Today (November 26), according to the official website of CDE, Shijiazhuang Pharmaceutical Group's application for listing of Class 3.3 new drug "Ustekinumab Injection" has been accepted.

Ustekinumab is a monoclonal antibody targeting the IL12/23 p40 subunit. It is understood that IL-12 and IL-23 are two naturally occurring cytokines that play a key role in immune-mediated inflammatory diseases. Ustekinumab can inhibit the signal transduction and cytokine cascade mediated by the two cytokines by binding to the p40 subunit shared by the two cytokines and preventing it from binding to the cell surface receptor IL-12β1.

The original product of ustekinumab injection was developed by Johnson & Johnson. Since its approval for marketing, its annual sales have continued to grow. In 2023, the global sales of this product successfully exceeded the US$10 billion mark, reaching US$10.858 billion.
According to the drug clinical trial registration and information disclosure platform, Shijiazhuang Pharmaceutical Group's ustekinumab injection has completed two clinical studies for the indication of psoriasis.
The application for marketing approval of ustekinumab injection by Shijiazhuang Pharmaceutical Group has been successfully accepted, which is expected to provide new options for relevant patients.

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