Analysis of whether mirikizumab has been launched in China
Milikizumab (Mirikizumab) is a monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23) and belongs to a new generation of biologics for inflammatory bowel disease. As the status of biological agents in the treatment of ulcerative colitis (UC) and Crohn's disease (CD) continues to increase, the progress of militizumab's global launch has attracted the attention of more and more patients.
As of now, the generic drug Milizumab has not been officially launched in the Chinese mainland market, nor has it entered the domestic medical insurance system. Therefore, it is temporarily unavailable through formal prescription channels in domestic hospitals and regular pharmacies. This means that if Chinese patients need to learn about the drug, they can only refer to overseas listing information and international drug experience, and actual accessibility is still limited.
From the international market, the pace of global approval of militizumab is relatively clear. The drug was first approved for marketing in Japan, and then received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in March 2023. It was officially approved in the European Union in May of the same year, approved in Canada in July, and finally completed marketing approval in the United States in October 2023. Its initial approval indication is for adults with moderately to severely active ulcerative colitis, mainly for people who have responded poorly to traditional treatments or other biological agents. As research advances, militizumab is gradually being used in the treatment of Crohn's disease and has entered clinical application.
Overall, Militizumab has completed regulatory approvals in multiple mainstream markets overseas, but is still in the unmarketed stage in China. Whether to introduce it into the country in the future still needs to be comprehensively judged based on various factors such as the company's application progress, regulatory approvals, and the domestic inflammatory bowel disease drug pattern.
Reference materials:https://en.wikipedia.org/wiki/Mirikizumab
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