Abbvie's blockbuster IL-23 inhibitor "Risankizumab" has been approved for marketing in China
Abbvie's IL-23 inhibitor "Risankizumab" was approved for marketing by the National Medical Products Administration (NMPA) of China on March 10, for use in adult patients with moderate to severe active Crohn's disease. This drug is aimed at patients who have inadequate response, loss of response, or intolerance to conventional therapies or biologics. Risankizumab is a humanized monoclonal antibody that treats related chronic immune diseases by selectively antagonizing IL-23
According to Zhitong Finance APP, on March 10, Abbvie (ABBV.US) announced that its Risankizumab injection and Risankizumab injection (subcutaneous) marketing applications have been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with moderate to severe active Crohn's disease who have inadequate response, loss of response, or intolerance to traditional therapy or biological agents.
Risankizumab is a humanized, IgG1 subtype monoclonal antibody that selectively antagonizes IL-23 by binding to the p19 subunit of IL-23. IL-23 is a cytokine associated with inflammation and is believed to be related to many chronic immune diseases. Risankizumab is a key product for Abbvie in the field of autoimmune diseases, and this approval includes both the Risankizumab injection and Risankizumab injection (subcutaneous) formulations, equipped with a portable delivery device.
According to Abbvie, in two induction clinical studies and one maintenance treatment clinical study, compared to placebo, Risankizumab showed significant improvements in endoscopic response (defined as a greater than 50% reduction in the Simplified Endoscopic Score for Crohn's Disease [SES-CD] from baseline, or for patients with isolated ileal disease and a baseline SES-CD of 4, a reduction of at least 2 points from baseline) and clinical remission (defined as a Crohn's Disease Activity Index [CDAI] <150) in both induction and maintenance treatment
