QYUNS-B (02509) received the notification of acceptance of the application and supplemental application for marketing approval for ustekinumab in the treatment of Crohn's disease.

QYUNS-B (02509) announced that on February 11, 2025, the application for market approval and supplementary application of ustekinumab injection (intravenous infusion) and ustekinumab injection (research and development code: QX001S/HDM3001-2) for Crohn's disease has been accepted. QX001S is a biosimilar of the original product Stelara (ustekinumab injection), with a mechanism of action that blocks the binding of the shared p40 subunit of IL-12 and IL-23 to the IL-12R1 receptor protein on target cells, thereby inhibiting IL-12 and IL-23-mediated signal transduction and cytokine cascade reactions. IL-12 and IL-23 are two naturally occurring cytokines that play a crucial role in immune-mediated inflammatory diseases. The acceptance of the application for ustekinumab for Crohn's disease indication is an important advancement in the development process of this drug, and will not have a significant impact on the company's current performance. It will be beneficial in the long term for expanding the product coverage and further enhancing the company's core competitiveness in the field of autoimmune diseases.