What is the current status of Milizumab in the Chinese market?

Milikizumab(Mirikizumab) has not yet been officially launched in mainland China. Although the approval process for this IL-23-targeting monoclonal antibody has entered a mature stage in developed countries such as Europe and the United States, and has been approved by the European Medicines Agency (EMA) and the Japanese Drug Regulatory Agency for the treatment of moderate to severe ulcerative colitis, it is still not approved in the Chinese market. The China Food and Drug Administration (NMPA) has not announced the acceptance or approval status of marketing applications related to militizumab, and domestic clinical trial registration information is also relatively limited.

The number of patients with inflammatory bowel disease (IBD) continues to grow in China, especially the prevalence of ulcerative colitis and Crohn's disease in urban areas. Although several biological agents (such as infliximab, ustekinumab, etc.) have been introduced to treat moderate to severe IBD, due to obvious differences in individual responses to biological agents, there is an urgent clinical need for more therapeutic drugs with diverse targets and novel mechanisms. Milizumab is a representative of this trend. Its unique IL-23p19 targeting mechanism provides new treatment hope for Chinese patients.

In the next few years, militizumab is expected to launch multi-center clinical studies in China and accelerate the registration process. With the international integration of China's drug review system and the opening of innovative drug review channels, as well as the government's increased attention to inflammatory bowel disease, it is only a matter of time before militizumab enters the Chinese market. Once approved, it will not only enrich local treatment options, but may also promote price negotiations into medical insurance and ease the financial burden of medication on patients.

At present, some Chinese patients have obtained milizumab through cross-border medical treatment or overseas drug purchase platforms. Although this method has not yet been incorporated into the routine treatment system, there are still issues with legality, safety and accessibility. Therefore, it is recommended that patients pay close attention to the approval and clinical progress of drugs under the guidance of doctors, and never use unapproved drugs on their own to ensure treatment effectiveness and safety.

Reference materials:https://omvoh.lilly.com/