Huadong Medicine (000963.SZ): The application for the indication of plaque psoriasis in children has been approved for the addition of ustekinumab injection.

Huadong Medicine (000963.SZ) announced that on March 3, 2025, its wholly-owned subsidiary Hangzhou Zhumai Huadong Pharmaceuticals Co., Ltd. ("Zhumai Huadong") received a Drug Supplement Application Approval Notice issued by the National Medical Products Administration (NMPA) for ustekinumab injection (commercial name: Sailexin, research code: HDM3001/QX001S) for the supplementary application for pediatric plaque psoriasis indication. It is reported that HDM3001 (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 and 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 key role in immune-mediated inflammatory diseases. HDM3001 (QX001S) is jointly promoted in Phase III clinical trials by Zhumai Huadong and QX Biopharma. The product received clinical approval in 2018, completed Phase I clinical trials in 2020, completed Phase III clinical research in June 2023, and was submitted for market approval by Zhumai Huadong as the drug registration applicant. It was approved in October 2024 for the treatment of moderate to severe plaque psoriasis in adults, making it the first approved biosimilar of ustekinumab injection in China. In February 2025, the application for market authorization and supplementary application of ustekinumab injection for Crohn's disease submitted by Zhumai Huadong was accepted. In December 2024, the supplementary application for ustekinumab injection for pediatric plaque psoriasis submitted by Zhumai Huadong was accepted and recently approved.