Eli Lilly's (LLY.US) pembrolizumab injection new indication application has been accepted by the CDE.

Today, the latest announcement on the official website of China's National Medical Products Administration Drug Evaluation Center (CDE) reveals that Eli Lilly and Company (LLY.US) has submitted a new indication application for the approval of mirikizumab injection and its subcutaneous injection form. Public information indicates that this is an IL-23 inhibitor developed by Eli Lilly and Company, which was once listed as one of the top 10 potential blockbuster therapies by Evaluate. The first marketing application for this drug in China was accepted by CDE in October last year for the indication of Crohn's disease. Based on public information, it is speculated that the indication for this application is likely for the treatment of moderate to severe active ulcerative colitis (UC) in adults. Mirikizumab is a humanized IgG4 monoclonal antibody that can bind to the p19 subunit of IL-23, blocking the inflammatory response mediated by IL-23. As an inflammatory cytokine, IL-23 is involved in multiple inflammation-related physiological processes and is believed to be associated with many immune-mediated chronic diseases, making it a therapeutic target for many autoimmune diseases. In October 2023, the US FDA approved mirikizumab for the treatment of moderate to severe active ulcerative colitis (UC) in adults. According to a previous press release by Eli Lilly, this is the first IL-23p19 antagonist approved for this patient population. The treatment regimen for ulcerative colitis with this product starts with an intravenous infusion of 300 mg every 4 weeks for a total of 3 infusions, followed by two subcutaneous injections of 100 mg every 4 weeks during the maintenance phase. In January 2025, mirikizumab was once again approved by the FDA for the treatment of moderate to severe active Crohn's disease (CD) in adults.