Baiotai: Usymro receives positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Baiotai announced that the company has received a notification from the European Medicines Agency that Usymro has received a positive opinion from the EMA Human Medicines Committee. CHMP recommended that the European Commission approve the market launch of Usymro for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderate to severe active Crohn's disease in adults and children. The drug is already undergoing commercialization processes in multiple regions worldwide, including the United States, Russia, Brazil, the European Union, the United Kingdom, Switzerland, and Australia. BAT2206 obtained FDA approval for market launch in May 2025 and has submitted a market authorization application to the Chinese NMPA. This positive opinion from CHMP is expected to expand the company's international market, enhance the international influence of the product, and have a positive impact on the company's long-term business performance.
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