Email: cspc@cspc.cn
Email: cspc@cspc.cn
October 25, 2022
“Tofacitinib Citrate Extended-Release Tablets (11mg)” developed by CSPC has obtained drug registration approval granted by the National Medical Products Administration of the People’s Republic of China, and is deemed to have passed the consistency of quality and efficacy evaluation of generic drugs.
Tofacitinib is the first oral administrated small-molecule inhibitor of Janus kinase (JAK) which blocks the intracellular signaling associated with inflammation in moderately to severely active rheumatoid arthritis. The Product is indicated for the treatment of rheumatoid arthritis (RA). It adopts the principle of osmoticcontrolled release mechanism, so that the drug can be released continuously and slowly to ensure the blood drug concentration is stable and unaffected by food. Further, the once-daily oral dosing facilitates the patients’ disease management. The Group has obtained the drug registration approval for Tofacitinib Citrate Tablets (5mg) in June 2021. The approval of the Product will further enrich the Group’s product portfolio for autoimmune diseases.
