▎WuXi AppTec Content Team Report

Today (October 9), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration just announced that Eli Lilly and Company...（Eli Lilly and Company）DeclaredMijizumab Injection and Its Subcutaneous Injection FormulationThe listing application has been accepted.Public information shows that this should be developed by Eli Lilly and Company.IL-23 Inhibitor Mirikizumab. The productPreviously designated as a breakthrough therapy by China's NMPA, it is under development for the treatment ofAdult patients with moderately to severely active Crohn's disease. Its indication for Crohn's disease has not been approved by regulatory agencies worldwide.

Screenshot source: CDE official website

Mirikizumab is a humanized IgG4 monoclonal antibody,Can bind to the p19 subunit of IL-23, blocking IL-23-mediated inflammatory responses。As an inflammatory cytokine, IL-23 is involved in multiple inflammation-related physiological processes and is considered to be associated with many immune-mediated chronic diseases, thus becoming a therapeutic target for numerous autoimmune diseases.

October 2023, U.S. FDAApprovalMirikizumab for the TreatmentAdult patients with moderate to severe active ulcerative colitis (UC)According to a previous press release from Eli Lilly, this is the first IL-23p19 antagonist used to treat this patient population. The product is used for the treatment of ulcerative colitis.Start with an intravenous infusion of 300 milligrams,Infused once every 4 weeks for a total of 3 infusions. During the maintenance treatment period, two 100 mg subcutaneous injections are administered every 4 weeks.。

In addition, the product has alsoInPhase 3 Trial VIVID-1Achieved Co-primary Endpoints in ChinaSignificant clinical remission achieved in moderate to severe active Crohn's disease (CD) adult patients for all primary and secondary endpoints.

According to the official website of the Chinese Clinical Trials Registry and Information Disclosure Platform, Eli Lilly and Company is conducting multiple Phase 3 clinical trials of mirikizumab in China for indications including:Moderate to severe active ulcerative colitis, moderate to severe active Crohn's disease。

From the clinical research data, according to publicly available information from Eli Lilly and Company, mirikizumab is used for the treatment ofModerate to Severe Active Ulcerative ColitisTwo Phase 3 clinical studies have yielded positive results, including a 12-week induction treatment study (UC-1) and a 40-week maintenance treatment study (UC-2). The trial results showed that treatment with mirikizumab after 12 weeks,65% of patients achieved clinical response, and 24% of patients achieved clinical remission.The clinical response and clinical remission rates in the placebo group were 43% and 15%, respectively.Among patients who achieved clinical remission at 12 weeks, 66% maintained clinical remission during one year of continuous treatment., the value in the placebo group was 40%. According to post-hoc analysis,Almost all (99%) patients who achieved clinical remission at 1 year were steroid-free for at least 3 months prior to the end of the 52-week assessment.。

In the phase 3 trial VIVID-1 for Crohn's disease, the investigational monoclonal antibody mirikizumab met the co-primary endpoints and all key secondary endpoints compared to placebo. The proportion of patients in the mirikizumab group who achieved clinical remission (defined as a total Crohn's Disease Activity Index [CDAI] score <150) at week 12 and clinical remission at week 52 was statistically higher than in the placebo group.(45.4% vs 19.6%)Compared with the placebo group, the proportion of patients in the mirikizumab group who achieved clinical remission at week 12 and endoscopic remission at week 52 (defined as a ≥50% reduction from baseline in the Simple Endoscopic Score for Crohn’s Disease [SES-CD] total score) was statistically higher.(38.0% vs 9.0%)。

[2] Public Information from Eli Lilly and Company