Huadong Medicine (000963.SZ) subsidiary received a drug registration acceptance notification.

Huadong Medicine (000963.SZ) announced that on February 11, 2025, its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (referred to as "Zhongmei Huadong") received a "Notice of Acceptance" issued by the National Medical Products Administration (NMPA) for the marketing authorization application and supplemental application of ustekinumab injection (intravenous infusion) and ustekinumab injection (research code: HDM3001-2/QX001S) for the treatment of Crohn's disease. HDM3001 (QX001S) is a biosimilar product of the original product Stelara (ustekinumab injection), which works by blocking the binding of the p40 subunit shared by IL-12 and IL-23 and the IL-12R1 receptor protein on the surface of target cells, thus inhibiting the signaling and cytokine cascade reactions 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. The acceptance of the marketing authorization application and supplemental application for ustekinumab for Crohn's disease is another important milestone in the development process of this drug. It will not have a significant impact on the company's current performance but will be beneficial in the long term for expanding the coverage of the product and further enhancing the company's core competitiveness in the field of autoimmune diseases.