inhibitor that targets JAK1. It can specifically block the JAK/STAT pathway and reduce adverse reactions such as anemia and thrombotic diseases, while achieving good clinical efficacy. As an oral small molecule targeted drug, the convenient administration method can significantly improve patients' treatment compliance.

According to the semi annual report of Hengrui Pharmaceutical in 2024, in addition to the indications listed above, the treatment of psoriatic arthritis, ulcerative colitis, active radiologically negative axial spondyloarthritis, and alopecia areata with imatinib is currently in phase 3 clinical trials. Hengrui Pharmaceutical has also developed the ointment, oral solution and alkali gel dosage forms of this product, which are being developed for the treatment of atopic dermatitis, graft-versus-host disease and vitiligo respectively.