Huadong Medicine's Subsidiary Gains NMPA Approval for Crohn's Disease Treatments

Stock News05-21 17:08

Huadong Medicine Co.,Ltd. (000963.SZ) announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received the "Drug Registration Certificate" and "Drug Supplement Application Approval Notice" from the National Medical Products Administration. The approvals pertain to the marketing authorization application and supplementary application for Ustekinumab Injection (Intravenous Infusion) (brand name: Saijiening®) and Ustekinumab Injection (brand name: Sajlexin®) (R&D code: HDM3001-2/QX001S) for the treatment of Crohn's disease. The company's Sajlexin® is a biosimilar to the originator product Stelara® (Ustekinumab Injection). Its mechanism of action involves blocking the binding of the p40 subunit, common to IL-12 and IL-23, to the IL-12Rβ1 receptor protein on the surface of target cells, thereby inhibiting the signal transduction and cytokine cascade mediated by IL-12 and IL-23. IL-12 and IL-23 are two naturally occurring cytokines that play a key role in immune-mediated inflammatory diseases.

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